Efficacyof Pilates Exercises in Lowback Pain (RCT)

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Physical Therapy; Pilates
• Intervention / Treatment: Other: pilates mat exercises and home exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Haydarpasa Numune Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VISUAL ANALOGUE SCALE (VAS) for pain	pain (min-max:0-10) Higher scores correlate to higher intensity of pain	6 months
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
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
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
Beck Depression Questionnaire	depression The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity.	6 months
Sit and reach test	flexibility	6 months
Modified Schöber and sit up tests	flexibility and endurance	6 months

Collaborators and Investigators

• Sponsor: Haydarpasa Numune Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): October 24, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Low back pain; Exercise Therapy; Abdominal Muscles; Paraspinal Muscles
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HNEAH-KAEK 2017/kk/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No