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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05392049
Other study ID # REC/RCR & AHS/22/0106
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date January 1, 2023

Study information

Verified date May 2022
Source Riphah International University
Contact Imran Amjad, PhD
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date January 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Bowen's therapy
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 relaxation
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.

Locations

Country Name City State
Pakistan Lahore Dental care clinic samnabad Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

Asquini 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. Review. — View Citation

de 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. — View Citation

Lee 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. — View Citation

Madariaga 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. — View Citation

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). pii: 1170. doi: 10.3390/jpm11111170. — View Citation

Osiewicz 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. — View Citation

Ram 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. — View Citation

Tanhan 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. 2021 Apr 5:1-13. doi: 10.1080/08869634.2021.1909454. [Epub ahead of print] — View Citation

Volkan-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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 4th week
Primary 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. 4th week
Primary 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 4th week
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