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

This study has been completed.
Sponsor:
Collaborator:
University of Southern California
Information provided by:
Franklin Pierce University
ClinicalTrials.gov Identifier:
NCT00257998
First received: November 23, 2005
Last updated: October 31, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Low Back Pain
Procedure: Mobilization
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Franklin Pierce University:

Primary Outcome Measures:
  • The Oswestry Disability Index, which will serve as the primary outcome measure. [ Time Frame: 4 weeks, 6 months ]

Estimated Enrollment: 240
Study Start Date: November 2005
Study Completion Date: October 2007
Intervention Details:
    Procedure: Mobilization
    manualtherapy techniques
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Duration of current episode < 16 days (judged from the patient's self-report)
    2. No symptoms extending distal to the knee (judged from the pain diagram)
    3. FABQ-W score <19
    4. At least one hip with >350 internal rotation range of motion (measured in prone)
    5. 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:

    1. Reproduction of low back or leg pain with straight leg raise at less than 450
    2. Muscle weakness involving a major muscle group of the lower extremity
    3. Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)
    4. Diminished or absent sensation to pinprick in any lower extremity dermatome
  3. Prior surgery to the lumbar spine or buttock
  4. Current pregnancy
  5. Past medical history of osteoporosis or spinal compression fracture
  6. Inability to comply with treatment schedule (weekly sessions for four weeks)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257998

Locations
United States, New Hampshire
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00257998     History of Changes
Other Study ID Numbers: HIC 05-17
Study First Received: November 23, 2005
Last Updated: October 31, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014