Efficacyof Pilates Exercises in Lowback Pain

NCT04135131 | Completed

• 1 other identifier: HNEAH-KAEK 2017/kk/19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Physical Therapy; Pilates

Keywords

Abdominal Muscles; Exercise Therapy; Low back pain; Paraspinal Muscles

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

PILATES MAT EXERCISE EFFECT ON LOW BACK PAIN

EXPERIMENTAL

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

HOME EXERCISE

PLACEBO COMPARATOR

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

Interventions

pilates mat exercises and home exercises OTHER

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.

HOME EXERCISE; PILATES MAT EXERCISE EFFECT ON LOW BACK PAIN

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

Study Sites (1)

Haydarpaşa Numune Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: chronic low back pain patients, which has home exercises or pilates
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Head of Physical Therapy

Model Details: Prospective, randomized-single blinded study

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 22, 2019
• Study Start: April 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: January 1, 2019
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)