NCT07610044

Brief 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress77%
Dec 2025Oct 2026

Study Start

First participant enrolled

December 11, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2026

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 17, 2026

Last Update Submit

May 21, 2026

Conditions

Keywords

Chronic Low Back PainPelvic Floor Muscle ExercisesSwiss Ball ExercisesCore StabilityLumbar PainPhysiotherapyRehabilitationExercise Therapy

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline and 6 weeks after intervention

Secondary Outcomes (3)

  • Change in Functional Disability Measured by Oswestry Disability Index (ODI)

    Baseline and 6 weeks after intervention

  • Change in Lumbar Range of Motion Measured by Inclinometer

    Baseline and 6 weeks after intervention

  • Change in Core Muscle Endurance Measured by Pressure Biofeedback Unit

    Baseline and 6 weeks after intervention

Study Arms (3)

Control Group (Baseline Physiotherapy)

ACTIVE COMPARATOR

Participants will receive baseline physiotherapy treatment including heating pad application, stretching exercises, and strengthening exercises.

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.

Other: Baseline PhysiotherapyOther: 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.

Other: Baseline PhysiotherapyOther: Pelvic Floor Muscle Exercises

Interventions

Baseline physiotherapy includes heating pad application, stretching exercises, and strengthening exercises for lumbar stabilization and pain reduction.

Control Group (Baseline Physiotherapy)Experimental Group (Pelvic Floor Muscle Exercises + Baseline Physiotherapy)Experimental Group (Swiss Ball Exercises + Baseline Physiotherapy)

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 Group (Swiss Ball Exercises + Baseline Physiotherapy)

Pelvic floor muscle exercises involve repeated contraction and relaxation cycles of pelvic floor muscles to improve core muscle activation, spinal support, and lumbar stability.

Experimental Group (Pelvic Floor Muscle Exercises + Baseline Physiotherapy)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore

Lahore, Punjab Province, Pakistan

Location

Related Publications (15)

  • 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.

    PMID: 28137402BACKGROUND
  • 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.

    PMID: 31664424BACKGROUND
  • 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.

    PMID: 39337874BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 35507483BACKGROUND
  • Casiano, V. E., Sarwan, G., Dydyk, A. M., & Varacallo, M. (2023). Back pain. In StatPearls [Internet]. StatPearls Publishing.

    BACKGROUND
  • 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.

    PMID: 32349867BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 29238262BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 29650015BACKGROUND
  • 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.

    PMID: 24268996BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 35003902BACKGROUND
  • 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.

    PMID: 35496721BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will remain blinded to participant allocation and intervention protocols to minimize assessment bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned into three parallel groups receiving different exercise-based physiotherapy interventions for chronic non-specific low back pain.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Physical Therapy Student

Study Record Dates

First Submitted

May 17, 2026

First Posted

May 27, 2026

Study Start

December 11, 2025

Primary Completion (Estimated)

September 11, 2026

Study Completion (Estimated)

October 11, 2026

Last Updated

May 27, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations