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Clinical Trials/NCT04135131
NCT04135131
Completed
Not Applicable

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

Haydarpasa Numune Training and Research Hospital1 site in 1 country60 target enrollmentApril 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Haydarpasa Numune Training and Research Hospital
Enrollment
60
Locations
1
Primary Endpoint
The Oswestry Disability Index
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
January 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Haydarpasa Numune Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Duygu Geler Külcü

Clinical Professor, Head of Physical Therapy

Haydarpasa Numune Training and Research Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

VISUAL ANALOGUE SCALE (VAS) for pain

Time Frame: 6 months

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

Sit and reach test

Time Frame: 6 months

flexibility

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.

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.

Modified Schöber and sit up tests

Time Frame: 6 months

flexibility and endurance

Beck Depression Questionnaire

Time Frame: 6 months

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

Study Sites (1)

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