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.
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.
Pakistan1 site, 1 recruiting
- 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
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.
- Conditions
- Temporomandibular Joint 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 group | Role | What they receive |
|---|---|---|
| Dry needling of masseter muscle | Experimental | 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. Receives: Other: dry needling of masseter |
| Myofacial massage therapy | Active comparator | 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. 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.
Numeric Pain Rating Scale (NPRS)
changes from the baseline pain intensity was measured using numeric pain rating scale
Measured: 5 mints at every session
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)
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.
- First posted27 Nov 2024
- Study start3 May 2024
- Primary completion3 Dec 2024 (estimated)
- Study completion13 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DysfunctionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lal Gul Khan, MScPT, Principal investigator, Riphah International University
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 18223525Okeson 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 17185061Chaudhary 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 20494623Travell 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 16813476Vier 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 30146108Leeuw 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 37924127Al-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 34674093Dib-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 35208580Chiarotto 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 30099210Nomura 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 17982559Zagalaz-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 34945153Gerwin 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects Of Dry Needling And Myofascial Massage Therapy On Masseter Muscle In Patients With Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT06708377
- Acronym / sponsor ID
- RiphahIU Samiullah Khan
- Conditions
- Temporomandibular Joint Dysfunction
- Keywords
- TMJ Dysfunction, Dry needling, Myofascial massage therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 3 Dec 2024 (estimated)
- Study completion
- 13 Dec 2024 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling of masseter muscle | Experimental | Other: dry needling of masseterExperimental 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. |
| Myofacial massage therapy | Active comparator | Other: myofascial massage therapy on masseter muscleControl 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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry needling of masseterExperimental 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 muscle |
| myofascial massage therapy on masseter muscleControl 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 | Myofacial massage therapy |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 5 mints at every session
changes from the baseline pain intensity was measured using numeric pain rating scale
Maximum Mouth Opening (MMO)
Time frame: 10 mint at every session
changes from baseline maximum mouth opening were measured in mm using fiber ruler
1 secondary outcome
Fonseca Anamnestic Index (FAI)
Time frame: 15 mints
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 18223525Poveda 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.
- Background: PubMed 17185061Okeson 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.
- BackgroundChaudhary 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
- Background: PubMed 20494623Fernandez-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.
- BackgroundTravell JG SD. Myofascial pain and dysfunction: the trigger point manual. Lippincott Williams & Wilkins. 1992.
- Background: PubMed 16813476Medlicott 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.
- Background: PubMed 30146108Vier 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.
- BackgroundLeeuw R. Orofacial pain: Guidelines for assessment, diagnosis, and management. Chicago: American Academy of Orofacial. 2008:1-24.
- Background: PubMed 37924127Menendez-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.
- Background: PubMed 34674093Al-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.
- Background: PubMed 35208580Dib-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.
- Background: PubMed 30099210Chiarotto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lal Gul Khan, MScPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
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.