Mechanical Low Back PainNCT02622789
Efficacy and Influence of Pilates Based Physical Therapy Exercises for Low Back Pain
An observational study of Mechanical Low Back Pain, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Pilates Exercises
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 1. Predominant LBP for a minimum of three consecutive months as diagnosed by a rehabilitation physician
Who cannot join
- . 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Andy Chien, PhD, +886-4-22053366 ext. 7307, achien@mail.cmu.edu.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Pilates Exercises
- Keywords
- Spinal alignment, Kinematics, Pilates, Physical Therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates ExercisesOther
Pilates method based stability exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Controls | Age-matched Healthy Controls | |
| General Exercises | Low Back Pain Participants Receiving General Exercises | |
| Pilates Exercises | Low Back Pain Participants Receiving Pilates Exercises Receives: Other: Pilates Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12-month
Secondary outcomes (3)
Modified Oswestry Disability Index
Questionnaires to determine patients' self-reported pain and functional disabilities
Measured: 12-month
Roland Morris Disability Questionnaire
Questionnaires to determine patients' self-reported pain and functional disabilities
Measured: 12-month
Short Form-36
Questionnaires to determine patients' self-reported pain and functional disabilities
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Low Back PainStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, China
- Responsible party
- Sponsor
- Investigators
- Andy Chien, PhD, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622789
- Sponsor's protocol ID
- CRREC-104-081
- Status last verified
- Jul 2016
- First submitted
- 8 Nov 2015
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Influence of Pilates Based Physical Therapy Exercises on Spinal Radiographic Kinematics and Functional Status in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT02622789
- Acronym / sponsor ID
- CRREC-104-081
- Conditions
- Mechanical Low Back Pain
- Keywords
- Spinal alignment, Kinematics, Pilates, Physical Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- China Medical University, China
- Study start
- Nov 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Age-matched Healthy Controls |
| General Exercises | – | –Low Back Pain Participants Receiving General Exercises |
| Pilates Exercises | – | Other: Pilates ExercisesLow Back Pain Participants Receiving Pilates Exercises |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1. Predominant LBP for a minimum of three consecutive months as diagnosed by a rehabilitation physician
Key exclusion criteria (8 listed)
- . Radicular neurological signs,
- . Trauma induced LBP,
- . Diagnosis of spinal deformity such as scoliosis or spondylolisthesis,
- . Spinal infection or tumor,
- . Rheumatologic conditions,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates ExercisesPilates method based stability exercise intervention | Other | Pilates Exercises |
Primary outcome
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.
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
3 secondary outcomes
Modified Oswestry Disability Index
Time frame: 12-month
Roland Morris Disability Questionnaire
Time frame: 12-month
Short Form-36
Time frame: 12-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy Chien, PhD principal investigator
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Low Back Pain, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andy Chien, PhD (+886-4-22053366 ext. 7307, achien@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Spino-pelvic Alignment Parameters (time frame: 12-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.