Trial record 1 of 1 for:    NCT00494065
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Chiropractic and Self-care for Back-Related Leg Pain

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern Health Sciences University
ClinicalTrials.gov Identifier:
NCT00494065
First received: June 27, 2007
Last updated: January 30, 2014
Last verified: January 2014

June 27, 2007
January 30, 2014
June 2007
October 2010   (final data collection date for primary outcome measure)
Patient-rated leg pain [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
patient-rated leg pain
Complete list of historical versions of study NCT00494065 on ClinicalTrials.gov Archive Site
  • Bothersomeness [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
  • Frequency [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
  • Disability [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
  • General Health Status [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
  • Fear Avoidance [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
  • Improvement [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
  • Medication Use [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Chiropractic and Self-care for Back-Related Leg Pain
Chiropractic and Self-care for Back-Related Leg Pain

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Sub-acute and Chronic Back-related Leg Pain
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
192
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00494065
R18HP07638, R18HP07638
Not Provided
Northwestern Health Sciences University
Northwestern Health Sciences University
Department of Health and Human Services
Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
Northwestern Health Sciences University
January 2014

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