Efficacy and Influence of Pilates Based Physical Therapy Exercises for Low Back Pain

• Conditions: Mechanical Low Back Pain
• Interventions: Other: Pilates Exercises

• Registration Number: NCT02622789
• Lead Sponsor: China Medical University Hospital

Brief Summary

An assessment of the effectiveness of Pilates based physical therapy exercises for patients with low back pain (LBP) and its influence on spinal movement and patient reported functional disability.

Detailed Description

Low back pain (LBP) is becoming a major public health problem associated with enormous economic burden on the modern society. Despite conservative interventions such as Pilates back exercises are routinely prescribed in clinical practice, most studies to date have only assessed its efficacy based on subjective patient reported outcomes with limited objective data available to clearly demonstrate the benefit of Pilates exercise on spinal alignment and mobility. Furthermore, patient adherence has been well identified to be an obstacle for effective home exercise program and the most cost-effective strategy to improve patient compliance remain unknown. Current study therefore aims to fulfil this gap in our knowledge by assessing the change of spinal alignment and kinematics utilizing dynamic radiographs performed pre- and post- a 6-week Pilates based physical therapy exercise program compare to a more generic hospital based back care exercise program. Furthermore, the effectiveness of conducing weekly phone reminders for 6 weeks on improving short (6-month) and long (12-month) term functional outcomes and patient compliance will also be assessed.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-08
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-07
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Predominant LBP for a minimum of three consecutive months as diagnosed by a rehabilitation physician

Exclusion Criteria

1. . Radicular neurological signs,
2. . Trauma induced LBP,
3. . Diagnosis of spinal deformity such as scoliosis or spondylolisthesis,
4. . Spinal infection or tumor,
5. . Rheumatologic conditions,
6. . Previous spinal surgery,
7. . History of hip or pelvic disorder that required treatment,
8. . Contradiction for radiographic exposure such as pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pilates Exercises	Pilates Exercises	Low Back Pain Participants Receiving Pilates Exercises

Primary Outcome Measures

Name	Time	Method
Radiographic Spino-pelvic Alignment Parameters	12-month	Thoroaco-lumbo-pelvic dynamic radiographs taken for both maximum flexion and extension will be analysed to determine parameters such as 1. Pelvic incidence angle, 2. Pelvic tilt angle, 3. Sacral slope angle, 4. Lumbosacral angle, 5. Lumbar lordosis angle and 6.
Radiographic Lumbar Spine Segmental and Global Range of Motion	12-month	Thoroaco-lumbo-pelvic dynamic radiographs taken for both maximum flexion and extension will be analysed to determine the lumbar spine segmental and its contribution to the global range of motion

Secondary Outcome Measures

Name	Time	Method
Modified Oswestry Disability Index	12-month	Questionnaires to determine patients' self-reported pain and functional disabilities
Roland Morris Disability Questionnaire	12-month	Questionnaires to determine patients' self-reported pain and functional disabilities
Short Form-36	12-month	Questionnaires to determine patients' self-reported pain and functional disabilities

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan