Clinical trial NCT00494065: Chiropractic and Self-care for Back-Related Leg Pain
Official title: Chiropractic and Self-care for Back-Related Leg Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sub-acute and Chronic Back-related Leg Pain
Lead sponsor: Northwestern Health Sciences University
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2007-06-29
Enrollment: 192
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Patient-rated leg pain
timeFrame: short-term = 12 weeks; long-term = 52 weeks
Secondary outcomes:
measure: Bothersomeness
timeFrame: short-term = 12 weeks; long-term = 52 weeks
measure: Frequency
timeFrame: short-term = 12 weeks; long-term = 52 weeks
measure: Disability
timeFrame: short-term = 12 weeks; long-term = 52 weeks
measure: General Health Status
timeFrame: short-term = 12 weeks; long-term = 52 weeks
measure: Fear Avoidance
timeFrame: short-term = 12 weeks; long-term = 52 weeks
measure: Patient Satisfaction
timeFrame: short-term = 12 weeks; long-term = 52 weeks
measure: Improvement
timeFrame: short-term = 12 weeks; long-term = 52 weeks
measure: Medication Use
timeFrame: short-term = 12 weeks; long-term = 52 weeks
measure: Biomechanical test measures: Continuous lumbar motion, Standing postural sway, Neuromuscular response to a sudden load, Straight leg raise test, Torso muscle endurance
timeFrame: short-term = 12 weeks
Other outcomes:
Locations:
city: Davenport
country: United States
facility: Palmer Center for Chiropractic Research
state: Iowa
city: Bloomington
country: United States
facility: Northwestern Health Sciences University
state: Minnesota
Study officials:
affiliation: Northwestern Health Sciences University
name: Gert Bronfort, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bronfort G, Hondras MA, Schulz CA, Evans RL, Long CR, Grimm R. Spinal manipulation and home exercise with advice for subacute and chronic back-related leg pain: a trial with adaptive allocation. Ann Intern Med. 2014 Sep 16;161(6):381-91. doi: 10.7326/M14-0006.
citation: Schulz CA, Hondras MA, Evans RL, Gudavalli MR, Long CR, Owens EF, Wilder DG, Bronfort G. Chiropractic and self-care for back-related leg pain: design of a randomized clinical trial. Chiropr Man Therap. 2011 Mar 22;19:8. doi: 10.1186/2045-709X-19-8.