Trials / Completed
CompletedNCT00494065
Chiropractic and Self-care for Back-Related Leg Pain
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 192 (actual)
- Sponsor
- Northwestern Health Sciences University · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2010-10-01
- Completion
- 2010-10-01
- First posted
- 2007-06-29
- Last updated
- 2014-01-31
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00494065. Inclusion in this directory is not an endorsement.