Clinical Trials: Pulsed Signal Therapy

[Double-Blind Trial 1]
A PROSPECTIVE DOUBLE-BLIND PLACEBO-CONTROLLED STUDY USING VERY LOW-FREQUENCY ELECTROMAGNETIC INDUCTION THERAPY IN THE TREATMENT OF PATIENTS WITH INFLAMMATORY AND NON-INFLAMMATORY ARTHRITIS. (Trock, et al) Summary: This initial U.S. pilot study included 23 treated and 24 placebo patients with various types of arthritis. The treated group showed statistically significant improvement after treatment compared to the placebo group as measured by pain on passive motion, patient report of tenderness, pain on activity, difficulty with activities of daily living, and global pain severity.

[Double-Blind Trial 2]
A PROSPECTIVE, RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY USING VERY LOW-FREQUENCY ELECTROMAGNETIC INDUCTION THERAPY IN THE TREATMENT OF PATIENTS WITH INFLAMMATORY AND NON-INFLAMMATORY ARTHRITIS. (Trock, et al) Summary: This U.S. trial included 14 treated and 11 placebo patients with osteoarthritis. The treated group showed statistically significant improvement after treatment compared to the placebo group as measured by worst pain score, worst difficulty with activities of daily living, worst pain with activities of daily living, pain on motion, tenderness, and physician's global assessment.

[Double-Blind Trial 3]
OSTEOARTHRITIS OF THE KNEE: A PROSPECTIVE, RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY USING VERY LOW-FREQUENCY ELECTROMAGNETIC INDUCTION THERAPY IN THE TREATMENT OF PATIENTS WITH INFLAMMATORY AND NON-INFLAMMATORY ARTHRITIS. (Trock, et al) Summary: This U.S. trial included 42 treated and 44 placebo patients with osteoarthritis of the knee. The treated group showed statistically significant improvement after treatment compared to the placebo group as measured by pain score (analog scale), difficulty with activities of daily living, pain on motion, tenderness, and physician's global assessment.

[Double-Blind Trial 4]
OSTEOARTHRITIS OF THE CERVICAL SPINE: A PROSPECTIVE, RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY USING VERY LOW-FREQUENCY ELECTROMAGNETIC INDUCTION THERAPY IN THE TREATMENT OF PATIENTS WITH INFLAMMATORY AND NON-INFLAMMATORY ARTHRITIS. (Trock, et al) Summary: This U.S. trial included 42 treated and 39 placebo patients with osteoarthritis of the cervical spine. The treated group showed statistically significant improvement after treatment compared to the placebo group as measured by pain score (analog scale), difficulty with activities of daily living, pain of passive motion, tenderness, patient's overall assessment, and physician's global assessment.

META-ANALYSIS OF DOUBLE-BLIND TRIALS 3 AND 4 USING VERY LOW-FREQUENCY ELECTROMAGNETIC INDUCTION THERAPY IN THE TREATMENT OF PATIENTS WITH INFLAMMATORY AND NON-INFLAMMATORY ARTHRITIS (Trock, et al)
Summary: Data from trials 3 and 4 were combined in a meta-analysis, since the studies were done with the same basic protocol, simultaneously by the same observers, with separate randomization of the two sites of disease.

OPEN TRIALS (Trock, et al)
Summary: In a series of U.S. open trials where neither the patients nor observers were blinded, 250 patients treated with PST were studied using the same observations as were made in the double-blind trials. Response was similar to those of the treated patients in the double-blind trials, with improvement observed in about 70 percent of patients.

PULSED SIGNAL THERAPY: TREATMENT OF CHRONIC PAIN DUE TO TRAUMATIC SOFT TISSUE INJURY. Hershler C, Sjaus A.
Summary: A retrospective study of 80 Canadian patients treated with pulsed signal therapy was conducted to assess the effectiveness of PST in the treatment of soft tissue injuries, compared to osteoarthritis. The study included 45 patients with osteoarthritis and 35 patients with soft tissue injuries. At six weeks post-treatment both groups experienced statistically significant improvement compared to their pre-treatment state, and both groups experienced the same range of improvement with the PST treatment.

PULSED SIGNAL THERAPY: PROSPECTIVE CLINICAL PROGRESS STUDY OF GONARTHROSIS. von Gumppenberg, Pfeiffer, and Martin.
Summary: Researchers in Germany conducted a prospective study of 74 patients with arthritis of the knee. Pre- and post-treatment observations were made using the standard PST monitoring protocol, the Potter standardized examination report, a self-assessment of everyday activities using a visual analog scale, and evaluation of pain intensity and loss of mobility using a visual analog scale. Six months following PST treatment there was a significant reduction in initial complaints, ranging from 55 to 66%.

STUDY TO VERIFY THE ANALGESIC EFFECTIVENESS OF PULSED SIGNAL THERAPY (PST) IN GONARTHROSIS. Menkes C-J and Perrot S.
Summary: This randomized, double-blind, placebo controlled study examined the effect of PST on 40 French patients with arthritis of the knee (21 treated and 19 placebo). Statistically significant improvement was found in pain during motion scale, and pain, discomfort, and difficulties encountered in a normal day.

STUDY OF THE EFFECTIVENESS OF PULSED SIGNAL THERAPY IN THE TREATMENT OF MUSCULOSKELETAL PATHOLOGIES. Radaelli, E.
Summary: A group of 111 Italian hospital outpatients with various musculoskeletal conditions was treated with Pulsed Signal Therapy at Niguarda Hospital, Milan. Six weeks post-treatment, statistically significant improvement was found in intensity of pain, frequency of pain, and limitation of movement, compared to baseline measurements.