- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02622789
Efficacy and Influence of Pilates Based Physical Therapy Exercises for Low Back Pain
July 26, 2016 updated by: China Medical University Hospital
Efficacy and Influence of Pilates Based Physical Therapy Exercises on Spinal Radiographic Kinematics and Functional Status in Patients With Low Back Pain
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andy Chien, PhD
- Phone Number: 7307 +886-4-22053366
- Email: achien@mail.cmu.edu.tw
Study Locations
-
-
-
Taichung, Taiwan, 404
- Recruiting
- China Medical University Hospital
-
Contact:
- Andy Chien, PhD
- Phone Number: 7307 +886-4-22053366
- Email: achien@mail.cmu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
It is anticipated that 100 patients with clinical signs and symptoms of low back pain (LBP) for at least 3 months will be recruited.
25 age-matched healthy control will also be recruited for the study.
Description
Inclusion Criteria:
1. Predominant LBP for a minimum of three consecutive months as diagnosed by a rehabilitation physician
Exclusion Criteria:
- . Radicular neurological signs,
- . Trauma induced LBP,
- . Diagnosis of spinal deformity such as scoliosis or spondylolisthesis,
- . Spinal infection or tumor,
- . Rheumatologic conditions,
- . Previous spinal surgery,
- . History of hip or pelvic disorder that required treatment,
- . Contradiction for radiographic exposure such as pregnancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Controls
Age-matched Healthy Controls
|
|
General Exercises
Low Back Pain Participants Receiving General Exercises
|
|
Pilates Exercises
Low Back Pain Participants Receiving Pilates Exercises
|
Pilates method based stability exercise intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiographic Spino-pelvic Alignment Parameters
Time Frame: 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.
|
12-month
|
Radiographic Lumbar Spine Segmental and Global Range of Motion
Time Frame: 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
|
12-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Oswestry Disability Index
Time Frame: 12-month
|
Questionnaires to determine patients' self-reported pain and functional disabilities
|
12-month
|
Roland Morris Disability Questionnaire
Time Frame: 12-month
|
Questionnaires to determine patients' self-reported pain and functional disabilities
|
12-month
|
Short Form-36
Time Frame: 12-month
|
Questionnaires to determine patients' self-reported pain and functional disabilities
|
12-month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andy Chien, PhD, China Medical University, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
November 8, 2015
First Submitted That Met QC Criteria
December 2, 2015
First Posted (Estimate)
December 7, 2015
Study Record Updates
Last Update Posted (Estimate)
July 27, 2016
Last Update Submitted That Met QC Criteria
July 26, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRREC-104-081
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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