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

Primary Purpose

HIV Infections, Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Health Coaching
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Temple University Kornberg School of Dentistry (TUKSoD)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gentle Movement

Health Coaching

Arm Description

Outcomes

Primary Outcome Measures

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)
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
Subjective Peripheral Neuropathy Screen Questionnaire (SPNSQ)
A valid and reliable measure of neuropathic pain symptoms for PLWH
Orebro Musculoskeletal Pain Screening Questionnaire (OMSPQ)
Measure used to assess musculoskeletal pain, with questions related pain site, and duration

Secondary Outcome Measures

Quality of Life (WHO-QOL-BREF)
Measure to assess feelings regarding quality of life, health, or other areas of one's life
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
Patient Health Questionnaire (PHQ-8)
The PHQ-9 is a commonly used measure of depression with strong psychometric properties for clinical populations
Pain Catastrophizing Scale (PCS)
13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.
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.
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

Full Information

First Posted
September 2, 2021
Last Updated
February 15, 2023
Sponsor
Temple University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05055596
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gentle Movement
Arm Type
Experimental
Arm Title
Health Coaching
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Health Coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Rating (VAS)
Description
Participants will be asked to rate their pain on a visual analog scale (ranging from 0, no pain, to 100, most extreme pain)
Time Frame
Each intervention group session (10 weeks)
Title
Brief Pain Inventory - Short Form (BPI)
Description
A self-report of pain intensity, impairment in mobility, impairment in activities of daily living, mood, and pain-related anxiety/fear
Time Frame
Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Title
Subjective Peripheral Neuropathy Screen Questionnaire (SPNSQ)
Description
A valid and reliable measure of neuropathic pain symptoms for PLWH
Time Frame
Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Title
Orebro Musculoskeletal Pain Screening Questionnaire (OMSPQ)
Description
Measure used to assess musculoskeletal pain, with questions related pain site, and duration
Time Frame
Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Secondary Outcome Measure Information:
Title
Quality of Life (WHO-QOL-BREF)
Description
Measure to assess feelings regarding quality of life, health, or other areas of one's life
Time Frame
Baseline (Week 0), Post-Intervention (Weeks 10-12), and 3-month Follow Up (Weeks 22-24)
Title
Perceived Stress Scale (PSS)
Description
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
Time Frame
Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Title
Patient Health Questionnaire (PHQ-8)
Description
The PHQ-9 is a commonly used measure of depression with strong psychometric properties for clinical populations
Time Frame
Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Title
Pain Catastrophizing Scale (PCS)
Description
13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.
Time Frame
Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Title
The Meditative Movement Inventory
Description
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.
Time Frame
Post-Intervention (Weeks 10-12)
Title
The HIV Medication Adherence Survey
Description
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
Time Frame
Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Other Pre-specified Outcome Measures:
Title
Feasibility
Description
Ability to recruit and retain participants through intervention and follow-up assessments
Time Frame
Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Title
Acceptability
Description
Participant self-reported satisfaction with intervention components
Time Frame
Post-Intervention (Weeks 10-12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eugene M Dunne, PhD
Phone
2157079655
Email
eugene.dunne@temple.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene M Dunne, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University Kornberg School of Dentistry (TUKSoD)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugene M Dunne, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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