Clinical trial NCT05055596: Improving Quality of Life for Adults Living With HIV and Chronic Pain
Official title: Improving Quality of Life for Adults Living With HIV and Chronic Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Infections
Chronic Pain
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-09-24
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Rating (VAS)
timeFrame: Each intervention group session (10 weeks)
measure: Brief Pain Inventory - Short Form (BPI)
timeFrame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
measure: Subjective Peripheral Neuropathy Screen Questionnaire (SPNSQ)
timeFrame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
measure: Orebro Musculoskeletal Pain Screening Questionnaire (OMSPQ)
timeFrame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Secondary outcomes:
measure: Quality of Life (WHO-QOL-BREF)
timeFrame: Baseline (Week 0), Post-Intervention (Weeks 10-12), and 3-month Follow Up (Weeks 22-24)
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
measure: The Meditative Movement Inventory
timeFrame: Post-Intervention (Weeks 10-12)
measure: The HIV Medication Adherence Survey
timeFrame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Other outcomes:
measure: Feasibility
timeFrame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
measure: Acceptability
timeFrame: Post-Intervention (Weeks 10-12)
Locations:
city: Philadelphia
country: United States
facility: Temple University Kornberg School of Dentistry (TUKSoD)
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Eugene M Dunne, PhD
role: PRINCIPAL_INVESTIGATOR
References: