NCT06534853

Brief Summary

This study is a randomised control trial and the purpose of this study is to determine the effects Post facilitation stretch versus reciprocal inhibition on pain, lumbar range of motion, apparent leg length discrepancy and lumbar lordotic angle in Quadratus Lumborum Syndrome.

Trial Health

57
Monitor

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 Sep 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

July 30, 2024

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pain intensity

    Pain is assessed by using numeric main rating scale comparing pre and post pain intensity. This is 11- point numeric scale ranges from '0' representing one pain extreme (e.g., "no pain") to '10' representing the other pain extreme

    2 weeks

  • Lumbar Range of Motion (ROM)

    It will measured using inclinometer

    2 weeks

  • Leg Length Discrepancy (LLD)

    Measure the distance between the anterior superior iliac spine (ASIS) and the medial malleolus.This method, referred to as the "direct" clinical method for measuring LLD, provides the apparent leg length discrepancy.

    2 weeks

  • Lumbar Lordotic Angle

    It will be measured using Flexible Ruler

    2 weeks

Study Arms (2)

PFS Group

EXPERIMENTAL

Group A along with Post facilitation stretch of quadratus lumborum will a comprehensive therapeutic regimen that includes a 10-minute session of hot pack therapy specifically targeted at the low back region. In addition to this, participants will receive trigger point release therapy to alleviate muscle tension. The treatment plan also incorporates a tailored exercise protocol designed to enhance back health and strength. This protocol includes: 1. Back isometric exercises 2. Bridging exercises 3. Cat and camel stretches 4. Prone press-ups 5. Abductor strengthening exercises

Other: Post Facilitation StretchOther: Conventional Physical Therapy

RI Group

EXPERIMENTAL

Group B along with Reciprocal inhibition of quadratus lumborum will a comprehensive therapeutic regimen that includes a 10-minute session of hot pack therapy specifically targeted at the low back region. In addition to this, participants will receive trigger point release therapy to alleviate muscle tension. The treatment plan also incorporates a tailored exercise protocol designed to enhance back health and strength. This protocol includes: 1. Back isometric exercises 2. Bridging exercises 3. Cat and camel stretches 4. Prone press-ups 5. Abductor strengthening exercises

Other: Reciprocal InhibitionOther: Conventional Physical Therapy

Interventions

The patient is placed in the lateral decubitus position with the affected side up and a Dutchman's roll or pillow under the iliac crest. Positioned at the edge of the table, the patient's inferior leg is flexed with the foot at the table's edge. The patient grasps the headpiece of the table with the superior hand, allowing the superior leg to drop off the back of the table.The therapist stands behind the patient, providing support to prevent posterior pelvic rotation with their thigh behind the pelvis. The cephalad hand grasps the top of the iliac crest and applies a caudad force, while the caudad hand gently guides the affected leg without generating force.The patient "hikes" the hip against the resistance from the therapist's cephalad hand, creating an isometric contraction for 5-10 seconds. The patient then relaxes, followed by a rapid stretch held for 10 seconds until the next barrier is reached. This procedure is repeated 3-5 times.

PFS Group

The patient is placed in the lateral decubitus position with the affected side up and a Dutchman's roll or pillow under the iliac crest. Positioned at the edge of the table, the patient's inferior leg is flexed with the foot at the table's edge. The patient grasps the headpiece of the table with the superior hand, allowing the superior leg to drop off the back of the table.The therapist stands behind the patient, providing support to prevent posterior pelvic rotation with their thigh behind the pelvis. The cephalad hand grasps the top of the iliac crest and applies a caudad force, while the caudad hand gently guides the affected leg without generating force.The patient "hikes" the hip against the resistance from the therapist's cephalad hand, creating an isometric contraction for 5-10 seconds. The patient then relaxes, followed by a rapid stretch held for 10 seconds until the next barrier is reached. This procedure is repeated 3-5 times.

RI Group

A comprehensive therapeutic regimen that includes a 10-minute session of hot pack therapy specifically targeted at the low back region. In addition to this, participants will receive trigger point release therapy to alleviate muscle tension.The treatment plan also incorporates a tailored exercise protocol designed to enhance back health and strength. This protocol includes: 1. Back isometric exercises 2. Bridging exercises 3. Cat and camel stretches 4. Prone press-ups 5. Abductor strengthening exercises

PFS GroupRI Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35 years
  • Both genders
  • Having pain of ≤ 8 on NPRS from at least 3 months
  • Pain decreases on supine lying
  • Any two of the following findings positive of unilateral quadratus lumborum on physical examination:
  • Taut bands
  • Local tenderness
  • Patient's pain recognition
  • Pain referral to greater trochanter
  • Local twitch response

You may not qualify if:

  • Painful isometric muscle testing of hip flexors, abductors, adductors, and extensors
  • Previous surgery of lower limb
  • Centralization/peripheralization
  • Lower back trauma
  • Positive SLR
  • Radiculopathy
  • Fracture/surgery of pelvic and/or hip region
  • Diagnosed fibromyalgia or other rheumatic diseases.
  • Lactating women
  • Intrauterine device
  • Pregnant women
  • Use of psychiatric medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Central Study Contacts

Aqsa Ayaz, MS-MSKPT*

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

September 1, 2023

Primary Completion

January 15, 2025

Study Completion

January 30, 2025

Last Updated

August 2, 2024

Record last verified: 2024-07

Locations