Electromagnetic transduction therapy and shockwave therapy in 86 patients with rotator cuff tendinopathy: A prospective randomized controlled trial.

Rotator cuff (RC) tendinopathy is the most common cause of shoulder pain. The effectiveness of electromagnetic transduction therapy (EMTT), a high energetic pulsed electromagnetic field therapy in this field has not been tested yet in combination with extracorporeal shock wave therapy (ESWT). A total of 86 patients with RC tendinopathy were randomized to undergo three sessions of ESWT in combination with 8 sessions of EMTT or sham-EMTT. Both intervention groups experienced significant and clinical relevant decrease of pain at all follow-up visits, and the functionality of the shoulder evaluated by the Constant Murley score increased significantly as well. The combination of EMTT + ESWT produced significantly greater pain reduction in the visual analogue scale compared to ESWT with sham-EMTT after 24 weeks, during which the Constant Murley score improved significantly when the combination of ESWT and EMTT was employed. In patients with RC tendinopathy, electromagnetic transduction therapy combined with extracorporeal shock wave therapy significantly improves pain and function compared to ESWT with sham-EMTT.

19 years outcome after cementless total hip arthroplasty with spongy metal structured implants in patients younger than 65 years.

BACKGROUND: Cementless fixation of total hip arthroplasties (THAs) is often favored in young, high-demanding patients due to the conservation of valuable bone-stock and easier revision if loosening has occurred. Long-term outcome data of the spongy metal structured implant used in the present study in patients younger than 65 years are still lacking. METHODS: We conducted a retrospective chart review and functional investigation (Merle d'Aubigné score, SF-12) of patients younger than 65 years at implantation treated with a spongy metal structured THA (n = 79) from one orthopedic university center from 1985 to 1989. RESULTS: At a 19-year mean follow-up (range: 15.3 - 21.3 years), the overall stem survival rate was 93.7 %, and the overall cup survival rate was 82.3 %. Revision surgeries of the stem were performed in all cases for aseptic loosening at an average of 15.3 ± 3.5 years after implantation. Acetabular components were revised for aseptic loosening and recurrent dislocation after inlay revision on an average of 11.8 ± 4.7 years after implantation. No other device related complications occurred within the 19-year follow-up period. No correlation was found between time of revision and gender or age. Clinical outcome scores (Merle d'Aubigné score, SF-12) revealed excellent to good results of the implanted THAs in 87 % of patients. CONCLUSIONS: We conclude that spongy metal structured cementless THAs implanted in young patients have an excellent survival and provide trustworthy clinical results at 19 years of follow-up.

Electromagnetic transduction therapy in non-specific low back pain: A prospective randomised controlled trial.

OBJECTIVES: A prospective randomised controlled trial to investigate the efficacy of electromagnetic transduction therapy (EMTT) for treatment of patients with non-specific low back pain. DESIGN: Two groups with non-specific low back pain were either treated with conventional therapy alone over 6 weeks or in combination with 8 sessions of EMTT. RESULTS: In both intervention groups the low back pain related pain and the degree of disability decreased significantly at follow-up visits. Combination of EMTT and conventional therapy proved significant superior to conventional therapy alone. CONCLUSION: EMTT is a promising treatment in patients with non-specific low back pain.

Randomized Placebo-Controlled Placebo Trial to Determine the Placebo Effect Size.

BACKGROUND: It is the gold standard to use a placebo treatment as the control group in prospective randomized controlled trials (RCTs). Although placebo-controlled trials can reveal an effect of an active treatment, the pure effect of a placebo treatment alone has never been presented or evaluated. No evidence-based, placebo-therapeutic options are currently available, and no placebo-controlled trials have been performed to elucidate the pure placebo effect. OBJECTIVES: To analyze the pure placebo effect on clinical, chronic pain through a blinded RCT. STUDY DESIGN: A prospective, randomized, placebo-controlled trial. SETTING: Medical University centers. METHODS: One-hundred eighty-two patients suffering from chronic plantar heel pain for over 6 months,who failed to respond to conservative treatments, were screened and 106 of these patients were enrolled into this study. The patients were randomly assigned to receive either a blinded placebo shockwave treatment or an unblinded placebo shockwave treatment. The primary outcome measure was the differences in percentage change of visual analogue scale (VAS) scores 6 weeks after the intervention. The secondary outcome measure was the differences in Roles and Maudsley pain score (RMS) 6 weeks after intervention. As an exploratory outcome, 2-sided group comparisons for baseline characteristics between active treatment and controls were done using the Mann-Whitney-U tests for group comparisons; treatment efficiency was calculated by the effect size coefficient and benchmarks for the Mann-Whitney estimator according to the t-test of 2 independent samples for quantitative data, as well as the Fisher's exact test for binary data. RESULTS: Patients from both groups did not differ with respect to heel pain ratings at baseline, for both the VAS (P = .476) and RMS (P = .810) scores. After 6 weeks, patients receiving the blinded placebo treatment reported less heel pain on both scales (VAS: P = .031; RMS: P = .004). Change scores of pain ratings were significantly higher in the blinded placebo group than in the un-blinded placebo group (VAS: P = .002; RMS: P = .002). LIMITATIONS: As the study represents the first to use an inverse placebo RCT (IPRCT), further conceptual and methodological issues need to be addressed to describe detailed, underlying mechanisms. Specific contextual, intrapersonal, and interpersonal factors modulating the placebo effects should be addressed in future IPRCTs. CONCLUSIONS: The present study indicated that true placebo effect sizes can be analyzed through a proper IPRCT design. Instead of treating high numbers of patients with placebos in a RCT, which increases the risk for subjects not receiving the active treatment, the IPRCT technique seems to be much more appropriate to analyze the effect sizes of any active treatment, in accordance with the Good Clinical Practice guidelines and Declarations of Helsinki. KEY WORDS: Pain, randomized controlled trial, RCT, placebo, effect size, inverse placebo, study, pain therapy.