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
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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 or disease||Intervention/treatment||Phase|
|Sub-acute and Chronic Back-related Leg Pain||Other: Home exercise Other: Chiropractic Spinal Manipulative Therapy + Home exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Chiropractic and Self-care for Back-Related Leg Pain|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
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
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.
- Patient-rated leg pain [ Time Frame: short-term = 12 weeks; long-term = 52 weeks ]
- 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 ]
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494065
|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|
|Principal Investigator:||Gert Bronfort, DC, PhD||Northwestern Health Sciences University|
|Responsible Party:||Northwestern Health Sciences University|
|Other Study ID Numbers:||
|First Posted:||June 29, 2007 Key Record Dates|
|Last Update Posted:||January 31, 2014|
|Last Verified:||January 2014|