Dry needling and upper cervical spinal manipulation in patients with temporomandibular disorder A multi center randomized clinical trial - Farmacologia I (2024)

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Full Terms & Conditions of access and use can be found athttps://www.tandfonline.com/action/journalInformation?journalCode=ycra20CRANIO®The Journal of Craniomandibular & Sleep PracticeISSN: (Print) (Online) Journal homepage: https://www.tandfonline.com/loi/ycra20Dry needling and upper cervical spinalmanipulation in patients with temporomandibulardisorder: A multi-center randomized clinical trialJames Dunning, Raymond Butts, Paul Bliton, Konstantinos Vathrakokoilis,Grant Smith, Chelsea Lineberger, Noah Eshleman, César Fernández-de-Las-Peñas & Ian A. YoungTo cite this article: James Dunning, Raymond Butts, Paul Bliton, Konstantinos Vathrakokoilis,Grant Smith, Chelsea Lineberger, Noah Eshleman, César Fernández-de-Las-Peñas & IanA. Young (2022): Dry needling and upper cervical spinal manipulation in patients withtemporomandibular disorder: A multi-center randomized clinical trial, CRANIO®, DOI:10.1080/08869634.2022.2062137To link to this article: https://doi.org/10.1080/08869634.2022.2062137© 2022 The Author(s). Published withlicense by Taylor & Francis Group, LLC.View supplementary material Published online: 12 Apr 2022. Submit your article to this journal Article views: 3069 View related articles View Crossmark data Citing articles: 3 View citing articles https://www.tandfonline.com/action/journalInformation?journalCode=ycra20https://www.tandfonline.com/loi/ycra20https://www.tandfonline.com/action/showCitFormats?doi=10.1080/08869634.2022.2062137https://doi.org/10.1080/08869634.2022.2062137https://www.tandfonline.com/doi/suppl/10.1080/08869634.2022.2062137https://www.tandfonline.com/doi/suppl/10.1080/08869634.2022.2062137https://www.tandfonline.com/action/authorSubmission?journalCode=ycra20&show=instructionshttps://www.tandfonline.com/action/authorSubmission?journalCode=ycra20&show=instructionshttps://www.tandfonline.com/doi/mlt/10.1080/08869634.2022.2062137https://www.tandfonline.com/doi/mlt/10.1080/08869634.2022.2062137http://crossmark.crossref.org/dialog/?doi=10.1080/08869634.2022.2062137&domain=pdf&date_stamp=2022-04-12http://crossmark.crossref.org/dialog/?doi=10.1080/08869634.2022.2062137&domain=pdf&date_stamp=2022-04-12https://www.tandfonline.com/doi/citedby/10.1080/08869634.2022.2062137#tabModulehttps://www.tandfonline.com/doi/citedby/10.1080/08869634.2022.2062137#tabModuleTMJDry needling and upper cervical spinal manipulation in patients with temporomandibular disorder: A multi-center randomized clinical trialJames Dunning, PhD, DPT, FAAOMPT a,b,c, Raymond Butts, PhD, DPTb,d, Paul Bliton, DPT, FAAOMPTb,e, Konstantinos Vathrakokoilis, PhD, PT, MScf, Grant Smith, DPT, FAAOMPTg, Chelsea Lineberger, DPT, FAAOMPTh, Noah Eshleman, DPT, FAAOMPTi, César Fernández-de-Las-Peñas, PhD, PTa,j and Ian A. Young, DSc, PT, OCSb,kaDepartment of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain; bAmerican Academy of Manipulative Therapy Fellowship in Orthopaedic Manual Physical Therapy, Montgomery, AL, USA; cMontgomery Osteopractic Physical Therapy & Acupuncture Clinic, Montgomery, AL, USA; dResearch Physical Therapy Specialists, Columbia, SC, USA; eAthletico Physical Therapy, Roscoe, IL, USA; fDepartment of Oral and Maxillofacial Surgery, Aristotle University of Thessaloniki, Greece; gAdvanced Manual Therapies, Alpharetta, GA, USA; hOsteopractic Physical Therapy of the Carolinas, Fort Mill, SC, USA; iPeak Physical Therapy & Sports Rehab, Helena, MT, USA; jEjercicio, Universidad Rey Juan CarlosCátedra de Clínica, Investigación y Docencia en Fisioterapia: Terapia Manual, Punción Seca y, Alcorcón, Spain; kTybee Wellness & Osteopractic, Tybee Island, GA, USAABSTRACTObjective: To compare the effects of dry needling and upper cervical spinal manipulation with interocclusal splint therapy, diclofenac, and temporomandibular joint (TMJ) mobilization in patients with temporomandibular disorder (TMD).Methods: One hundred-twenty patients with TMD were randomized to receive six treatment sessions of dry needling plus upper cervical spinal manipulation (n = 62) or interocclusal splint therapy, diclofenac, and joint mobilization to the TMJ (n = 58).Results: Patients receiving dry needling and upper cervical spinal manipulation experienced significantly greater reductions in jaw pain intensity over the last 7 days (VAS: F = 23.696; p < 0.001) and active pain-free mouth opening (F = 29.902; p < 0.001) than those receiving interocclusal splint therapy, diclofenac, and TMJ mobilization at the 3-month follow-up.Conclusion: Dry needling and upper cervical spinal manipulation was more effective than inter-occlusal splint therapy, diclofenac, and TMJ mobilization in patients with TMD.KEYWORDS Temporomandibular disorder; dry needling; spinal manipulation; joint mobilization; interocclusal splint therapyIntroductionTemporomandibular disorder (TMD) is considered the third most prominent pain condition world-wide [1]. While only 5% of adults with TMD from the general population seek clinical treatment [2], 16–59% and 33– 86% of the worldwide population suffer from TMD symptoms and clinical signs, respectively [3]. TMD is a multifactorial condition [4] that appears to be asso-ciated with age, systemic illness, hormonal factors, habi-tual activity, and occlusal variation, with a strong psychosocial component [5]. Headaches [6] and neck pain [7] also seem to be associated with TMD.Clinical manifestations of TMD include pain in the joint and or/muscles of mastication, limited mandibular range of motion, crepitus, and functional limitation or deviation of the jaw [8]. An inter-professional consortium recently updated and validated diagnostic criteria for classifying TMD according to three main groups: muscle disorders, disc displacements, and joint dysfunction [9]. The clinical diagnostic criteria for all three groups has been shown to be both sensitive and specific, with excel-lent inter-rater reliability [10]. While nonsteroidal anti- inflammatory drugs (NSAIDs) and muscle relaxants may improve symptoms associated with TMD when used as a first-line treatment [11,12], these drugs have significant side effects, and long-term use is not recommended [13]. In addition, there is little evidence to support the long- term efficacy of surgery in patients with TMD [14].Many patients with TMD often seek conservative interventions [15]; however, the evidence for using electrophysical modalities such as laser therapy, ultra-sound, TENS, iontophoresis [16], and also the appli-cation of isolated exercise is limited [17]. Although a 2004 Cochrane review found insufficient evidence to advocate splint therapy for TMD [18], a posterior meta-analysis of 538 patients found improved range of motion and decreased intensity and frequency of CONTACT James Dunning jamesdunning@hotmail.com Montgomery Osteopractic Physical Therapy & Acupuncture, 505 Cloverdale Road, Montgomery, AL, 36106, U.S.ASupplemental data for this article can be accessed on the publisher’s websiteCRANIO®: THE JOURNAL OF CRANIOMANDIBULAR & SLEEP PRACTICE https://doi.org/10.1080/08869634.2022.2062137© 2022 The Author(s). Published with license by Taylor & Francis Group, LLC. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc- nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.http://orcid.org/0000-0002-1194-0108https://doi.org/10.1080/08869634.2022.2062137http://www.tandfonline.comhttps://crossmark.crossref.org/dialog/?doi=10.1080/08869634.2022.2062137&domain=pdf&date_stamp=2022-04-09jaw pain following interocclusal splint therapy [19]. A large-scale systematic review found inconclusive evidence for the use oftemporomandibular joint (TMJ) mobilization alone for TMD [20]; however, the use of joint mobilization in combination with other conservative treatments, such as exercise, is supported by current literature [21–24]. Notably, mobilization or manipulation [15], when used alone and directed to the upper cervical spine [25] or in conjunction with a multi-modal treatment (e.g., exer-cise, mandibular mobilization, myofascial release, muscle energy, and/or tender-trigger point therapy) for the craniomandibular system [21,24] has demon-strated a large effect on mouth opening and jaw pain reduction when compared to other active interventions.Patients with TMD have been shown to exhibit both peripheral and central pain; therefore, needling therapies may provide an additional treatment option [26]. Dry needling (DN) refers to the insertion of monofilament needles without injectate into muscles, ligaments, ten-dons, connective tissue, scar tissue, and peri-neural tissue for the management of neuromusculoskeletal conditions [27,28]. While the terminology and theoretical constructs of acupuncture and DN are different [29], both have been shown to elicit biochemical, biomechanical, endo-crinological, and neurovascular changes associated with reductions in pain and disability [30].In a recent systematic review, DN outperformed procaine, methocarbamol and paracetamol for improving TMD pain intensity, and it resulted in significant improvements in pressure pain thresholds compared with sham DN [31]. Another systematic review of 28 clinical trials concluded that both wet needling (i.e., botulinum toxin, platelet-rich plasma, or collagen) and dry needling are effective for decreas-ing pain and improving mouth opening in patients with TMD [32].When given separately, needling therapy and upper cervical spinal manipulation have each been found to be moderately effective for TMD. However, to date, no studies have attempted to combine these two treatments and compare their additive effects in patients with TMD. Therefore, the purpose of this multi-center, ran-domized clinical trial was to compare the combined effects of DN and upper cervical spinal manipulation to interocclusal splint therapy, NSAIDs, and TMJ mobi-lization in patients with TMD. The authors hypothe-sized that patients in the DN and upper cervical spinal manipulation group would experience greater improve-ments in jaw pain and mouth opening than those receiv-ing splint therapy, NSAIDs, and TMJ mobilization group.Materials and methodsStudy designThis randomized, single-blinded, multi-center, parallel- group clinical trial was conducted following the Consolidated Standards of Reporting Trials (CONSORT) extension for pragmatic clinical trials [33]. The trial was approved by the ethics committee at Universidad Rey Juan Carlos, Madrid, Spain (URJC-DPTO 36–2017), and the trial was prospectively registered (ClinicalTrials.gov: NCT03409874). All subjects provided and signed informed consent before their enrollment in the study.ParticipantsConsecutive individuals with TMD from 10 outpatient physical therapy clinics in 10 different states (Alabama, Arizona, Florida, Georgia, Louisiana, Maryland, Michigan, Montana, North Carolina, and Virginia) were screened for eligibility criteria and recruited over a 26-month period (from February 1 2018 to March 31 2020). To be eligible, patients had to be at least 18 years old and meet the following criteria: (1) a clinical diag-nosis of temporomandibular disorder consistent with the Revised TMD group 1 Muscle Disorders Diagnostic Algorithm [34]; (2) having experienced TMD symptoms for at least 3 months; and (3) an intensity of TMD symptoms of at least 30 mm on the VAS (0–100 mm) [35,36]. The exclusion criteria are described in Table 1.Table 1. Exclusion Criteria.Exclusion Criteria● History of traumatic injury or surgery related to temporomandibular disorder (TMD).● Symptoms indicative of disc displacement, arthrosis, or arthritis of the temporomandibular joint (TMJ), consistent with category II and III of the Research Diagnostic Criteria for temporomandibular disorders.● Concomitant diagnosis of any primary headache (i.e., tension type headache or migraine) except cervicogenic headaches.● Diagnosis of fibromyalgia.● Diagnosis of systematic disease such as rheumatoid arthritis, lupus erythematosus, or psoriatic arthritis.● Presence of neurologic disorder such as trigeminal neuralgia.● Having received physical therapy, chiropractic, acupuncture, or splint treatment for TMD within the last 3 months.● History of taking prescription nonsteroidal anti-inflammatory drugs (NSAIDs) within the last 3 months.● History of taking non-prescription NSAIDs (i.e. more than intermit-tently) within the last 3 months.● Known sensitivity to acetylsalicylic acid with impaired coagulation or with ulcer, kidney, or liver dysfunction.● Presence of a cardiac pacemaker, metal allergy, or severe needle phobia.● Serious cardiovascular disease, psychiatric disorder, or cognitive impairment.● One or more contraindications to dry needling or manual therapy.● Currently pregnant.2 J. DUNNING ET AL.Treating therapistsTen physical therapists (mean age, 37.3 years, SD 9.1) delivered interventions in this trial. They had an average of 10.1 (SD 7.7) years of clinical experi-ence, had completed a 54-hour post-graduate certifi-cation program that included practical training in DN for TMD, and were current students in a 60- hour post graduate certificate program that included practical training in non-thrust joint mobilization to the TMJ and high-velocity low-amplitude thrust manipulation to the upper cervical spine. All treating therapists were Fellows-in-Training within an APTA- accredited Fellowship program in Orthopedic Manual Physical Therapy, had heterogeneous back-grounds in terms of prior manual therapy/orthopedic training, and worked in private outpatient physical therapy practice. All participating therapists were required to study a manual of standard operating procedures and participate in a 6-hr training session with a principal investigator to ensure the standardi-zation of the protocol and treatment.Examination procedureAll patients provided demographic information and completed self-report measures followed by a standardized history and physical examination at baseline. Participants received a standardized physical examination, during which the affected TMJ was exam-ined, so as to confirm that the patient fell within the revised group 1 muscle disorders diagnostic algorithm; i.e., patients who presented with group II or group III TMD were ruled out [34]. The physical examination included, but was not limited to, palpation of muscles of mastication with a minimum of two lbs of pressure and maximum assisted and unassisted opening. Active, pain-free mouth opening was also measured, as follows: the patient was asked to open their mouth as wide as possible without causing pain, from a supine position. At the end position, the distance between the upper and lower central incisors was measured in mm, and the average was taken over three attempts. The intra-tester reliability of this procedure has been found to be high (ICC = 0.9–0.98) [37].Randomization and blindingFollowing baseline examination, patients were ran-domly assigned to receive dry needling and upper cervical spinal manipulation or interocclusal splint therapy, NSAIDs, and non-thrust mobilization to the TMJ. Randomization was conducted using a computer-generated randomized table of numbers created by a statistician not otherwise involved in the trial. Individual and sequentially numbered index cards with the random assignment were prepared, folded, and placed in sealed opaque envelopes for each of the 10 data collection sites. The clinicians administering the self-report outcome questionnaires were blinded to thepatient’s treatment group assign-ment. It was not possible to blind patients or treating therapists.InterventionsAll participants received up to eight treatment sessions at a frequency of once or twice per week over a 4-week period. In either group, fewer treatment sessions could be completed if symptom resolution occurred sooner.The active comparison group received an interocclu-sal appliance, NSAIDs (diclofenac), and non-thrust joint mobilization to the TMJ. The interocclusal appli-ances were prepared by general dentists based on the TMJ impairments of each patient. Patients were instructed to wear the device each night for 4 consecu-tive weeks. During the course of the study, patients were permitted to visit their healthcare provider to have their appliance adjusted, as needed. Patients in the active comparison group were also prescribed diclofenac (Voltaren) 3X50mg per day for 4 weeks. If symptoms improved, the patient was allowed to reduce the dosage to 2X50mg per day. Topical and oral diclofenac have been shown to be effective for patients with TMD [38]. All patients within the comparison group were required to maintain a diary so as to ensure compliance with the Table 2. Baseline characteristics by treatment assignment.Baseline VariableDry Needling + Spinal Manipulation (n = 62)Interocclusal Splint Therapy + NSAIDs + Mobilization (n = 58)Gender (male/female) 16/46 14/44Age (years) 40.2 ± 12.4 43.0 ± 13.1Weight (kg) 73.2 ± 14.5 72.8 ± 14.6Height (cm) 169.8 ± 8.1 170.0 ± 8.5Duration of symptoms (years)7.3 ± 8.2 6.8 ± 7.6Number of treatment sessions6.3 ± 1.9 6.6 ± 1.7Average jaw pain intensity over the last 7 days (VAS, 0–100)53.9 ± 13.7 53.5 ± 13.6Jaw pain intensity over the past 24 hrs (VAS, 0–100)48.8 ± 15.2 49.6 ± 13.3Active pain-free mouth opening (mm)32.0 ± 6.9 32.3 ± 7.6Data are mean (SD), except for gender. VAS: Visual analog scale, 0–100, lower scores indicate greater function; Active pain-free mouth opening, higher scores indicate less pain and greater function; mm: Millimeters; NSAIDs: Nonsteroidal anti-inflammatory drugs.CRANIO®: THE JOURNAL OF CRANIOMANDIBULAR & SLEEP PRACTICE 3nightly use of the interocclusal appliance and the diclo-fenac dosage. Diaries were reviewed during follow-up appointments at 2 and 4 weeks to ensure compliance.Patients in the active comparison group also received 10 mins of impairment-based non-thrust joint mobili-zation per the recommendations of Shaffer et al. [15]. Notably, two studies found mobilization directed to the TMJ to improve joint restriction [15,20]. Moreover, the use of TMJ mobilization in conjunction with other conservative strategies has been linked to improvements in pain and mandibular range of motion [35,39].Patients allocated to the experimental group received up to eight sessions of DN at a frequency of 1–2 times per week for 4 weeks using a standardized protocol of 7 points (Figure 1) for 20 min, as described in Appendix 1 [16]. While the exact etiology of TMD is still unknown, the condition seems to be associated with a disruption of the TMJ capsule, the articular disc, and the muscles of mastication [40]. Therefore, needles targeted pathoana-tomical structures of TMD, including the inferior head of the lateral pterygoid muscle, the superficial masseter muscle, the temporalis muscle, and the peri-articular capsule of the posterior TMJ [41,42]. Clinicians were also permitted to insert needles into the superior head of the lateral pterygoid and the medial pterygoid based on the sensitivity of the patient and/or the presence of symptoms in that region.Sterilized disposable stainless steel acupuncture nee-dles were used with three sizes: 0.18 mm x 15 mm, 0.25 mm x 30 mm, and 0.30 mm x 40 mm. The lateral aspect of the patient’s face and forehead were cleaned with alcohol. The depth of needle insertion ranged from 10 mm to 35 mm, depending on the anatomical struc-ture being targeted (e.g., inferior head of the lateral pterygoid muscle, superficial masseter muscle, peri- articular capsule of the posterior TMJ, anterosuperior or anteroinferior aspect of the temporalis muscle) and the patient’s constitution (i.e., size and muscle thick-ness). Following insertion, needles were manipulated bi- directionally to elicit a sensation of aching, tingling, deep pressure, heaviness, or warmth. Needle manipula-tion has been linked to tissue mechano-transduction [43,44], vasodilation [45,46], and peripheral [47,48] and central analgesia [49–51]. The needles were then left in situ for 15–30 mins [52,53], depending on the sensitivity of the patient and their response to the treat-ment. Clinicians were permitted to manipulate needles bi-directionally every 4–5 mins, as needed, to achieve an appropriate treatment dosage. In cases of bilateral TMD, both sides were treated, but only the most painful side at baseline was recorded and analyzed throughout the study to satisfy the assumption of independent data [54].Patients in the experimental group also received at least one treatment that included high-velocity, low- amplitude thrust manipulation to the upper cervical spine (Figure 2) targeting C0-C1, C1-C2, or C2-C3, as described in previously published studies [55,56] and Appendix 1. The selection of the spinal segment to target was left to the discretion of the treating therapist and was based on a combination of patient report and manual examination findings. Clinicians were told to expect multiple audible cavitation sounds as a result of the manipulation to the upper cervical spine [56–60].Figure 2. High-velocity low-amplitude thrust manipulation tar-geting the upper cervical spine.Figure 1. Standardized protocol (7 needles) for dry needling for temporomandibular disorder (TMD).4 J. DUNNING ET AL.The current study did not include exercise therapy as part of the experimental or comparison groups because a recent meta-analysis concluded that exercise therapy approaches used for patients with TMD did not signifi-cantly improve functional outcomes; furthermore, the most appropriate dosage parameters (frequency, inten-sity, and duration) remain unknown [17].Outcome measuresThe primary outcome was average jaw pain intensity over the last 7 days, as measured by the Visual Analog Scale (VAS). VAS ratings were collected at baseline, 2 weeks, 6 weeks, and 3 months. The VAS consists of a 100 mm line, whereby the left side represents “no pain,” and the right side represents “the worst pain imaginable.” Patients were asked to make a mark on the line at the position that best represented their average pain intensity over the last 7 days. The VAS is an efficient, reliable, and valid method of measuring subjective pain intensity in various patient popula-tions, including TMD [61–64]. The minimal clinically important difference (MCID) for the VAS has been shown to be 9–11 mm [65,66], and the minimal detect-able change (MDC) for pain related to TMD is 10– 14 mm on the VAS [67].Secondary outcomes included jaw pain intensity over the past 24 hrs (VAS), active pain-free mouth opening (mm), and the Global Rating of Change (GROC). VAS ratings and active mouth opening outcomes were collected at baseline, 2 weeks, 6 weeks, and 3 months after the initial treatment session. Active pain-free mouth opening is a common variable used to measure functional improvements in patients with TMD [35,68,69]. In addition, at 2 weeks, 6 weeks, and 3 months follow-ing the initial treatment session, patients completed a 15-point GROC question based on a scale described by Jaeschke et al. [70]. The scale ranges from −7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Intermittent descriptors of worsening or improving are assigned values from −1 to −6 and +1 to +6, respectively. Scores of +4 and +5 have typically been indicative of moderate changes in patientstatus [70].Treatment side effectsPatients were asked to report any adverse events. Adverse events were defined as a sequelae of one- week duration with any symptom perceived as dis-tressing and unacceptable to the patient, requiring further treatment [71]. The treating therapists and patients in the group that received DN as part of their treatment were instructed to pay particular attention to the presence of ecchymosis and post- needling soreness.Sample size determinationThe sample size calculations were based on detecting a between-group moderate effect size of 0.55 on the main outcome (average jaw pain intensity over the last 7 days) at 3 months, using a 1-tailed test, an alpha level (α) of 0.05, and a desired power (β) of 90%. The esti-mated desired sample size was calculated to be at least 58 participants per group.Statistical analysisStatistical analysis was performed using SPSS software, version 28.0 (Chicago, IL, USA), according to the inten-tion-to-treat principle. Means, standard deviations, and/ or 95% confidence intervals were calculated for each variable. The Kolmogorov-Smirnov test revealed a normal distribution of the variables (p > 0.05). Baseline demographic and clinical variables were com-pared between groups using independent Student’s t-tests for continuous data and χ2 tests of independence for categorical data.The effects of treatment on jaw pain intensity (VAS) and active pain-free mouth opening (mm) were each examined with a 2-by-4 mixed model analysis of covar-iance (ANCOVA) with the treatment group as the between-subjects factor and time (baseline, 2 weeks, 6 weeks, and 3 months) as the within-subjects factor. Separate ANCOVAs were performed with VAS (average jaw pain rating over the past 7 days), VAS (average jaw pain rating over the last 24 hrs), and active pain-free mouth opening (mm) as the dependent variable. Age and duration of symptoms were entered as covariates.For each ANCOVA, the main hypothesis of interest was the 2-way interaction (group by time) with a Bonferroni-corrected alpha of 0.0125 (four time points). The authors used χ2 tests to compare self- perceived improvement on the GROC. To enable com-parison of between-group effect sizes, standardized mean differences (SMDs) in score were calculated by dividing mean score differences between groups by the pooled standard deviation. Number needed to treat (NNT) was calculated using each definition for a successful outcome (a GROC score of 5 or greater [70] at 3 months and a 50% improvement from baseline to 3 months on the VAS [62,63,65]).CRANIO®: THE JOURNAL OF CRANIOMANDIBULAR & SLEEP PRACTICE 5ResultsBetween February 2018 and March 2020, 257 consecu-tive patients with TMD were screened for eligibility (Figure 3). One hundred-twenty patients (46.7%) satis-fied all the inclusion criteria, agreed to participate, and were randomly allocated into the DN and upper cervical spinal manipulation (n = 62) group or the interocclusal splint therapy, NSAIDs, and non-thrust joint mobiliza-tion to the TMJ (n = 58) group. Randomization resulted in similar baseline characteristics for all variables (Table 2). The reasons for ineligibility are found in Figure 3, which provides a flow diagram of patient recruitment and retention. There was no significant difference (p = 0.427) between the mean number of completed treatment sessions for the DN and upper cervical spinal manipulation group (mean: 6.29) and the interocclusal splint therapy, NSAIDs, and non- thrust mobilization group (mean: 6.55). In the experi-mental group, the mean number of treatment sessions that included high-velocity low-amplitude thrust manipulation to the upper cervical spine was 5.23 (SD 2.02). No patients were lost at any of the follow-up periods in either group. None of the participants in any group reported receiving other interventions during the study.Thirty-four patients assigned to the DN and upper cervical spinal manipulation group (54.8%) experienced post-needling muscle soreness, and 12 (19.4%) experi-enced mild bruising (ecchymosis), which most com-monly resolved spontaneously within 48 hrs and 2– 257 consecutive patients with temporomandibular pain screened for eligibilityNot eligible (n=126)- Did not meet all inclusion criteria (n=28)- History of traumatic injury/fracture to the lateral face (n=5)- Signs/symptoms of disc displacement, arthrosis/arthritis of the TMJ (n=4)- History of surgery related to TMD (n=5)- Had concomitant diagnosis of tension type headache or migraine (n=12)- History of whiplash injury in the previous 6 weeks (n=4)- History of ibromyalgia diagnosis (n=4)- History of systemic disease such as rheumatoid arthritis, lupus, or psoriatic arthritis (n=2)- Had received physical therapy, acupuncture, chiropractic or interocclusal splint therapy in the previous 3 months (n=13)- Presence of a neurological disorder such as trigeminal neuralgia (n=4)- History of taking prescription NSAIDs within the previous 3 months (n=13)- History of regularly taking non-prescription NSAIDs (i.e., more than intermittent) within the previous 3 months (n=18)- Cardiac pacemaker, metal allergy or severe needle phobia (n=4)- Known sensitivity to acetylsalicylic acid, with impaired coagulation or with ulcer, kidney or liver dysfunction (n=1)- History of psychiatric disorder or cognitive impairment (n=2)- Presented with 1 or more contraindications to dry needling (n=5)- Presented with 1 or more contraindications to manual therapy (n=2)Eligiblen = 131Random assignment (n = 120)Dry Needling and Upper Cervical Spinal Manipulation group, n = 62Interocclusal Splint Therapy, NSAIDs and Mobilization toTMJ group, n = 58Agreed to participate & signed informed consent, n = 120Declined to participaten = 11Available for 2-week follow-upn = 58Available for 2-week follow-upn = 62Available for 6-week follow-upn = 62Available for 6-week follow-upn = 58Available for 3-month follow-upn = 58Available for 3-month follow-upn = 62D questionnaire (n=3)Figure 3. CONSORT flow diagram of patient recruitment and retention.6 J. DUNNING ET AL.4 days, respectively. Three patients (4.8%) in the DN and upper cervical manipulation group experienced bruising that lasted 5–7 days before spontaneously resolving. Five patients (8.1%) in the DN and upper cervical spinal manipulation group experienced drowsi-ness, headache, or nausea, which spontaneously resolved within several hours. No major adverse events were reported in the dry needling and upper cervical spinal manipulation group.Adjusting for baseline outcomes, the mixed-model ANCOVA revealed a significant group-by-time inter-action for the primary outcome of average jaw pain intensity over the last 7 days (VAS: F = 23.696; p < 0.001, Table 3). Patients in the DN and spinal manipulation group experienced greater reductions in average jaw pain intensity at 2 weeks (Δ −13.9; 95%CI: −20.1, −7.7; p < 0.001), 6 weeks (Δ −19.0; 95%CI: −25.4, −12.6; p < 0.001), and 3 months (Δ −21.9; 95%CI: −29.1, −14.7; p < 0.001) than those in the interocclusal splint therapy, NSAIDs, and non- thrust TMJ mobilization group (Figure 4). For the primary outcome (average jaw pain intensity over the last 7 days), between-group effect sizes for the VAS were large (SMD: 0.81; 95%CI: 0.44, 1.19) at 2 weeks, 6 weeks (SMD: 1.07; 95%CI: 0.69, 1.45), and 3 months (SMD: 1.10; 95%CI: 0.72, 1.48) after the first treatment session in favor of the DN and spinal manipulation group.The intention-to-treat analysis also revealed a significant group-by-time interaction for active pain- free mouth opening (mm: F = 29.902; p < 0.001, Figure 5) in favor of the DN and spinal manipulation group (Table 3). For active pain-free mouth opening (mm), between-group effect sizes were large at 2 weeks (SMD: 0.96; 95%CI: 0.58, 1.34), 6 weeks (SMD: 1.21;95%CI: 0.82, 1.60), and 3 months (SMD: 1.61; 95%CI: 1.19, 2.02) after the first treatment session in favor of the DN and spinal manipulation group.There was a significant group-by-time interaction for jaw pain intensity over the past 24 hrs (VAS: F = 22.432; p < 0.001, Figure 6) in favor of the DN and spinal manipulation group (Table 3). Between-group effect Table 3. Within-group and between-group mean scores by randomized treatment assignment.OutcomesTimeline Scores: Mean ± SD (95% CI) Within-Group Change Scores: Mean (95% CI)Between-Group Differences: Mean (95% CI)Dry Needling + Spinal Manipulation (n = 62)Interocclusal Splint Therapy + NSAIDs + Mobilization (n = 58)Average jaw pain intensity over the last 7 days (VAS 0–100)Baseline 53.9 ± 13.7 (50.4, 57.4) 53.5 ± 13.6 (49.9, 57.0)2 weeks 23.9 ± 12.7 (20.7, 27.1) 37.4 ± 17.3 (32.8, 41.9)Change baseline → 2 weeks−30.0 (−34.5, −25.5) −16.1 (−20.4, −11.8) −13.9 (−20.1, −7.7); SMD = 0.81; p< 0.0016 weeks 15.5 ± 15.4 (11.6, 19.4) 34.0 ± 15.9 (29.9, 38.2)Change baseline → 6 weeks−38.4 (−42.9, −33.8) −19.4 (−24.0, −14.9) −19.0 (−25.4, −12.6); SMD = 1.07; p< 0.0013 months 14.4 ± 16.2 (10.3, 18.5) 35.8 ± 16.5 (31.5, 40.2)Change baseline → 3 months−39.5 (−44.9, −34.0) −17.6 (−22.3, −12.9) −21.9 (−29.1, −14.7); SMD = 1.10; p< 0.001Jaw pain intensity over the past 24 hours (VAS 0–100)Baseline 48.8 ± 15.2 (45.0, 52.7) 49.6 ± 13.3 (46.1, 53.1)2 weeks 21.2 ± 16.1 (17.1, 25.3) 34.1 ± 16.9 (29.6, 38.5)Change baseline → 2 weeks−27.6 (−32.3, −23.0) −15.6 (−19.7, −11.4) −12.1 (−18.2, −5.9); SMD = 0.71; p< 0.0016 weeks 12.7 ± 15.4 (8.7, 16.6) 31.8 ± 17.8 (27.2, 36.5)Change baseline → 6 weeks−36.1 (−40.4, −31.9) −17.8 (−21.9, −13.7) −18.4 (−24.2, −12.5); SMD = 1.14; p< 0.0013 months 13.2 ± 16.6 (9.0, 17.4) 33.1 ± 17.5 (28.5, 37.7)Change baseline → 3 months−35.6 (−40.7, −30.5) −16.6 (−20.7, −12.4) −19.1 (−25.7, −12.5); SMD = 1.05; p< 0.001Active pain-free mouth opening (mm)Baseline 32.0 ± 6.9 (30.2, 33.7) 32.3 ± 7.6 (30.3, 34.4)2 weeks 39.8 ± 8.6 (37.6, 42.0) 34.9 ± 7.3 (33.0, 36.8)Change baseline → 2 weeks7.8 (6.1, 9.5) 2.6 (1.6, 3.5) 5.3 (3.3, 7.2); SMD = 0.96; p< 0.0016 weeks 42.7 ± 8.5 (40.5, 44.8) 35.9 ± 6.6 (34.1, 37.6)Change baseline → 6 weeks10.7 (8.9, 12.6) 3.5 (2.4, 4.7) 7.2 (5.1, 9.4); SMD = 1.21; p< 0.0013 months 44.1 ± 7.9 (42.1, 46.1) 35.4 ± 7.4 (33.4, 37.3)Change baseline → 3 months12.1 (10.4, 13.9) 3.0 (2.0, 4.1) 9.1 (7.1, 11.1); SMD = 1.61; p< 0.001VAS: Visual analog scale, 0–100, lower scores indicate greater function; Active pain-free mouth opening, higher scores indicate less pain and greater function; mm: Millimeters; SMD: Standardized mean difference; SD: Standard deviation; CI: Confidence interval; NSAIDs: Nonsteroidal anti-inflammatory drugsCRANIO®: THE JOURNAL OF CRANIOMANDIBULAR & SLEEP PRACTICE 7sizes for jaw pain intensity over the past 24 hrs (VAS) were moderate (SMD: 0.71; 95%CI: 0.34, 1.07) at 2 weeks, large (SMD:1.14; 95%CI: 0.75, 1.52) at 6 weeks, and large (SMD: 1.05; 95%CI: 0.66, 1.43) at 3 months after the first treatment session in favor of the DN and spinal manipulation group.Based on the cutoff score of ≥ +5 on the GROC [70], significantly (X2 = 22.558; p < 0.001) more patients (n = 44, 71%) within the DN and spinal manipulation group achieved a successful outcome compared to the interocclusal splint therapy, NSAIDs, and TMJ mobili-zation group (n = 16, 28%) at 3 months follow-up (Table 4). Therefore, based on the cut-off score of ≥ +5 on the GROC, the NNT was 2.3 (95%CI 1.7, 3.7) in favor of the DN and spinal manipulation group at 3-month follow-up. Likewise, based on a 50% improve-ment from baseline to 3 months in average jaw pain intensity over the last 7 days on the VAS, the NNT was 1.8 (95%CI 1.4, 2.5) in favor of the DN and spinal manipulation group at 3-month follow-up.* ** * * *Follow-up3 months6 weeks2 weeksBaselineAverage Jaw Pain Intensity over the last 7 days (VAS, 0-100) 6 05 04 03 02 01 00Error bars: 95% CIInterocclusal Splint Therapy, NSAIDs & MobilizationDry Needling & Spinal ManipulationTreatment GroupFigure 4. Evolution of average jaw pain intensity over the last 7 days (VAS) throughout the course of the study, stratified by randomized treatment assignment. Values are mean and 95% confidence interval.Figure 5. Evolution of active pain-free mouth opening (mm) throughout the course of the study, stratified by randomized treatment assignment. Values are mean and 95% confidence interval.8 J. DUNNING ET AL.DiscussionA mean of 6 sessions of DN primarily targeting the inferior head of the lateral pterygoid muscle, the super-ficial masseter muscle, the anterosuperior and anteroin-ferior aspects of the temporalis muscle, and the peri- articular capsule of the posterior TMJ combined with upper cervical spinal manipulation resulted in greater improvements in average jaw pain intensity over the last 7 days (Δ −21.9; 95%CI: −29.1, −14.7; p < 0.001), jaw pain intensity over the past 24 hrs (Δ −19.1; 95%CI: −25.7, −12.5; p < 0.001), and active pain-free mouth opening (Δ 9.1 mm; 95%CI: 7.1, 11.1; p < 0.001), in comparison to interocclusal splint therapy, NSAIDs, and non-thrust joint mobilization to the TMJ at the 3-month follow-up.For average jaw pain intensity over the last 7 days (VAS), between-group effect sizes were large at 6 weeks and 3 months, respectively, in favor of the DN and spinal manipulation group. The between-group difference for change in the primary outcome (average jaw pain inten-sity over the last 7 days) at 3 months, as measured by the VAS, was large and exceeded the MCID (9–11 mm) [65,66] and the MDC (10–14 mm) for pain [67]. For active pain-free mouth opening (mm), the point estimate for the between-group difference at 3 months also demonstrated a large between-group effect size in favor of the DN and spinal manipulation group. The NNT suggests for every two patients treated with the combina-tion of DN and upper cervical spinal manipulation rather than interocclusal splint therapy, NSAIDs and non-thrust joint mobilization, one additional patient with TMD achieves clinically important reductions in jaw pain intensity and “moderate” to “large” changes in self- perceived improvement ratings at 3 months.In a review of seven trials, Jung et al. [72] concluded there is limited evidence for the use of acupuncture for TMD. However, only one trial [73] in the Jung et al. [72] review utilized manual needle manipulation, and 60 of the 91 needle locations were inserted into distal points (i.e., primarily in the hands and feet) far removed from the region of pain and dysfunction instead of the local muscles of mastication and/or peri-articular tissue * ** * * *Follow-up3 months6 weeks2 weeksBaselineJaw Pain Intensity over the past 24 hours (VAS, 0-100)6 05 04 03 02 01 00Error bars: 95% CIInterocclusal Splint Therapy, NSAIDs & MobilizationDry Needling & Spinal ManipulationTreatment GroupFigure 6. Evolution of jaw pain intensity over the past 24 hrs (VAS) throughout the course of the study, stratified by randomized treatment assignment. Values are mean and 95% confidence interval.Table 4. Self-perceived improvement measured with the Global Rating of Change (GROC) in both groups [n (%)].Global Rating of Change (GROC, −7 to +7) Dry Needling + Spinal Manipulation (n = 62) Interocclusal Splint Therapy + NSAIDs + Mobilization (n = 58)3 months after the first treatment sessionSmall changes (+2/+3) 2 (3.2%)/6 (9.7%) 13 (22.4%)/8 (13.8%)Moderate changes (+4/+5) 3 (4.8%)/12 (19.4%) 6 (10.3%)/11 (19.0%)Large changes (+6/+7) 16 (25.8%)/16 (25.8%) 2 (3.4%)/3 (5.2%)NSAIDs: Nonsteroidal anti-inflammatory drugs.CRANIO®: THE JOURNAL OF CRANIOMANDIBULAR & SLEEP PRACTICE 9associatedwith the TMJ capsule. Notably, acupuncture [74–76] and DN [69,77] trials that have directed need-ling to the local muscles of mastication (i.e., the lateral pterygoids, masseter, and temporalis) with manual and/ or electric stimulation have reported statistically signifi-cant improvements in pain and function, which is con-sistent with the findings of the present study. While a number of studies further recommend acupuncture [78] and DN [79] for joint osteoarthritis, the present study is one of the first to additionally insert needles in structures anatomically related to the posterior capsule of the TMJ itself, a primary anatomical structure that is seemingly associated with the pathophysiology of TMD [40,42,80]. This approach may be advantageous, as it may facilitate mechano-transduction of peri-articular connective tissue [43,44], improved vasodilation and, hence, blood flow to the affected area [81,82], opioid recruitment [81,83,84], and joint lubrication [85,86].Similar to the findings of the present study, the use of spinal manipulation directed to the upper cervical spine has previously been found to improve jaw pain, mouth opening, pressure pain sensitivity, and mandibular kine-matics (i.e., amplitude and velocity) in patients with TMD and/or neck pain [22,87–89], which may be due to the concomitant movement of the occipito-atlantal (C0-C1) joint and the C1-C3 facet joints and their neu-rophysiological association in the activation of the mus-cles of mastication [90]. There is also a significant overlap of the C1-C3 dorsal horns that receive nocicep-tive afferent input from the upper neck and the trigemi-nocervical nucleus [91,92]. Given that the trigeminal nerve provides motor innervation to the muscles of mastication and sensory innervation to the TMJ via the auriculotemporal branch of the mandibular branch of the trigeminal nerve [93], there is a neurophysiological relationship between the upper cervical spine and TMD.LimitationsThere are three important limitations to the current trial. First, the present study did not use a placebo- needling or control group. Although the authors recog-nize the use of a placebo-needling group as an ideal situation [94], the goal of the current study was to compare an experimental intervention (DN and upper cervical spinal manipulation) to a common conven-tional intervention (interocclusal splint therapy, NSAIDs, and mobilization to the TMJ) to more accu-rately determine the new treatment’s effect size [95,96] without the potential for an inflated between-group effect size [96,97]. Trials measure relative efficacy of a treatment compared to a control, placebo, or usual care [94]. The authors believe the question of whether the experimental intervention (DN and upper cervical spinal manipulation) works any better or provides any different outcome than a common conventional inter-vention (interocclusal splint therapy, NSAIDs, and mobilization to the TMJ) is meaningful to clinicians and to patients with TMD. In addition, a recent second-ary analysis of an individual patient data meta-analysis of 29 trials (n = 19,827) of acupuncture for chronic pain concluded that real acupuncture was superior to sham needling irrespective of the subtype of control or sham procedure (penetrating or non-penetrating) [98]. Moreover, a PRISMA-compliant meta-analysis of nine trials and 231 patients found real acupuncture to be more effective than nonpenetrating and laser sham acu-puncture for reducing TMD pain [99]. Second, there is a risk of treatment bias secondary to all treating thera-pists being associated with the same post-graduate fel-lowship program in orthopedic manual physical therapy. However, treatment bias is not uncommon in manual therapy trials that require a very specific and advanced skill set. Future studies could compare the effectiveness of direct manual therapy procedures (e.g., high-velocity low-amplitude thrust manipulation) with indirect manual therapy approaches (e.g., muscle energy techniques) in patients with TMD.Third, the interocclusal appliances in the comparison group were prepared by general dentists based on the needs of each individual patient. As such, different types of appliances may have been used. Moreover, some appliances may have required more frequent and/or involved adjustments for some patients than others, which may have caused some variability within the comparison group.ConclusionThe results of the current randomized clinical trial demonstrated that patients with TMD who received dry needling and upper cervical spinal manipulation experienced significantly greater improvements in jaw pain intensity and active pain-free mouth opening compared to the group that received interocclusal splint therapy, NSAIDs, and non-thrust joint mobili-zation to the TMJ. Future studies should examine the effectiveness of different types and dosages of dry needling and spinal manipulation and include a long- 10 J. DUNNING ET AL.term follow-up.Author contributions, data sharing, and patient involvementJD, RB, KV, and CFdlP participated in the conception, design, data acquisition, statistical analyses, data interpretation, draft-ing and revision of the manuscript. PB and IY were involved in the data interpretation, drafting and revision of the manu-script. GS, CL, and NE were involved in data collection and revision of the manuscript. All authors read and approved the final version of the manuscript. All data relevant to the study are included in the article or are available as supplementary files. Although the study was approved by the ethics commit-tee at Universidad Rey Juan Carlos, Madrid, Spain (URJC- DPTO 36-2017) and the trial was prospectively registered (ClinicalTrials.gov: NCT03409874), there was no additional patient and/or public involvement in the design, conduct, interpretation, and/or translation of the research.AcknowledgmentsThe authors wish to thank all the participants of the study. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.Disclosure StatementDr. Dunning is the President of the American Academy of Manipulative Therapy (AAMT) and the Director of the AAMT Fellowship in Orthopaedic Manual Physical Therapy. AAMT provides postgraduate training programs in spinal manipula-tion, spinal mobilization, dry needling, extremity manipula-tion, extremity mobilization, instrument-assisted soft tissue mobilization, therapeutic exercise, and differential diagnosis to licensed physical therapists, osteopaths, and medical doc-tors. Drs. James Dunning, Raymond Butts, Paul Bliton, and Ian Young are senior instructors for AAMT. The other authors declare that they have no potential competing interests. None of the authors received any funding for this study.FundingThe study was approved by the ethics committee at Universidad Rey Juan Carlos, Madrid, Spain (URJC-DPTO 36-2017) ClinicalTrials.gov: NCT03409874ORCIDJames Dunning, PhD, DPT, FAAOMPT http://orcid.org/ 0000-0002-1194-0108References[1] Prasad SR, Kumar NR, Shruthi HR, et al. Temporomandibular pain. J Oral Maxillofac Pathol. 2016;20(2):272–275. DOI:10.4103/0973-029X.185902.[2] Gauer RL, Semidey MJ. Diagnosis and treatment of temporomandibular disorder. Am Fam Phys. 2015;91 (6):378–388.[3] Tanaka E, Detamore MS, Mercuri LG. Degenerative disorders of the temporomandibular joint: etiology, diagnosis, and treatment. J Dent Res. 2008;87 (4):296–307.[4] Mujakperuo HR, Watson M, Morrison R, et al. Pharmacological interventions for pain in patients with temporomandibular disorders. Cochrane Database Syst Rev. 2010(10):CD004715[5] Svensson P, Kumar A. 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DUNNING ET AL.https://doi.org/10.4317/medoral.20384https://doi.org/10.1142/S0192415X17500513https://doi.org/10.1142/S0192415X17500513https://doi.org/10.1097/AJP.0000000000000634https://doi.org/10.1016/j.pain.2009.08.004https://doi.org/10.1016/S1566-0702(02)00051-6https://doi.org/10.1016/S1566-0702(02)00051-6https://doi.org/10.1007/s11655-010-0513-1https://doi.org/10.1007/s11655-010-0513-1https://doi.org/10.2519/jospt.2010.3257https://doi.org/10.2519/jospt.2010.3257https://doi.org/10.1016/j.jmpt.2008.12.003https://doi.org/10.1016/j.jmpt.2008.12.003https://doi.org/10.1016/j.jpain.2010.03.005https://doi.org/10.1016/j.jpain.2010.03.005https://doi.org/10.1371/journal.pone.0093739AbstractIntroductionMaterials and methodsStudy designParticipantsTreating therapistsExamination procedureRandomization and blindingInterventionsOutcome measuresTreatment side effectsSample size determinationStatistical analysisResultsDiscussionLimitationsConclusionAuthor contributions, data sharing, and patient involvementAcknowledgmentsDisclosure StatementFundingORCIDReferences
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