NCT05392049

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

May 23, 2022

Conditions

Temporomandibular Joint Disorders

Keywords

Temporomandibular disorderPost isometric relaxationTemporomandibular joint pain

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Bowen's therapy

EXPERIMENTAL

Bowens therapy will be given to 12 patients of temporomandibular joint disorder .

Other: Bowen's therapy

Post isometric relaxation

EXPERIMENTAL

post isometric relaxation technique will be given to12 patients of temporomandibular joint disorder.

Other: Post isometric relaxation

Interventions

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.

Bowen's therapy
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.

Post isometric relaxation

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore Dental care clinic samnabad

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • 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.

    PMID: 34834522BACKGROUND

  • 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.

    PMID: 32979853BACKGROUND

  • 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.

    PMID: 29972708BACKGROUND

  • 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.

    PMID: 28792365BACKGROUND

  • 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.

    PMID: 33218522BACKGROUND

  • 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. 2023 Jul;41(4):389-401. doi: 10.1080/08869634.2021.1909454. Epub 2021 Apr 5.

    PMID: 33818314BACKGROUND

  • 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.

    PMID: 34810363BACKGROUND

  • 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.

    PMID: 34547165BACKGROUND

  • 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.

    PMID: 34931336BACKGROUND

  • Javed 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.

    PMID: 38867195DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Muhammad Salman Bashir, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

03324390125imran.amjad@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

June 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)