NCT05709925

Brief Summary

This study is a Randomized Control Trial in which participants aged 18-50 years having diagnosed chronic mechanical low back pain will be recruited into two groups. Group A will be receiving myofascial release using stripping technique whereas, Group B will be receiving Instrument Assisted Soft Tissue Mobilization using long bar tool. Afterwards, post-treatment stretching would be performed in both the groups. Final assessment of pain, range of motion and disability will be done on last treatment session.

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
50

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Aug 2022

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

Study Start

First participant enrolled

August 11, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 25, 2023

Last Update Submit

February 1, 2023

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Lumbar range of motion

    Range of motion is the ability of a joint to go through its complete spectrum of movement and it will be measured using gravity-based inclinometer.

    3 weeks

Secondary Outcomes (2)

  • Pain Intensity

    3 weeks

  • Lumbar Disability

    3 weeks

Study Arms (2)

Group A

OTHER

Group A will be receiving moist heat for 10 minutes followed by myofascial release through stripping technique to the lumbar region. After that post-treatment stretching would be performed. Total treatment plan would be of 30 minutes, comprising of total 9 sessions (3 weeks), 3 sessions on alternate days

Procedure: myofascial release

Group B

EXPERIMENTAL

Group B will be receiving moist heat for 10 minutes followed by Instrument Assisted Soft Tissue Mobilization using long bar tool for 5-7 minutes with gentle horizontal stroking at an angle of 45 degrees. After that, post treatment stretching consisting of 2-3 sets of 10 repetitions of the targeted muscle group will be performed.Total treatment plan will be of 3 weeks comprising of total 9 sessions, 3 sessions on alternate days.

Procedure: Instrument Assisted Soft Tissue Mobilization

Interventions

Instrument Assisted Soft Tissue MobilizationPROCEDURE

The Graston Technique which is the Instrument Assisted Soft Tissue Mobilization is the use of a firm instrument to break tissue adhesions and mobilize scar tissue thus improving pain, range of motion and disability.

Group B
myofascial releasePROCEDURE

myofascial release through stripping technique to the lumbar region.

Group A

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals aged 18-50 years with diagnosed chronic mechanical low back pain.
  • Males and females both.
  • Participants having symptoms of duration more than 3 months.
  • Numeric Pain Rating Scale (NPRS) score of 5 or more.

You may not qualify if:

  • Patient with a history of recent spinal surgery and related trauma.
  • Participants with a history of pregnancy.
  • Participants with a history of infection, tumor and spinal fracture.
  • Participants with diagnosed Psychiatric Disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (1)

  • Gul S, Bashir S, Kayani NM, Sabir Z, Qurat-Ul-Ain H. Effects of instrument assisted soft tissue mobilisation in patients with chronic mechanical low back pain----A randomized control trial. J Pak Med Assoc. 2025 Feb;75(2):181-185. doi: 10.47391/JPMA.11511.

    PMID: 39948773DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be unaware of the type of the intervention they would be receiving.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Group Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 2, 2023

Study Start

August 11, 2022

Primary Completion

March 30, 2023

Study Completion

June 30, 2023

Last Updated

February 2, 2023

Record last verified: 2023-01

Locations

PA(1)