Morrow DJ, Fischer EP, Walder AM, Jubran NI. Nonopioid alternatives to addressing pain intensity: a retrospective look at two noninvasive pain treatment devices. Federal Practitioner, 2019;36(4): 181-187.

Devices

Alpha-Stim^®, Cold laser

Key Variable

Pain, anxiety and depression

Objective

Research the response in veterans with chronic pain to nonopioid treatments with Alpha-Stim CES and cold laser therapy.

Design

Veterans were referred to the pain multi-modality clinic for a face-to-face assessment and recommendations in developing a comprehensive pain treatment plan. The staff was trained to manufacturers guidelines and then the veterans were trained on how to use the devices at home. Veterans who had chronic or persistent pain (≥ 3 months) that interfered with function or quality of life were considered good candidates for a device trial if they are actively involved in pain self-care, logistically able to participate, able to use a device long-term, and had no contraindications. For Alpha-Stim M (AS-M), veterans came to the clinic 5 days a week for 2 weeks. For cold laser therapy, veterans attend the clinic 5 days a week for 1 week.

Primary Effectiveness Endpoint

Assess response of pain by comparing Alpha-Stim and a cold laser device (LTO).

Secondary Outcome Measures

Determine if the treatment devices had any effect in reducing comorbid anxiety and depression,

Key Inclusion Criteria

Gives informed written and oral consent to the study.

Key Exclusion Criteria

• Pregnancy
• Implantation with a pacemaker or an implantable cardioverter device (ICD).

Protocol Summary

Data for veterans who completed valid treatments of AS-M or LTO from May 9, 2014 to August 20, 2016, were included in the analyses. For an AS-M treatment to be considered valid, the veteran must have attended at least 8 sessions and completed assessment instruments at baseline (preintervention) and following completion (postintervention). For an LTO treatment to be considered valid, the veteran must have attended at least 4 sessions and completed assessment measures at baseline and after completion. Participants completed a daily pain log and recorded self-ratings (0-to-10 scale) of pain and relaxation levels before and after using the device. These scores were primarily used to assist in determining whether goals, set collaboratively by the clinician and the veteran at the first session, had been met. Veterans completed the following measures at baseline and after trial completion:

• The Beck Depression Inventory (BDI)
• The Beck Anxiety Inventory (BAI)
• The Pain Catastrophizing Scale (PCS)
• The Subjective Units of Distress Scale (SUD)
• The Brief Pain Inventory (BPI)

Results

Subjects

Device trials were initiated for 161 veterans (LTO, 70; AS-M, 91). Distribution of devices was unequal because veterans are assigned to one device or the other based on clinical presentation. Failure to complete a trial (n = 46; 28.6%) typically was because of travel barriers, lack of interest in continuing, and for 3 veterans, reports of headaches that they attributed to the AS-M treatment. Of the 115 participants who completed valid trials, 88 (76.5%) also completed assessment measures at pre- and postintervention (LTO = 38; AS-M = 50). None of the participants in this study completed trials with both the AS-M and LTO devices. Most participants were male (84.1%) and rural residents (85.5%). The average age of participants was 56.6 years, and < 20% were Operation Enduring Freedom/Operation Iraqi Freedom/Operation NewDawn-era veterans.

Data Analysis

Descriptive statistics were used to characterize the sample overall and by modality.

Paired t tests were used to assess changes on each assessment measure over time and for

each device separately. The significance of change was assessed for 8 outcomes for each device. In this context, using a conservative Bonferroni correction, significance was set at p<.006. Because AS-M is designed to address depression, anxiety, and sleep as well as pain, whereas LTO is not, device assignments were based on clinical considerations rather than randomization. Therefore, no comparisons were made between devices, and outcomes were assessed independently for the 2 devices.

Conclusion

Treatment with AS-M and LTO were both associated with statistically significant reductions in pain severity (BPI), pain interference (BPI), daily pain intensity scores (daily pain log), and pain catastrophizing (PCS). Use of AS-M was associated with statistically significant improvements in depression (BDI), anxiety (BAI), and distress (SUD) scores. In addition, veterans completing AS-M treatment showed a statistically significant improvement in self-reported relaxation scores. Nonpharmacologic, noninvasive devices pose fewer risks and seem to be more effective in reducing pain intensity than traditional treatments, including medications or surgical intervention. In light of the current emphasis on evidence-based health care and as the evidence for the effectiveness of noninvasive pain devices modalities grows, it is likely that treatments incorporating modalities such as microcurrent electrical therapy (MET), CES, and LTO will become common options for managing chronic pain.

Limitations

The findings were limited because they were derived from a retrospective, quality improvement evaluation of outcomes from a single VA clinic. Findings must be considered in the context of the relatively small samples of veterans. Because analyses were conducted as part of a quality improvement effort, veterans were offered a specific device based on clinical indications, there were no comparisons between devices, and there was no comparison group. Although most participants were using medication and other treatments as part of their pain treatment plan, all reported continued pain intensity before use of a device so the results achieved from the devices were above the results achieved from medications.