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
  Purpose

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.


Condition Intervention
Sub-acute and Chronic Back-related Leg Pain
Other: Home exercise
Other: Chiropractic Spinal Manipulative Therapy + Home exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chiropractic and Self-care for Back-Related Leg Pain

Resource links provided by NLM:


Further study details as provided by Northwestern Health Sciences University:

Primary Outcome Measures:
  • Patient-rated leg pain [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 192
Study Start Date: June 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Chiropractic Spinal Manipulative Therapy + Home exercise
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.
Active Comparator: 2
Home exercise
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494065

Locations
United States, Iowa
Palmer Center for Chiropractic Research
Davenport, Iowa, United States, 52803
United States, Minnesota
Northwestern Health Sciences University
Bloomington, Minnesota, United States, 55337
Sponsors and Collaborators
Northwestern Health Sciences University
Investigators
Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
  More Information

No publications provided

Responsible Party: Northwestern Health Sciences University
ClinicalTrials.gov Identifier: NCT00494065     History of Changes
Other Study ID Numbers: R18HP07638, R18HP07638
Study First Received: June 27, 2007
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 22, 2014