Microcurrent Treatment for Chronic Debilitating Pain

NCT ID: NCT04011176

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-09

Study Completion Date

2022-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Opioid Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard treatment + placebo

Placing the microcurrent pads on the patient but not turning on the microcurrent box for 30 minutes once a week for 6 weeks

Group Type PLACEBO_COMPARATOR

Standard treatment + placebo

Intervention Type PROCEDURE

Placebo microcurrent

Standard treatment + Microcurrent Therapy

100-300µA microcurrent delivered for 20-300 minutes, once a week for 6 weeks

Group Type EXPERIMENTAL

Standard treatment + Microcurrent Therapy

Intervention Type PROCEDURE

Actual microcurrent

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard treatment + placebo

Placebo microcurrent

Intervention Type PROCEDURE

Standard treatment + Microcurrent Therapy

Actual microcurrent

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Paul Crawford

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Paul Crawford

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Varney SM, Bebarta VS, Mannina LM, Ramos RG, Ganem VJ, Carey KR. Emergency medicine providers' opioid prescribing practices stratified by gender, age, and years in practice. World J Emerg Med. 2016;7(2):106-10. doi: 10.5847/wjem.j.1920-8642.2016.02.004.

Reference Type BACKGROUND
PMID: 27313804 (View on PubMed)

Jeffery DD, Babeu LA, Nelson LE, Kloc M, Klette K. Prescription drug misuse among U.S. active duty military personnel: a secondary analysis of the 2008 DoD survey of health related behaviors. Mil Med. 2013 Feb;178(2):180-95. doi: 10.7205/milmed-d-12-00192.

Reference Type BACKGROUND
PMID: 23495464 (View on PubMed)

Jeffery DD, May L, Luckey B, Balison BM, Klette KL. Use and abuse of prescribed opioids, central nervous system depressants, and stimulants among U.S. active duty military personnel in FY 2010. Mil Med. 2014 Oct;179(10):1141-8. doi: 10.7205/MILMED-D-14-00002.

Reference Type BACKGROUND
PMID: 25269133 (View on PubMed)

Chen JH, Humphreys K, Shah NH, Lembke A. Distribution of Opioids by Different Types of Medicare Prescribers. JAMA Intern Med. 2016 Feb;176(2):259-61. doi: 10.1001/jamainternmed.2015.6662. No abstract available.

Reference Type BACKGROUND
PMID: 26658497 (View on PubMed)

Levy B, Paulozzi L, Mack KA, Jones CM. Trends in Opioid Analgesic-Prescribing Rates by Specialty, U.S., 2007-2012. Am J Prev Med. 2015 Sep;49(3):409-13. doi: 10.1016/j.amepre.2015.02.020. Epub 2015 Apr 18.

Reference Type BACKGROUND
PMID: 25896191 (View on PubMed)

Gabriel A, Sobota R, Gialich S, Maxwell GP. The use of Targeted MicroCurrent Therapy in postoperative pain management. Plast Surg Nurs. 2013 Jan-Mar;33(1):6-8; quiz 9-10. doi: 10.1097/PSN.0b013e3182844219.

Reference Type BACKGROUND
PMID: 23446501 (View on PubMed)

Pilla A, Fitzsimmons R, Muehsam D, Wu J, Rohde C, Casper D. Electromagnetic fields as first messenger in biological signaling: Application to calmodulin-dependent signaling in tissue repair. Biochim Biophys Acta. 2011 Dec;1810(12):1236-45. doi: 10.1016/j.bbagen.2011.10.001. Epub 2011 Oct 8.

Reference Type BACKGROUND
PMID: 22005645 (View on PubMed)

Rohde C, Chiang A, Adipoju O, Casper D, Pilla AA. Effects of pulsed electromagnetic fields on interleukin-1 beta and postoperative pain: a double-blind, placebo-controlled, pilot study in breast reduction patients. Plast Reconstr Surg. 2010 Jun;125(6):1620-1629. doi: 10.1097/PRS.0b013e3181c9f6d3.

Reference Type BACKGROUND
PMID: 20527063 (View on PubMed)

Strauch B, Herman C, Dabb R, Ignarro LJ, Pilla AA. Evidence-based use of pulsed electromagnetic field therapy in clinical plastic surgery. Aesthet Surg J. 2009 Mar-Apr;29(2):135-43. doi: 10.1016/j.asj.2009.02.001.

Reference Type BACKGROUND
PMID: 19371845 (View on PubMed)

Iodice P, Lessiani G, Franzone G, Pezzulo G. Efficacy of pulsed low-intensity electric neuromuscular stimulation in reducing pain and disability in patients with myofascial syndrome. J Biol Regul Homeost Agents. 2016 Apr-Jun;30(2):615-20.

Reference Type BACKGROUND
PMID: 27358158 (View on PubMed)

Taylor AG, Anderson JG, Riedel SL, Lewis JE, Kinser PA, Bourguignon C. Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia. Pain Manag Nurs. 2013 Dec;14(4):327-335. doi: 10.1016/j.pmn.2011.07.002. Epub 2011 Oct 6.

Reference Type BACKGROUND
PMID: 24315255 (View on PubMed)

Rajpurohit B, Khatri SM, Metgud D, Bagewadi A. Effectiveness of transcutaneous electrical nerve stimulation and microcurrent electrical nerve stimulation in bruxism associated with masticatory muscle pain--a comparative study. Indian J Dent Res. 2010 Jan-Mar;21(1):104-6. doi: 10.4103/0970-9290.62816.

Reference Type BACKGROUND
PMID: 20427917 (View on PubMed)

Koopman JS, Vrinten DH, van Wijck AJ. Efficacy of microcurrent therapy in the treatment of chronic nonspecific back pain: a pilot study. Clin J Pain. 2009 Jul-Aug;25(6):495-9. doi: 10.1097/AJP.0b013e31819a6f3e.

Reference Type BACKGROUND
PMID: 19542797 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FWH20190097h

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Use of tDCS in the Orofacial Pain
NCT05584384 RECRUITING NA
Magnets in the Treatment of Sciatica
NCT00044109 COMPLETED PHASE2