HIV Infections
Conditions
Keywords
peripheral neuropathy, pain, TENS, Mindfulness Meditation
Brief summary
This study is to explore the effects of transcutaneous nerve stimulation (TENS) and mindfulness meditation in persons living with HIV (PLHIV) and painful neuropathy in the feet.
Detailed description
The overall goal of this study is to conduct an interventional pilot trial of mindfulness meditation and transcutaneous nerve stimulation (TENS) to mitigate the symptoms and improved function in persons living with HIV (PLHIV) and painful neuropathy in the feet. . The investigators aim to determine the feasibility and effects of (1) mindfulness meditation or (2) transcutaneous nerve stimulation (TENS) on clinical and functional outcomes in participants with HIV-associated painful distal sensory polyneuropathy in the feet. This aim will be achieved with a randomized control pilot trial with 3 groups: TENS group, Mindfulness Mediation Group, and Usual Treatment (Control) group. The interventions will be performed at home over a period of 6 weeks.
Interventions
Transcutaneous nerve stimulation (TENS) is a simple home base treatment to manage pain. It involves electrical current applied to the skin through self-adhering electrodes, using a TENS3000 device (TENSPros.com).
BEHAVIORALMindfulness Meditation
Mindfulness mediation is a guided mediation process to improve awareness of being present in the moment.
Sponsors
Rutgers University
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
co-investigators involved with measurement for the interventional phase will not know which of the 3 groups a participant was randomized to
Intervention model description
randomized controlled interventional pilot with 3 groups (2 treatment groups and 1 control group)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of HIV infection currently treated with antiretroviral therapy (ART) * cluster of differentiation 4 cell (CD4 cell) count of at least 200 cells/mm3 * 18-64 years of age * able to read and write in English * means to travel to a study site * presence of peripheral neuropathy symptoms in feet * average daily self-reported pain in the feet of at least 3/10 on a 0-10 numerical pain scale * pain in the feet present for at least the past 3 months * no changes in medications used to manage pain in the past 4 weeks * no use of TENS or mindfulness meditation in the prior 6 months * availability of a mobile phone to receive text messages over the course of the intervention period
Exclusion criteria
* current opportunistic infection(s) * cluster of differentiation 4 cell (CD4 cell) count \<200 cells/mm3 * dementia * uncontrolled psychiatric disorder * wounds or sores on the feet * musculoskeletal or neurological conditions (other than distal sensory neuropathy) that may affect gait * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity From Baseline to 7 Weeks | 7 weeks | Responses to questions on the Brief Pain Inventory Pain Intensity subscale used to generate pain intensity score. Minimum score=0; maximum score=10; higher score=worse outcome. Thus if change is a negative value, that indicates improvement. If the change is a positive value, that indicates worsening. |
| Change in Pain Interference From Baseline to 7 Weeks | 7 weeks | Responses to questions on the Brief Pain Inventory Pain Interference subscale used to generate pain interference score. Minimum score=0; maximum score=10; higher score=worse outcome. Thus if change is a negative value, that indicates improvement. If the change is a positive value, that indicates worsening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking Velocity From Baseline to 7 Weeks | 7 weeks | a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes |
| Change in Step Length From Baseline to 7 Weeks | 7 weeks | a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes |
| Change in Stride Width From Baseline to 7 Weeks | 7 weeks | a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes |
| Change in Cadence From Baseline to 7 Weeks | 7 weeks | a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes |
| Change in Walking Endurance From Baseline to 7 Weeks | 7 weeks | Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes). |
| Change in Physical Performance (SPPB Composite Score) From Baseline to 7 Weeks | 7 weeks | Physical performance score generated via the Short Physical Performance Battery. (SPPB). SPPB procedures generate a total score reflective of physical performance. Minimum score=0; maximum score=12; lower score=worse outcome. |
| Change in Whole Body Strength From Baseline to 7 Weeks | 7 weeks | Mid-thigh pull test will be used to generate a score expressed as Newtons that is reflective of whole body strength. |
| Change in Pain Pressure Threshold at Dorsal Web Space of Foot From Baseline to 7 Weeks | 7 weeks | Pain pressure threshold (expressed in Newtons) at lower extremity landmarks via use of a digital algometer. |
| Change in Pain Pressure Threshold at Proximal Tibia From Baseline to 7 Weeks | 7 weeks | Pain pressure threshold (expressed in Newtons) at lower extremity landmarks via use of a digital algometer. |
| Change in Mental Quality of Life (QOL) From Baseline to 7 Weeks | 7 weeks | Mental health QOL subscale from the Medical Outcomes Study HIV Health Survey (MOS-HIV). Minimum score=0; maximum score=100; lower score=worse outcome. |
| Change in Physical Quality of Life (QOL) From Baseline to 7 Weeks | 7 weeks | Physical Health Summary Score generated via responses on the Medical Outcomes Study HIV Health Survey (MOS-HIV). Minimum score=0; maximum score=100; lower score=worse outcome. |
| Change in Pain-Related Quality of Life From Baseline to 7 Weeks | 7 weeks | Pain-related QOL subscale score generated via responses on the Medical Outcomes Study HIV Health Survey (MOS-HIV). Minimum score=0; maximum score=100; lower score=worse outcome. |
| Change in Anxiety From Baseline to 7 Weeks | 7 weeks | Self-reported anxiety as determined by the anxiety subscale of the Hospital Depression and Anxiety Scale. Minimum score=0; maximum score=21; higher score=worse outcome. |
| Change in Depression From Baseline to 7 Weeks | 7 weeks | Self-reported depression as determined by the depression subscale of the Hospital Depression and Anxiety Scale. Minimum score=0; maximum score=21; higher score=worse outcome. |
| Change in Pain Catastrophizing From Baseline to 7 Weeks | 7 weeks | Self-reported catastrophizing behaviors using with the Pain Catastrophizing Scale. Minimum score=0; maximum score=52; higher score=worse outcome. |
| Change in Resilience From Baseline to 7 Weeks | 7 weeks | Self-reported resilience using the 6-item Brief Resilience Scale. Minimum score=1; maximum score=5; lower score=worse outcome. |
| Adherence to Home-based Treatment Over 6 Weeks | over 6 weeks | Adherence to home based intervention is defined as total number of treatment sessions completed over 6 weeks via direct communication with participants |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid M Kietrys, PhD
Rutgers
Participant flow
Recruitment details
Participants recruited from April 2022 through September 2024. Participants recruited at various locations: Jefferson Health Specialty Care HIV Clinic (Voorhees, NJ); University Hospital Infectious Disease (Newark, NJ), Broadway House (Newark, NJ), and HIV support groups at various locations in PA and NJ including Siloam Wellness (Philadelphia PA), Harrison House (Paramus, NJ), and The Salon (Newark, NJ).
Pre-assignment details
90 of 151 screened individuals did not meet the inclusion criteria for reasons such as not having neuropathy, not having pain of at least 3/10 in the feet, not having a CD4 count of 200 or higher, or having some condition that interferes with walking. 18 individuals met eligibility criteria but then elected not to enroll due to personal reasons or reasons not shared. 7 individuals were not enrolled for other reasons such as unknown CD4 count or not completing the screening process.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
None listed