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Chiropractic and Self-care for Back-Related Leg Pain

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ClinicalTrials.gov Identifier: NCT00494065
Recruitment Status : Completed
First Posted : June 29, 2007
Last Update Posted : January 31, 2014
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Northwestern Health Sciences University

Tracking Information
First Submitted Date  ICMJE June 27, 2007
First Posted Date  ICMJE June 29, 2007
Last Update Posted Date January 31, 2014
Study Start Date  ICMJE June 2007
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2007)
Patient-rated leg pain [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2007)
Patient-rated leg pain
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2007)
  • Bothersomeness [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  • Frequency [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  • Disability [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  • General Health Status [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  • Fear Avoidance [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  • Patient Satisfaction [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  • Improvement [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  • Medication Use [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
  • Biomechanical test measures: Continuous lumbar motion, Standing postural sway, Neuromuscular response to a sudden load, Straight leg raise test, Torso muscle endurance [ Time Frame: short-term = 12 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chiropractic and Self-care for Back-Related Leg Pain
Official Title  ICMJE Chiropractic and Self-care for Back-Related Leg Pain
Brief Summary

The primary aims of the project are to determine the clinical efficacy of chiropractic Spinal Manipulative Therapy (SMT) plus self-care education versus self-care education alone in 192 patients with sub-acute and chronic Back Related Leg Pain (BRLP) in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome variable is leg pain and secondary outcome variables include low back pain, disability, bothersomeness and frequency of symptoms, general health status, and fear avoidance behavior.

Secondary aims are to describe and estimate between group differences in patient satisfaction, improvement, medication use, straight leg raise, torso endurance, and three biomechanical measures: continuous spinal motion, postural sway, and neuromuscular response to sudden load. Patient perceptions of treatment will also be assessed.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sub-acute and Chronic Back-related Leg Pain
Intervention  ICMJE
  • Other: Home exercise
    Patient education will be provided by trained therapists under the supervision of licensed chiropractic clinicians. Patients will attend four, 1 hour, one-on-one sessions.
  • Other: Chiropractic Spinal Manipulative Therapy + Home exercise
    The number and frequency of treatments will be determined by the individual chiropractor, based on patient-rated symptoms, disability, palpation, and pain provocation tests. Up to 20 treatments will be provided over the 12 week treatment period, each treatment visit lasting from 10-20 minutes. Treatment will include manual spinal manipulation and mobilization.
Study Arms  ICMJE
  • Experimental: 1
    Chiropractic Spinal Manipulative Therapy + Home exercise
    Intervention: Other: Chiropractic Spinal Manipulative Therapy + Home exercise
  • Active Comparator: 2
    Home exercise
    Intervention: Other: Home exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2007)
192
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Back-related leg pain > 3 on 0 to 10 scale.
  • Sub-acute or chronic back-related leg pain defined as current episode > 4 weeks duration.
  • Back-related leg pain classified as 2, 3, 4, or 6 using the Quebec Task Force (QTF) Classification system. This includes radiating pain into the proximal or distal part of the lower extremity, with or without neurological signs, with possible compression of a nerve root.
  • 21 years of age and older.
  • Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in the previous month).

Exclusion Criteria:

  • Ongoing treatment for leg or low back pain by other health care providers.
  • Progressive neurological deficits or cauda equina syndrome.
  • QTF classifications 5 (spinal fracture) and 11 (other diagnoses including visceral diseases, compression fractures, metastases). These are serious conditions not amenable to the conservative treatments proposed.
  • QTF 7 (spinal stenosis syndrome characterized by pain and/or paresthesias in one or both legs aggravated by walking).
  • Uncontrolled hypertension or metabolic disease.
  • Blood clotting disorders.
  • Severe osteoporosis.
  • Inflammatory or destructive tissue changes of the spine.
  • Patients with surgical lumbar spine fusion or patients with multiple incidents of lumbar surgery. This is a subgroup of low back pain patients which generally have a poorer prognosis.
  • Pregnant or nursing women.
  • Current or pending litigation. Patients seeking financial compensation tend to respond differently to treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00494065
Other Study ID Numbers  ICMJE R18HP07638
R18HP07638
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Northwestern Health Sciences University
Study Sponsor  ICMJE Northwestern Health Sciences University
Collaborators  ICMJE Department of Health and Human Services
Investigators  ICMJE
Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
PRS Account Northwestern Health Sciences University
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP