통합 의학(PRIMe)을 통한 통증 완화?: 장기 코로나19에 대한 침술의 타당성

실험적: 침 요법

참가자들은 8회의 침술 치료 세션을 받게 됩니다.

절차: 침 요법

자격을 갖춘 침술사는 장기간의 코로나19 관련 통증 증상을 완화하기 위해 선택한 신체 및 귀 경혈에 멸균 일회용 침술 바늘을 삽입합니다. 바늘은 20분 동안 유지한 후 제거됩니다. 바늘을 모두 제거한 후 침술사는 참가자의 왼쪽 귀에 Pyonex 압정 바늘(0.3mm)을 삽입하고 참가자에게 최대 5일 동안 귀에 바늘을 꽂을 것을 제안합니다.

간섭 없음: 평소 관리

참가자는 장기간의 코로나 증상에 대해 의사로부터 현재 또는 권장되는 치료를 계속 받게 됩니다.

Pain, Enjoyment and General Activity (PEG)

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.

Pain Catastrophizing Scale (PCS) Short Form

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-29

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.

PROMIS Cognitive Function

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.

UW Pain Related Self-Efficacy Scale (PRSE)

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.

Total Time to Recruit All Study Participants

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

Study Participants' Retention in Treatment Arm

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

Survey Response Rates

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.

Adherance to the Treatment Protocol

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.

Number of Visits Where Participants Adhered to Treatment Recommendations

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