BackgroundLow back pain (LBP) is a major health problem in modern society, with 70-85% of the population experiencing LBP at some time in their lives. Each year, 5-10% of the workforce misses work due to LBP, most for less than 7 days. Almost 10% of all patients are at risk of developing chronic pain and disability. Little clinical evidence is available for the majority of treatments used in LBP therapy. However, moderate evidence exists for interdisciplinary rehabilitation, exercise, acupuncture, spinal manipulation, and cognitive behavioral therapy for subacute and chronic LBP. The SMATH® system (system for automatic thermomechanic massage in health) is a new medical device (MD) that combines basic principles of mechanical massage, thermotherapy, acupressure, infrared therapy, and moxibustion. SMATH® is suitable for automatic multidisciplinary treatment on patients with non-specific sub-acute and chronic LBP.Methods/designThis paper describes the protocol for a double-blinded, sham-controlled, randomized, single-center short term clinical trial in patients with non-specific sub-acute and chronic LBP aged 18 to 70 years. The primary outcome will be the effectiveness of SMATH® versus sham therapy (medical device without active principles) determined by evaluating self perceived physical function with Roland Morris Disability Questionnaire (RMDQ) scores after 4 weeks of treatment (end of treatment). Major secondary outcome will be effectiveness of SMATH® determined by evaluating self perceived physical function comparing RMDQ scores between end of treatment and baseline. The trial part of the study will take 7 months while observational follow-up will take 11 months. The sample size will be 72 participants (36 for each arm). The project has been approved by the Ethical Committee of Cremona Hospital, Italy on 29 November 2010.DiscussionCompared to other medical specialties, physical and rehabilitation medicine (PRM) has not yet received the deserved recognition from clinicians and researchers in the scientific community, especially for medical devices. The best way to change this disadvantage is through well-conducted clinical research in sham-controlled randomized trials. Sham treatment groups are essential for improving the level of evidence-based practice in PRM. The present trial will counter the general lack of evidence concerning medical devices used in LBP therapy.Trial RegistrationISRCTN: ISRCTN08714168
Purpose
After total knee arthroplasty (TKA), pain and swelling, especially in older and less cooperative patients, can limit the retrieval of a good range of motion and muscle tone and consequently the achievement of an optimal function outcome. A high-tech knee pad made of metal fibers emitting infrared energy was used in a group of patients undergoing TKA to assess its efficacy in the postoperative period with respect to a group with a placebo.
Methods
Twelve patients used knee pads after surgery for 3 weeks and were evaluated using visual analog scale (VAS), Knee Society Rating Score, Cincinnati Knee Rating Score, and painkillers at specific timings.
Results
At 3 weeks, all scores improved in a significant manner in the treated group compared with the placebo group. At 2 months after surgery, VAS was better in the study group than the control group, whereas other parameters were similar. However, the use of rescue drugs was less in the study group than in the placebo group.
Conclusion
A high-tech knee pad may contribute to a faster recovery within the first week after a knee replacement, limiting the use of painkillers and allowing a quick functional recovery by the control of pain and postoperative effusion.
Level of Evidence
Level II, randomized prospective study with small sample size.
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