Temporomandibular Joint DisordersNCT05392049
Effects of Bowen's Therapy and Post Isometric Relaxation Techniques in Patients of Temporomandibular Joint Disorder
A study testing Bowen's therapy and Post isometric relaxation in people with Temporomandibular Joint Disorders, run by Riphah International University at 1 site in Pakistan.
Trial summary
the aim of this study to compare effects of Bowen's therapy and post isometric relaxation techniques on pain, range of motions and function in patients with TMJ disorder. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Bowen's therapy and Post isometric relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and Female Participant aged 20-50.
- Pain on function.
- Restricted jaw movement.
- Clicking, popping sound.
- Tenderness in muscle of mastication.
- Joint tenderness.
- With a restricted mandibular range of motion 40mmor less measured interincisal.
Who cannot join
- Systematic arthropathy such as.
- Rheumatoid arthritis
- Fracture of jaw or TMJ.
- Malignant history of face and jaw.
- Prevent history of jaw or TMJ surgery.
- Subject has/ had dental/ orthodontic treatment within the past 14 days
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore Dental care clinic samnabad
Lahore, Punjab Province, 54000
Muhammad Salman Bashir, PhD, +923334497959, salman.bashir@riphah.edu.pk
Sunaina Javed, MSPT(OM)
About this study
Official title: Comparative Effects of Bowen's and Post Isometric Relaxation Techniques on Pain, Range of Motion and Function in Patients With Temporomandibular Joint Disorder
the aim of this study to compare effects of Bowen's therapy and post isometric relaxation techniques on pain, range of motions and function in patients with TMJ disorder.
Read the detailed description
Temporomandibular joint disorder is a very common and serious problem of mouth and face pain related condition that mostly effect in quality of life and compromise the daily functional activities of a patient. It can be caused by any trauma, biomechanical, neuromuscular and psychologically related problems. Patient may come in acute and chronic phase. Patient condition mostly vary and worsen day by day, it thoughts that TMJD going interval throw out the life span of patient. Medicine, physical therapy interventions and surgical procedures are use in treatment of TMJ disorder. This study will conducted the comparative effects of Bowen's and post-isometric relaxation techniques on pain, ROM and functions in TMJ patients.
The study would be randomized clinical trial. Total 24 subjects will be assigned randomly into two groups by using lottery methods. Baseline treatment will be same (ultrasound, tapping) in both groups. Group A will be treated by Bowen's therapy and Group B will be treated by post-isometric relaxation technique for 30 min session (2 sessions/week and total 4 weeks). Numeric Pain Rating Scale, maximum mouth opening inter-incisal rural and jaw functional limitation scale-20 would be used as an outcome measurement tool for pain, range of motion and function respectively. Measurement will be taken at Baseline and at the end of the 4th week's treatment session. After assessing the normality data will be analyzed by using parametric / nonparametric test.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Bowen's therapy, Post isometric relaxation
- Keywords
- Temporomandibular disorder, Post isometric relaxation, Temporomandibular joint pain
- 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.
Bowen's therapyOther
Bowens technique will be apply on patients of TMJ for 2 repetitions in 1 set, 4 sets in each session for 4 weeks.
Post isometric relaxationOther
post isometric relaxation technique and jaw exercises (strengthen the weakened muscles, stretch the shortened muscles) with dosage 5 times/session, 5 sec rest and 2times/week for 4 weeks will apply on patients.
| Study group | Role | What they receive |
|---|---|---|
| Bowen's therapy | Experimental | Bowens therapy will be given to 12 patients of temporomandibular joint disorder . Receives: Other: Bowen's therapy |
| Post isometric relaxation | Experimental | post isometric relaxation technique will be given to12 patients of temporomandibular joint disorder. Receives: Other: Post isometric relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS for pain
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: 4th week
Maximum Mouth opening (Inter- incisal Rural) for rang of motion
Maximum mouth opening is a vital and objective clinical parameter for assessment of stomatognathic region and it represents the range of vertical mandibular range of movement.The distance between the upper central incisor and lower incisor determined by flexible intra-oral ruler ,it is valid and reliable tool for measure TMJ distance.
Measured: 4th week
Jaw Functional Limitation Scale for functional activity
Jaw functional limitation is a 20 items,3 level functional scale mastication, vertical jaw mobility, emotional and verbal expression. NO LIMITATION'' score have 0 and SEVER LIMITATION '' have 10 score
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Salman Bashir, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392049
- Sponsor's protocol ID
- REC/RCR & AHS/22/0106
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moleirinho-Alves PMM, Cebola PMTC, Dos Santos PDG, Correia JP, Godinho C, Oliveira RANDS, Pezarat-Correia PLC. Effects of Therapeutic and Aerobic Exercise Programs on Pain, Neuromuscular Activation, and Bite Force in Patients with Temporomandibular Disorders. J Pers Med. 2021 Nov 10;11(11):1170. doi: 10.3390/jpm11111170.
PubMed 34834522Madariaga VI, Jasim H, Ghafouri B, Ernberg M. Myogenous temporomandibular disorders and salivary markers of oxidative stress-A cross-sectional study. J Oral Rehabil. 2021 Jan;48(1):1-9. doi: 10.1111/joor.13100. Epub 2020 Oct 5.
PubMed 32979853de Paiva Bertoli FM, Bruzamolin CD, de Almeida Kranz GO, Losso EM, Brancher JA, de Souza JF. Anxiety and malocclusion are associated with temporomandibular disorders in adolescents diagnosed by RDC/TMD. A cross-sectional study. J Oral Rehabil. 2018 Oct;45(10):747-755. doi: 10.1111/joor.12684. Epub 2018 Jul 20.
PubMed 29972708Osiewicz MA, Lobbezoo F, Loster BW, Loster JE, Manfredini D. Frequency of temporomandibular disorders diagnoses based on RDC/TMD in a Polish patient population. Cranio. 2018 Sep;36(5):304-310. doi: 10.1080/08869634.2017.1361052. Epub 2017 Aug 9.
PubMed 28792365Lee K, Lewis GN. Short term relief of multisite chronicpain with Bowen Therapy: A double-blind, randomized controlled trial. J Bodyw Mov Ther. 2020 Oct;24(4):271-279. doi: 10.1016/j.jbmt.2020.06.025. Epub 2020 Jul 30.
PubMed 33218522Tanhan A, Ozer AY, Polat MG. Efficacy of different combinations of physiotherapy techniques compared to exercise and patient education in temporomandibular disorders: A randomized controlled study. Cranio. 2023 Jul;41(4):389-401. doi: 10.1080/08869634.2021.1909454. Epub 2021 Apr 5.
PubMed 33818314Ram HK, Shah DN. Comparative evaluation of occlusal splint therapy and muscle energy technique in the management of temporomandibular disorders: A randomized controlled clinical trial. J Indian Prosthodont Soc. 2021 Oct-Dec;21(4):356-365. doi: 10.4103/jips.jips_332_21.
PubMed 34810363Volkan-Yazici M, Kolsuz ME, Kafa N, Yazici G, Evli C, Orhan K. Comparison of Kinesio Taping and manual therapy in the treatment of patients with bruxism using shear-wave elastography-A randomised clinical trial. Int J Clin Pract. 2021 Dec;75(12):e14902. doi: 10.1111/ijcp.14902. Epub 2021 Oct 8.
PubMed 34547165Asquini G, Pitance L, Michelotti A, Falla D. Effectiveness of manual therapy applied to craniomandibular structures in temporomandibular disorders: A systematic review. J Oral Rehabil. 2022 Apr;49(4):442-455. doi: 10.1111/joor.13299. Epub 2022 Jan 17.
PubMed 34931336Javed S, Bashir MS, Mehmood A, Noor R, Ikram M, Hussain G. Comparative effects of post isometric relaxation technique and Bowen's therapy on pain, range of motion and function in patients with temporomandibular joint disorder. BMC Oral Health. 2024 Jun 12;24(1):679. doi: 10.1186/s12903-024-04440-1.
PubMed 38867195
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Bowen's and Post Isometric Relaxation Techniques on Pain, Range of Motion and Function in Patients With Temporomandibular Joint Disorder
- ClinicalTrials.gov ID
- NCT05392049
- Acronym / sponsor ID
- REC/RCR & AHS/22/0106
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Temporomandibular disorder, Post isometric relaxation, Temporomandibular joint pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 26 May 2022 (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.
the aim of this study to compare effects of Bowen's therapy and post isometric relaxation techniques on pain, range of motions and function in patients with TMJ disorder.
Detailed description
Temporomandibular joint disorder is a very common and serious problem of mouth and face pain related condition that mostly effect in quality of life and compromise the daily functional activities of a patient. It can be caused by any trauma, biomechanical, neuromuscular and psychologically related problems. Patient may come in acute and chronic phase. Patient condition mostly vary and worsen day by day, it thoughts that TMJD going interval throw out the life span of patient. Medicine, physical therapy interventions and surgical procedures are use in treatment of TMJ disorder. This study will conducted the comparative effects of Bowen's and post-isometric relaxation techniques on pain, ROM and functions in TMJ patients.
The study would be randomized clinical trial. Total 24 subjects will be assigned randomly into two groups by using lottery methods. Baseline treatment will be same (ultrasound, tapping) in both groups. Group A will be treated by Bowen's therapy and Group B will be treated by post-isometric relaxation technique for 30 min session (2 sessions/week and total 4 weeks). Numeric Pain Rating Scale, maximum mouth opening inter-incisal rural and jaw functional limitation scale-20 would be used as an outcome measurement tool for pain, range of motion and function respectively. Measurement will be taken at Baseline and at the end of the 4th week's treatment session. After assessing the normality data will be analyzed by using parametric / nonparametric test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bowen's therapy | Experimental | Other: Bowen's therapyBowens therapy will be given to 12 patients of temporomandibular joint disorder . |
| Post isometric relaxation | Experimental | Other: Post isometric relaxationpost isometric relaxation technique will be given to12 patients of temporomandibular joint disorder. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and Female Participant aged 20-50.
- Pain on function.
- Restricted jaw movement.
- Clicking, popping sound.
- Tenderness in muscle of mastication.
Key exclusion criteria (6 listed)
- Systematic arthropathy such as.
- Rheumatoid arthritis
- Fracture of jaw or TMJ.
- Malignant history of face and jaw.
- Prevent history of jaw or TMJ surgery.
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 |
|---|---|---|
| Bowen's therapyBowens technique will be apply on patients of TMJ for 2 repetitions in 1 set, 4 sets in each session for 4 weeks. | Other | Bowen's therapy |
| Post isometric relaxationpost isometric relaxation technique and jaw exercises (strengthen the weakened muscles, stretch the shortened muscles) with dosage 5 times/session, 5 sec rest and 2times/week for 4 weeks will apply on patients. | Other | Post isometric relaxation |
Primary outcome
NPRS for pain
Time frame: 4th week
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Maximum Mouth opening (Inter- incisal Rural) for rang of motion
Time frame: 4th week
Maximum mouth opening is a vital and objective clinical parameter for assessment of stomatognathic region and it represents the range of vertical mandibular range of movement.The distance between the upper central incisor and lower incisor determined by flexible intra-oral ruler ,it is valid and reliable tool for measure TMJ distance.
Jaw Functional Limitation Scale for functional activity
Time frame: 4th week
Jaw functional limitation is a 20 items,3 level functional scale mastication, vertical jaw mobility, emotional and verbal expression. NO LIMITATION'' score have 0 and SEVER LIMITATION '' have 10 score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Background: PubMed 34834522Moleirinho-Alves PMM, Cebola PMTC, Dos Santos PDG, Correia JP, Godinho C, Oliveira RANDS, Pezarat-Correia PLC. Effects of Therapeutic and Aerobic Exercise Programs on Pain, Neuromuscular Activation, and Bite Force in Patients with Temporomandibular Disorders. J Pers Med. 2021 Nov 10;11(11):1170. doi: 10.3390/jpm11111170.
- Background: PubMed 32979853Madariaga VI, Jasim H, Ghafouri B, Ernberg M. Myogenous temporomandibular disorders and salivary markers of oxidative stress-A cross-sectional study. J Oral Rehabil. 2021 Jan;48(1):1-9. doi: 10.1111/joor.13100. Epub 2020 Oct 5.
- Background: PubMed 29972708de Paiva Bertoli FM, Bruzamolin CD, de Almeida Kranz GO, Losso EM, Brancher JA, de Souza JF. Anxiety and malocclusion are associated with temporomandibular disorders in adolescents diagnosed by RDC/TMD. A cross-sectional study. J Oral Rehabil. 2018 Oct;45(10):747-755. doi: 10.1111/joor.12684. Epub 2018 Jul 20.
- Background: PubMed 28792365Osiewicz MA, Lobbezoo F, Loster BW, Loster JE, Manfredini D. Frequency of temporomandibular disorders diagnoses based on RDC/TMD in a Polish patient population. Cranio. 2018 Sep;36(5):304-310. doi: 10.1080/08869634.2017.1361052. Epub 2017 Aug 9.
- Background: PubMed 33218522Lee K, Lewis GN. Short term relief of multisite chronicpain with Bowen Therapy: A double-blind, randomized controlled trial. J Bodyw Mov Ther. 2020 Oct;24(4):271-279. doi: 10.1016/j.jbmt.2020.06.025. Epub 2020 Jul 30.
- Background: PubMed 33818314Tanhan A, Ozer AY, Polat MG. Efficacy of different combinations of physiotherapy techniques compared to exercise and patient education in temporomandibular disorders: A randomized controlled study. Cranio. 2023 Jul;41(4):389-401. doi: 10.1080/08869634.2021.1909454. Epub 2021 Apr 5.
- Background: PubMed 34810363Ram HK, Shah DN. Comparative evaluation of occlusal splint therapy and muscle energy technique in the management of temporomandibular disorders: A randomized controlled clinical trial. J Indian Prosthodont Soc. 2021 Oct-Dec;21(4):356-365. doi: 10.4103/jips.jips_332_21.
- Background: PubMed 34547165Volkan-Yazici M, Kolsuz ME, Kafa N, Yazici G, Evli C, Orhan K. Comparison of Kinesio Taping and manual therapy in the treatment of patients with bruxism using shear-wave elastography-A randomised clinical trial. Int J Clin Pract. 2021 Dec;75(12):e14902. doi: 10.1111/ijcp.14902. Epub 2021 Oct 8.
- Background: PubMed 34931336Asquini G, Pitance L, Michelotti A, Falla D. Effectiveness of manual therapy applied to craniomandibular structures in temporomandibular disorders: A systematic review. J Oral Rehabil. 2022 Apr;49(4):442-455. doi: 10.1111/joor.13299. Epub 2022 Jan 17.
- Derived from this study: PubMed 38867195Javed S, Bashir MS, Mehmood A, Noor R, Ikram M, Hussain G. Comparative effects of post isometric relaxation technique and Bowen's therapy on pain, range of motion and function in patients with temporomandibular joint disorder. BMC Oral Health. 2024 Jun 12;24(1):679. doi: 10.1186/s12903-024-04440-1.
- 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. This study is not recruiting at the moment.
Muhammad Salman Bashir, PhD 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 Bowen's therapy and Post isometric relaxation in people with Temporomandibular Joint Disorders, 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 7 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: status not confirmed, as of the sponsor's last update on 26 May 2022. 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?
Results are not available in the source record.
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?
NPRS for pain (time frame: 4th week). The study lists 3 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 NCT05392049, which also lists 10 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 26 May 2022.