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| Name | Class |
|---|---|
| Thomas Jefferson University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Meditation | Experimental | 6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home |
|
| Transcutaneous nerve stimulation (TENS) | Experimental | 6 weeks of daily TENS treatment performed at home |
|
| Usual Care | No Intervention | Usual care (no additional treatment) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Nerve Stimulation (TENS) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity From Baseline to 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. | 7 weeks |
| Change in Pain Interference From Baseline to 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. | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Walking Velocity From Baseline to 7 Weeks | a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes | 7 weeks |
| Change in Step Length From Baseline to 7 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M Kietrys, PhD | Rutgers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Physical Therapy Program | Blackwood | New Jersey | 08012 | United States | ||
| Rutgers Physical Therapy Program |
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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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Meditation | 6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home Mindfulness Meditation: Mindfulness mediation is a guided mediation process to improve awareness of being present in the moment. |
| FG001 | Transcutaneous Nerve Stimulation (TENS) | 6 weeks of daily TENS treatment performed at home Transcutaneous Nerve Stimulation (TENS): 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). |
| FG002 | Usual Care | Usual care (no additional treatment) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Meditation | 6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home Mindfulness Meditation: Mindfulness mediation is a guided mediation process to improve awareness of being present in the moment. |
| BG001 | Transcutaneous Nerve Stimulation (TENS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Intensity From Baseline to 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. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
up to 7 weeks
Study interventions did not pose risk of mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness Meditation | 6 weeks of daily mindfulness meditation (guided by audio recordings) performed at home Mindfulness Meditation: Mindfulness mediation is a guided mediation process to improve awareness of being present in the moment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Kietrys | Rutgers University | 856-566-7186 | kietrydm@shp.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2024 | Apr 14, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 18, 2024 | Mar 4, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D010523 | Peripheral Nervous System Diseases |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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randomized controlled interventional pilot with 3 groups (2 treatment groups and 1 control group)
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co-investigators involved with measurement for the interventional phase will not know which of the 3 groups a participant was randomized to
| Mindfulness Meditation | Behavioral | Mindfulness mediation is a guided mediation process to improve awareness of being present in the moment. |
|
a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes
| 7 weeks |
| Change in Stride Width From Baseline to 7 Weeks | a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes | 7 weeks |
| Change in Cadence From Baseline to 7 Weeks | a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes | 7 weeks |
| Change in Walking Endurance From Baseline to 7 Weeks | Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes). | 7 weeks |
| Change in Physical Performance (SPPB Composite Score) From Baseline to 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. | 7 weeks |
| Change in Whole Body Strength From Baseline to 7 Weeks | Mid-thigh pull test will be used to generate a score expressed as Newtons that is reflective of whole body strength. | 7 weeks |
| Change in Pain Pressure Threshold at Dorsal Web Space of Foot From Baseline to 7 Weeks | Pain pressure threshold (expressed in Newtons) at lower extremity landmarks via use of a digital algometer. | 7 weeks |
| Change in Pain Pressure Threshold at Proximal Tibia From Baseline to 7 Weeks | Pain pressure threshold (expressed in Newtons) at lower extremity landmarks via use of a digital algometer. | 7 weeks |
| Change in Mental Quality of Life (QOL) From Baseline to 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. | 7 weeks |
| Change in Physical Quality of Life (QOL) From Baseline to 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. | 7 weeks |
| Change in Pain-Related Quality of Life From Baseline to 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. | 7 weeks |
| Change in Anxiety From Baseline to 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. | 7 weeks |
| Change in Depression From Baseline to 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. | 7 weeks |
| Change in Pain Catastrophizing From Baseline to 7 Weeks | Self-reported catastrophizing behaviors using with the Pain Catastrophizing Scale. Minimum score=0; maximum score=52; higher score=worse outcome. | 7 weeks |
| Change in Resilience From Baseline to 7 Weeks | Self-reported resilience using the 6-item Brief Resilience Scale. Minimum score=1; maximum score=5; lower score=worse outcome. | 7 weeks |
| Adherence to Home-based Treatment 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 | over 6 weeks |
| Newark |
| New Jersey |
| 07101 |
| United States |
6 weeks of daily TENS treatment performed at home Transcutaneous Nerve Stimulation (TENS): 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). |
| BG002 | Usual Care | Usual care (no additional treatment) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
6 weeks of daily TENS treatment performed at home
Transcutaneous Nerve Stimulation (TENS): 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).
| OG002 | Usual Care | Usual care (no additional treatment) |
|
|
|
| Primary | Change in Pain Interference From Baseline to 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. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
|
|
| Secondary | Change in Walking Velocity From Baseline to 7 Weeks | a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes | Posted | Mean | Standard Deviation | meters per second | 7 weeks |
|
|
|
|
| Secondary | Change in Step Length From Baseline to 7 Weeks | a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes | Posted | Mean | Standard Deviation | meters | 7 weeks |
|
|
|
|
| Secondary | Change in Stride Width From Baseline to 7 Weeks | a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes | Posted | Mean | Standard Deviation | meters | 7 weeks |
|
|
|
|
| Secondary | Change in Cadence From Baseline to 7 Weeks | a gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes | Posted | Mean | Standard Deviation | steps per minute | 7 weeks |
|
|
|
|
| Secondary | Change in Walking Endurance From Baseline to 7 Weeks | Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes). | Posted | Mean | Standard Deviation | meters | 7 weeks |
|
|
|
|
| Secondary | Change in Physical Performance (SPPB Composite Score) From Baseline to 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. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
|
|
| Secondary | Change in Whole Body Strength From Baseline to 7 Weeks | Mid-thigh pull test will be used to generate a score expressed as Newtons that is reflective of whole body strength. | Posted | Mean | Standard Deviation | newtons | 7 weeks |
|
|
|
|
| Secondary | Change in Pain Pressure Threshold at Dorsal Web Space of Foot From Baseline to 7 Weeks | Pain pressure threshold (expressed in Newtons) at lower extremity landmarks via use of a digital algometer. | Posted | Mean | Standard Deviation | Newtons | 7 weeks |
|
|
|
|
| Secondary | Change in Pain Pressure Threshold at Proximal Tibia From Baseline to 7 Weeks | Pain pressure threshold (expressed in Newtons) at lower extremity landmarks via use of a digital algometer. | Posted | Mean | Standard Deviation | Newtons | 7 weeks |
|
|
|
|
| Secondary | Change in Mental Quality of Life (QOL) From Baseline to 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. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
|
|
| Secondary | Change in Physical Quality of Life (QOL) From Baseline to 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. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
|
|
| Secondary | Change in Pain-Related Quality of Life From Baseline to 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. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
|
|
| Secondary | Change in Anxiety From Baseline to 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. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
|
|
| Secondary | Change in Depression From Baseline to 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. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
|
|
| Secondary | Change in Pain Catastrophizing From Baseline to 7 Weeks | Self-reported catastrophizing behaviors using with the Pain Catastrophizing Scale. Minimum score=0; maximum score=52; higher score=worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
|
|
| Secondary | Change in Resilience From Baseline to 7 Weeks | Self-reported resilience using the 6-item Brief Resilience Scale. Minimum score=1; maximum score=5; lower score=worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
|
|
| Secondary | Adherence to Home-based Treatment 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 | Usual care group did not perform the TENS or mindfulness intervention and were not assessed for this measure | Posted | Mean | Standard Deviation | number of treatment sessions completed | over 6 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Transcutaneous Nerve Stimulation (TENS) | 6 weeks of daily TENS treatment performed at home Transcutaneous Nerve Stimulation (TENS): 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). | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Usual Care | Usual care (no additional treatment) | 0 | 12 | 0 | 12 | 0 | 12 |
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Not provided
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| Mean Difference (Net) |
| .114 |
| 2-Sided |
| 95 |
| -2.44 |
| 2.67 |
| Superiority |
| Median Difference (Net) |
| -1.66 |
| 2-Sided |
| 95 |
| -8.41 |
| 5.08 |
| Superiority |
| Mean Difference (Net) |
| 1.59 |
| 2-Sided |
| 95 |
| -.062 |
| 3.25 |
| Superiority |
| Mean Difference (Net) |
| .03 |
| 2-Sided |
| 95 |
| -.99 |
| 1.04 |
| Superiority |
| Mean Difference (Net) |
| -4.92 |
| 2-Sided |
| 95 |
| -11.67 |
| 1.84 |
| Superiority |
| Mean Difference (Net) |
| 13.79 |
| 2-Sided |
| 95 |
| -42.59 |
| 70.17 |
| Superiority |
| Mean Difference (Net) |
| .011 |
| 2-Sided |
| 95 |
| -1.23 |
| 1.26 |
| Superiority |
| Mean Difference (Net) |
| .06 |
| 2-Sided |
| 95 |
| -1.58 |
| 1.7 |
| Superiority |
| Mean Difference (Net) |
| -1.04 |
| 2-Sided |
| 95 |
| -11.17 |
| 9.08 |
| Superiority |
| Mean Difference (Net) |
| 0.21 |
| 2-Sided |
| 95 |
| -18.47 |
| 4.06 |
| Superiority |
| Mean Difference (Net) |
| 2.60 |
| 2-Sided |
| 95 |
| -5.38 |
| 10.58 |
| Superiority |
| Mean Difference (Net) |
| -2.9 |
| 2-Sided |
| 95 |
| -8.07 |
| 2.27 |
| Superiority |
| Mean Difference (Net) |
| -1.35 |
| 2-Sided |
| 95 |
| -21.27 |
| 18.57 |
| Superiority |
| Mean Difference (Net) |
| .719 |
| 2-Sided |
| 95 |
| -2.5 |
| 3.93 |
| Superiority |
| Mean Difference (Net) |
| -.93 |
| 2-Sided |
| 95 |
| -3.31 |
| 1.45 |
| Superiority |
| Mean Difference (Net) |
| -6.42 |
| 2-Sided |
| 95 |
| -16.9 |
| 4.05 |
| Superiority |
| Mean Difference (Net) |
| .099 |
| 2-Sided |
| 95 |
| -.412 |
| .612 |
| Superiority |