Efficacyof Pilates Exercises in Lowback Pain

NCT ID: NCT04135131

Last Updated: 2019-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2019-01-01

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.

Conditions

Low Back Pain; Physical Therapy; Pilates

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

pilates mat exercises and home exercises

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

pilates mat exercises and home exercises

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Haydarpasa Numune Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Duygu Geler Külcü

Clinical Professor, Head of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Haydarpaşa Numune Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HNEAH-KAEK 2017/kk/19

Identifier Type: -

Identifier Source: org_study_id