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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT012679-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | Participants will receive 8 sessions of acupuncture treatment |
|
| Usual Care | No Intervention | Participants will continue to receive any current or recommended treatments from their doctors for their long COVID symptoms. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Week 0), Mid-Point (Week 4), Post-Intervention (Week 8), and Final Follow-Up (Week 20) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Time to Recruit All Study Participants | Timely recruitment of study participants (criteria: complete recruitment of 60 participants within five months); | Prior to enrollment |
| Study Participants' Retention in Treatment Arm |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nikki Gentile, MD, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Medicine Primary Care at Northgate | Seattle | Washington | 98125 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture | Participants in the Acupuncture group were asked to attend 8 weekly acupuncture sessions. Each session took place at a central primary care clinic. The visits lasted 1 hour and included a brief assessment, needle insertion at selected body and ear acupoints while the participant lay supine. After removing the needles, up to 10 Pyonex press tags (shallow needles) were applied to specific points, and participants were instructed to keep them in place for at least 3 days. |
| FG001 | Usual Care | Participants in the usual care group did not receive any additional treatment from the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture | Participants in the Acupuncture group were asked to attend 8 weekly acupuncture sessions. Each session took place at a central primary care clinic. The visits lasted 1 hour and included a brief assessment, needle insertion at selected body and ear acupoints while the participant lay supine. After removing the needles, up to 10 Pyonex press tags (shallow needles) were applied to specific points, and participants were instructed to keep them in place for at least 3 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was calculated based on date of birth and the date of their enrollment into the study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number of participants analyzed is determined by the number of participants who completed the primary outcome measure survey. | Posted | Mean | Standard Deviation | Score | Baseline (Week 0), Mid-Point (Week 4), Post-Intervention (Week 8), and Final Follow-Up (Week 20) |
|
From enrollment until the end of follow-up (week 20)
For this study, a serious adverse event was anything requiring hospitalization, an ED visit, or death. None of the SAEs were related to the study. Adverse events included bruising or localized pain at the needle site.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture | Participants in the Acupuncture group were asked to attend 8 weekly acupuncture sessions. Each session took place at a central primary care clinic. The visits lasted 1 hour and included a brief assessment, needle insertion at selected body and ear acupoints while the participant lay supine. After removing the needles, up to 10 Pyonex press tags (shallow needles) were applied to specific points, and participants were instructed to keep them in place for at least 3 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising at the needle site | Skin and subcutaneous tissue disorders | Systematic Assessment |
This is a small proof-of-concept study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Gentile | University of Washington | 206-616-3961 | ngentile@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2026 | Mar 24, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 24, 2024 | Mar 24, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Baseline (Week 0), Post-Intervention (Week 8) and Final Follow-Up (Week 20) |
| 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. | Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-up (Week 20) |
| 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. | Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-Up (Week 20) |
| 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. | Weeks 0, 8, 20 |
Retention of participants in the treatment (criteria: 75% of participants attend at least 6 of 8 acupuncture visits)
| Weeks 1-8 |
| 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. | Weeks 0, 4, 8, 20 |
| 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. | Weeks 1 - 8 |
| 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) | Weeks 1-8 |
| Withdrawal by Study Team |
|
| BG001 | Usual Care | Participants in the usual care group did not receive any additional treatment as part of the study. They were instructed to continue receiving any care recommended to them by their PCP or Long COVID Clinician. |
| BG002 | Total | Total of all reporting groups |
All participates reported age
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Usual Care | Participants in the usual care group did not receive any additional treatment as part of the study. They were instructed to continue receiving any care recommended to them by their PCP or Long COVID Clinician. |
|
|
| Secondary | 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. | The number analyzed is determined by the number of participants who completed each survey time point. | Posted | Mean | Standard Deviation | Score | Baseline (Week 0), Post-Intervention (Week 8) and Final Follow-Up (Week 20) |
|
|
|
| Secondary | 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. | The number of participants reported for each arm and time point reflects the number of completed survey responses. | Posted | Mean | Standard Deviation | Scores | Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-up (Week 20) |
|
|
|
| Secondary | 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. | The number analyzed is determined by the number of participants who completed each survey time point. | Posted | Mean | Standard Deviation | Scores | Baseline (Week 0), Post-Intervention (Week 8), and Final Follow-Up (Week 20) |
|
|
|
| Secondary | 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. | The number analyzed is determined by the number of participants who completed each survey time point. | Posted | Mean | Standard Deviation | T-Scores | Weeks 0, 8, 20 |
|
|
|
| Other Pre-specified | Total Time to Recruit All Study Participants | Timely recruitment of study participants (criteria: complete recruitment of 60 participants within five months); | Posted | Number | months | Prior to enrollment |
|
|
|
| Other Pre-specified | Study Participants' Retention in Treatment Arm | Retention of participants in the treatment (criteria: 75% of participants attend at least 6 of 8 acupuncture visits) | Only participants in the acupuncture arm are included in this measure. We had 11 participants withdraw from the study post-randomization and before their first acupuncture appointment - those individuals were not included in this measure analysis. The reason for withdrawal was primarily issues traveling to the acupuncture clinic (high traffic, too late, etc.) | Posted | Count of Participants | Participants | Weeks 1-8 |
|
|
|
| Other Pre-specified | 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. | We had 11 acupuncture participants withdraw from the study post-randomization and before their first acupuncture appointment - the denominator for the surveys are the number of still-active participants who received the survey. The reason for withdrawal was primarily issues traveling to the acupuncture clinic (high traffic, too late, etc.) | Posted | Count of Participants | Participants | Weeks 0, 4, 8, 20 |
|
|
|
| Other Pre-specified | 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. | Only participants in the acupuncture arm are included in this measure. We had 11 participants withdraw from the study post-randomization and before their first acupuncture appointment - those individuals were not included in this measure analysis. The reason for withdrawal was primarily issues traveling to the acupuncture clinic (high traffic, too late, etc.) | Posted | Number | Acupuncture Visits | Weeks 1 - 8 | AcupunctureVisits | AcupunctureVisits |
|
|
|
| Other Pre-specified | 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) | Only participants in the acupuncture arm are included in this measure. We had 11 participants withdraw from the study post-randomization and before their first acupuncture appointment - those individuals were not included in this measure analysis. The reason for withdrawal was primarily issues traveling to the acupuncture clinic (high traffic, too late, etc.) Not all visits used the Pyonex press needles, so the number of visits these applied to is different than the total number of visits | Posted | Number | AcupunctureVisits | Weeks 1-8 | Visits | Visits |
|
|
|
| 1 |
| 46 |
| 10 |
| 46 |
| 9 |
| 46 |
| EG001 | Usual Care | Participants in the usual care group did not receive any additional treatment as part of the study. They were instructed to continue receiving any care recommended to them by their PCP or Long COVID Clinician. | 1 | 47 | 11 | 47 | 0 | 47 |
|
| Accidental injury (fracture or foreign body) | Injury, poisoning and procedural complications | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| Allergic reaction | Immune system disorders | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| Cardiac symptoms (palpitations or chest pain) | Cardiac disorders | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| Eye disorder (acute vision loss) | Eye disorders | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| General symptoms requiring evaluation | General disorders | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| Genitourinary or gynecologic symptoms | Renal and urinary disorders | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| Genitourinary or gynecologic symptoms | Reproductive system and breast disorders | Systematic Assessment |
|
| Infection (COVID-19 or influenza) | Infections and infestations | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| Musculoskeletal pain or injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| Neurologic symptoms (dizziness) | Nervous system disorders | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| Peripheral swelling | Skin and subcutaneous tissue disorders | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| Psychiatric disorders (psychosis) | Psychiatric disorders | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| Respiratory disorders (asthma exacerbation or epistaxis) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| Hospitalized for planned surgery | Surgical and medical procedures | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| Venous thromboembolism or suspected pulmonary embolism | Vascular disorders | Systematic Assessment | Event was assessed through EHR review; not related to receiving the intervention. |
|
| Localized pain at needle site | Skin and subcutaneous tissue disorders | Systematic Assessment | Discomfort with needle, typically reported in the visit and the needle is removed |
|
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| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Post-Intervention (Week 8) |
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| Final Follow-Up (Week 20) |
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| Ability to Participate in Social Roles: Post Intervention (Week 8) |
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| Ability to Participate in Social Roles: Final Follow-Up (Week 20) |
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| Anxiety/Fear: Baseline (Week 0) |
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| Anxiety/Fear: Post Intervention (Week 8) |
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| Anxiety/Fear: Final Follow-Up (Week 20) |
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| Depression/Sadness: Baseline (Week 0) |
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| Depression/Sadness: Post Intervention (Week 8) |
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| Depression/Sadness: Final Follow-Up (Week 20) |
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| Fatigue: Baseline (Week 0) |
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| Fatigue: Post Intervention (Week 8) |
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| Fatigue: Final Follow-Up (Week 20) |
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| Pain Interference: Baseline (Week 0) |
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| Pain Interference: Post Intervention (Week 8) |
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| Pain Interference: Final Follow-Up (Week 20) |
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| Physical Function: Baseline (Week 0) |
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| Physical Function: Post Intervention (Week 8) |
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| Physical Function: Final Follow-Up (Week 20) |
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| Sleep Disturbance: Baseline (Week 0) |
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| Sleep Disturbance: Post Intervention (Week 8) |
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| Sleep Disturbance: Final Follow-Up (Week 20) |
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| Pain Intensity: Baseline (Week 0) |
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| Pain Intensity: Post Intervention (Week 8) |
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| Pain Intensity: Final Follow-Up (Week 20) |
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| Post Intervention (Week 8) |
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| Final Follow-Up (Week 20) |
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| Post Intervention (Week 8) |
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| Final Follow-Up (Week 20) |
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| Midpoint (Week 4) |
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| Post-Intervention (Week 8) |
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| Final Follow-Up (Week 20) |
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