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Completed

NCT Number: NCT04135131

Efficacyof Pilates Exercises in Lowback Pain

OBJECTIVE: To investigate the effects of pilates exercise by training the muscles responsible for core stabilization in patients with chronic non-specific low back pain (CNLPB); considering pain, functional level, depression, quality of life, and muscle thickness measured by Ultrasound Imaging and to compare it with home based exercise.

MATERIAL AND METHODS: A prospective, randomized-single blinded study included 60 female patients with CNLBP aged 18-60 years. Patients were randomized into 2 groups. The first group (n=30) performed pilates 3 days/week for 8 weeks. Sessions lasted about one hour and supervised by a pilates trainer. The second group (n=30) was given home exercise program 3 times/week for 8 weeks, each session lasting one hour. The evaluations were made both at the beginning and end of the treatment. Evaluation parameters included VAS (visual analogue scale), Oswestry Disability Index, Qubec Disability Scale, Short Form-36 (SF-36), Beck Depression Questionnaire, sit and reach test, Modified Schöber test, sit up test. Multifidus and abdominal muscle thickness were measured by Ultrasonographic Imaging.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Physical Therapy Pilates Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Haydarpaşa Numune Education and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

A prospective, randomized-single blinded study included 60 female patients with CNLBP aged 18-60 years. Patients were randomized into 2 groups. The first group (n=30) performed pilates 3 days/week for 8 weeks. Sessions lasted about one hour and supervised by a pilates trainer. The second group (n=30) was given home exercise program 3 times/week for 8 weeks, each session lasting one hour. The evaluations were made both at the beginning and end of the treatment. Evaluation parameters included VAS (visual analogue scale), Oswestry Disability Index, Qubec Disability Scale, Short Form-36 (SF-36), Beck Depression Questionnaire, sit and reach test, Modified Schöber test, sit up test. Multifidus and abdominal muscle thickness were measured by Ultrasonographic Imaging.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic non-specific low back pain for >3 months,
  • visual analog scale (VAS) score of 3-6
  • female patients aged 18-60 years,
  • body mass index (BMI) within normal limits (18.5-24.9 kg/m²)
  • ability to continue the program.

Exclusion criteria

  • Malignancies,
  • infections
  • inflammatory diseases
  • severe osteoporosis,
  • arthritis
  • metabolic bone diseases
  • pregnancy
  • cardiovascular diseases that limit effort capacity
  • other musculoskeletal conditions that may impede attaining positions required in exercises
  • a history of spinal surgery
  • cognitive impairment.

Treatment and study plan

pilates mat exercises and home exercises

Other

Patients with low back pain were randomized into pilates (group 1) or home exercise group (group 2) 3 times/week for 8 weeks. Pilates mat exercise program comprised three sessions a week for 8 weeks (Monday, Wednesday, and Friday), with each session being scheduled for 1 h (5-min warm-up, 50-min exercise, and 5-min cooling) and each set comprising 10 repetitions. The home exercise program included the pelvic tilt in the supine position, hamstring stretch, hip flexors and lumbar extensor stretch, bridge, strengthening the abdominal muscles, cat/camel exercises in the crawl position, leaning on the forearms in the prone position, strengthening the back extensors, and crossed-arms/legs lift exercises.

Primary outcomes

  1. VISUAL ANALOGUE SCALE (VAS) for pain

    Time frame: 6 months

    pain (min-max:0-10) Higher scores correlate to higher intensity of pain

  2. The Oswestry Disability Index

    Time frame: 6 months

    lowback functional disability The minimum score is 0% and the maximum score is 100%. Higher scores correlate to greater disability.

  3. The Quebec Back Pain Disability Scale

    Time frame: 6 months

    low back pain The minimum score is 20 and the maximum score is 100. Higher scores correlate to greater disability.

  4. Short Form-36

    Time frame: 6 months

    (quality of life) questionnaire that covers eight health domains;Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.

  5. Beck Depression Questionnaire

    Time frame: 6 months

    depression The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity.

  6. Sit and reach test

    Time frame: 6 months

    flexibility

  7. Modified Schöber and sit up tests

    Time frame: 6 months

    flexibility and endurance

Sponsors and collaborators

Lead sponsor

Haydarpasa Numune Training and Research Hospital

Other

Registry information

Official study title

Comparison of The Efficacy of Pilates Exercises and Home Exercise Program on Pain, Functional Level and Thickness of Core Muscles in Patients With Low Back Pain

Acronym: RCT

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Oct 22, 2019
Registry last updated
Oct 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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