search
Back to results

Efficacyof Pilates Exercises in Lowback Pain (RCT)

Primary Purpose

Low Back Pain, Physical Therapy, Pilates

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
pilates mat exercises and home exercises
Sponsored by
Haydarpasa Numune Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Low Back Pain focused on measuring Abdominal Muscles, Exercise Therapy, Low back pain, Paraspinal Muscles

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Haydarpaşa Numune Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PILATES MAT EXERCISE EFFECT ON LOW BACK PAIN

HOME EXERCISE

Arm Description

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

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

Outcomes

Primary Outcome Measures

VISUAL ANALOGUE SCALE (VAS) for pain
pain (min-max:0-10) Higher scores correlate to higher intensity of pain
The Oswestry Disability Index
lowback functional disability The minimum score is 0% and the maximum score is 100%. Higher scores correlate to greater disability.
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.
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.
Beck Depression Questionnaire
depression The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity.
Sit and reach test
flexibility
Modified Schöber and sit up tests
flexibility and endurance

Secondary Outcome Measures

Full Information

First Posted
September 29, 2019
Last Updated
October 22, 2019
Sponsor
Haydarpasa Numune Training and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04135131
Brief Title
Efficacyof Pilates Exercises in Lowback Pain
Acronym
RCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haydarpasa Numune Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Physical Therapy, Pilates
Keywords
Abdominal Muscles, Exercise Therapy, Low back pain, Paraspinal Muscles

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized-single blinded study
Masking
None (Open Label)
Masking Description
chronic low back pain patients, which has home exercises or pilates
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PILATES MAT EXERCISE EFFECT ON LOW BACK PAIN
Arm Type
Experimental
Arm Description
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
Arm Title
HOME EXERCISE
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
pilates mat exercises and home exercises
Intervention Description
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 Measure Information:
Title
VISUAL ANALOGUE SCALE (VAS) for pain
Description
pain (min-max:0-10) Higher scores correlate to higher intensity of pain
Time Frame
6 months
Title
The Oswestry Disability Index
Description
lowback functional disability The minimum score is 0% and the maximum score is 100%. Higher scores correlate to greater disability.
Time Frame
6 months
Title
The Quebec Back Pain Disability Scale
Description
low back pain The minimum score is 20 and the maximum score is 100. Higher scores correlate to greater disability.
Time Frame
6 months
Title
Short Form-36
Description
(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.
Time Frame
6 months
Title
Beck Depression Questionnaire
Description
depression The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity.
Time Frame
6 months
Title
Sit and reach test
Description
flexibility
Time Frame
6 months
Title
Modified Schöber and sit up tests
Description
flexibility and endurance
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 cognitive impairment.
Facility Information:
Facility Name
Haydarpaşa Numune Education and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacyof Pilates Exercises in Lowback Pain

We'll reach out to this number within 24 hrs