Chronic Pain
Conditions
Brief summary
Due to its specific pathophysiology and impact on health outcomes, the Institute of Medicine has described chronic pain as a complex chronic disease and a national public health crisis. The unique neurobiological basis and psychosocial context of chronic pain in HIV-infected patients underscores the importance of developing and testing a behavioral intervention specifically tailored to this population. This study will pilot test a newly-developed behavioral intervention for chronic pain tailored to individuals with HIV.
Detailed description
Chronic pain is a chronic condition with a unique neurobiologic basis, which has a substantial impact on physical and emotional function. Chronic pain in HIV-infected patients is common, and associated with serious health consequences, including up to 10 times greater odds of impaired physical function. Many pharmacologic therapies, including opioids, often do not lead to improved pain and function, and carry significant risk. Evidence-based behavioral interventions are among the most effective and safe non-pharmacologic chronic pain treatments investigated in the general medical population. Therefore, behavioral interventions to improve pain, physical, and emotional function in HIV-infected patients are needed. There is much to be learned from existing interventions. However, the success of a behavioral intervention is heavily influenced by how well it is tailored to the target population's biological, psychological, and social environment. Therefore, in this study investigators will conduct a two-arm pilot randomized controlled trial of a recently-developed behavioral intervention compared to routine HIV and pain care, to determine feasibility, acceptability, and preliminary impact.
Interventions
BEHAVIORALIntervention
The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain.
BEHAVIORALControl
The control group will receive treatment as usual. The treatment as usual or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Enrolled in the Center for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort 2. Age ≥ 18 years 3. Chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least moderate pain for at least 3 months) 4. Moderately severe and impairing chronic pain (PEG pain questionnaire = average of all three times is 4 or greater)
Exclusion criteria
1. Do not speak or understand English 2. Are planning a new pain treatment like surgery 3. Cannot attend the group sessions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Feasibility: Median Number of Study Intervention Sessions Attended by Participants | From baseline throughout the entire 16 week intervention period | Participants are expected to attend 6 one-on-one sessions and 6 group sessions. Maximum sessions if all attended per participant would be 12 sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Outcome Assessment Feasibility: Number (Percentage) of Participants Who Complete Outcome Assessments Within One Month | From the conclusion of the intervention through 30 days (Intervention Group). From the last group session through 30 days (Control Group). | Outcome assessments are administered to participants by study staff. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain. | 22 |
| Control The control group will receive treatment as usual. The treatment as usual or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group. | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 4 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 51 years | 51 years | 51 years |
| Number of participants with undetectable viral load (blood test, measured in copies/mL) | 21 Participants | 21 Participants | 42 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 19 Participants | 38 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Female | 11 Participants | 14 Participants | 25 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 1 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Intervention Feasibility: Median Number of Study Intervention Sessions Attended by Participants
Participants are expected to attend 6 one-on-one sessions and 6 group sessions. Maximum sessions if all attended per participant would be 12 sessions.
Time frame: From baseline throughout the entire 16 week intervention period
Population: All 22 participants were assessed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Intervention Feasibility: Median Number of Study Intervention Sessions Attended by Participants | 9 Study Sessions |
Secondary
Outcome Assessment Feasibility: Number (Percentage) of Participants Who Complete Outcome Assessments Within One Month
Outcome assessments are administered to participants by study staff.
Time frame: From the conclusion of the intervention through 30 days (Intervention Group). From the last group session through 30 days (Control Group).
Population: All 22 participants in each arm were analyzed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Outcome Assessment Feasibility: Number (Percentage) of Participants Who Complete Outcome Assessments Within One Month | Completed outcome assessment | 19 Participants |
| Intervention | Outcome Assessment Feasibility: Number (Percentage) of Participants Who Complete Outcome Assessments Within One Month | Did not complete outcome assessment | 3 Participants |
| Control | Outcome Assessment Feasibility: Number (Percentage) of Participants Who Complete Outcome Assessments Within One Month | Completed outcome assessment | 17 Participants |
| Control | Outcome Assessment Feasibility: Number (Percentage) of Participants Who Complete Outcome Assessments Within One Month | Did not complete outcome assessment | 5 Participants |