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Effectiveness of Three Manual Physical Therapy Techniques in a Subgroup of Patients With Low Back Pain

Sponsor
Franklin Pierce University (Other)
Overall Status
Completed
CT.gov ID
NCT00257998
Collaborator
University of Southern California (Other)
240
Enrollment
1
Location
23
Duration (Months)
10.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Recently a clinical prediction rule (CPR) has been developed and validated that accurately identifies patients with low back pain that are likely to benefit from a lumbo-pelvic manipulation. The studies that developed and validated the rule used the identical manipulation procedure. However, recent evidence suggests that different manual therapy techniques may result in the same outcome.Purpose: The purpose of this study is to investigate the effectiveness of three different manual therapy techniques in a subgroup of patient with low back pain that satisfy the CPR.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Mobilization
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of the Effectiveness of Three Manual Physical Therapy Techniques in a Subgroup of Patients With Low Back Pain Who Satisfy a Clinical Prediction Rule: A Randomized Clinical Trial.
Study Start Date :
Nov 1, 2005
Actual Study Completion Date :
Oct 1, 2007

Outcome Measures

Primary Outcome Measures

  1. The Oswestry Disability Index, which will serve as the primary outcome measure. [4 weeks, 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Chief complaint of pain and/or numbness in the lumbar spine, buttock, and/or lower extremity

  2. Oswestry disability score of at least 25%

  3. Age greater than 18 years and less than 60 years

  4. At least four out of five of the following criteria:

  5. Duration of current episode < 16 days (judged from the patient's self-report)

  6. No symptoms extending distal to the knee (judged from the pain diagram)

  7. FABQ-W score <19

  8. At least one hip with >350 internal rotation range of motion (measured in prone)

  9. Stiffness in the lumbar spine (judged from segmental mobility testing)

Exclusion Criteria:

  1. Red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)

  2. Signs consistent with nerve root compression, this includes any one of the following:

  3. Reproduction of low back or leg pain with straight leg raise at less than 450

  4. Muscle weakness involving a major muscle group of the lower extremity

  5. Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)

  6. Diminished or absent sensation to pinprick in any lower extremity dermatome

  7. Prior surgery to the lumbar spine or buttock

  8. Current pregnancy

  9. Past medical history of osteoporosis or spinal compression fracture

  10. Inability to comply with treatment schedule (weekly sessions for four weeks)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rehabilitation Services of Concord Hospital Concord New Hampshire United States 03301

Sponsors and Collaborators

  • Franklin Pierce University
  • University of Southern California

Investigators

  • Principal Investigator: Joshua Cleland, DPT, OCS, Franklin Pierce University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00257998
Other Study ID Numbers:
  • HIC 05-17
First Posted:
Nov 24, 2005
Last Update Posted:
Nov 2, 2007
Last Verified:
Oct 1, 2007
Additional relevant MeSH terms:
Back Pain
Low Back Pain

Study Results

No Results Posted as of Nov 2, 2007