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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mobilization
Sponsored by
Franklin Pierce University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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)

Sites / Locations

  • Rehabilitation Services of Concord Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 23, 2005
Last Updated
October 31, 2007
Sponsor
Franklin Pierce University
Collaborators
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT00257998
Brief Title
Effectiveness of Three Manual Physical Therapy Techniques in a Subgroup of Patients With Low Back Pain
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 Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Franklin Pierce University
Collaborators
University of Southern California

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Mobilization
Intervention Description
manualtherapy techniques
Primary Outcome Measure Information:
Title
The Oswestry Disability Index, which will serve as the primary outcome measure.
Time Frame
4 weeks, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Cleland, DPT, OCS
Organizational Affiliation
Franklin Pierce University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Services of Concord Hospital
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16472379
Citation
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.
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Effectiveness of Three Manual Physical Therapy Techniques in a Subgroup of Patients With Low Back Pain

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