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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00257998
Recruitment Status : Completed
First Posted : November 24, 2005
Last Update Posted : November 2, 2007
University of Southern California
Information provided by:
Franklin Pierce University

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
Low Back Pain Procedure: Mobilization Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2005
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Intervention Details:
  • Procedure: Mobilization
    manualtherapy techniques

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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:

    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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00257998

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

Layout table for additonal information Identifier: NCT00257998    
Other Study ID Numbers: HIC 05-17
First Posted: November 24, 2005    Key Record Dates
Last Update Posted: November 2, 2007
Last Verified: October 2007
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms