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Temporomandibular Joint DysfunctionNCT06708377

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

A study testing dry needling of masseter and myofascial massage therapy on masseter muscle in people with Temporomandibular Joint Dysfunction, run by Riphah International University at 1 site in Pakistan.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 45 years
Conditions the study is for
Temporomandibular Joint Dysfunction
What is being tested?
dry needling of masseter and myofascial massage therapy on masseter muscle
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 sitePakistan
Study dates
3 May 2024to 13 Dec 2024
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Imran Amjad, PhD contact

03324390125

imran.amjad@riphah.edu.pk

samiullah khan, dpt contact

03162665686

ksamiullah1010@gmail.com

Pakistan1 site, 1 recruiting
  • Riphah International University

    Islamabad, Federal, 44000

    Imran Amjad, PhD, 03324390125, imran.amjad@riphah.edu.pk

    Lal Gul Khan, MScPT, 03002146287, lalgul.khan@riphah.edu.pk

    Recruiting

Other trials in Pakistan

About this study

Official title: Comparison of Effects Of Dry Needling And Myofascial Massage Therapy On Masseter Muscle In Patients With Temporomandibular Joint Dysfunction

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.

Being tested
dry needling of masseter, myofascial massage therapy on masseter muscle
Keywords
TMJ Dysfunction, Dry needling, Myofascial massage therapy
Medical subject headings
Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dry needling of masseterOther

    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.

  • myofascial massage therapy on masseter muscleOther

    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

Study groups in NCT06708377
Study groupRoleWhat they receive
Dry needling of masseter muscleExperimentalExperimental 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.
Receives: Other: dry needling of masseter
Myofacial massage therapyActive comparatorControl 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.
Receives: Other: myofascial massage therapy on masseter muscle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Pain Rating Scale (NPRS)

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

    Measured: 5 mints at every session

  2. Maximum Mouth Opening (MMO)

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

    Measured: 10 mint at every session

Secondary outcomes (1)
  1. Fonseca Anamnestic Index (FAI)

    changes from baseline TMJ Dysfunction was measured using FAI

    Measured: 15 mints

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2024
  2. Study start3 May 2024
  3. Primary completion3 Dec 2024 (estimated)
  4. Study completion13 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06708377
Sponsor's protocol ID
RiphahIU Samiullah Khan
Status last verified
Nov 2024
First submitted
25 Nov 2024
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing dry needling of masseter and myofascial massage therapy on masseter muscle in people with Temporomandibular Joint Dysfunction, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Scale (NPRS) (time frame: 5 mints at every session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06708377, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

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