Kulkarni, A.D. The use of microcurrent electrical therapy and cranial electrotherapy stimulation in pain control. Clinical Practice of Alternative Medicine. 2001; 2(2):99-102.

Funding Source, Location of Study or Author’s Affiliation
Nav-Durga Hospital, Bombay, India.

Device
Alpha-Stim^® 100

Key Variables
Pain, depression, and anxiety.

Objective
Assess the effectiveness of Alpha-Stim microcurrent electrical therapy (MET), cranial electrotherapy stimulation (CES) or a combination of both therapies for patients who had been refractory to previous treatments.

Design
Daily treatment with MET or CES over three weeks for one hour. CES was given to all patients in which clinical depression or anxiety states appeared to accompany their pain complaint.

Primary Outcome Measures
Pain was scored on an 11-point self-rating VAS scale, with 0 being no pain and 10 being the most intense pain they had experienced to date.

Secondary Outcome Measures

• Depression
• Anxiety

Key Inclusion Criteria

• Refractory response to pain.
• No medications for pain relief

Key Exclusion Criteria
None reported.

Protocol Summary
Daily treatments for one hour daily, Monday through Friday, for three weeks. No pain medications were taken during the study period. MET was given via probes or self-adhesive electrodes at 600 uA. CES current was regulated by each patient from 100 to 300 uA.

Device Application Protocol
The treatment strategies were either CES, MET via probe electrodes, MET via self-adhesive electrodes, or a combination of CES and one or the other type of MET electrode. MET, when given, was given by either probes or self-adhesive electrodes at 600 uA. Treatment with CES for one hour daily over three weeks, regulated by each patient, ranging from 100 to 300 uA. Participants were instructed to turn the current up until they felt a bit lightheaded and then turn it down to their comfort level.

Statistical Analysis Plan
Comparison of mean self-report measures of pain, depression, and anxiety pre- and post-treatment.

Results

Subjects
A total of 20 patients who had been refractory to previous treatments completed informed consent and joined the study in the order that they presented at the first author’s hospital pain clinic. Ages ranged from 30 to 75 years (mean=44) and 15 were females. No study blinding is reported.

Data Analysis
Statistical analysis revealed the following:

• Nine patients (45%) left the study early following reduction of their pain to a level between 0 and 1.5 on the 11-point scale.
• One had complete remission of her pain after only two treatments.
• Of three patients who received no relief, none returned for the final week of treatment. Seven patients (35%) who were treated with CES plus self-adhesive electrodes began at an average pain level of 7.7 (range 5-10) and ended with an average of 3.7 (range 0-10), or a 52% reduction in pain from an average of 12 days of treatment.
• Seven patients who were treated with CES plus probes fared even better beginning with a pain level of 7.1 (range 4-8) and ending at an average of 1.1 (range 1-6), or an 85% reduction of pain from an average of 8.1 days of treatment. Five patients (25%) were treated with CES only. They experienced an average of 50% drop in their pain level from 4.4 (range 3-7) to 2.2 (range 0.5-5) with an average of 10.6 days of treatment.
• No negative side effects were reported.

Conclusions
Treatment response was associated with length of time since pain onset. Patients who had been in pain for two months and four months improved 94% and 100 %, respectively. Patients with I00% pain reduction had pain lasting four years, five years, and six years. The overall correlation between duration of pain and improvement following treatment was – 0.19, not significant with this number of subjects. When this was broken down into those whose pain had lasted less than a year and compared with those whose pain had lasted five years or more, the correlation was -0.05 and -0.42, neither of which was statistically significant. The authors concluded that MET and CES are effective treatments for chronic pain patients.

Limitations
This study had a small sample size consisting primarily of females, which could limit generalizability of the results. The author states the original intent was to conduct a double-blind randomized controlled trial, but “found out that our patient group could not be depended on for that kind of cooperation.” Instead, the therapist determined the appropriate treatment regimen based on symptoms. While this is consistent with clinical practice, it can potentially introduce bias into the reported results, according to the Cochrane Risk of Bias tool.

Study Quality: FAIR