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Efficacyof Pilates Exercises in Lowback Pain (RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135131
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Duygu Geler Külcü, Haydarpasa Numune Training and Research Hospital

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Physical Therapy Pilates Other: pilates mat exercises and home exercises Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized-single blinded study
Masking: None (Open Label)
Masking Description: chronic low back pain patients, which has home exercises or pilates
Primary Purpose: Screening
Official 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
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PILATES MAT EXERCISE EFFECT ON LOW BACK PAIN
Patients were randomized into pilates (group 1) or home exercise group (group 2) 3 times/week for 8 weeks. The evaluations were made at the beginning and end of the treatment. Outcome parameters were VAS, Oswestry Disability Index, Qubec Disability Scale, Short Form-36, Beck Depression Questionnaire, sit and reach, Modified Schöber and sit up tests. Multifidus and abdominal muscle thickness were measured by ultrasound image
Other: pilates mat exercises and home exercises
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.

Placebo Comparator: HOME EXERCISE
The 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. Patients were asked to perform three sets of exercises (10 repetitions) for three times a week for 8 weeks. Exercise training was provided by a physiotherapist. Patients were also provided an illustrated exercise brochure along with an exercise diary to record the number of days on which exercise was performed. They were followed up by phone calls every 2 weeks
Other: pilates mat exercises and home exercises
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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • cognitive impairment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135131


Locations
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Turkey
Haydarpaşa Numune Education and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Haydarpasa Numune Training and Research Hospital
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Responsible Party: Duygu Geler Külcü, Clinical Professor, Head of Physical Therapy, Haydarpasa Numune Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04135131    
Other Study ID Numbers: HNEAH-KAEK 2017/kk/19
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duygu Geler Külcü, Haydarpasa Numune Training and Research Hospital:
Abdominal Muscles
Exercise Therapy
Low back pain
Paraspinal Muscles
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms