Chronic Pain
Conditions
Brief summary
This project focuses on whether nonspecific factors as well as patient characteristics contribute to treatment outcome differences. The project uses assessment instruments, computerized adaptive tests (CATs), from the Patient-Reported Outcomes Measurement Information System (PROMIS®). The research team has recently developed and tested (using PROMIS methods) a set of instruments to assess non-specific factors in healing from the patient's perspective. These instruments, the Healing Encounters and Attitudes Lists (HEAL) assess the Patient-Provider Connection, Treatment Expectancy, views of the Healthcare Environment, Positive and Negative Attitudes, Spirituality, and Attitude toward Complementary and Alternative Medicine (CAM). HEAL CAT's, like other PROMIS CATs, are brief, easy to use and understand, and are designed to apply to a broad spectrum of treatments and health conditions. In this project, the investigators aim to 1) evaluate whether HEAL predicts chronic pain treatment outcomes, 2) examine heterogeneity of treatment effects based upon HEAL and PROMIS scores in integrative and conventional medicine settings, and 3) interview patients and their clinicians regarding the utility of HEAL, PROMIS and a Pain Log for enhancing communication. The investigators will administer HEAL CATs and other PROMIS CATs (depression, anxiety, sleep disturbance, fatigue and physical function) to 200 patients who are starting treatment for chronic pain in integrative medicine and conventional medicine settings. Follow-up assessments will be completed 2 and 4 months after baseline testing. The investigators will evaluate factors that may predict which patients judge themselves to be improved, the same, or worsened. Some of the possible factors that may contribute to improvement include HEAL scores, emotional distress, or the preference for CAM or conventional treatment. The investigators are also interested in learning whether patients find the assessments to be clear and useful. A subset of 50 patients and approximately 10 clinicians will complete interviews about the HEAL and PROMIS questions, and about the Pain Log developed by a patient advocacy group partner, the American Chronic Pain Association. By interviewing patients and their healthcare providers, the investigators hope to determine the clarity and acceptability of the HEAL and other assessments, and to learn whether HEAL and PROMIS summaries enhance patient-provider communication in the clinical partnership.
Interventions
None listed
Sponsors
University of Pittsburgh
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and older * able to read and understand English * able to answer questionnaires on a computer * starting a new treatment for chronic pain or having just started a new treatment within the past month * expecting to continue their course of treatment
Exclusion criteria
* psychotic disorders * substance abuse by self report
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain Intensity | 6-8 weeks | PROMIS Pain Intensity is a three item scale measuring the severity of pain at its worst (past week), average (past week), and current level using a five-point Likert-type scale (i.e., no pain=1, mild=2, moderate=3, severe=4, very severe=5). Scores on the 3 items are summed to create a raw score, which can range from 3 to 15. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see http://www.healthmeasures.net/promis-scoring-manuals for details ). |
| PROMIS Pain Interference | 6-8 weeks | Computerized adaptive test measuring interference of pain in everyday functioning using five-point Likert-type scales with two types or response options (i.e., not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5, and never=1, rarely=2, sometimes=3, often=4, always=5). Scores on the items are summed to create a raw score. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see http://www.healthmeasures.net for details of CAT administration and scoring). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression of Change (CGI) | 6-8 weeks | Patient's rating of current symptom level compared to baseline assessment using a five-point bipolar scale: Much better(2), Somewhat better(1), No change(0), Somewhat worse(-1), Much worse(-2) |
Countries
United States
Participant flow
Recruitment details
Over a 1 year period, 218 persons beginning treatment for chronic pain at conventional medicine clinics (pain clinics, physical therapy, primary care) (n=105), and integrative medicine centers (n=113) were invited to complete online assessments at 3 time-points: Baseline, 2 month, and 4 month follow-up.
Pre-assignment details
9 participants enrolled (completed consent) and did not continue in the study: 2 Integrative / Complementary Alternative Medicine (CAM) and 1 Conventional withdrew after signing consent form; 2 CAM and 4 Conventional did not meet eligibility criteria after signing consent form.
Participants by arm
| Arm | Count |
|---|---|
| Integrative Medicine Group Patients receiving chiropractic care, acupuncture, massage therapy, or meditation training for chronic pain | 109 |
| Conventional Medicine Group Patients receiving conventional medicine care (physical therapy, medication management, injections, etc.) for chronic pain. | 100 |
| Total | 209 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 16 Weeks | Completed 6-8 week, missed 16 week | 2 | 2 |
| 16 Weeks | Lost to Follow-up | 3 | 0 |
| 6-8 Weeks | Missed 6-8 week, eligible for 16 week | 10 | 1 |
Baseline characteristics
| Characteristic | Integrative Medicine Group | Total | Conventional Medicine Group |
|---|---|---|---|
| Age, Continuous | 45.6 years STANDARD_DEVIATION 14.5 | 47.5 years STANDARD_DEVIATION 14.9 | 49.5 years STANDARD_DEVIATION 15 |
| Education Greater than or equal to 4-year degree | 55 Participants | 108 Participants | 53 Participants |
| Education Less than 4-year degree | 53 Participants | 100 Participants | 47 Participants |
| Education Missing | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 14 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants | 194 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 36 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 87 Participants | 159 Participants | 72 Participants |
| Sex: Female, Male Female | 82 Participants | 157 Participants | 75 Participants |
| Sex: Female, Male Male | 27 Participants | 52 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 0 / 100 |
| other Total, other adverse events | 0 / 109 | 0 / 100 |
| serious Total, serious adverse events | 0 / 109 | 0 / 100 |
Outcome results
Primary
PROMIS Pain Intensity
PROMIS Pain Intensity is a three item scale measuring the severity of pain at its worst (past week), average (past week), and current level using a five-point Likert-type scale (i.e., no pain=1, mild=2, moderate=3, severe=4, very severe=5). Scores on the 3 items are summed to create a raw score, which can range from 3 to 15. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see http://www.healthmeasures.net/promis-scoring-manuals for details ).
Time frame: 6-8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrative Medicine Group | PROMIS Pain Intensity | 50.1 T-score metric | Standard Deviation 6.6 |
| Conventional Medicine Group | PROMIS Pain Intensity | 52.9 T-score metric | Standard Deviation 6.2 |
Primary
PROMIS Pain Interference
Computerized adaptive test measuring interference of pain in everyday functioning using five-point Likert-type scales with two types or response options (i.e., not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5, and never=1, rarely=2, sometimes=3, often=4, always=5). Scores on the items are summed to create a raw score. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see http://www.healthmeasures.net for details of CAT administration and scoring).
Time frame: 6-8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrative Medicine Group | PROMIS Pain Interference | 59.4 T-score metric | Standard Deviation 8.1 |
| Conventional Medicine Group | PROMIS Pain Interference | 63.1 T-score metric | Standard Deviation 6.6 |
Secondary
Clinical Global Impression of Change (CGI)
Patient's rating of current symptom level compared to baseline assessment using a five-point bipolar scale: Much better(2), Somewhat better(1), No change(0), Somewhat worse(-1), Much worse(-2)
Time frame: 6-8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Integrative Medicine Group | Clinical Global Impression of Change (CGI) | Somewhat worse | 4 participants |
| Integrative Medicine Group | Clinical Global Impression of Change (CGI) | Much worse | 1 participants |
| Integrative Medicine Group | Clinical Global Impression of Change (CGI) | Much better | 16 participants |
| Integrative Medicine Group | Clinical Global Impression of Change (CGI) | No change | 20 participants |
| Integrative Medicine Group | Clinical Global Impression of Change (CGI) | Better | 46 participants |
| Integrative Medicine Group | Clinical Global Impression of Change (CGI) | Missing | 22 participants |
| Conventional Medicine Group | Clinical Global Impression of Change (CGI) | Missing | 5 participants |
| Conventional Medicine Group | Clinical Global Impression of Change (CGI) | Somewhat worse | 10 participants |
| Conventional Medicine Group | Clinical Global Impression of Change (CGI) | Better | 51 participants |
| Conventional Medicine Group | Clinical Global Impression of Change (CGI) | No change | 23 participants |
| Conventional Medicine Group | Clinical Global Impression of Change (CGI) | Much worse | 2 participants |
| Conventional Medicine Group | Clinical Global Impression of Change (CGI) | Much better | 9 participants |