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

Mechanical Low Back Pain Clinical Trial

Official title:

Efficacy and Influence of Pilates Based Physical Therapy Exercises on Spinal Radiographic Kinematics and Functional Status in Patients With Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02622789
• Other study ID #: CRREC-104-081
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2015
• Last updated: July 26, 2016
• Start date: November 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2016
• Source: China Medical University Hospital
• Contact: Andy Chien, PhD
• Phone: +886-4-22053366
• Email: achien[@]mail.cmu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Mechanical Low Back Pain

Intervention

Other:
• Pilates Exercises
Pilates method based stability exercise intervention

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	China Medical University, China

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Spino-pelvic Alignment Parameters	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.	12-month	No
Primary	Radiographic Lumbar Spine Segmental and Global Range of Motion	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	12-month	No
Secondary	Modified Oswestry Disability Index	Questionnaires to determine patients' self-reported pain and functional disabilities	12-month	No
Secondary	Roland Morris Disability Questionnaire	Questionnaires to determine patients' self-reported pain and functional disabilities	12-month	No
Secondary	Short Form-36	Questionnaires to determine patients' self-reported pain and functional disabilities	12-month	No