Long COVID, Pain
Conditions
Brief summary
The goal of this preliminary study is to test methods and procedures to be used in a fully-powered trial to evaluate acupuncture treatment effectiveness. Specifically, we will test the feasibility of conducting a 2-arm randomized clinical trial for evaluating the effectiveness of acupuncture for pain in patients with long COVID. Researchers will compare pain intensity and impact on general activities over 5 months in those who receive acupuncture treatment compared to patients who are receiving usual long COVID care. Participants will complete 4 online surveys at weeks 0, 4, 8, and 20. These surveys include validated mental and physical health questionnaires. Participants who are randomly selected to receive the intervention will receive 8 acupuncture treatment sessions.
Detailed description
Long-COVID has negatively impacted millions of individuals' quality of life, daily functioning, and ability to work, and has placed enormous demands on the healthcare system. Pain-related symptoms are reported by a large subset of patients with long COVID, and yet pain is still not consistently addressed in workups or treatment plans. Thus, we have chosen to study acupuncture for improving pain, quality of life, and function in individuals experiencing long COVID-related pain. Acupuncture has been shown to be successful in treating various types of chronic pain and should lend itself to similar results with pain related to long COVID. Furthermore, acupuncture focuses on treating the whole patient, which makes it uniquely well-suited for a complex condition affecting multiple body systems, like long COVID. We propose an initial study to determine the feasibility of successfully conducting a subsequent fully-powered pragmatic randomized trial evaluating the effectiveness of Traditional Chinese Medicine (TCM) acupuncture for persistent pain problems experienced by persons with long COVID. Acupuncture is a physical treatment that aims to correct imbalances in the body (including inflammation and pain) within a Chinese Medicine paradigm. Our specific aims are to: 1. Assess the feasibility of conducting a randomized clinical trial comparing acupuncture with usual care alone for reducing pain in patients with long COVID; 2. Evaluate the overall patient experience with participation in the feasibility trial and solicit suggestions about how the study procedures, documents, and treatment protocols could be improved to facilitate participation and better meet participants' needs; and 3. Revise study procedures, protocols, and instruments to prepare for a fully-powered pragmatic randomized trial. Participants randomized to acupuncture will receive a total of 8 weekly individual treatments lasting one hour each. Participants will lie supine on a treatment table while the acupuncturist inserts needles in selected body points. Bilateral needling of the pre-specified acupuncture points will be performed according to TCM principles and will include efforts to obtain De Qi. This study has the potential to help patients with long COVID improve function and quality of life, and to provide clinicians with more tools to effectively respond to their patients' needs. This study will occur through the University of Washington (UW) Long COVID Clinic at the UW Primary Care Northgate Clinic site.
Interventions
PROCEDUREAcupuncture
A licensed acupuncturist will insert sterile disposable acupuncture needles in the selected body and ear acupoints aiming to alleviate long COVID related pain symptoms. Needles will be removed after 20 minutes of retention. After all the needles are removed, the acupuncturist will insert Pyonex press tack needles (0.3mm) in the participants' left ears and suggest the participants retain them in their ears for up to 5 days.
Sponsors
University of Washington
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥ 18 years of age at the time of consent. * Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization * Report pain symptoms including musculoskeletal pain (joint, muscle, bone pain), chest pain, abdominal pain, headache, back pain, nerve pain, and pain in ear following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent. * Report pain intensity (0-10 scale) ≥4 in the last 7 days.28 * As of today, has been seen by a clinician in the UW Long COVID Clinic either in-person or via telehealth/virtual visit * Able to speak and read English and provide informed consent to complete the study requirements.
Exclusion criteria
* \<18 years of age at the time of consent. * Reports absence of pain, pain for less than 12 weeks, or a pain intensity \<4 over the last 7 days. * Report baseline level of pain for those who have pre-existing chronic pain (i.e., chronic pain condition(s) present prior to COVID-19 illness AND chronic pain not worsened post-COVID). * Already received acupuncture treatment for long COVID symptoms. * Unable to travel to the UW Northgate Clinic once a week for 8 weeks for acupuncture treatments. * Has seizure disorder with high risk of seizure (i.e., new diagnosis of seizure disorder and/or new medication in the last 3 months, or uncontrolled/unclear triggers for seizures). * Is currently Pregnant * Is receiving active cancer therapy * Has severe neutropenia (\<500 WBC) due to any cause within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain, Enjoyment and General Activity (PEG) | Baseline (Week 0), Mid-Point (Week 4), Post-Intervention (Week 8), and Final Follow-Up (Week 20) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing Scale (PCS) Short Form | Baseline (Week 0), Post-Intervention (Week 8) and Final Follow-Up (Week 20) | 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 | Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-up (Week 20) | 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 | Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-Up (Week 20) | 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) | Weeks 0, 8, 20 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNikki Gentile, MD, PhD
University of Washington
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.82 years STANDARD_DEVIATION 12.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 62 Participants |
| Sex/Gender, Customized Female | 35 Participants |
| Sex/Gender, Customized Male | 12 Participants |
| Sex/Gender, Customized Prefer Not to Answer | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 46 | 1 / 47 |
| other Total, other adverse events | 9 / 46 | 0 / 47 |
| serious Total, serious adverse events | 10 / 46 | 11 / 47 |
Outcome results
None listed