NCT06858072

Brief Summary

To find effective therapeutic interventions for QLS, a study is being conducted to compare the efficacy of two promising techniques: Transverse Friction Massage (TFM) and Instrument-Assisted Soft Tissue Mobilization (IASTM) . Participants will be randomly assigned to either the TFM or IASTM groups. Outcome measures will be collected before and after the intervention, including pain levels assessed through NPRS, range of motion using inclinometer and posture by measuring leg length discrepancy with tape method.Non probability convenience sampling will be used and 34 partcipants will be randomly allocated in two groups after meeting inclusion criteria.Both groups will receive hotpack for 10-15min.Stretching quadratus lumborum will also be performed with strengthening on the opposite side of affected quadratus lumborum.This methodology provides a solid assessment of the effectiveness of TFM and IASTM for Quadratus Lumborum Syndrome therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

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

May 2, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
Last Updated

March 5, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

February 20, 2025

Last Update Submit

March 4, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain rating scale(NPRS)

    The Numeric Pain Rating Scale (NPRS-11) has been widely used clinically to assess pain. Universal pain screening with a 0-10 pain intensity numeric pain rating scale (NPRS) has been widely implemented in primary care. The current study will use this scale to measure pain in the lumbosacral joint. A numerical pain rating scale (NPRS) requires patients to rate their pain on a defined scale. For example, 0 is no pain, and 10 is the worst. NPRS scores ≤ 5 correspond to mild, 6-7 to moderate, and scores ≥8 to severe pain regarding pain-related interference with functioning

    8 weeks

  • Range of motion

    The range of motion of the lumbosacral joint will be measured through an inclinometer for lumbar flexion (40-60 degrees), extension (20-35 degrees), and rotations (15-25 degrees) range of motion.

    8 weeks

  • Posture

    Leg length discrepancy (LLD) is a "direct" measurement using a tape measure that can be utilized to measure the "true" leg length from the anterior superior iliac spine (ASIS) to the medial malleolus. The "apparent" leg length is measured from the umbilicus to the medial malleolus, considered normal up to 1 cm, with mild LLD ranging from 1 to 2 cm, moderate LLD from 2 to 5 cm, and severe LLD greater than 5 cm

    8 weeks

Study Arms (2)

Instrument assisted soft tissue mobilization

EXPERIMENTAL

IASTM (Instrument-Assisted Soft Tissue Mobilization) in four specific body areas for four weeks. The quadratus lumborum, posterior fascia, sacrum, hip lateral rotators, and hamstring bilaterally

Other: Instrument assissted soft tissue mobilization(IASTM)

Transverse friction massage

ACTIVE COMPARATOR

therapist will perform the transverse friction massage using their thumb to apply pressure across the muscle fibers of Quadratus Lumborum

Other: Transverse friction massage

Interventions

IASTM (Instrument-Assisted Soft Tissue Mobilization) in four specific body areas. The quadratus lumborum, posterior fascia, sacrum, hip lateral rotators, and hamstring bilaterally were these areas. The subjects were asked to kneel directly on the bed to stimulate the lumbar posterior muscles erector spinae (iliocostalis, longissimus), lumborum, and multifidus. At the same time, the IASTM treatment was applied to the rear fascia. The same treatment was applied to the sacrum while the subject kneeled on the bed. For hip lateral rotators, the IASTM treatment was applied to the gluteus maximus and gluteus medius while kneeling in a prone position with knee and hip flexion. Similarly, for the hamstring bilaterally, the IASTM treatment was applied to the biceps femoris, semitendinosus, and semimembranosus while in a prone position. The instrument was used for about 20 seconds in a direction parallel to the muscle fibers being treated and then for an additional 20 sec perpendicular to fibres

Instrument assisted soft tissue mobilization

patient was lying prone while the therapist administered a transverse friction massage to the affected area. Before the massage, the therapist cleansed and dried the place to be treated, ensuring it was free of dirt or debris. The therapist used their palpation skills to locate the site of pain and apply the massage technique accordingly. The therapist performed the transverse friction massage using their thumb to apply pressure across the muscle fiber, with each repetition lasting for two minutes

Transverse friction massage

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales 18-40years
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age group between 18-40years
  • Males only with target population was office workers
  • NPRS\>4
  • Patients with a positional fault of the pelvis (lateral tilt)
  • Patients having chronic LBP for more than six months
  • Hyperirritable spot or taut band
  • Positive jump sign for trigger points/ Referred pain related to the trigger point area
  • Positive Lewis's functional palpation test for QL overactivity
  • At least one trigger point in Quadratus lumborum
  • Leg length discrepancy due to QL tightness

You may not qualify if:

  • Congenital or acquired spinal deformities
  • Spinal stenosis or radiculopathy
  • Diagnosed disc prolapse
  • Rheumatoid arthritis
  • Any malignancy
  • Recent history of surgery less than three months
  • Acute infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hafiz Medical and diagnostic Center johar town Lahore

Lahore, Punjab Province, 53200, Pakistan

Location

Study Officials

  • Faiza Amjad, PhD

    Riphah international universiy

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 20, 2025

First Posted

March 5, 2025

Study Start

May 2, 2023

Primary Completion

December 23, 2023

Study Completion

July 2, 2024

Last Updated

March 5, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations