Trial Outcomes & Findings for Effects of TENS and Mindfulness Meditation in Persons With HIV-related Neuropathy (NCT NCT04868123)
NCT ID: NCT04868123
Last Updated: 2026-07-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
7 weeks
Results posted on
2026-07-08
Participant Flow
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).
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.
Participant milestones
| Measure |
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.
|
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).
|
Usual Care
Usual care (no additional treatment)
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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).
|
Usual Care
Usual care (no additional treatment)
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
1
|
Baseline Characteristics
Effects of TENS and Mindfulness Meditation in Persons With HIV-related Neuropathy
Baseline characteristics by cohort
| Measure |
Mindfulness Meditation
n=12 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=12 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).
|
Usual Care
n=12 Participants
Usual care (no additional treatment)
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 6.5 • n=9 Participants
|
61.4 years
STANDARD_DEVIATION 10.4 • n=27 Participants
|
55.9 years
STANDARD_DEVIATION 9.5 • n=267 Participants
|
58.9 years
STANDARD_DEVIATION 9.1 • n=265 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
18 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
18 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
30 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
18 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
8 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
7 Participants
n=265 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=9 Participants
|
12 participants
n=27 Participants
|
12 participants
n=267 Participants
|
36 participants
n=265 Participants
|
PRIMARY outcome
Timeframe: 7 weeksResponses 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.
Outcome measures
| Measure |
Mindfulness Meditation
n=10 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Pain Intensity From Baseline to 7 Weeks
|
-0.8 score on a scale
Standard Deviation 1.4
|
0.3 score on a scale
Standard Deviation 1.9
|
-0.5 score on a scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 7 weeksResponses 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.
Outcome measures
| Measure |
Mindfulness Meditation
n=10 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Pain Interference From Baseline to 7 Weeks
|
0.1 score on a scale
Standard Deviation 3.5
|
0.2 score on a scale
Standard Deviation 2.8
|
-0.1 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 7 weeksa gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes
Outcome measures
| Measure |
Mindfulness Meditation
n=9 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Walking Velocity From Baseline to 7 Weeks
|
2.7 meters per second
Standard Deviation 15.1
|
0.9 meters per second
Standard Deviation 8.0
|
2.2 meters per second
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 7 weeksa gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes
Outcome measures
| Measure |
Mindfulness Meditation
n=9 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Step Length From Baseline to 7 Weeks
|
0.6 meters
Standard Deviation 5.3
|
1.4 meters
Standard Deviation 1.7
|
-0.3 meters
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 7 weeksa gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes
Outcome measures
| Measure |
Mindfulness Meditation
n=9 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Stride Width From Baseline to 7 Weeks
|
1.1 meters
Standard Deviation 3.6
|
-0.2 meters
Standard Deviation 1.1
|
0 meters
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 7 weeksa gait characteristic as captured by ZENO instrumented walkway / PKMAS software over a period of 6 minutes
Outcome measures
| Measure |
Mindfulness Meditation
n=9 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Cadence From Baseline to 7 Weeks
|
2.8 steps per minute
Standard Deviation 4.0
|
-1.9 steps per minute
Standard Deviation 8.6
|
1.9 steps per minute
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 7 weeksWalking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes).
Outcome measures
| Measure |
Mindfulness Meditation
n=10 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Walking Endurance From Baseline to 7 Weeks
|
10.9 meters
Standard Deviation 47.2
|
9.0 meters
Standard Deviation 81.8
|
-9.2 meters
Standard Deviation 36.8
|
SECONDARY outcome
Timeframe: 7 weeksPhysical 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.
Outcome measures
| Measure |
Mindfulness Meditation
n=10 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Physical Performance (SPPB Composite Score) From Baseline to 7 Weeks
|
0.3 score on a scale
Standard Deviation 1.2
|
0.4 score on a scale
Standard Deviation 1.6
|
0.4 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 7 weeksMid-thigh pull test will be used to generate a score expressed as Newtons that is reflective of whole body strength.
Outcome measures
| Measure |
Mindfulness Meditation
n=10 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=7 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Whole Body Strength From Baseline to 7 Weeks
|
0.5 newtons
Standard Deviation 1.9
|
0.1 newtons
Standard Deviation 1.9
|
0 newtons
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 7 weeksPain pressure threshold (expressed in Newtons) at lower extremity landmarks via use of a digital algometer.
Outcome measures
| Measure |
Mindfulness Meditation
n=10 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Pain Pressure Threshold at Dorsal Web Space of Foot From Baseline to 7 Weeks
|
0.8 Newtons
Standard Deviation 13.3
|
-1.8 Newtons
Standard Deviation 12.4
|
-1.0 Newtons
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 7 weeksPain pressure threshold (expressed in Newtons) at lower extremity landmarks via use of a digital algometer.
Outcome measures
| Measure |
Mindfulness Meditation
n=10 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Pain Pressure Threshold at Proximal Tibia From Baseline to 7 Weeks
|
5.6 Newtons
Standard Deviation 17.1
|
-4.0 Newtons
Standard Deviation 11.4
|
3.4 Newtons
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: 7 weeksMental health QOL subscale from the Medical Outcomes Study HIV Health Survey (MOS-HIV). Minimum score=0; maximum score=100; lower score=worse outcome.
Outcome measures
| Measure |
Mindfulness Meditation
n=10 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=6 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Mental Quality of Life (QOL) From Baseline to 7 Weeks
|
2.7 score on a scale
Standard Deviation 7.2
|
0.2 score on a scale
Standard Deviation 7.8
|
-4.3 score on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 7 weeksPhysical 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.
Outcome measures
| Measure |
Mindfulness Meditation
n=10 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=6 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Physical Quality of Life (QOL) From Baseline to 7 Weeks
|
0.8 score on a scale
Standard Deviation 7.0
|
0.4 score on a scale
Standard Deviation 5.2
|
1.2 score on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 7 weeksPain-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.
Outcome measures
| Measure |
Mindfulness Meditation
n=10 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Pain-Related Quality of Life From Baseline to 7 Weeks
|
4.4 score on a scale
Standard Deviation 19.7
|
2.8 score on a scale
Standard Deviation 23.6
|
5.1 score on a scale
Standard Deviation 21.3
|
SECONDARY outcome
Timeframe: 7 weeksSelf-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.
Outcome measures
| Measure |
Mindfulness Meditation
n=10 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=10 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Anxiety From Baseline to 7 Weeks
|
-1.6 score on a scale
Standard Deviation 3.9
|
-0.6 score on a scale
Standard Deviation 2.1
|
-1.2 score on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 7 weeksSelf-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.
Outcome measures
| Measure |
Mindfulness Meditation
n=8 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Depression From Baseline to 7 Weeks
|
0.2 score on a scale
Standard Deviation 3.4
|
-1.4 score on a scale
Standard Deviation 2.1
|
-0.1 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 7 weeksSelf-reported catastrophizing behaviors using with the Pain Catastrophizing Scale. Minimum score=0; maximum score=52; higher score=worse outcome.
Outcome measures
| Measure |
Mindfulness Meditation
n=10 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Pain Catastrophizing From Baseline to 7 Weeks
|
-0.7 score on a scale
Standard Deviation 9.9
|
-6.2 score on a scale
Standard Deviation 13.7
|
0.5 score on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: 7 weeksSelf-reported resilience using the 6-item Brief Resilience Scale. Minimum score=1; maximum score=5; lower score=worse outcome.
Outcome measures
| Measure |
Mindfulness Meditation
n=10 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
n=11 Participants
Usual care (no additional treatment)
|
|---|---|---|---|
|
Change in Resilience From Baseline to 7 Weeks
|
-0.3 score on a scale
Standard Deviation 0.5
|
0 score on a scale
Standard Deviation 0.7
|
-0.1 score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: over 6 weeksPopulation: Usual care group did not perform the TENS or mindfulness intervention and were not assessed for this measure
Adherence to home based intervention is defined as total number of treatment sessions completed over 6 weeks via direct communication with participants
Outcome measures
| Measure |
Mindfulness Meditation
n=10 Participants
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.
|
Transcutaneous Nerve Stimulation (TENS)
n=8 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).
|
Usual Care
Usual care (no additional treatment)
|
|---|---|---|---|
|
Adherence to Home-based Treatment Over 6 Weeks
|
26.7 number of treatment sessions completed
Standard Deviation 13.9
|
23.9 number of treatment sessions completed
Standard Deviation 15.9
|
—
|
Adverse Events
Mindfulness Meditation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Transcutaneous Nerve Stimulation (TENS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place