Chronic Pain, Mood Change, Opioid Misuse, Opioid-Related Disorders, Opioid Use Disorder
Conditions
Keywords
Acupuncture
Brief summary
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.
Detailed description
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.
Interventions
DEVICEModified Battlefield Acupuncture + National Acupuncture Detoxification Association protocol
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.
Sponsors
National Institute on Drug Abuse (NIDA)
Albert Einstein College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Acupuncture
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old, 2. English proficiency; 3. receiving methadone treatment at an OTP through the Montefiore network for at least 12 weeks, with no dose change in 14 days to ensure treatment stability; 4. chronic pain of at least moderate pain severity (score of at least 4 on the Pain, Enjoyment of Life and General Activity (PEG) scale); 5. willingness to participate in all study components; and 6. ability to provide informed consent
Exclusion criteria
1. Have pending surgery or invasive pain management procedure; 2. Have a pending or planned relocation; 3. have an acutely or exacerbation of psychotic, suicidal, or homicidal conditions that preclude the ability to participate; and 4. pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Percentage Consented | During the informed consent process, prior to the intervention | The percentage of total participants screened who have been consented will be calculated and reported. |
| Feasibility - Percentage Retained | Upon completion of the study, up to four weeks | The percentage of total participants consented who complete the study will be calculated and reported. |
| Adherence to acupuncture treatments | At 0, 2, and 4 week study visits, up to four weeks total | 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. |
| Acceptability/Satisfaction | Upon completion of the study, up to four weeks | 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. |
Countries
United States
Outcome results
None listed