NCT07441031

Brief Summary

Low back pain is a complex of musculoskeletal disorders or muscular imbalance and one of the most common problems of patients referred to physiotherapy clinics, but still diagnosis and especially the provision of special back pain therapy is a challenge. According to the studies, 84% of the population at least once in a lifetime. Non-specific Lower back pain NSLBP does not have any specific cause and almost 90% of patients experience undiagnosed pathologic LBP. It is multifactorial and has different causes depends on the type of injury. Common etiologies behind NSLBP are muscular weakness, postural instability, fascial restriction, lumbo-pelvic muscle imbalance, change in spinal curvature and abnormal tilting of pelvic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

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, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

February 23, 2026

Last Update Submit

February 23, 2026

Conditions

Keywords

Myofascial Release TherapyExerciseLow Back PainLumbarLordosis

Outcome Measures

Primary Outcomes (3)

  • Inclinometer:

    An inclinometer (or clinometer), is an instrument used for measuring the angles of slope/tilt and elevation/depression of an object with respect to gravity. The average ranges of anterior tilting are 13.0 ± 4.9° degree. The inter-class reliability showed that there was a low 16 reliability of absolute angular error by digital inclinometer (with ICC=0.467 and Pvalue=0.004).

    8 WEEKS

  • Numerical Pain Rating Scale (NPRS):

    Tool for the assessment of pain intensity (NPRS) will be used. This scale ranges from 0 to 10, where 0 indicates "no pain" at all and 10 indicates "worst pain". NPRS have shown high test- retest reliability (r = 0.96 and 0.95, respectively).

    8 WEEKS

  • Flexicurve

    The Flexicurve (portable flexible rubber ruler) is a non-invasive and inexpensive tool used to perform the quick assessment of spinal curvatures. Therefore, it is some time consider as the valuable instrument to evaluate kyphosis and lordosis in the clinical set-up. According to the literature, it is reliable and valid with 85% Sensitivity and 97% specificity.

    8 WEEKS

Study Arms (2)

McGill exercise with Three-Dimensional Myofascial Release along with Baseline.

EXPERIMENTAL

Patients will receive McGill exercise with Three-Dimensional Myofascial Release along with Baseline Physical therapy treatment protocol.

Other: McGill exercise with 3 D Myofascial Release.

McGill exercise without 3-D MFR along with Baseline protocol.

ACTIVE COMPARATOR

Patients Will receive McGill exercise without 3-D MFR along with Baseline protocol.

Other: McGill exercise without 3-D MFR

Interventions

Treatment will include McGill's big 3 core exercises initially 2 sets of 10rep then progress with increasing sets and repetitions. And 3-D Myofascial release stretches, each for 90sec. 1 set of 3rep in every physiotherapy session. Patient will get 3 sessions of 40-45minutes, per week for 6 weeks.

McGill exercise with Three-Dimensional Myofascial Release along with Baseline.

Perform McGill's big 3 core exercises initially 2 sets of 10rep then progress with increasing sets and repetitions. Patient will get total 3 sessions per week of 40- 45minutes for 6 weeks.

McGill exercise without 3-D MFR along with Baseline protocol.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pain rate 3-7 on NPRS.
  • Localized back pain between the 12th rib and the gluteal folds.
  • Hyperlordotic curvature of lumber spine beyond range 37° to 42°.
  • No radiating pain or paresthesia during SLR.
  • No evidence of congenital anomalies.
  • Diagnosed hyprlordotic lumbar.
  • Positive special test (mini 2): Thomas test, wall test, The modified Schöber technique test (MST), The fingertip-to-floor test and Straight leg raise test.

You may not qualify if:

  • Individual with diagnosed neurological and rheumatologically disorder.
  • History of abdominal, lumber or sacral spine, recent spinal surgery.
  • Person on painkillers during last 3 months.
  • Having history of spinal fracture.
  • Females in post-partum period or pregnancy.
  • History of Severe osteoporosis, Tumor.
  • Severe heart failure or respiratory failure, active drug addiction, active psychiatric pathology.
  • Intervertebral disc pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah rehabilitation clinic Lahore.

Lahore, Punjab Province, 56700, Pakistan

Location

MeSH Terms

Conditions

Motor ActivityLow Back PainLordosis

Condition Hierarchy (Ancestors)

BehaviorBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Faiza Taufiq

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants received McGill exercise with and without 3-Dimensional Myofascial release technique.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2026

First Posted

February 27, 2026

Study Start

February 15, 2025

Primary Completion

January 5, 2026

Study Completion

January 5, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations