Opioid Use, Pain
Conditions
Brief summary
To compare the efficacy of standard pain treatment and placebo (a microcurrent faux treatment) as opposed to standard pain treatment and microcurrent therapy in any primary care patients over a three month period.
Detailed description
This study is not intended to be definitive and should be considered an exploratory randomized trial to determine conditions for which microcurrent is more effective. Thus, extensive subgroup analyses will be performed so that definitive trials can be developed. This is a single-blind study where subjects will not know if they are receiving microcurrent treatment.
Interventions
PROCEDUREStandard treatment + placebo
Placebo microcurrent
PROCEDUREStandard treatment + Microcurrent Therapy
Actual microcurrent
Sponsors
Paul Crawford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\* Inclusion Criteria: * Male and female Active Duty members and DoD beneficiaries * Age 18 years or older * Chronic debilitating pain * PROMIS-57 T score is 60 or above
Exclusion criteria
* Pregnant * Implanted pacemaker * Spinal cord stimulator * Illicit drug use including marijuana use * Epilepsy or a history of seizures * Other implanted device (e.g., insulin pump, opioid pump, or defibrillator) * Chronic debilitating pain referred or recruited as measured by PROMIS-57 T score is below 60
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores | PRE-TREATMENT: time 0 (week 0) | PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). In most cases 50 equals the mean in the U.S. general population. PROMIS-57 is a collection of 8-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. |
| Measure Yourself Medical Outcome Profile (MYMOP) | PRE-TREATMENT: time 0 (week 0) | MYMOP measures the outcomes that the patient considers the most important.The patient chooses one or two symptoms that they are seeking help with, and that they consider to be the most important. They also choose an activity of daily living that is limited or prevented by this problem. These choices are written down in the patient's own words and the patient scores them for severity over the past week on a seven-point scale. Lastly wellbeing is scored on a similar scale. Produces a 7-point scale (0=as good as it could be, 6=as bad as it could be) for individual items of Symptoms, Activity, and Wellbeing as well as the MYMOP profile score |
| Defense and Veterans Pain Rating Scale (DVPRS) | PRE-TREATMENT: time 0 (week 0) | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioids taken | screening, time 0 (week 0), time 1 (week 1), time 2 (week 2), time 3 (week 3), time 4 (week 4), time 5 (week 5), time 6 (week 12) | Opioids taken measured in morphine equivalent units (MEU; milligrams) |
Countries
United States
Outcome results
None listed