N/A
N=107
Chiropractic Manipulation and Medical Care for Low Back Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01211613 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Oswestry Low Back Pain Disability Index — -16.0; -8.9; -9.5 units on a scale — p=0.009
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Manual Manipulation (Procedure); Mechanically-assisted manipulation (Device); Standard Medical Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oswestry Low Back Pain Disability Index |
-16.0; -8.9; -9.5 | 0.009 sig |
| SECONDARY Numeric Pain Rating Score. |
-3.7; -2.6; -1.9 | 0.002 sig |
Summary
The investigators will be comparing the effectiveness of two types of chiropractic manipulation and standard medical care for patients with a recent onset of low back pain. The two types of chiropractic treatments being compared will be hands-on (manual) manipulation and mechanical-assisted (Activator) manipulation. The standard medical care will consist of a medical examination and prescription for over-the-counter anti-inflammatory medication.
Eligibility Criteria
Inclusion Criteria
- Age: ≥ 18 years of age
- Ability to read and write English
- Experiencing a new episode of low back pain (LBP) with onset in the past 3 months
- Oswestry Disability Index score between 20-70 points (0-100 scale)
- Numeric pain rating score between 3-8 points (0-10 scale)
Exclusion Criteria
- Prior history of lumbar spine surgery
- History of unstable spondylolisthesis, spinal stenosis, or scoliosis > 20°
- Signs or symptoms suggestive of nerve root tension and/or neurological deficit in the lower extremity
- History of metastatic cancer, osteoporosis, long-term corticosteroid use, or any other red flags of serious illness including the following: unexplained weight loss of >10% of body weight, spinal pain associated with fever, and severe night pain unrelieved by medication
- Receiving any physical therapy, chiropractic therapy, or any other manual therapy for this episode of LBP (within the past 3 months)
- Receiving any on-going medical care for this episode of low back pain
- Current use of opiate or other prescription medications for low back pain
Data sourced from ClinicalTrials.gov (NCT01211613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.