NCT06976242

Brief Summary

This randomized controlled trial aims to compare the effectiveness of elastic resistance training and free weight training in strengthening the gluteus medius muscle among patients with chronic non-specific low back pain. Weakness in the gluteus medius can contribute to pelvic instability and altered gait patterns, which may exacerbate low back pain. While both elastic resistance and free weight exercises are commonly used in rehabilitation, there is limited evidence comparing their relative benefits in this population. This study evaluates improvements in pain, muscle strength, and overall gait speed following each intervention. The findings will help guide clinicians in choosing the most effective and accessible strengthening method for patients with chronic non-specific low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

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

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable low-back-pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

September 3, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

May 8, 2025

Last Update Submit

September 1, 2025

Conditions

Keywords

Gluteus MediusLow Back PainChronic Non-Specific Low Back PainExercise Therapy

Outcome Measures

Primary Outcomes (3)

  • Change in Pain Intensity

    Pain will be assessed using the Numeric Pain Rating Scale (NPRS), a self-reported 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).

    Baseline and at 4 weeks post-intervention

  • Change in Gluteus Medius Muscle Strength

    Muscle strength will be measured using a manual muscle testing to assess isometric strength of the gluteus medius. A system of manually testing weakness of muscles by assuming different positions and performing movements against gravity or gravity eliminated depending on the strength of the and 5 indicates the muscle can hold anti-gravity position against maximum resistance.

    Baseline and at 4 weeks post-intervention

  • Change in Overall Gait Speed

    Gait speed will be measured using the 10-Meter Walk Test (10MWT), recorded in meters per second (m/s).

    Baseline and at 4 weeks post-intervention

Study Arms (2)

Elastic Resistance Training with Conventional Training

EXPERIMENTAL

The participants in this group will receive elastic resistance training with conventional training. The intervention would be given 5 times per week on alternate days for 4 weeks. Each exercise session will be given in 2sets of 8 repetitions each set.

Procedure: Elastic Resistance TrainingProcedure: Conventional Training

Free Weight Training along with Conventional Training

ACTIVE COMPARATOR

The participants in this group will receive free weight training along with conventional training. The intervention frequency will be the same as group A (5 times/week for 4 weeks). Each exercise session will be given in 2 sets of 8 repetitions each set.

Procedure: Free Weight ExercisesProcedure: Conventional Training

Interventions

The type of resistance exercises in which the participants use the Thera Band of yellow and red colours (weight about 2-2.5 kg with full elongation) for resistance training

Also known as: Resistance Band Training, Theraband Exercise
Elastic Resistance Training with Conventional Training

The type of resistance exercises in which the participants use weight cuffs (weight 2-2.5 kg) tied to their lower leg for resistance training

Free Weight Training along with Conventional Training

The conventional training includes side-lying hip abductions, standing weighted abductions, and lateral step-ups exercises.

Elastic Resistance Training with Conventional TrainingFree Weight Training along with Conventional Training

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 30-60 years
  • Both males and females of any race and ethnicity
  • Musculoskeletal condition that affects the gluteus Medius of hip
  • MMT for gluteus medius is 3 or less than 3
  • chronic stage of nonspecific low back pain
  • Cognitively intact (mini mental scale) and able to walk 10 meters with or without support.
  • Volunteer participations.

You may not qualify if:

  • Post-surgical conditions like TKR, THR.
  • Any contraindication to exercise.
  • Female individuals who have muscular weakness due to pregnancy
  • Any neurological conditions (myopathies, neuropathies) causing muscular weakness
  • Chronic low back pain in which Gluteus Medius weakness is not measurable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehman Medical Institute

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Publications (11)

  • Roelker SA, Kautz SA, Neptune RR. Muscle contributions to mediolateral and anteroposterior foot placement during walking. J Biomech. 2019 Oct 11;95:109310. doi: 10.1016/j.jbiomech.2019.08.004. Epub 2019 Aug 9.

    PMID: 31451199BACKGROUND
  • Ventura JD, Klute GK, Neptune RR. Individual muscle contributions to circular turning mechanics. J Biomech. 2015 Apr 13;48(6):1067-74. doi: 10.1016/j.jbiomech.2015.01.026. Epub 2015 Feb 2.

    PMID: 25700608BACKGROUND
  • Kasitinon D, Li WX, Wang EXS, Fredericson M. Physical Examination and Patellofemoral Pain Syndrome: an Updated Review. Curr Rev Musculoskelet Med. 2021 Dec;14(6):406-412. doi: 10.1007/s12178-021-09730-7. Epub 2021 Oct 29.

    PMID: 34713383BACKGROUND
  • Bauer CM, Rast FM, Ernst MJ, Meichtry A, Kool J, Rissanen SM, Suni JH, Kankaanpaa M. The effect of muscle fatigue and low back pain on lumbar movement variability and complexity. J Electromyogr Kinesiol. 2017 Apr;33:94-102. doi: 10.1016/j.jelekin.2017.02.003. Epub 2017 Feb 13.

    PMID: 28226298BACKGROUND
  • Lanza MB, Rock K, Marchese V, Addison O, Gray VL. Hip Abductor and Adductor Rate of Torque Development and Muscle Activation, but Not Muscle Size, Are Associated With Functional Performance. Front Physiol. 2021 Oct 14;12:744153. doi: 10.3389/fphys.2021.744153. eCollection 2021.

    PMID: 34721067BACKGROUND
  • Sheahan PJ, Diesbourg TL, Fischer SL. The effect of rest break schedule on acute low back pain development in pain and non-pain developers during seated work. Appl Ergon. 2016 Mar;53 Pt A:64-70. doi: 10.1016/j.apergo.2015.08.013. Epub 2015 Sep 10.

    PMID: 26674405BACKGROUND
  • Khayambashi K, Ghoddosi N, Straub RK, Powers CM. Hip Muscle Strength Predicts Noncontact Anterior Cruciate Ligament Injury in Male and Female Athletes: A Prospective Study. Am J Sports Med. 2016 Feb;44(2):355-61. doi: 10.1177/0363546515616237. Epub 2015 Dec 8.

    PMID: 26646514BACKGROUND
  • Butowicz CM, Ebaugh DD, Noehren B, Silfies SP. VALIDATION OF TWO CLINICAL MEASURES OF CORE STABILITY. Int J Sports Phys Ther. 2016 Feb;11(1):15-23.

    PMID: 26900496BACKGROUND
  • Qiu J, Zhou T, Jin H, Pan Y, Qian T, Xue C, Xia W, Shi H, An B. Effect of adding hip exercises to general rehabilitation treatment of knee osteoarthritis on patients' physical functions: a randomized clinical trial. BMC Sports Sci Med Rehabil. 2023 Nov 23;15(1):158. doi: 10.1186/s13102-023-00772-7.

    PMID: 37996958BACKGROUND
  • Lorenzetti S, Ostermann M, Zeidler F, Zimmer P, Jentsch L, List R, Taylor WR, Schellenberg F. How to squat? Effects of various stance widths, foot placement angles and level of experience on knee, hip and trunk motion and loading. BMC Sports Sci Med Rehabil. 2018 Jul 17;10:14. doi: 10.1186/s13102-018-0103-7. eCollection 2018.

    PMID: 30026952BACKGROUND
  • Psilander N, Eftestol E, Cumming KT, Juvkam I, Ekblom MM, Sunding K, Wernbom M, Holmberg HC, Ekblom B, Bruusgaard JC, Raastad T, Gundersen K. Effects of training, detraining, and retraining on strength, hypertrophy, and myonuclear number in human skeletal muscle. J Appl Physiol (1985). 2019 Jun 1;126(6):1636-1645. doi: 10.1152/japplphysiol.00917.2018. Epub 2019 Apr 11.

    PMID: 30991013BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gulab Noor, MSPT

    Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar

    PRINCIPAL INVESTIGATOR
  • Dr Hazrat Bilal, PhD*

    Institute of Physical Medicine and Rehabilitation, Khyber Medical University Peshawar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and assessors performing pre- and post-intervention evaluations will be blinded to group allocation to reduce bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either an elastic resistance training group or a free weight training group to compare outcomes related to pain, strength, and gait speed.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 16, 2025

Study Start

April 1, 2025

Primary Completion

June 29, 2025

Study Completion

August 15, 2025

Last Updated

September 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Data obtained through this study may be provided to qualified researchers with academic interested in the stated study area after its proper monitoring. Data or samples shared will be coded, with no PHI included. Prior permission of the investigators, participants and concerned departments will be obtained.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data requests can be submitted starting 12 months after article publication.
Access Criteria
Access can be requested by qualified researchers through proper approval of the investigators.

Locations