Microcurrent Treatment for Chronic Debilitating Pain

Pain Clinical Trial

Official title:

Microcurrent Treatment for Chronic Debilitating Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04011176
• Other study ID #: FWH20190097h
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2022
• Source: Mike O'Callaghan Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

**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

Related Conditions & MeSH terms

• Opioid Use
• Pain

Intervention

Procedure:
• Standard treatment + placebo
Placebo microcurrent
• Standard treatment + Microcurrent Therapy
Actual microcurrent

Locations

Country	Name	City	State
United States	Mike O'Callaghan Military Medical Center	Nellis Air Force Base	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Paul Crawford

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	PRE-TREATMENT: time 0 (week 0)
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	PRE-TREATMENT: time 1 (week 1)
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	PRE-TREATMENT: time 2 (week 2)
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	PRE-TREATMENT: time 3 (week 3)
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	PRE-TREATMENT: time 4 (week 4)
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	PRE-TREATMENT: time 5 (week 5)
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	PRE-TREATMENT: time 6 (week 12)
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	POST-TREATMENT: time 0 (week 0)
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	POST-TREATMENT: time 1 (week 1)
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	POST-TREATMENT: time 2 (week 2)
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	POST-TREATMENT: time 3 (week 3)
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	POST-TREATMENT: time 4 (week 4)
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	POST-TREATMENT: time 5 (week 5)
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	POST-TREATMENT: time 6 (week 12)
Primary	Patient-Reported Outcomes Information System (PROMIS) -57 Profile standardized T-Scores	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.	SCREENING
Primary	Measure Yourself Medical Outcome Profile (MYMOP)	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	PRE-TREATMENT: time 0 (week 0)
Primary	Measure Yourself Medical Outcome Profile (MYMOP)	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	PRE-TREATMENT: time 1 (week 1)
Primary	Measure Yourself Medical Outcome Profile (MYMOP)	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	PRE-TREATMENT: time 2 (week 2)
Primary	Measure Yourself Medical Outcome Profile (MYMOP)	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	PRE-TREATMENT: time 3 (week 3)
Primary	Measure Yourself Medical Outcome Profile (MYMOP)	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	PRE-TREATMENT: time 4 (week 4)
Primary	Measure Yourself Medical Outcome Profile (MYMOP)	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	PRE-TREATMENT: time 5 (week 5)
Primary	Measure Yourself Medical Outcome Profile (MYMOP)	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	PRE-TREATMENT: time 6 (week 12)
Primary	Measure Yourself Medical Outcome Profile (MYMOP)	MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged.; 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	POST-TREATMENT: time 0 (week 0)
Primary	Measure Yourself Medical Outcome Profile (MYMOP)	MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged.; 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	POST-TREATMENT: time 1 (week 1)
Primary	Measure Yourself Medical Outcome Profile (MYMOP)	MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged.; 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	POST-TREATMENT: time 2 (week 2)
Primary	Measure Yourself Medical Outcome Profile (MYMOP)	MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged.; 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	POST-TREATMENT: time 3 (week 3)
Primary	Measure Yourself Medical Outcome Profile (MYMOP)	MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged.; 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	POST-TREATMENT: time 4 (week 4)
Primary	Measure Yourself Medical Outcome Profile (MYMOP)	MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged.; 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	POST-TREATMENT: time 5 (week 5)
Primary	Measure Yourself Medical Outcome Profile (MYMOP)	MYMOP measures the outcomes that the patient considers the most important.On follow-up questionnaires the wording of the previously chosen items is unchanged.; 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	POST-TREATMENT: time 6 (week 12)
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	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.	PRE-TREATMENT: time 0 (week 0)
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	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.	PRE-TREATMENT: time 1 (week 1)
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	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.	PRE-TREATMENT: time 2 (week 2)
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	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.	PRE-TREATMENT: time 3 (week 3)
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	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.	PRE-TREATMENT: time 4 (week 4)
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	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.	PRE-TREATMENT: time 5 (week 5)
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	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.	PRE-TREATMENT: time 6 (week 6)
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	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.	POST-TREATMENT: time 0 (week 0)
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	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.	POST-TREATMENT: time 1 (week 1)
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	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.	POST-TREATMENT: time 2 (week 2)
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	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.	POST-TREATMENT: time 3 (week 3)
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	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.	POST-TREATMENT: time 4 (week 4)
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	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.	POST-TREATMENT: time 5 (week 5)
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	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.	POST-TREATMENT: time 6 (week 6)
Secondary	Opioids taken	Opioids taken measured in morphine equivalent units (MEU; milligrams)	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)