NCT02622789

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

3.1 years

First QC Date

November 8, 2015

Last Update Submit

July 26, 2016

Conditions

Keywords

Spinal alignmentKinematicsPilatesPhysical Therapy

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

Other: Pilates Exercises

Interventions

Pilates method based stability exercise intervention

Pilates Exercises

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Andy Chien, PhD

    China Medical University, China

    PRINCIPAL INVESTIGATOR

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

Locations