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

NCT ID: NCT00257998

Last Updated: 2007-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2007-10-31

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Mobilization

manualtherapy techniques

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: collaborator

Franklin Pierce University

OTHER

Sponsor Role: lead

Principal Investigators

Joshua Cleland, DPT, OCS

Role: PRINCIPAL_INVESTIGATOR

Franklin Pierce University

Locations

Rehabilitation Services of Concord Hospital

Concord, New Hampshire, United States

Countries

United States

References

Cleland JA, Fritz JM, Childs JD, Kulig K. 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: study protocol of a randomized clinical trial [NCT00257998]. BMC Musculoskelet Disord. 2006 Feb 10;7:11. doi: 10.1186/1471-2474-7-11.

Reference Type: BACKGROUND

PMID: 16472379 (View on PubMed)

Other Identifiers

HIC 05-17

Identifier Type: -

Identifier Source: org_study_id