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Enrolling by invitation NCT07610044

Pelvic Floor Exercises Versus Swiss Ball Exercises in Patients With Non-Specific Chronic Low Back Pain

No phase Interventional Non-specific Chronic Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Baseline Physiotherapy, Swiss Ball Exercises, Pelvic Floor Muscle Exercises.
Who it may be relevant to
Registry conditions: Non-specific Chronic Low Back Pain. Basic parameters: 18 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Other Baseline Physiotherapy
    Baseline physiotherapy includes heating pad application, stretching exercises, and strengthening exercises for lumbar stabilization and pain reduction.
  • Other Swiss Ball Exercises
    Swiss ball exercises include curl-up, bridging, and front plank exercises performed on a swiss ball to improve core stability, balance, and muscle endurance.
  • Other Pelvic Floor Muscle Exercises
    Pelvic floor muscle exercises involve repeated contraction and relaxation cycles of pelvic floor muscles to improve core muscle activation, spinal support, and lumbar stability.

Primary outcome measures

  • Change in Pain Severity Measured by Revised Short McGill Pain Questionnaire-2 (SF-MPQ-2) [Time frame: Baseline and 6 weeks after intervention]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • University of Lahore — Lahore

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. PMID 28137402
  • 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 31664424
  • 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 39337874
  • 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.
  • 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 35507483
  • 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. PMID 32349867
  • 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.

Identifiers

NCT: NCT07610044 · UOL/IREB/25/15/03/33

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗