Chronic Pain
Conditions
Keywords
chronic pain, opioid, complementary
Brief summary
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.
Detailed description
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.
Interventions
OTHERNon-pharmacological pain treatment
Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
Sponsors
Spokane Regional Health District
University of Washington Institute for Translational Health Science (KL2)
Rayce Rudeen Foundation
Washington State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single group studied over 6 weeks time
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* enrollment in treatment at the CHAS Perry St or partnering clinic; * age greater than 18 years; * ability to read, speak, and write English; * diagnosed with a chronic, non-cancer-based painful medical condition; * ability to provide informed consent.
Exclusion criteria
* pregnancy; * diagnosis of a cancer-based painful medical condition; * any other medical or psychiatric condition that the PI or Co-PI physician of record determine might compromise safe study participation (including but not limited to active psychosis, history of frequent psychiatric hospitalizations, severe anxiety with claustrophobia, aggression)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating | 6 weeks | 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). |
| PROMIS Pain Interference Rating | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Self-efficacy for Managing Symptoms Short Form 4a | 6 weeks | 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). |
| PROMIS Self-efficacy for Managing Emotions Short Form 4a | 6 weeks | 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). |
| Interpersonal Needs Questionnaire | 6 weeks | 9-item scale asking how one feels about others score range 0-28 (lower score indicates more unmet interpersonal needs) |
| Current Opioid Misuse Measure | 6 weeks | 17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse) |
| Spiritual Well-being Index | 6 weeks | 4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being) |
| Anxiety Using Generalized Anxiety Disorder (GAD-7) | 6 weeks | 7-item scale with score range 0-21 (higher score is worsened anxiety) |
| Depressive Symptoms Using Patient Health Questionnaire (PHQ-8) | 6 weeks | Patient Health Questionnaire (PHQ-8) 8-item scale with score range 0-24 (higher score is worsened depressive symptoms) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Attendance in Scheduled Telehealth Sessions | 6 weeks | Percentage of scheduled telehealth sessions attended by participants (calculated as total number attended/total number scheduled) |
| IBM Computer Usability and Satisfaction Questionnaires | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Single Arm Pain Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 60.4 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| PROMIS Pain Intensity Scale | 68.6 units on a scale STANDARD_DEVIATION 6.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 1 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
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).
Time frame: 6 weeks
Population: Participants with pre and post data for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm Pain Treatment | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating | Pre | 68.3 score on a scale | Standard Deviation 6.3 |
| Single Arm Pain Treatment | Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Rating | Post | 64.4 score on a scale | Standard Deviation 6 |
Comparison: Paired t tests of pre and posttest datap-value: <0.001t-test, 2 sided
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.
Time frame: 6 weeks
Population: Participants with pre and post data for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm Pain Treatment | PROMIS Pain Interference Rating | Pre | 69.9 units on a scale | Standard Deviation 5.5 |
| Single Arm Pain Treatment | PROMIS Pain Interference Rating | Post | 64.3 units on a scale | Standard Deviation 8.3 |
Comparison: Paired t tests of pre and posttest datap-value: 0.003t-test, 2 sided
Secondary
Anxiety Using Generalized Anxiety Disorder (GAD-7)
7-item scale with score range 0-21 (higher score is worsened anxiety)
Time frame: 6 weeks
Population: Participants with pre and post data for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm Pain Treatment | Anxiety Using Generalized Anxiety Disorder (GAD-7) | Pre | 5.9 units on a scale | Standard Deviation 4.7 |
| Single Arm Pain Treatment | Anxiety Using Generalized Anxiety Disorder (GAD-7) | Post | 5.2 units on a scale | Standard Deviation 5.2 |
Comparison: Paired t tests of pre and posttest datap-value: 0.517t-test, 2 sided
Secondary
Current Opioid Misuse Measure
17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse)
Time frame: 6 weeks
Population: Participants with pre and post data for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm Pain Treatment | Current Opioid Misuse Measure | Pre | 7.1 units on a scale | Standard Deviation 4.9 |
| Single Arm Pain Treatment | Current Opioid Misuse Measure | Post | 6.8 units on a scale | Standard Deviation 4.4 |
p-value: 0.811t-test, 2 sided
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)
Time frame: 6 weeks
Population: Participants with pre and post data for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm Pain Treatment | Depressive Symptoms Using Patient Health Questionnaire (PHQ-8) | Pre | 10.7 score on a scale | Standard Deviation 5.9 |
| Single Arm Pain Treatment | Depressive Symptoms Using Patient Health Questionnaire (PHQ-8) | Post | 7.6 score on a scale | Standard Deviation 5 |
Comparison: Paired t tests of pre and posttest datap-value: 0.011t-test, 2 sided
Secondary
Interpersonal Needs Questionnaire
9-item scale asking how one feels about others score range 0-28 (lower score indicates more unmet interpersonal needs)
Time frame: 6 weeks
Population: Participants with pre and post data for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm Pain Treatment | Interpersonal Needs Questionnaire | Post | 24.5 units on a scale | Standard Deviation 13.5 |
| Single Arm Pain Treatment | Interpersonal Needs Questionnaire | Pre | 27.7 units on a scale | Standard Deviation 14.4 |
Comparison: Paired t tests of pre and posttest datap-value: 0.012t-test, 2 sided
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).
Time frame: 6 weeks
Population: Participants with pre and post data for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm Pain Treatment | PROMIS Self-efficacy for Managing Emotions Short Form 4a | Pre | 43.4 units on a scale | Standard Deviation 6.3 |
| Single Arm Pain Treatment | PROMIS Self-efficacy for Managing Emotions Short Form 4a | Post | 44.4 units on a scale | Standard Deviation 5.1 |
Comparison: Paired t tests of pre and posttest datap-value: 0.456t-test, 2 sided
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).
Time frame: 6 weeks
Population: Participants with pre and post data for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm Pain Treatment | PROMIS Self-efficacy for Managing Symptoms Short Form 4a | Pre | 39.4 units on a scale | Standard Deviation 5.2 |
| Single Arm Pain Treatment | PROMIS Self-efficacy for Managing Symptoms Short Form 4a | Post | 41.2 units on a scale | Standard Deviation 5.3 |
Comparison: Paired t tests of pre and posttest datap-value: 0.168t-test, 2 sided
Secondary
Spiritual Well-being Index
4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being)
Time frame: 6 weeks
Population: Participants with pre and post data for analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm Pain Treatment | Spiritual Well-being Index | Pre | 15 units on a scale | Standard Deviation 4.1 |
| Single Arm Pain Treatment | Spiritual Well-being Index | Post | 15.1 units on a scale | Standard Deviation 3.5 |
Comparison: Paired t tests of pre and posttest datp-value: 0.941t-test, 2 sided
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.
Time frame: 6 weeks
Population: Participants with satisfaction data completed - 1 did not participate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm Pain Treatment | IBM Computer Usability and Satisfaction Questionnaires | 6.59 mean of summed scores on a scale | Standard Deviation 0.62 |
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)
Time frame: 6 weeks
Population: All participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm Pain Treatment | Percentage of Attendance in Scheduled Telehealth Sessions | 95.8 percentage of sessions attended |