Trial Outcomes & Findings for Pain Relief With Integrative Medicine (PRIMe)?: Feasibility of Acupuncture for Long COVID (NCT NCT06476496)

Individuals were recruited through the UW Long COVID Clinic. Those who opted in with the clinic to be contacted for research opportunities received an email describing the study and a link to the screener to determine eligibility. Recruitment was open for 2-3 weeks before the acupuncture sessions began until all open acupuncture spots were filled.

All participates reported age

The PEG is a widely used brief, three-item instrument that measures average pain intensity, enjoyment of life, and general activity in the past week, each rated on a 0 to 10 scale. Scores are calculated by averaging the scores of each of the three items. A higher score indicates worse pain impact.

The Pain Catastrophizing Scale (PCS) - Short Form is a 6-item self-report measure of catastrophic thinking related to pain, including rumination, magnification, and helplessness. PCS is a commonly used measure of pain experience and catastrophizing. Each measure is scored on a scale of 0 to 4. The PCS-SF score is determined by the sum of all 6 items; scores range from 0 to 24. Higher scores indicate greater catastrophizing.

PROMIS® (Patient-Reported Outcomes Measurement Information System) is a collection of person-centered tools that assess and track physical, mental, and social health in both adults and children. The PROMIS-29 Questionnaire includes 4-item short forms that measure anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and social role participation, along with a single item for pain intensity. Raw scores were converted to T-scores (using an adult referent population), ranging from 0 to 100, with a mean of 50 and a standard deviation (SD) of 10 in the reference population. High scores indicate more of the concept being measured (e.g., for physical function and ability to participate in social activities, a higher score signifies greater function; for all other domains, a higher score indicates worse function). Pain intensity is a single item scored separately on a scale of 0 to 10, with higher scores representing worse pain.

The PROMIS Cognitive Function scale complements the PROMIS-29 with questions relevant to participants with Long COVID comorbidities, such as "brain fog." This scale measures patient-perceived cognitive deficits. Aspects include mental clarity, focus, verbal and nonverbal memory, verbal fluency, and perceived changes in cognitive functions. The scale consists of 8 items, each rated from 1 to 5 to generate a raw score; all 8 items must be answered for the scale to be scored. The T-score converts the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

Pain-related self-efficacy is an individual's belief in their ability to accomplish important tasks and activities despite their pain. Identified subdomains include: Control/tolerance of/cope with symptoms, ability to manage the impact of pain on mood and psychological functioning, interpersonal relationships, and confidence to accomplish goals despite pain. The UW-PRSE was developed in a sample of adults living with chronic pain (mild to severe pain with average pain intensity of 3 or above on a scale from 0 to 10 for six months or longer and for at least half the days). This study used the 6-item short form. Individual items are summed, and the total sum is then transformed to an IRT-based T-score. T-Scores are standardized scores with a mean of 50 and a standard deviation (SD) of 10. The mean score of the calibration sample included only individuals with chronic pain. A higher T-Score indicates higher self-efficacy.

Timely recruitment of study participants (criteria: complete recruitment of 60 participants within five months);

Retention of participants in the treatment (criteria: 75% of participants attend at least 6 of 8 acupuncture visits)

Questionnaire Response Rates: (criterion: 70% of participants complete baseline, mid-point, and post-treatment questionnaires; 75% complete final questionnaire) The baseline survey was required to complete enrollment.

Intervention fidelity (criteria: 80% of sessions fully adhere to the acupuncture treatment protocol). Each acupuncture visit was tracked, and a secondary acupuncturist provided quality control and reviewed the visit for fidelity to the acupuncture protocol.

Participant Adherence to treatment recommendations (criteria: 50% leave acupuncture needles in place for at least 3 days)