Efficacy and Influence of Pilates Based Physical Therapy Exercises for Low Back Pain
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 8, 2015
CompletedFirst Posted
Study publicly available on registry
December 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 27, 2016
July 1, 2016
3.1 years
November 8, 2015
July 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (3)
Modified Oswestry Disability Index
12-month
Roland Morris Disability Questionnaire
12-month
Short Form-36
12-month
Study Arms (3)
Controls
Age-matched Healthy Controls
General Exercises
Low Back Pain Participants Receiving General Exercises
Pilates Exercises
Low Back Pain Participants Receiving Pilates Exercises
Interventions
Eligibility Criteria
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.
You may qualify if:
- \. Predominant LBP for a minimum of three consecutive months as diagnosed by a rehabilitation physician
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China Medical University Hospitallead
- China Medical University, Chinacollaborator
Study Sites (1)
China Medical University Hospital
Taichung, 404, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andy Chien, PhD
China Medical University, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2015
First Posted
December 7, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
July 27, 2016
Record last verified: 2016-07