NCT05971953

Brief Summary

The aim of this randomized controlled trial is to find the effect of muscle energy technique for trigger points of muscle of mastication for reducing pain , improving mouth opening and jaw functional limitations.

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
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

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

July 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2024

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

July 25, 2023

Last Update Submit

August 31, 2023

Conditions

Keywords

trigger pointsmuscles of masticationhamstring

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale VAS

    The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.

    2 weeks

Secondary Outcomes (2)

  • Inch Tape

    2 weeks

  • Jaw Functional Limitation Scale

    2 weeks

Study Arms (2)

Muscle Energy Technique

ACTIVE COMPARATOR

Muscle Energy Technique

Other: Muscle Energy Technique

Conventional PT

OTHER

Hot pack Ischemic compression

Other: Conventional PT

Interventions

They would be receiving treatment as follow: The patient is instructed to gently attempt to push down on the practitioner's shoulder with the leg against the practitioner's resistance( 75% of his and her available strength). After the relaxation, the muscle is lengthened more aggressively beyond the barrier and held for up to 15 seconds. Frequency: 10 reps for 4 times/week for 2 consecutive weeks. Intensity: moderate intensity (pain free) Time: 20 mins

Muscle Energy Technique

They would be receiving conventional treatment as follow: including hot pack for 10 mins ischemic compression for 60 seconds .Frequency: 5 reps with 60 sec hold for 4 times/week for 2 weeks Intensity: moderate-high intensity (depending on pain tolerance) Time: 10 mins

Conventional PT

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age group 25 to 50 years..
  • Diagnosis of trps using the diagnostic criteria:
  • Presence of palpable taut band in a skeletal muscle.
  • Presence of hypersensitive tendor spot in a taut band
  • Spontaneous response of the typical referred pain pattern.
  • A local twitch response provided by snapping palpation of taut band.
  • Reproduction of the typical referred pain pattern of Trp in response to compression.
  • Reduced mouth opening \< 40nm

You may not qualify if:

  • Diagnosis of fibromyalgia.
  • History of whiplash injury
  • History of any surgery in the cranio cervical region
  • Having under gone any myofacial pain therapy
  • No lower extremity or low back pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Myofascial Pain SyndromesTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesCraniomandibular DisordersMandibular DiseasesJaw DiseasesJoint DiseasesStomatognathic Diseases

Study Officials

  • KINZA ANWAR, MS-OMPT

    RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

KINZA ANWAR, MS-OMPT

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 2, 2023

Study Start

August 30, 2023

Primary Completion

March 10, 2024

Study Completion

April 28, 2024

Last Updated

September 5, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations