- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06976242
- Original Trial
Comparison Of The Effectiveness Of Elastic Resistance Versus Free Weight Training Of Gluteus Medius In Improving Pain, Strength, And Overall Gait Speed In Patients With Chronic Non-Specific Low Back Pain
Comparison Of The Effectiveness Of Elastic Resistance Versus Free Weight Training Of Gluteus Medius In Improving Pain, Strength, And Overall Gait Speed In Patients With Chronic Non-Specific Low Back Pain: Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The gluteus medius plays a vital role in pelvic stabilization and maintaining proper gait mechanics. Dysfunction or weakness in this muscle is frequently associated with chronic non-specific low back pain, a condition affecting a significant proportion of the population. Rehabilitation strategies that target the gluteus medius are crucial for restoring lumbar-pelvic stability, optimizing functional movement, and reducing pain.
Free weight training, using equipment like dumbbells and barbells, is a traditional method to enhance muscle strength and improve neuromuscular coordination. However, it often requires proper supervision to avoid injury due to the need for controlled movements and joint stability. On the other hand, elastic resistance training, which employs tools like resistance bands or tubes, offers a safer, cost-effective, and portable alternative. It allows progressive resistance throughout the range of motion, matching the user's strength curve and facilitating home-based exercise programs.
This randomized controlled trial is designed to compare these two training modalities, which are elastic resistance versus free weights in terms of their effectiveness at improving gluteus medius strength, reducing low back pain, and enhancing gait speed in patients with chronic non-specific low back pain. The trial includes baseline and post-intervention assessments using validated clinical tools for measuring pain, strength, and gait speed.
The goal is to determine which intervention yields greater clinical benefit and offers a more practical approach for implementation in therapeutic settings, especially for populations with limited access to conventional gym equipment. The findings could contribute valuable evidence to inform clinical decision-making in physical therapy and rehabilitation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Khyber Pakhtunkhwa
-
Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
- Rehman Medical Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Elastic Resistance Training with Conventional Training
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.
|
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
Other Names:
The conventional training includes side-lying hip abductions, standing weighted abductions, and lateral step-ups exercises.
|
|
Active Comparator: Free Weight Training along with Conventional Training
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.
|
The conventional training includes side-lying hip abductions, standing weighted abductions, and lateral step-ups exercises.
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Intensity
Time Frame: Baseline and at 4 weeks post-intervention
|
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
Time Frame: Baseline and at 4 weeks post-intervention
|
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
Time Frame: Baseline and at 4 weeks post-intervention
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: 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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMU/DIR/CTU/2025/001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
University of Kansas Medical CenterCompletedLower Back Pain | Low Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, Postural | Postural Low Back Pain | Mechanical Low Back Pain | Low Back Ache | Recurrent Low Back Pain | Lower Back Pain Chronic | Low Back Pain, Posterior Compartment | Low BackacheUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
Istanbul UniversityIstinye UniversityCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, PosturalTurkey
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
General Incorporated Foundation Ryukyuseimeisaiseikai...CompletedChronic Low Back Pain | Non-specific Low Back Pain | Low Back Pain (LBP)Japan
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
MMJ Labs LLCNational Institute on Drug Abuse (NIDA); Sport and Spine Rehab Clinical Research...CompletedChronic Low-back Pain | Pain, Intractable | Acute Low-back PainUnited States
-
Pamukkale UniversityCompletedLow Back Disorder | Low Back Pain (LBP)Turkey
Clinical Trials on Elastic Resistance Training
-
Bruno FigueiraCompletedPerformance | StrengthLithuania
-
Beijing Sport UniversityNot yet recruitingRespiration DisordersChina
-
Riphah International UniversityCompletedSports Physical Therapy | Anthropometric Measurements and Elastic Resistance TrainingPakistan
-
Lou QingqingCompleted
-
Chang Bing Show Chwan Memorial HospitalUnknown
-
China Medical University HospitalCompleted
-
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical...CompletedBody Weight Changes | Sarcopenia | Prader Labhart Willi SyndromeTaiwan
-
University of MichiganEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedAnterior Cruciate Ligament InjuryUnited States
-
University of DerbyCompletedAcute Effects of Elastic Band Resistance on Postural Stability and Physical Function in Older AdultsOld Age; Debility | Stability | Balance | PosturographyUnited Kingdom
-
The University of Hong KongHospital Authority, Hong KongRecruiting