The goal of this study is to determine how patients with chronic pain and opioid use disorder will respond to treatment with acupuncture, including whether there will be any changes in mood (as an exploratory outcome). Results from this study have the potential to inform future studies in patients who would consider using acupuncture as an intervention for their conditions.
In this 4-week pilot study, the feasibility of recruiting a sample of participants in a modified Battlefield Acupuncture + National Acupuncture Detoxification Association (BFA + NADA) protocol will be assessed. Utilizing a novel BFA (Battlefield Acupuncture) plus a NADA (National Acupuncture Detoxification Association) protocol, approximately 20 participants with chronic pain and Opioid Use Disorder (OUD), receiving Methadone through an Opioid Treatment Program (OTP) at Montefiore Medical Center, will be recruited. Each participant will receive a modified BFA + NADA treatment, twice per week over 4 weeks for a total of 8 treatments at the clinic. All participants will also have the small seeds placed to facilitate at-home acupressure treatment. In this feasibility study, the investigator team will collect feasibility data from each participant at every session over the course of 4 weeks. Feasibility outcomes are defined in the Outcome Measures of this registration. As part of the study, the following will also be monitored to explore preliminary efficacy: (1) pain intensity and physical functioning, (2) opioid cravings and substance use, and (3) mood, insomnia, and stress. The research team will conduct surveys assessing pain, physical functions, the changes in stress, mood, insomnia and psychological changes at baseline, and before and after every treatment. These will all be exploratory as this is a feasibility study. Note: Following discussions with the Principal Investigator and Sponsor this study was re-categorized as a feasibility study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
The delivery of modified BFA + NADA will be administered in a setting designed to ensure that patients are comfortable, with their backs well-supported. With regards to needling technique, participants' ears will be cleaned, and sterile acupuncture needles will be placed on the BFA or NADA points, using proper technique. Auricular acupuncture needles are thin, between 0.12 - 0.18mm, and are less than 1 inch long. The needles will remain in the ear until the session is complete. On the alternative ear, seeds are another modality of auricular acupuncture treatment that will be used. Seeds are comprised of small circular balls comprised of a natural plant, no more than 1.5 mm diameter size. The seeds are attached to a small piece of adhesive tape and are placed on one's ear. The seeds remain on the ear and the given point can be massaged and stimulated as indicated.
Montefiore Division of Substance Abuse (DoSA) Wellness Center at Melrose
The Bronx, New York, United States
Feasibility - Percentage Consented
The percentage of total participants screened who have been consented will be calculated and reported.
Time frame: During the informed consent process, prior to the intervention
Feasibility - Percentage Retained
The percentage of total participants consented who complete the study will be calculated and reported.
Time frame: Upon completion of the study, up to four weeks
Adherence to acupuncture treatments
Adherence to acupuncture treatments treatments will also be used to assess feasibility. Adherence the intervention will be defined as the percentage of participants who completed all scheduled acupuncture treatments. Adherence will be successful if participants attend at least 50% of acupuncture treatments.
Time frame: At 0, 2, and 4 week study visits, up to four weeks total
Acceptability/Satisfaction
Acceptability of and Satisfaction with the intervention will be assessed using a single outcome measure, the Patient Global Impression of Change Scale. This scale consists of a single question asking the participant to rate acceptability/satisfaction of the intervention on a seven-point scale ranging from 1 (= very much better) to 7 ( = very much worse). Higher scores are associated with less favorable participant perceptions of the intervention. Group mean scores will be summarized.
Time frame: Upon completion of the study, up to four weeks
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Enrollment
17