Improving Quality of Life for Adults Living With HIV and Chronic Pain

HIV Infections Clinical Trial

Official title:

Improving Quality of Life for Adults Living With HIV and Chronic Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05055596
• Other study ID #: K23AT010099
• Secondary ID: K23AT010099
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: December 15, 2024

Study information

• Verified date: April 2024
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• HIV Infections

Intervention

Behavioral:
• Tai 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).
• Health 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.

Locations

Country	Name	City	State
United States	Temple University Kornberg School of Dentistry (TUKSoD)	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility	Ability to recruit and retain participants through intervention and follow-up assessments	Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Other	Acceptability	Participant self-reported satisfaction with intervention components	Post-Intervention (Weeks 10-12)
Primary	Pain Rating (VAS)	Participants will be asked to rate their pain on a visual analog scale (ranging from 0, no pain, to 100, most extreme pain)	Each intervention group session (10 weeks)
Primary	Brief Pain Inventory - Short Form (BPI)	A self-report of pain intensity, impairment in mobility, impairment in activities of daily living, mood, and pain-related anxiety/fear	Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Primary	Subjective Peripheral Neuropathy Screen Questionnaire (SPNSQ)	A valid and reliable measure of neuropathic pain symptoms for PLWH	Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Primary	Orebro Musculoskeletal Pain Screening Questionnaire (OMSPQ)	Measure used to assess musculoskeletal pain, with questions related pain site, and duration	Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Secondary	Quality of Life (WHO-QOL-BREF)	Measure to assess feelings regarding quality of life, health, or other areas of one's life	Baseline (Week 0), Post-Intervention (Weeks 10-12), and 3-month Follow Up (Weeks 22-24)
Secondary	Perceived Stress Scale (PSS)	Measure to assess frequency and severity of stressful situations, which may be relevant for people living with HIV and chronic pain as they manage intersecting chronic illnesses	Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Secondary	Patient Health Questionnaire (PHQ-8)	The PHQ-9 is a commonly used measure of depression with strong psychometric properties for clinical populations	Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Secondary	Pain Catastrophizing Scale (PCS)	13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.	Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Secondary	The Meditative Movement Inventory	This is a 17-item questionnaire aiming to capture in descriptions different aspects of meditative movement, such as the meditative state of mind, breathing, flow of movement and affective quality.	Post-Intervention (Weeks 10-12)
Secondary	The HIV Medication Adherence Survey	Medication adherence will be assessed using a validated brief 3-item measure for PLWH, which assesses number of days missed, difficulty following instructions, and self-rating of medication adherence in the past 30 days	Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)