Low Back Pain Clinical Trial
— RCTOfficial 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
Verified date | October 2019 |
Source | Haydarpasa Numune Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 1, 2019 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Haydarpasa Numune Education and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Haydarpasa Numune Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VISUAL ANALOGUE SCALE (VAS) for pain | pain (min-max:0-10) Higher scores correlate to higher intensity of pain | 6 months | |
Primary | The Oswestry Disability Index | lowback functional disability The minimum score is 0% and the maximum score is 100%. Higher scores correlate to greater disability. | 6 months | |
Primary | The Quebec Back Pain Disability Scale | low back pain The minimum score is 20 and the maximum score is 100. Higher scores correlate to greater disability. | 6 months | |
Primary | Short Form-36 | (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. | 6 months | |
Primary | Beck Depression Questionnaire | depression The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity. | 6 months | |
Primary | Sit and reach test | flexibility | 6 months | |
Primary | Modified Schöber and sit up tests | flexibility and endurance | 6 months |
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