Results from Clinical Trial
Clinical trial of ArthriFon for joint pain treatment
The Electrochemical Research Corporation from 10/30/04 to 02/28/05 conducted study to assess the effectiveness of ArthriFon, (Model ART-14-2) to reduce joint pain caused by OA.
Objective:
To show effectivess of the Vibroacoustic joint stimulator, ArthriFon, to reduce joint pain caused by OA.
Design:
Single group design in which volunteer participants/consumers responded to a structured telephone survey developed by the ECR Corp.
Study population:
ECR Corp. customers, who had purchased the Vibroacoustic joint stimulator, ArthriFon, three months prior to study to treat their joint pain caused by DJD.
Study procedure:
The investigators used the company database to contact patients who had purchased the Vibroacoustic joint stimulator, ArthriFon, three months prior to beginning of study. Research personnel conducted the structured telephone interviews with those who agreed to participate; contacting each in the sequence s/he had purchased the device until they reached the targeted number of cases (N= 100).
Every joint on which the customers had used the ArthriFon was considered as separate case, i.e., knee joint, shoulder joint. Patients responses were kept anonymous. The following information was collected through the interviews: age, gender, duration of joint pain; joints that were treated with ArthriFon; treatment/s used before trying the ArthriFon; how long the consumer had been using the ArthriFon; how often the consumer used the ArthriFon each week; improvements in the joint pain after use of ArthriFon; the amount of time until joint pain was reduced; whether or not the effectiveness of ArthriFon treatment changed after experiencing the initial pain reduction; whether or not the consumer was continuing to use the ArthriFon; and any side effects experienced as a result of using the ArthriFon.
Main Outcome Measure:
Level of pain reduction achieved as a result of using the ArthriFon was recorded.
Results:
The research personnel identified 124 cases/joints (11 groups of joints) for which of the ArthriFon had been used to treat pain due to DJD.
The knee constituted the predominant number of cases, 45 or 36.3%; followed by the shoulder 14 cases or 11.3%; foot 12 cases or 9.67%; and the back 11 cases or 8.9%. The patients/consumers median age was 66.6 years old.
Better adherence to the protocol would potentially increase this number.
The majority of the patients/consumers initially purchased the device for knee pain treatment and later used it for other joints. Most of them (76 or 61.3%) reported pain duration of 3 or more years; 98 (79%) had previous treatment for arthritis consisting of medications and/or intra-articular steroid injection and/or physical therapy and/or surgery; 68 (54.8%) used ArthriFon for less than 3 months, and 56 (45.2%) more than 3 months. At the time of purchase of the ArthriFon, the physician or designee instructed the patients to make two applications of the ArthriFon a day; 71 joint pain cases (57.25%) reported the device use twice daily, while 53 (42.75%) reported use once a day; 81 (65.3%) joint pain cases reported that they experienced pain relief that ranged from mild to significant following use of the device, which took about 2.34 weeks to achieve the pain reduction in their joints. Seventy-five joint pain cases (60.5%) reported at the time of the survey that they were continuing to use ArthriFon to treat their joint pain.
Conclusion:
This survey population of elderly people with long duration of joint pain found the ArthriFon to be effective for joint pain relief. Almost two-thirds of joint pain cases (65.3%) reported some pain relief; that the device was well tolerated, with 60.5% continuing treatment. Consumers did not report any side effects during use of the ArthriFon. However, patient/consumer adherence to the treatment recommendations was poor with only 57.25% of joint pain cases using the ArthriFon as directed. Better adherence to the treatment regimen could potentially lead to better outcomes.
Consumers reported the problems they experienced using the ArthriFon and reasons for discontinuation of use as follows: sound too loud, difficult to hold the four vibraphones in position over the area of pain, uncertainty of placement of the vibraphones on inappropriate areas to achieve pain reduction; did not feel the vibration; and that the joint pain became worse in the beginning of treatment and consequently they stopped applying the device to the joint/s.
Our study done for model ART 14-2, which now is obsolete. New models, mention on our site, addressed most our customers complains.
While this study is preliminary and has its limitations, the investigators believe that Vibroacoustic (Sound) therapy used locally has great potential and can become the tool for joint pain treatment.
The Vibroacoustic joint stimulator, ArthriFonavailable vibration therapy to reduce pain associated with DJD. The investigators have corrected some of ArthriFon problems identified by the patients/consumers such as making available to the patient an elastic knee support to secure the vibraphones in place over the treatment area and the development of a picture guide to identify vibraphone placement for all joints.