Clinical trial NCT02622789: Efficacy and Influence of Pilates Based Physical Therapy Exercises for Low Back Pain
Official title: Efficacy and Influence of Pilates Based Physical Therapy Exercises on Spinal Radiographic Kinematics and Functional Status in Patients With Low Back Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mechanical Low Back Pain
Keywords: Spinal alignment
Kinematics
Pilates
Physical Therapy
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: China Medical University, China
First posted: 2015-12-07
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Radiographic Spino-pelvic Alignment Parameters
timeFrame: 12-month
measure: Radiographic Lumbar Spine Segmental and Global Range of Motion
timeFrame: 12-month
Secondary outcomes:
measure: Modified Oswestry Disability Index
timeFrame: 12-month
measure: Roland Morris Disability Questionnaire
timeFrame: 12-month
measure: Short Form-36
timeFrame: 12-month
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University, China
name: Andy Chien, PhD
role: PRINCIPAL_INVESTIGATOR
References: