Non-specific Chronic Low Back PainNCT07610044
Pelvic Floor Exercises Versus Swiss Ball Exercises in Patients With Non-Specific Chronic Low Back Pain
A study testing Baseline Physiotherapy, Swiss Ball Exercises and Pelvic Floor Muscle Exercises in people with Non-specific Chronic Low Back Pain, run by University of Lahore at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare the effectiveness of pelvic floor muscle exercises and swiss ball exercises in females with non-specific chronic low back pain. The study evaluates pain intensity, disability, lumbar range of motion, and core muscle endurance following different rehabilitation protocols. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Non-specific Chronic Low Back Pain
- What is being tested?
- Baseline Physiotherapy, Swiss Ball Exercises and Pelvic Floor Muscle Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Dec 2025to 11 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Previous or planned spinal surgery
- Pelvic floor surgery or abdominal surgery
- Pregnancy or postnatal period
- Urinary incontinence
- Neurological motor weakness or deformity
- Spinal stenosis
Show all 9Show fewer
- Osteoporosis
- Disc herniation
- Degenerative or inflammatory spinal conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Effects of Pelvic Floor Muscle Exercises and Swiss Ball Exercises in Patients With Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial
This randomized controlled trial aims to compare the effectiveness of pelvic floor muscle exercises and swiss ball exercises in females with non-specific chronic low back pain. The study evaluates pain intensity, disability, lumbar range of motion, and core muscle endurance following different rehabilitation protocols.
Read the 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.
- Conditions
- Non-specific Chronic Low Back Pain
- Being tested
- Baseline Physiotherapy, Swiss Ball Exercises, Pelvic Floor Muscle Exercises
- Keywords
- Chronic Low Back Pain, Pelvic Floor Muscle Exercises, Swiss Ball Exercises, Core Stability, Lumbar Pain, Physiotherapy, Rehabilitation, Exercise Therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline PhysiotherapyOther
Baseline physiotherapy includes heating pad application, stretching exercises, and strengthening exercises for lumbar stabilization and pain reduction.
Swiss Ball ExercisesOther
Swiss ball exercises include curl-up, bridging, and front plank exercises performed on a swiss ball to improve core stability, balance, and muscle endurance.
Pelvic Floor Muscle ExercisesOther
Pelvic floor muscle exercises involve repeated contraction and relaxation cycles of pelvic floor muscles to improve core muscle activation, spinal support, and lumbar stability.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Baseline Physiotherapy) | Active comparator | Participants will receive baseline physiotherapy treatment including heating pad application, stretching exercises, and strengthening exercises. Receives: Other: Baseline Physiotherapy |
| Experimental Group (Swiss Ball Exercises + Baseline Physiotherapy) | Experimental | Participants will receive baseline physiotherapy combined with swiss ball exercises including curl-up, bridging, and front plank exercises. Receives: Other: Baseline Physiotherapy; Other: Swiss Ball Exercises |
| Experimental Group (Pelvic Floor Muscle Exercises + Baseline Physiotherapy) | Experimental | Participants will receive baseline physiotherapy combined with pelvic floor muscle exercises for core stabilization and pain reduction. Receives: Other: Baseline Physiotherapy; Other: Pelvic Floor Muscle Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Severity Measured by Revised Short McGill Pain Questionnaire-2 (SF-MPQ-2)
Pain severity and pain quality will be assessed using the Revised Short McGill Pain Questionnaire Version-2 (SF-MPQ-2).
Measured: Baseline and 6 weeks after intervention
Secondary outcomes (3)
Change in Functional Disability Measured by Oswestry Disability Index (ODI)
Functional disability associated with chronic low back pain will be measured using the Oswestry Disability Index questionnaire.
Measured: Baseline and 6 weeks after intervention
Change in Lumbar Range of Motion Measured by Inclinometer
Lumbar flexion, extension, lateral flexion, and rotation range of motion will be measured using an inclinometer.
Measured: Baseline and 6 weeks after intervention
Change in Core Muscle Endurance Measured by Pressure Biofeedback Unit
Core muscle endurance including transverse abdominis, quadratus lumborum, and pelvic floor muscles will be measured using a pressure biofeedback unit.
Measured: Baseline and 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start11 Dec 2025
- Primary completion11 Sep 2026 (estimated)
- Study completion11 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Non-specific Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned into three parallel groups receiving different exercise-based physiotherapy interventions for chronic non-specific low back pain.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lahore Hospital (ULH)
- Responsible party
- Principal investigator, Rubina Khalil, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610044
- Sponsor's protocol ID
- UOL/IREB/25/15/03/33
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this study was conducted as an academic research project. The informed consent obtained from participants did not include provisions for public data sharing, and the dataset contains sensitive personal health information. Data will be stored securely and used only for academic and research purposes in accordance with institutional ethics approval.
Publications
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.
PubMed 28137402de 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.
PubMed 31664424Custers 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.
PubMed 39337874Choi, 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.
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.
PubMed 35507483Casiano, 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.
PubMed 32349867Bandy, 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.
PubMed 29238262Arovah, 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.
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.
PubMed 29650015Altman 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.
PubMed 24268996Aksen-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.
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.
PubMed 35003902Abdel-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.
PubMed 35496721
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Pelvic Floor Muscle Exercises and Swiss Ball Exercises in Patients With Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07610044
- Acronym / sponsor ID
- UOL/IREB/25/15/03/33
- Conditions
- Non-specific Chronic Low Back Pain
- Keywords
- Chronic Low Back Pain, Pelvic Floor Muscle Exercises, Swiss Ball Exercises, Core Stability, Lumbar Pain, Physiotherapy, Rehabilitation, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Collaborators
- University of Lahore Hospital (ULH)
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 11 Sep 2026 (estimated)
- Study completion
- 11 Oct 2026 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to compare the effectiveness of pelvic floor muscle exercises and swiss ball exercises in females with non-specific chronic low back pain. The study evaluates pain intensity, disability, lumbar range of motion, and core muscle endurance following different rehabilitation protocols.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned into three parallel groups receiving different exercise-based physiotherapy interventions for chronic non-specific low back pain.
| Arm | Type | Receives |
|---|---|---|
| Control Group (Baseline Physiotherapy) | Active comparator | Other: Baseline PhysiotherapyParticipants will receive baseline physiotherapy treatment including heating pad application, stretching exercises, and strengthening exercises. |
| Experimental Group (Swiss Ball Exercises + Baseline Physiotherapy) | Experimental | Other: Baseline Physiotherapy, Other: Swiss Ball ExercisesParticipants will receive baseline physiotherapy combined with swiss ball exercises including curl-up, bridging, and front plank exercises. |
| Experimental Group (Pelvic Floor Muscle Exercises + Baseline Physiotherapy) | Experimental | Other: Baseline Physiotherapy, Other: Pelvic Floor Muscle ExercisesParticipants will receive baseline physiotherapy combined with pelvic floor muscle exercises for core stabilization and pain reduction. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- Previous or planned spinal surgery
- Pelvic floor surgery or abdominal surgery
- Pregnancy or postnatal period
- Urinary incontinence
- Neurological motor weakness or deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline PhysiotherapyBaseline physiotherapy includes heating pad application, stretching exercises, and strengthening exercises for lumbar stabilization and pain reduction. | Other | Control Group (Baseline Physiotherapy), Experimental Group (Pelvic Floor Muscle Exercises + Baseline Physiotherapy), Experimental Group (Swiss Ball Exercises + Baseline Physiotherapy) |
| Swiss Ball ExercisesSwiss ball exercises include curl-up, bridging, and front plank exercises performed on a swiss ball to improve core stability, balance, and muscle endurance. | Other | Experimental Group (Swiss Ball Exercises + Baseline Physiotherapy) |
| Pelvic Floor Muscle ExercisesPelvic floor muscle exercises involve repeated contraction and relaxation cycles of pelvic floor muscles to improve core muscle activation, spinal support, and lumbar stability. | Other | Experimental Group (Pelvic Floor Muscle Exercises + Baseline Physiotherapy) |
Primary outcome
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).
3 secondary outcomes
Change in Functional Disability Measured by Oswestry Disability Index (ODI)
Time frame: Baseline and 6 weeks after intervention
Change in Lumbar Range of Motion Measured by Inclinometer
Time frame: Baseline and 6 weeks after intervention
Change in Core Muscle Endurance Measured by Pressure Biofeedback Unit
Time frame: Baseline and 6 weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 28137402Souza 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.
- Background: PubMed 31664424de 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.
- Background: PubMed 39337874Custers 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.
- BackgroundChoi, 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.
- Background: PubMed 35507483Chiarotto 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.
- BackgroundCasiano, V. E., Sarwan, G., Dydyk, A. M., & Varacallo, M. (2023). Back pain. In StatPearls [Internet]. StatPearls Publishing.
- Background: PubMed 32349867Bernard 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.
- BackgroundBandy, 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.
- Background: PubMed 29238262Atalay 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.
- BackgroundArovah, 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.
- Background: PubMed 29650015Amundsen 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.
- Background: PubMed 24268996Altman 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this study was conducted as an academic research project. The informed consent obtained from participants did not include provisions for public data sharing, and the dataset contains sensitive personal health information. Data will be stored securely and used only for academic and research purposes in accordance with institutional ethics approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline Physiotherapy, Swiss Ball Exercises and Pelvic Floor Muscle Exercises in people with Non-specific Chronic Low Back Pain, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Severity Measured by Revised Short McGill Pain Questionnaire-2 (SF-MPQ-2) (time frame: Baseline and 6 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07610044, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.