N/A
Completed N=750
Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel.
Lower Back Pain
Source: ClinicalTrials.gov NCT01692275 ↗
Enrolled (actual)
750
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Numerical Rating Scale (NRS) for Prior Week — 4.27; 4.36; 4.73; 4.45 units on a scale
Summary
The purpose of this study is to evaluate the effectiveness of chiropractic manipulative therapy for pain management and improved function in active duty service members with low back pain that do not require surgery. The study will also measure the impact of a tobacco cessation program delivered to participants allocated to the chiropractic arm.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numerical Rating Scale (NRS) for Prior Week |
4.27; 4.36; 4.73; 4.45; 4.68; 4.87 | — |
| PRIMARY Roland Morris Disability Questionnaire (RMDQ) |
9.94; 9.36; 10.65; 10.21; 8.81; 9.2 | — |
| SECONDARY Bothersomeness of Symptoms |
3.6; 3.5; 3.7; 3.6; 3.5; 3.4 | — |
| SECONDARY Numerical Pain Rating Scale (NRS) for Past 24 Hours |
5.4; 5.6; 6.1; 5.9; 5.4; 5.4 | — |
| SECONDARY Healthcare Utilization & Medication Use |
25; 36; 28; 34; 39; 40 | — |
| SECONDARY Global Improvement Scale |
1; 2; 7; 16; 0; 4 | — |
| SECONDARY Patient Satisfaction |
5.65; 7.64; 6.04; 8.34; 4.34; 7.45 | — |
| SECONDARY Patient Expectation |
8.2; 8.4; 8.1; 8.3; 8.6; 8.5 | — |
| SECONDARY Back Pain Functional Scale (BPFS) |
39.48; 39.18; 37.68; 38; 39.97; 39.98 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-50 (Inclusive)
- Diagnosis of acute, subacute or chronic low back pain
- Ability to provide voluntary written informed consent
- Active duty at one of the three participating military sites
Exclusion Criteria
- LBP from other than somatic tissues as determined by history, examination and course (i.e., pain referred from visceral conditions)
- Co-morbid pathology or poor health conditions that may directly impact spinal pain
- Volunteers who have case histories and physical examination findings indicating other than average good health
- Bone and joint pathology contraindicating CMT (Chiropractic Manipulative Therapy)
- Volunteers with recent spinal fracture (within the last 8 weeks), recent spinal surgery (within the last 12 weeks), concurrent spinal or paraspinal tumor(s), spinal or paraspinal infection(s), inflammatory arthropathies and significant/severe osteoporosis will be referred for appropriate care
- Other contraindications for CMT of the lumbar spine and pelvis (i.e., unstable spinal segments, cauda equine syndrome)
- Pregnant or planning to become pregnant within 3 months
- Altered mental capacity as determined by the clinician
- Unable to speak English
- Use of manipulative care for any reason within the past month
- Unwilling to provide phone and electronic contact information
- Unable to confirm that they will not be transferred during the active phase of the study, i.e., deployment, receive orders for a distant duty assignment or training site or otherwise be absent from the current military site over the next 8 weeks (active study participation period).
- Does not agree to be enrolled regardless of group assignment
- PTSD Classification
Data sourced from ClinicalTrials.gov (NCT01692275). 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. Informational only — not medical advice.