N/A
Completed N=195
Spinal Manipulation Services vs. Prescription Drug Therapy for Long-term Care
Source: ClinicalTrials.gov NCT03669354 ↗Enrolled (actual)
195
Serious AEs
—
Results posted
Sep 2021
Primary outcomePrimary: Self-reported QOL - Physical Health — 41.7; 28.8; 31.8; 32.9 units on a scale
Summary
Our overall objective is to assess the value of Spinal Manipulation Services as compared to Prescription Drug Therapy for long-term management of chronic Law back Pain (LBP). Our central hypothesis is that among aged Medicare beneficiaries with chronic LBP, utilization of SMS offers superior value (to both patient and payer) for long-term care as compared to PDT.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-reported QOL - Physical Health |
41.7; 28.8; 31.8; 32.9 | — |
| PRIMARY Satisfaction With Care |
8.9; 7.2; 4.9; 8.2 | — |
| PRIMARY Beliefs Regarding Back Pain and Its Treatment |
68; 7; 33; 46; 9; 19 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects will include Medicare Fee for Service beneficiaries (male or female), aged 65-84 years, residing in the US, and enrolled under Medicare Parts A, B, and D who have experienced an episode of chronic low back pain (defined as lasting three months or longer).
Exclusion Criteria
- Subjects with diagnosis of cancer will be excluded from the study population to avoid confounding of the reason for use of prescription opioids. Subjects over the age of 85 will also be excluded.
Data sourced from ClinicalTrials.gov (NCT03669354). 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.