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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02622789
Other study ID # CRREC-104-081
Secondary ID
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


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
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