ClinicalTrials.gg
RecruitingNCT06708377Updated Nov 27, 2024

Dry Needling and Myofascial Massage Therapy on Patient With Temporomandibular Joint Dysfunction

An interventional study of dry needling of masseter and myofascial massage therapy on masseter muscle in Temporomandibular Joint Dysfunction, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled May 2024, registered Nov 2024).
  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study summary

Comparison of effects of dry needling and myofascial massage therapy on masseter muscle in patients with temporomandibular joint dysfunction. A randomized control trial was conducted at DSK Physio \& Rehab Centre, Ulfat Dental Associates and The Physiotherapy Clinic, Islamabad. The sample size was 24 calculated through G-power 3.1. The participants were divided into two interventional groups each having 12 participants. The study duration was six months. Sampling technique applied was convenience sampling for recruitment and group randomization using flip coin method. Only 25 to 45 years participants with having TMJ Dysfunction and reduced mouth opening were included in the study. Tools used in this study are NPRS, Maximal Mouth Opening and Fonseca Anamnestic Index. Data was collected at baseline, at the end of 1st week and 3rd week. Data analyzed through SPSS version26.

Read the detailed description

Temporomandibular joint (TMJ) dysfunction encompasses a range of conditions affecting the jaw joint and surrounding muscles, often resulting in pain, restricted movement, and functional impairment. Temporomandibular disorder (TMD) can be categorized as intra-articular, affecting structures within the temporomandibular joint (TMJ), or extra-articular, involving surrounding muscles and structures. Intra-articular TMD includes conditions like disc displacement, osteoarthritis, or subluxation, while extra-articular TMD manifests as muscle pain or dysfunction, such as myofascial pain syndrome.

Reduced mouth opening or limited mandibular range of motion, is a condition characterized by restricted movement of the TMJ resulting in diminished ability to open the mouth. It can arise from various etiologies including trauma, inflammation, muscle dysfunction, or surgical interventions affecting the masticatory muscles or TMJ. Trismus may manifest acutely or chronically and can significantly impair oral functions such as eating, speaking, and oral hygiene maintenance. Assessment typically involves measurement of maximal inter-incisal opening (MIO) using standardized methods, with normal values varying depending on age, gender, and population.

The Maximal Mouth Opening (MMO) generalized reference range is from 42 to 60 mm.

Patients diagnosed with myofascial temporomandibular disorder (TMD) commonly present myofascial trigger points (MTrPs) located in both the neck and masticatory muscles. These trigger points are believed to be integral to the development and expression of myofascial TMD symptoms. MTrPs represent hypersensitive sites within taut bands of skeletal muscle or muscle fascia. Their activation can lead to a range of sensory, motor, neurological, and autonomic symptoms, contributing significantly to the clinical presentation of myofascial TMD. Among the various treatment modalities, myofascial massage therapy and dry needling have gained attention for their potential efficacy in managing TMJ dysfunction, particularly in addressing the associated muscular component.

Myofascial massage therapy targets the fascia, the connective tissue surrounding muscles, aiming to release tension, improve blood flow, and restore mobility. Massage therapy can help break down trigger points through several mechanisms. Firstly, it increases blood flow to the affected area, which helps deliver oxygen and nutrients while removing waste products, aiding in tissue repair. It can also disrupt the tight muscle fibers and release tension, allowing the muscle to relax and the trigger point to dissipate. Additionally, massage stimulates the nervous system, promoting the release of endorphins and other natural pain-relieving chemicals, which can help alleviate discomfort associated with trigger points. Lastly, the pressure and manipulation applied during massage can physically break down adhesions and knots within the muscle tissue, helping to release the trigger point.In the context of TMJ dysfunction, myofascial massage may involve techniques such as effleurage, petrissage, and trigger point therapy to alleviate muscle tightness, reduce pain, and enhance jaw function.

This approach focuses on manual manipulation of soft tissues to promote relaxation and alleviate muscular imbalances contributing to TMJ symptoms. Dry needling involves the insertion of thin needles into trigger points or areas of muscular tension to elicit a therapeutic response. Unlike acupuncture, which follows traditional Chinese medicine principles, dry needling targets specific muscular trigger points rather than meridian pathways.

In the context of TMJ dysfunction, dry needling aims to deactivate hyperirritable trigger points, reduce muscle tension, and alleviate pain by promoting local blood flow and releasing endogenous opioids. The recent systematic review emphasized the necessity for conducting larger trials with a decreased risk of bias to thoroughly evaluate the impact of dry needling on myofascial temporomandibular disorder (TMD). This recommendation stems from the observation of both the low quality of evidence and the heightened risk of bias evident in certain studies included in the review.

While both myofascial massage therapy and dry needling target muscular dysfunction associated with TMJ disorders, they differ in their mechanisms of action and application. Myofascial massage therapy relies on manual manipulation techniques to directly address muscle tension and fascial restrictions, promoting relaxation and improved tissue mobility. In contrast, dry needling involves the precise insertion of needles into trigger points to stimulate neuromuscular responses and induce therapeutic effects, such as pain relief and muscle relaxation. Dry needling is a common intervention in clinical practice nowadays, but its effectiveness compared to other conservative treatment modalities, such as manual therapy, remains unclear.

In a 2022 network meta-analysis (NMA), which evaluated the effectiveness of twelve different treatment modalities for patients with myofascial temporomandibular disorder (TMD), manual therapy emerged as the most effective treatment option. Nevertheless, the authors advised a careful interpretation of the findings, citing study limitations and a paucity of robust evidence.

According to a systematic review published in 2023, it was concluded that no significant differences in terms of pain reduction was observed between dry needling and manual therapy in patients with myofascial TMD. High variability was observed in available literature for methods of application of these interventions.

Despite growing interest in myofascial massage therapy and dry needling for TMJ dysfunction, there remains a gap in the literature regarding direct comparisons of their efficacy, safety, and long-term outcomes. While individual studies have investigated the effects of each modality separately, few studies have directly compared their effectiveness in improving TMJ symptoms and functional outcomes. Additionally, factors such as treatment protocols, patient characteristics, and practitioner expertise may influence treatment outcomes and complicate direct comparisons between myofascial massage therapy and dry needling.

This lack of comparative randomized clinical trials between dry needling and myofascial massage therapy limits determine which technique of the two is better. So, the available literature has only made indirect comparisons and therefore, the current study aims to find the comparative effectiveness of myofascial massage therapy and dry needling for TMJ dysfunction. The findings will help inform evidence-based management strategies for TMJ dysfunction.

02

Conditions studied

  • Temporomandibular Joint Dysfunction

Keywords

  • TMJ Dysfunction
  • Dry needling
  • Myofascial massage therapy
03

In context

Temporomandibular Joint Disorders

621 studies on the registry are indexed under Temporomandibular Joint Disorders; 161 are open to participants now.

This study's planned enrollment of 24 is below the median of 46 across 439 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,176 studies on the registry; 637 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants with TMJ dysfunction
  • A mouth opening of less than 39 mm for males and 36mm for females
  • Patients with Trigger points in tout band of masseter
  • Mild to moderate pain on NPRS
  • 45-75 points on Fonseca's questionnaire

Exclusion criteria

Exclusion Criteria:

  • Bell's palsy
  • Trigeminal neuralgia
  • Wearing any form of dental prosthesis
  • Any form of surgery in or around the TMJ
  • History of trauma or fracture in and around the TMJ
  • Not consenting to take part in the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Dry needling of masseter muscle

    Experimental group included Dry needling of masseter muscle for 30 second to 2 minutes into the trigger point. Conventional heating pad or face pad for 15 minutes. Therapeutic ultrasound with Frequency: 3MHz, Intensity: 0.75 - 1 W/cm2, Time: Based on treatment head and pulse factor. Temporomandibular joint mobilization (Maitland)-caudal glide, anterior-posterior glide, grade II, III, IV 3 reps x 3 sets per session. 6 x 6 exercise protocol of Rocabado, 6 reps per exercise x 6/day.

    Other: dry needling of masseter

  • Active comparator
    Myofacial massage therapy

    Control group included Myofascial massage - sliding and kneading, for 30 minutes per session/3x per week. Conventional heating pad or face pad for 15 minutes. Therapeutic ultrasound with Frequency: 3MHz, Intensity: 0.75 - 1 W/cm2, Time: Based on treatment head and pulse factor. Temporomandibular joint mobilization (Maitland)-caudal glide, anterior-posterior glide, grade II, III, IV 3 reps x 3 sets per session. 6 x 6 exercise protocol of Rocabado, 6 reps per exercise x 6/day.

    Other: myofascial massage therapy on masseter muscle

Interventions

  • Otherdry needling of masseter

    Experimental group included Dry needling of masseter muscle for 30 second to 2 minutes into the trigger point. Conventional heating pad or face pad for 15 minutes. Therapeutic ultrasound with Frequency: 3MHz, Intensity: 0.75 - 1 W/cm2, Time: Based on treatment head and pulse factor. Temporomandibular joint mobilization (Maitland)-caudal glide, anterior-posterior glide, grade II, III, IV 3 reps x 3 sets per session. 6 x 6 exercise protocol of Rocabado, 6 reps per exercise x 6/day.

  • Othermyofascial massage therapy on masseter muscle

    Control group included Myofascial massage - sliding and kneading, for 30 minutes per session/3x per week. Conventional heating pad or face pad for 15 minutes. Therapeutic ultrasound with Frequency: 3MHz, Intensity: 0.75 - 1 W/cm2, Time: Based on treatment head and pulse factor. Temporomandibular joint mobilization (Maitland)-caudal glide, anterior-posterior glide, grade II, III, IV 3 reps x 3 sets per session. 6 x 6 exercise protocol of Rocabado, 6 reps per exercise x 6/day

06

What researchers measure

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    changes from the baseline pain intensity was measured using numeric pain rating scale

    Time frame: 5 mints at every session

  2. Maximum Mouth Opening (MMO)

    changes from baseline maximum mouth opening were measured in mm using fiber ruler

    Time frame: 10 mint at every session

Secondary outcomes

  1. Fonseca Anamnestic Index (FAI)

    changes from baseline TMJ Dysfunction was measured using FAI

    Time frame: 15 mints

07

Study locations

1 of 1 sites recruiting
  • Riphah International University
    Islamabad, Federal 44000, Pakistan
    Recruiting
08

References and documents

Publications

  • Poveda Roda R, Diaz Fernandez JM, Hernandez Bazan S, Jimenez Soriano Y, Margaix M, Sarrion G. A review of temporomandibular joint disease (TMJD). Part II: Clinical and radiological semiology. Morbidity processes. Med Oral Patol Oral Cir Bucal. 2008 Feb 1;13(2):E102-9. PubMed 18223525 ↗
  • Okeson JP. Joint intracapsular disorders: diagnostic and nonsurgical management considerations. Dent Clin North Am. 2007 Jan;51(1):85-103, vi. doi: 10.1016/j.cden.2006.09.009. PubMed 17185061 ↗
  • Chaudhary F, Ahmad B, Butt D, Hameed S, Bashir U. Normal range of maximum mouth opening in pakistani population: A cross-sectional study. Journal of International Oral Health. 2019;11:353
  • Fernandez-de-Las-Penas C, Galan-Del-Rio F, Alonso-Blanco C, Jimenez-Garcia R, Arendt-Nielsen L, Svensson P. Referred pain from muscle trigger points in the masticatory and neck-shoulder musculature in women with temporomandibular disoders. J Pain. 2010 Dec;11(12):1295-304. doi: 10.1016/j.jpain.2010.03.005. Epub 2010 May 21. PubMed 20494623 ↗
  • Travell JG SD. Myofascial pain and dysfunction: the trigger point manual. Lippincott Williams & Wilkins. 1992.
  • Medlicott MS, Harris SR. A systematic review of the effectiveness of exercise, manual therapy, electrotherapy, relaxation training, and biofeedback in the management of temporomandibular disorder. Phys Ther. 2006 Jul;86(7):955-73. PubMed 16813476 ↗
  • Vier C, Almeida MB, Neves ML, Santos ARSD, Bracht MA. The effectiveness of dry needling for patients with orofacial pain associated with temporomandibular dysfunction: a systematic review and meta-analysis. Braz J Phys Ther. 2019 Jan-Feb;23(1):3-11. doi: 10.1016/j.bjpt.2018.08.008. Epub 2018 Aug 22. PubMed 30146108 ↗
  • Leeuw R. Orofacial pain: Guidelines for assessment, diagnosis, and management. Chicago: American Academy of Orofacial. 2008:1-24.
  • Menendez-Torre A, Pintado-Zugasti AM, Zaldivar JNC, Garcia-Bermejo P, Gomez-Costa D, Molina-Alvarez M, Arribas-Romano A, Fernandez-Carnero J. Effectiveness of deep dry needling versus manual therapy in the treatment of myofascial temporomandibular disorders: a systematic review and network meta-analysis. Chiropr Man Therap. 2023 Nov 3;31(1):46. doi: 10.1186/s12998-023-00489-x. PubMed 37924127 ↗
  • Al-Moraissi EA, Conti PCR, Alyahya A, Alkebsi K, Elsharkawy A, Christidis N. The hierarchy of different treatments for myogenous temporomandibular disorders: a systematic review and network meta-analysis of randomized clinical trials. Oral Maxillofac Surg. 2022 Dec;26(4):519-533. doi: 10.1007/s10006-021-01009-y. Epub 2021 Oct 21. PubMed 34674093 ↗
  • Dib-Zakkour J, Flores-Fraile J, Montero-Martin J, Dib-Zakkour S, Dib-Zaitun I. Evaluation of the Effectiveness of Dry Needling in the Treatment of Myogenous Temporomandibular Joint Disorders. Medicina (Kaunas). 2022 Feb 9;58(2):256. doi: 10.3390/medicina58020256. PubMed 35208580 ↗
  • Chiarotto A, Maxwell LJ, Ostelo RW, Boers M, Tugwell P, Terwee CB. Measurement Properties of Visual Analogue Scale, Numeric Rating Scale, and Pain Severity Subscale of the Brief Pain Inventory in Patients With Low Back Pain: A Systematic Review. J Pain. 2019 Mar;20(3):245-263. doi: 10.1016/j.jpain.2018.07.009. Epub 2018 Aug 10. PubMed 30099210 ↗
  • Nomura K, Vitti M, Oliveira AS, Chaves TC, Semprini M, Siessere S, Hallak JE, Regalo SC. Use of the Fonseca's questionnaire to assess the prevalence and severity of temporomandibular disorders in Brazilian dental undergraduates. Braz Dent J. 2007;18(2):163-7. doi: 10.1590/s0103-64402007000200015. PubMed 17982559 ↗
  • Zagalaz-Anula N, Sanchez-Torrelo CM, Acebal-Blanco F, Alonso-Royo R, Ibanez-Vera AJ, Obrero-Gaitan E, Rodriguez-Almagro D, Lomas-Vega R. The Short Form of the Fonseca Anamnestic Index for the Screening of Temporomandibular Disorders: Validity and Reliability in a Spanish-Speaking Population. J Clin Med. 2021 Dec 14;10(24):5858. doi: 10.3390/jcm10245858. PubMed 34945153 ↗
  • Gerwin RD, Shannon S, Hong CZ, Hubbard D, Gevirtz R. Interrater reliability in myofascial trigger point examination. Pain. 1997 Jan;69(1-2):65-73. doi: 10.1016/s0304-3959(96)03248-4. PubMed 9060014 ↗
  • Lew J, Kim J, Nair P. Comparison of dry needling and trigger point manual therapy in patients with neck and upper back myofascial pain syndrome: a systematic review and meta-analysis. J Man Manip Ther. 2021 Jun;29(3):136-146. doi: 10.1080/10669817.2020.1822618. Epub 2020 Sep 22. PubMed 32962567 ↗
  • Biasotto-gonzalez DA. Abordagem interdisciplinar das disfunções temporomandibulares: Editora Manole Ltda; 2005.
  • Gomes CA, Politti F, Andrade DV, de Sousa DF, Herpich CM, Dibai-Filho AV, Gonzalez Tde O, Biasotto-Gonzalez DA. Effects of massage therapy and occlusal splint therapy on mandibular range of motion in individuals with temporomandibular disorder: a randomized clinical trial. J Manipulative Physiol Ther. 2014 Mar-Apr;37(3):164-9. doi: 10.1016/j.jmpt.2013.12.007. Epub 2014 Jan 3. PubMed 24387891 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Dec 2024, 7 months after the start.

Of 246 non-industry interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 7 months is below that.

Counting every sponsor, half of 250 studies reached it within 11 months; a quarter within 5 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2024
First posted
Nov 27, 2024
StartActual
May 3, 2024
Primary completionEst.
Dec 3, 2024
CompletionEst.
Dec 13, 2024
Last update
Nov 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06708377
Responsible party
Sponsor
First posted
Nov 27, 2024
Start date
May 3, 2024
Primary completion
Dec 3, 2024 (estimated)
Completion
Dec 13, 2024 (estimated)
Last update
Nov 27, 2024

Study contacts

Imran Amjad, PhD
Contact
imran.amjad@riphah.edu.pk
03324390125
samiullah khan, dpt
Contact
ksamiullah1010@gmail.com
03162665686
Lal Gul Khan, MScPT
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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