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

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

Study Locations

      • Taichung, Taiwan, 404
        • Recruiting
        • China Medical University Hospital
        • Contact:

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:

  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 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.

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.

Clinical Trials on Mechanical Low Back Pain

Clinical Trials on Pilates Exercises

3
Subscribe