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| Name | Class |
|---|---|
| Spokane Regional Health District | UNKNOWN |
| University of Washington Institute for Translational Health Science (KL2) | OTHER |
| Rayce Rudeen Foundation | UNKNOWN |
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This study investigates how adults prescribed opioids for chronic noncancer pain respond to invitations to try non-opioid options of massage therapy, yoga therapy, chiropractic and physical therapies. Options will be available via telehealth consultation visits using a computer or smartphone with internet connection. The investigators will measure effects on pain, pain-related symptoms, and opioid use over time using a single-group design.
Participants will be recruited from local primary care practices and asked to complete a baseline survey. They will then meet with a registered nurse via teleconference for a complete pain assessment. At the end of the session, participants will be asked to choose two of four available modalities for telehealth consultation. Participants will be scheduled for six telehealth sessions, once per week x six weeks with three consultations per each chosen therapy. Measurements of pain, mood, sleep, medicine use will be captured at baseline, three weeks and six weeks and examined for changes over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm pain treatment | Experimental | Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-pharmacological pain treatment | Other | Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating | Full scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Intensity Scale version 3a that measures the construct pain intensity or severity in three items for how much it hurts on average, at its worst and at its least in the past 7 days. Scale ranges from minimum "no pain" =1 to maximum "very severe" =5 pain with a possible sum of 3-15. A total sum of the 3 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome (range 40-70 after T-score conversion). | 6 weeks |
| PROMIS Pain Interference Rating | Scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Interference Scale that measures the construct pain interference in 8 items for how much pain interferes with a variety of activities in the past 7 days. Scale ranges from minimum "not at all" =1 to maximum "very much" =5 pain with a possible sum of 8-40. A total sum of the 8 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms Using Patient Health Questionnaire (PHQ-8) | Patient Health Questionnaire (PHQ-8) 8-item scale with score range 0-24 (higher score is worsened depressive symptoms) | 6 weeks |
| PROMIS Self-efficacy for Managing Symptoms Short Form 4a |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Attendance in Scheduled Telehealth Sessions | Percentage of scheduled telehealth sessions attended by participants (calculated as total number attended/total number scheduled) | 6 weeks |
| IBM Computer Usability and Satisfaction Questionnaires |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Health Association of Spokane | Spokane | Washington | 99201 | United States | ||
| Washington State University College of Nursing |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Pain Treatment | Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Pain Treatment | Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating | Full scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Intensity Scale version 3a that measures the construct pain intensity or severity in three items for how much it hurts on average, at its worst and at its least in the past 7 days. Scale ranges from minimum "no pain" =1 to maximum "very severe" =5 pain with a possible sum of 3-15. A total sum of the 3 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome (range 40-70 after T-score conversion). | Participants with pre and post data for analysis | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
6 weeks
Severity of event was rated as (select one): Grade 1 - Mild; Grade 2 - Moderate; Grade 3 - Severe Participants were evaluated by RN as to whether there was a reasonable possibility that the experimental COMFORT intervention caused the event.
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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 | Single Arm Pain Treatment | Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks Non-pharmacological pain treatment: Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild | Ear and labyrinth disorders | Non-systematic Assessment | Vertigo reported by participant; does not believe it was related to the study intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marian Wilson | Washington State University | 509-324-7443 | marian.wilson@wsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 15, 2021 | May 1, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Single group studied over 6 weeks time
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Self-efficacy self-report (range 4-20 with higher score better symptom management self-efficacy). Scores converted into T scores with 50 as the average for US adults and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a better outcome (range 40-70 after T-score conversion).
| 6 weeks |
| PROMIS Self-efficacy for Managing Emotions Short Form 4a | Self-efficacy self-report (range 4-20 ). Converted to T score where 50 equals the US adults average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a better outcome for self-efficacy for managing emotions (range 40-70 after T-score conversion). | 6 weeks |
| Anxiety Using Generalized Anxiety Disorder (GAD-7) | 7-item scale with score range 0-21 (higher score is worsened anxiety) | 6 weeks |
| Interpersonal Needs Questionnaire | 9-item scale asking how one feels about others score range 0-28 (lower score indicates more unmet interpersonal needs) | 6 weeks |
| Current Opioid Misuse Measure | 17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse) | 6 weeks |
| Spiritual Well-being Index | 4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being) | 6 weeks |
The IBM Computer Usability and Satisfaction Questionnaires was adapted to measure tele-visit program usability and satisfaction with a 4-item survey to gauge participant satisfaction with the intervention using 1-7 Likert scale. A total mean satisfaction rating was generated from the combined mean 4 satisfaction items (possible mean range 1-7 where higher score means higher satisfaction) on a Likert-style scale: The Likert-style scale for each item was: 1: Strongly disagree- 7: Strongly agree where higher numbers indicate greater satisfaction.
| 6 weeks |
| Spokane |
| Washington |
| 99201 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PROMIS Pain Intensity Scale | Full scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Intensity Scale version 3a that measures the construct pain intensity or severity in three items for how much it hurts on average, at its worst and at its least in the past 7 days. Scale ranges from minimum "no pain" =1 to maximum "very severe" =5 pain with a possible sum of 3-15. A total sum of the 3 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Primary | PROMIS Pain Interference Rating | Scale name is PROMIS (Patient-Reported Outcome Measurement Information System) Pain Interference Scale that measures the construct pain interference in 8 items for how much pain interferes with a variety of activities in the past 7 days. Scale ranges from minimum "not at all" =1 to maximum "very much" =5 pain with a possible sum of 8-40. A total sum of the 8 items is converted into a T-score where 50 is equivalent to the U.S. general population average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a worse outcome. | Participants with pre and post data for analysis | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
|
| Secondary | Depressive Symptoms Using Patient Health Questionnaire (PHQ-8) | Patient Health Questionnaire (PHQ-8) 8-item scale with score range 0-24 (higher score is worsened depressive symptoms) | Participants with pre and post data for analysis | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| Secondary | PROMIS Self-efficacy for Managing Symptoms Short Form 4a | Self-efficacy self-report (range 4-20 with higher score better symptom management self-efficacy). Scores converted into T scores with 50 as the average for US adults and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a better outcome (range 40-70 after T-score conversion). | Participants with pre and post data for analysis | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
|
| Secondary | PROMIS Self-efficacy for Managing Emotions Short Form 4a | Self-efficacy self-report (range 4-20 ). Converted to T score where 50 equals the US adults average and + /- 10 points is equivalent to the standard deviation. Higher values are considered to be a better outcome for self-efficacy for managing emotions (range 40-70 after T-score conversion). | Participants with pre and post data for analysis | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
|
| Secondary | Anxiety Using Generalized Anxiety Disorder (GAD-7) | 7-item scale with score range 0-21 (higher score is worsened anxiety) | Participants with pre and post data for analysis | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
|
| Secondary | Interpersonal Needs Questionnaire | 9-item scale asking how one feels about others score range 0-28 (lower score indicates more unmet interpersonal needs) | Participants with pre and post data for analysis | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
|
| Secondary | Current Opioid Misuse Measure | 17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse) | Participants with pre and post data for analysis | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
|
| Secondary | Spiritual Well-being Index | 4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being) | Participants with pre and post data for analysis | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
|
| Other Pre-specified | Percentage of Attendance in Scheduled Telehealth Sessions | Percentage of scheduled telehealth sessions attended by participants (calculated as total number attended/total number scheduled) | All participants | Posted | Number | percentage of sessions attended | 6 weeks | telehealth sessions | telehealth sessions |
|
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| Other Pre-specified | IBM Computer Usability and Satisfaction Questionnaires | The IBM Computer Usability and Satisfaction Questionnaires was adapted to measure tele-visit program usability and satisfaction with a 4-item survey to gauge participant satisfaction with the intervention using 1-7 Likert scale. A total mean satisfaction rating was generated from the combined mean 4 satisfaction items (possible mean range 1-7 where higher score means higher satisfaction) on a Likert-style scale: The Likert-style scale for each item was: 1: Strongly disagree- 7: Strongly agree where higher numbers indicate greater satisfaction. | Participants with satisfaction data completed - 1 did not participate | Posted | Mean | Standard Deviation | mean of summed scores on a scale | 6 weeks |
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| 0 |
| 16 |
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| 16 |
| 1 |
| 16 |
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