Comparing FairMed Device to TENS for Chronic Back Pain
Author Information
Author(s): Karen L Barker, Christopher J Elliott, Catherine M Sackley, Jeremy CT Fairbank
Primary Institution: Nuffield Orthopaedic Centre NHS Trust
Hypothesis
Can the FairMed device provide effective treatment for chronic low back pain compared to TENS?
Conclusion
FairMed was not inferior to TENS treatment.
Supporting Evidence
- The primary outcome showed no significant difference in pain intensity between FairMed and TENS (p=0.82).
- 60 patients were recruited and randomised into two groups for the trial.
- Participants used their assigned device for 30 minutes, twice a day, for 3 weeks.
- Baseline characteristics of the two groups were comparable.
Takeaway
This study tested a new device called FairMed to help with back pain, but it didn't work any better than a common treatment called TENS.
Methodology
A single-blinded, randomised controlled, non-inferiority trial with 60 patients using either FairMed or TENS for 3 weeks.
Potential Biases
Potential bias from lack of masking and the challenges of conducting a non-inferiority trial.
Limitations
The study was limited by the functionality and reliability of the FairMed device, with many devices developing faults during the trial.
Participant Demographics
Mean age of participants was 53.4 years, with equal percentages of men and women.
Statistical Information
P-Value
0.82
Statistical Significance
p=0.82
Digital Object Identifier (DOI)
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