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Chiropractic and Self-Care for Back-Related Leg Pain
This study is currently recruiting participants.
Study NCT00494065   Information provided by Northwestern Health Sciences University
First Received: June 27, 2007   Last Updated: March 25, 2009   History of Changes

June 27, 2007
March 25, 2009
June 2007
August 2009   (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 ]
  • 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 ]
 
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.

 
 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Sub-Acute and Chronic Back-Related Leg Pain
  • Other: Home exercise
  • Other: Chiropractic Spinal Manipulative Therapy + Home exercise
  • Experimental: Chiropractic Spinal Manipulative Therapy + Home exercise
  • Active Comparator: Home exercise
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
192
August 2009
August 2009   (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: Gert Bronfort, DC, PhD (952) 885-5413 gbronfort@nwhealth.edu
United States
 
NCT00494065
Gert Bronfort, DC, PhD, Northwestern Health Sciences University
R18HP07638, R18HP07638
Northwestern Health Sciences University
Department of Health and Human Services
Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
Northwestern Health Sciences University
March 2009

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