- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07610044
Pelvic Floor Exercises Versus Swiss Ball Exercises in Patients With Non-Specific Chronic Low Back Pain
Comparative Effects of Pelvic Floor Muscle Exercises and Swiss Ball Exercises in Patients With Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Non-specific chronic low back pain is a common musculoskeletal disorder associated with pain, restricted lumbar mobility, and reduced functional capacity. Weakness of core stabilizing muscles contributes significantly to spinal instability and persistent symptoms.
Exercise-based physiotherapy interventions including pelvic floor muscle exercises and swiss ball exercises are commonly used to improve core stability, lumbar mobility, muscle endurance, and pain management.
This randomized controlled trial will compare the effects of:
Baseline physiotherapy alone Baseline physiotherapy combined with swiss ball exercises Baseline physiotherapy combined with pelvic floor muscle exercises
A total of 69 participants will be randomly allocated into three parallel groups. Outcome measures including pain, disability, lumbar range of motion, and muscle endurance will be assessed before and after intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- University of Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Females aged 18-35 years
- Chronic non-specific low back pain for more than 3 months
- Restricted lumbar range of motion
- Positive straight leg raise test
- Positive femoral nerve tension test
- Positive slump test
- Willing to participate in the study
Exclusion Criteria:
- Previous or planned spinal surgery
- Pelvic floor surgery or abdominal surgery
- Pregnancy or postnatal period
- Urinary incontinence
- Neurological motor weakness or deformity
- Spinal stenosis
- Osteoporosis
- Disc herniation
- Degenerative or inflammatory spinal conditions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group (Baseline Physiotherapy)
Participants will receive baseline physiotherapy treatment including heating pad application, stretching exercises, and strengthening exercises.
|
Baseline physiotherapy includes heating pad application, stretching exercises, and strengthening exercises for lumbar stabilization and pain reduction.
|
|
Experimental: Experimental Group (Swiss Ball Exercises + Baseline Physiotherapy)
Participants will receive baseline physiotherapy combined with swiss ball exercises including curl-up, bridging, and front plank exercises.
|
Baseline physiotherapy includes heating pad application, stretching exercises, and strengthening exercises for lumbar stabilization and pain reduction.
Swiss ball exercises include curl-up, bridging, and front plank exercises performed on a swiss ball to improve core stability, balance, and muscle endurance.
|
|
Experimental: Experimental Group (Pelvic Floor Muscle Exercises + Baseline Physiotherapy)
Participants will receive baseline physiotherapy combined with pelvic floor muscle exercises for core stabilization and pain reduction.
|
Baseline physiotherapy includes heating pad application, stretching exercises, and strengthening exercises for lumbar stabilization and pain reduction.
Pelvic floor muscle exercises involve repeated contraction and relaxation cycles of pelvic floor muscles to improve core muscle activation, spinal support, and lumbar stability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Severity Measured by Revised Short McGill Pain Questionnaire-2 (SF-MPQ-2)
Time Frame: Baseline and 6 weeks after intervention
|
Pain severity and pain quality will be assessed using the Revised Short McGill Pain Questionnaire Version-2 (SF-MPQ-2).
|
Baseline and 6 weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Functional Disability Measured by Oswestry Disability Index (ODI)
Time Frame: Baseline and 6 weeks after intervention
|
Functional disability associated with chronic low back pain will be measured using the Oswestry Disability Index questionnaire.
|
Baseline and 6 weeks after intervention
|
|
Change in Lumbar Range of Motion Measured by Inclinometer
Time Frame: Baseline and 6 weeks after intervention
|
Lumbar flexion, extension, lateral flexion, and rotation range of motion will be measured using an inclinometer.
|
Baseline and 6 weeks after intervention
|
|
Change in Core Muscle Endurance Measured by Pressure Biofeedback Unit
Time Frame: Baseline and 6 weeks after intervention
|
Core muscle endurance including transverse abdominis, quadratus lumborum, and pelvic floor muscles will be measured using a pressure biofeedback unit.
|
Baseline and 6 weeks after intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Agnus Tom A, Rajkumar E, John R, Joshua George A. Determinants of quality of life in individuals with chronic low back pain: a systematic review. Health Psychol Behav Med. 2022 Jan 5;10(1):124-144. doi: 10.1080/21642850.2021.2022487. eCollection 2022.
- Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available.
- Amundsen PA, Evans DW, Rajendran D, Bright P, Bjorkli T, Eldridge S, Buchbinder R, Underwood M, Froud R. Inclusion and exclusion criteria used in non-specific low back pain trials: a review of randomised controlled trials published between 2006 and 2012. BMC Musculoskelet Disord. 2018 Apr 12;19(1):113. doi: 10.1186/s12891-018-2034-6.
- Custers P, Van de Kelft E, Eeckhaut B, Sabbe W, Hofman A, Debuysscher A, Van Acker G, Maes G. Clinical Examination, Diagnosis, and Conservative Treatment of Chronic Low Back Pain: A Narrative Review. Life (Basel). 2024 Aug 29;14(9):1090. doi: 10.3390/life14091090.
- Souza MC, Jennings F, Morimoto H, Natour J. Swiss ball exercises improve muscle strength and walking performance in ankylosing spondylitis: a randomized controlled trial. Rev Bras Reumatol Engl Ed. 2017 Jan-Feb;57(1):45-55. doi: 10.1016/j.rbre.2016.09.009. Epub 2016 Oct 20. English, Portuguese.
- de Souza IMB, Sakaguchi TF, Yuan SLK, Matsutani LA, do Espirito-Santo AS, Pereira CAB, Marques AP. Prevalence of low back pain in the elderly population: a systematic review. Clinics (Sao Paulo). 2019 Oct 28;74:e789. doi: 10.6061/clinics/2019/e789. eCollection 2019.
- Choi, Y., & Lee, S. (2021). Effects of pressure biofeedback application location for subjects with lumbar instability on pelvic rotation and hip joint abductor muscle activity during the Clam exercise. Physical Therapy Rehabilitation Science, 10(2), 90-97.
- Casiano, V. E., Sarwan, G., Dydyk, A. M., & Varacallo, M. (2023). Back pain. In StatPearls [Internet]. StatPearls Publishing.
- Bernard S, Gentilcore-Saulnier E, Masse-Alarie H, Moffet H. Is adding pelvic floor muscle training to an exercise intervention more effective at improving pain in patients with non-specific low back pain? A systematic review of randomized controlled trials. Physiotherapy. 2021 Mar;110:15-25. doi: 10.1016/j.physio.2020.02.005. Epub 2020 Mar 2.
- Bandy, W. D., & Lairamore, C. (2023). MEASUREMENT of RANGE of MOTION of the THORACIC and LUMBAR SPINE. Joint Range of Motion and Muscle Length Testing-E-Book: Joint Range of Motion and Muscle Length Testing-E-Book, 235.
- Atalay E, Akova B, Gur H, Sekir U. Effect of Upper-Extremity Strengthening Exercises on the Lumbar Strength, Disability and Pain of Patients with Chronic Low Back Pain: A Randomized Controlled Study. J Sports Sci Med. 2017 Dec 1;16(4):595-603. eCollection 2017 Dec.
- Arovah, N. I., Agustiningtyas, I., & Pratiwi, K. S. (2025). Concurrent and Convergent Validity of Goniometers Versus Bubble Inclinometers in Measuring Thoracolumbar Movement in Low Back Pain Patients. Medical Rehabilitation, 28(3), 27-34.
- Altman BM. Definitions, concepts, and measures of disability. Ann Epidemiol. 2014 Jan;24(1):2-7. doi: 10.1016/j.annepidem.2013.05.018. Epub 2013 Oct 29.
- Aksen-Cengizhan, P., Onay, D., Sever, O., & Doğan, A. A. (2018). A comparison between core exercises with Theraband and Swiss Ball in terms of core stabilization and balance performance. Isokinetics and exercise science, 26(3), 183-191.
- Abdel-Aziem AA, Abdelraouf OR, El-Basatiny HMY, Draz AH. The Effects of Stabilization Exercises Combined With Pelvic Floor Exercise in Women With Nonspecific Low Back Pain: A Randomized Clinical Study. J Chiropr Med. 2021 Dec;20(4):229-238. doi: 10.1016/j.jcm.2021.12.008. Epub 2022 Apr 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOL/IREB/25/15/03/33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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 Non-specific Chronic Low Back Pain
-
Bahçeşehir UniversityNot yet recruitingChronic Non-specific Low Back PainTurkey (Türkiye)
-
Kirsehir Ahi Evran UniversitesiRecruitingEffects of Virtual Reality-Assisted Pain Neuroscience Education on Chronic Nonspecific Low Back PainChronic Non-Specific Low Back PainTurkey (Türkiye)
-
University of HailNot yet recruitingNon Specific Chronic Low Back PainSaudi Arabia
-
Maheen RaufRecruitingNon-specific Chronic Low Back PainPakistan
-
Cairo UniversityCompletedNon Specific Chronic Low Back PainEgypt
-
Riphah International UniversityCompletedNon Specific Chronic Low Back PainPakistan
-
Medipol UniversityNot yet recruitingNon-specific Chronic Low Back PainTurkey (Türkiye)
-
Dina Abdelhady Hammad Attia AhmedEnrolling by invitation
-
October 6 UniversityActive, not recruitingNon Specific Chronic Low Back PainJordan
-
National Yang Ming Chiao Tung UniversityNot yet recruitingChronic Low Back Pain (Non-specific, Uncomplicated)
Clinical Trials on Baseline Physiotherapy
-
University Hospital Inselspital, BerneCompletedBreast CancerSwitzerland
-
Riphah International UniversityRecruitingHemiplegic Cerebral PalsyPakistan
-
Xuanwu Hospital, BeijingNot yet recruitingCerebral Venous Sinus ThrombosisChina
-
Fondation IldysLP3C, University of Brest; LaTim LaboratoryRecruitingChildren With a Need of Rehabilitation for HandwritingFrance
-
Medical College of WisconsinNational Institute of Mental Health (NIMH)CompletedHIV Prevention and Assessment ReactivitySouth Africa
-
Clinica Universidad de Navarra, Universidad de...RecruitingObesity | Breast Cancer | Health, SubjectiveSpain
-
Marmara UniversityRecruitingPeriodontitis | Periodontal DiseasesTurkey
-
Eisai Inc.CompletedThrombocytopenia Associated With Liver DiseaseUnited States, China, Spain, Argentina, Belgium, Israel, Mexico, Romania, Japan, Brazil, Russian Federation, Germany, Italy, Czechia, Canada, Australia, France
-
Hopital FochCompleted
-
Eisai Inc.CompletedTreatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective ProcedureThrombocytopenia Associated With Liver DiseaseUnited States, Italy, China, Taiwan, Spain, Belgium, Poland, Portugal, Canada, Korea, Republic of, Australia, Brazil, Chile, Austria, Germany, Hungary, France, Argentina, United Kingdom, Thailand