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

NCT00257998 | Completed Phase 1

• 1 other identifier: HIC 05-17
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The Oswestry Disability Index, which will serve as the primary outcome measure.

  4 weeks, 6 months

Interventions

Mobilization PROCEDURE

manualtherapy techniques

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chief complaint of pain and/or numbness in the lumbar spine, buttock, and/or lower extremity
• Oswestry disability score of at least 25%
• Age greater than 18 years and less than 60 years
• At least four out of five of the following criteria:
• Duration of current episode \< 16 days (judged from the patient's self-report)
• No symptoms extending distal to the knee (judged from the pain diagram)
• FABQ-W score \<19
• At least one hip with \>350 internal rotation range of motion (measured in prone)
• Stiffness in the lumbar spine (judged from segmental mobility testing)

You may not qualify if:

• Red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
• Signs consistent with nerve root compression, this includes any one of the following:
• Reproduction of low back or leg pain with straight leg raise at less than 450
• Muscle weakness involving a major muscle group of the lower extremity
• Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)
• Diminished or absent sensation to pinprick in any lower extremity dermatome
• Prior surgery to the lumbar spine or buttock
• Current pregnancy
• Past medical history of osteoporosis or spinal compression fracture
• Inability to comply with treatment schedule (weekly sessions for four weeks)

Sponsors & Collaborators

• Franklin Pierce University: lead
• University of Southern California: collaborator

Study Sites (1)

Rehabilitation Services of Concord Hospital

Concord, New Hampshire, 03301, United States

Location

Related Publications (1)

• 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.

  PMID: 16472379 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joshua Cleland, DPT, OCS

  Franklin Pierce University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2005
• First Posted: November 24, 2005
• Study Start: November 1, 2005
• Study Completion: October 1, 2007
• Last Updated: November 2, 2007

Record last verified: 2007-10

Locations

US (1)