Efficacy and Influence of Pilates Based Physical Therapy Exercises for Low Back Pain

NCT ID: NCT02622789

Last Updated: 2016-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-12-31

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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Controls

Age-matched Healthy Controls

No interventions assigned to this group

General Exercises

Low Back Pain Participants Receiving General Exercises

No interventions assigned to this group

Pilates Exercises

Low Back Pain Participants Receiving Pilates Exercises

Pilates Exercises

Intervention Type: OTHER

Pilates method based stability exercise intervention

Interventions

Pilates Exercises

Pilates method based stability exercise intervention

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University, China

OTHER

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andy Chien, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University, China

Locations

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Andy Chien, PhD

Role: CONTACT

achien@mail.cmu.edu.tw

+886-4-22053366 ext. 7307

Facility Contacts

Andy Chien, PhD

Role: primary

achien@mail.cmu.edu.tw

+886-4-22053366 ext. 7307

Other Identifiers

CRREC-104-081

Identifier Type: -

Identifier Source: org_study_id