NCT05158556

Brief Summary

Trigger point are hyper-irritable points, appear as nodules on palpation, discrete and focal spots in the taut band of skeletal muscles. Myofascial release technique and instrument assisted soft tissue mobilization both techniques are used to break the adhesions and mobilize the soft tissue, releasing the trigger points. The study will contribute in comparing the level of pain threshold perceived by males and females in our society. .Moreover, finding a noninvasive effective treatment that is non-exhaustive for the therapist and non-painful for the patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

December 13, 2021

Last Update Submit

March 8, 2022

Conditions

Keywords

trigger point,myofascial releaseinstrument assisted soft tissue mobilizationrange of motionpain

Outcome Measures

Primary Outcomes (5)

  • Numeric Pain Rating Scale

    Numeric Pain Rating Scale is an 11 point tool used to assess the pain intensity among people. Its value ranges from 0 to 10, where 0 means no pain and 10 means worst possible pain. It is a reliable and valid tool (r=0.96, its validity correlations range from 0.86 to 0.95.Assesment was performed at the base line and after 6-weeks.

    for 6 weeks

  • Pain Sensitivity Questionnaire

    Pain sensitivity questionnaire is a valid and reliable tool used to measure pain perception in different populations. Cronbach's alpha value for the Pain Sensitivity Questionnaire was 0.92. Assesment was performed at the base line and after 6-weeks.

    for 6 weeks

  • inclinometer

    An inclinometer is a device used by physical therapist to measure range of motion for spinal posture. An inclinometer gives more accurate, precise and reproducible Range of motion measurements than goniometer. It is a reliable and valid tool r=0.93, validity=0.92. Assesment was performed at the base line and after 6-weeks.

    for 6 weeks

  • Modified Somatic Perception Questionnaire

    Modified Somatic Perception Questionnaire is a self-report scale consists of 13 items. It helps to find out the complaints that are associated with psychological responses. The scale has ICC value 0.72. Assesment was performed at the base line and after 6-weeks.

    for 6 weeks

  • algometer

    Algometer is a reliable and valid tool used to measure the pressure pain threshold. intraclass correlation coefficient value =0.91. Assesment was performed at the base line and after 6-weeks.

    for 6 weeks

Study Arms (2)

myofascial release technique

EXPERIMENTAL

Myofascial Release Technique will be applied with forearm/ ulnar border of palm. deep pressure will be applied and glided medially towards the thoraco-lumbar region.ins

Other: Myofascial Release TechniqueOther: Instrument Assisted Soft tissue Mobilization

Instrument Assisted Soft Tissue Mobilization

EXPERIMENTAL

instrument assisted soft tissue mobilization is done via M2T Blade. it is a multifunctional instrument consisting of many planes and is very effective in treating pain and spasm. Its efficacy is proven over soft tissues that it releases fascial tightness.

Other: Myofascial Release TechniqueOther: Instrument Assisted Soft tissue Mobilization

Interventions

Myofascial Release Technique will be applied with forearm/ ulnar border of palm. Deep pressure will be applied and glided medially towards the thoraco-lumbar region.

Instrument Assisted Soft Tissue Mobilizationmyofascial release technique

instrument assisted soft tissue mobilization is done via M2T Blade. it is a multifunctional instrument consisting of many planes and is very effective in treating pain and spasm. Its efficacy is proven over soft tissues that it releases fascial tightness.

Instrument Assisted Soft Tissue Mobilizationmyofascial release technique

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with at least one active trigger point in lumbar region.
  • Office workers sitting in office \> 5 hours a day.
  • Targeting both deep and superficial muscles.

You may not qualify if:

  • History of spinal surgeries
  • Trauma
  • Acute Fractures
  • Tuberculosis spine
  • Wounds, Infections or any other cause of back pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muzaffar Khan Surgical Hospital

Rawalpindi, Punjab Province, 43600, Pakistan

Location

MeSH Terms

Conditions

Myofascial Pain SyndromesPain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • maria khalid, Ms-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2021

First Posted

December 15, 2021

Study Start

February 15, 2021

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations