Chronic Pain, HIV Infections
Conditions
Brief summary
Chronic pain is highly comorbid among the 1.2 million persons living with HIV, with recent prevalence estimates ranging from 55-67%. Needed are evidenced-based non-pharmacological interventions to improve chronic pain management and reduce the demand for opioids in the United States. The proposed research will address this need by examining the feasibility and acceptability of Tai Chi as a mind-body intervention for chronic pain management in an HIV population.
Detailed description
Persons living with HIV (PLWH) are at increased risk for chronic pain conditions, with prevalence rates estimated to be between 55-67%. While acute pain is a life-sustaining biological response to tissue damage or injury, chronic pain is a separate condition that often causes significant physical and psychological suffering. Causes of chronic pain among PLWH include disease progression, the impact of the virus on immune and nervous system function, and medication side-effects. PLWH, like many other chronic pain patients, may be prescribed opioid medications, which have not been found to be effective in managing non-cancer related chronic pain. Additionally, the significant risk of dependence and overdose far outweigh the potential benefit of opioid medications for chronic pain. Governing bodies in medicine have called for non-pharmacological interventions to be considered front-line treatment recommendations for chronic pain management. Mind-body interventions, such as mindfulness, yoga, and Tai Chi, have been shown to be effective at reducing pain symptoms and improving psychological outcomes for individuals with chronic pain. Unfortunately, few studies have examined the use of mind-body interventions for chronic pain management for PWLH, with even fewer using formative research to modify interventions to meet the unique needs of this vulnerable population. The research plan proposed in this application will address these gaps in the literature. This study will examine the feasibility and acceptability of a mind-body intervention, Qigong/Tai Chi Easy, for chronic pain management among PLWH. The researchers will recruit 40 individuals from the Comprehensive HIV Program at Temple Health. Following informed consent, participants will be randomized to mind-body arm or health education control arm. Participants in both arms will complete baseline assessment followed by a 10-week intervention. The mind-body intervention group will meet weekly for 60-minute sessions and be provided with a video for at-home practice. The health education group will also meet weekly for 60 minutes and be assigned weekly homework related to the topics discussed in session. At the conclusion of the 10 weeks, participants will complete at post-intervention assessment. A 3-month follow up assessment will also be completed. In addition to feasibility (i.e., recruitment rates, retention) and acceptability (i.e., satisfaction ratings), the researchers will assess pain symptoms (general and specific), perceived stress, depression, quality of life, and HIV medication adherence. The researchers anticipate that the study will demonstrate feasibility and acceptability as evidenced by adequate enrollment, retention, and satisfaction. Findings from the proposed study will be used to inform a future research grant with power to detect efficacy of the mind-body intervention for chronic pain management.
Interventions
BEHAVIORALTai Chi
Qigong/Tai Chi Easy is a manualized intervention with formal training for instructors through the Institute of Integral Qigong and Tai Chi (IIQTC). The protocol can be modified based on participant needs and physical abilities. Qigong/Tai Chi Easy uses a series of repeated and simple-to-learn movements (rather than long forms with complicated choreography).
BEHAVIORALHealth Coaching
The Health Education group will be adapted from a previously developed time and attention control condition used in HIV research. Additional health education material will be based on information learned in the qualitative interviews conducted prior to the start of this study. Examples of session material include the following: sleep hygiene, healthy diet, sun safety, and healthy homes.
Sponsors
Temple University
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 45 and older; * HIV positive status based on clinical records; * chronic pain condition based on clinical records; * English speaking; * physically able to participate in a Tai Chi program
Exclusion criteria
* Inability or unwillingness to provide informed consent * Inability or unwillingness to travel to Temple Dental School; * Inability or unwillingness to engage in 10-week intervention; * Non-English speaking; * Active substance use disorder; * Acutely suicidal or psychotic; * Self-reported participation in another research study related to chronic-pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity - Brief Pain Inventory | Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24) | Participants will be asked to rate their pain, ranging from 0, no pain, to 10, most extreme pain, on average in the past week. Higher scores indicate worse pain. |
| Pain Interference - Brief Pain Inventory | Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24) | A self-report of impairment in mobility, impairment in activities of daily living, mood, and pain-related anxiety/fear. The pain interference subscale score is the average of 7 items, with responses that range from 0-10. Higher scores indicate worse pain interference. |
| Feasibility to Execute Study Protocol | Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24) | Ability to recruit and retain participants through intervention and follow-up assessments |
| Participant Satisfaction Questionnaire (PSQ) - Acceptability | Post-Intervention (Weeks 10-12) | Participant self-reported satisfaction with intervention components. Response to question: "How would you rate your overall satisfaction with this program?" |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale (PSS) | Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24) | The Perceived Stress Scale is a measure of self-reported stress in the past month. There are 13 items and responses range from 0 (never) to 4 (very often). A total score is calculated and can range from 0 to 52, with higher scores indicated a greater degree of perceived stress. |
| Patient Health Questionnaire (PHQ-8) | Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24) | The PHQ-9 is a commonly used measure of depression with strong psychometric properties for clinical populations. The scale consists of 8 items, with responses ranging from 0 (not at all) to 3 (nearly every day). Total scores are calculated and possible scores range from 0 to 24, with higher scores indicated more depressive symptoms. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREugene M Dunne, PhD
Temple University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 3 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 | 7 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
None listed