Efficacyof Pilates Exercises in Lowback Pain

Low Back Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04135131
• Other study ID #: HNEAH-KAEK 2017/kk/19
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: October 2019
• Source: Haydarpasa Numune Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2019
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Physical Therapy
• Pilates

Intervention

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.

Locations

Country	Name	City	State
Turkey	Haydarpasa Numune Education and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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