NCT03747640

Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis

Completed NA Results posted Last updated 25 March 2022

What this trial tests

NA trial testing Self Transcranial Direct Current Stimulation (tDCS) in Knee Osteoarthritis in 30 participants. Completed in 8 March 2019.

Timeline

28 November 2018

Primary endpoint
8 March 2019

8 March 2019

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	28 November 2018
Primary completion	8 March 2019
Estimated completion	8 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Self Transcranial Direct Current Stimulation (tDCS)
• mindfulness-based meditation
• Sham Self Transcranial Direct Current Stimulation (tDCS)
• sham meditation

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Adults 50 to 85, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS) Primary · baseline, 2 weeks

The NRS assess average pain over the past 24 hours from 0 (no pain) to 100 (most intense pain imaginable).

Group	Value	95% CI
tDCS With Mindfulness-based Meditation	-24.67	± 12.88
Sham tDCS With Sham Meditation	-3.33	± 10.63

Change in Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Secondary · baseline, 2 weeks

The WOMAC ranges from 0 to 96, with higher scores indicating worse osteoarthritis (OA) pain-related symptoms.

Group	Value	95% CI
tDCS With Mindfulness-based Meditation	-12.60	± 17.97
Sham tDCS With Sham Meditation	-0.53	± 10.01

Psychosocial Symptoms as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-short Form Secondary · baseline

The 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.

Group	Value	95% CI
tDCS With Mindfulness-based Meditation	17.13	± 5.66
Sham tDCS With Sham Meditation	16.20	± 5.41

Psychosocial Symptoms as Assessed by the PROMIS Anxiety-short Form Secondary · 2 weeks

The 7-item PROMIS Anxiety Short Form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.

Group	Value	95% CI
tDCS With Mindfulness-based Meditation	14.27	± 6.71
Sham tDCS With Sham Meditation	14.27	± 5.68

Psychosocial Symptoms as Assessed by PROMIS Depression-short Form Secondary · baseline

The 8-item PROMIS Depression Short Form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.

Group	Value	95% CI
tDCS With Mindfulness-based Meditation	13.93	± 7.74
Sham tDCS With Sham Meditation	14.00	± 5.39

Psychosocial Symptoms as Assessed by PROMIS Depression-short Form Secondary · 2 weeks

The 8-item PROMIS Depression Short Form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.

Group	Value	95% CI
tDCS With Mindfulness-based Meditation	11.93	± 6.94
Sham tDCS With Sham Meditation	12.20	± 4.83

Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form Secondary · baseline

The 8-item PROMIS Sleep Disturbance Short Form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.

Group	Value	95% CI
tDCS With Mindfulness-based Meditation	23.87	± 7.22
Sham tDCS With Sham Meditation	23.67	± 7.49

Psychosocial Symptoms as Assessed by PROMIS Sleep Disturbance-short Form Secondary · 2 weeks

The 8-item PROMIS Sleep Disturbance Short Form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.

Group	Value	95% CI
tDCS With Mindfulness-based Meditation	18.27	± 4.43
Sham tDCS With Sham Meditation	21.13	± 7.06

Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS) Secondary · baseline

The Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. Each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).The PCS total score is computed by summing responses to all 13 items, with total scores ranging from 0 - 52. Higher scores indicate a worse outcome.

Group	Value	95% CI
tDCS With Mindfulness-based Meditation	21.53	± 14.46
Sham tDCS With Sham Meditation	16.73	± 13.15

Psychosocial Symptoms as Assessed by the Pain Catastrophizing Scale (PCS) Secondary · 2 weeks

The Pain Catastrophizing Scale (PCS) consists of 13 items assessing three components of catastrophizing: rumination, magnification, and helplessness. Each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).The PCS total score is computed by summing responses to all 13 items, with total scores ranging from 0 - 52. Higher scores indicate a worse outcome.

Group	Value	95% CI
tDCS With Mindfulness-based Meditation	15.80	± 13.62
Sham tDCS With Sham Meditation	14.80	± 14.97

Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI) Secondary · baseline

The Freiburg Mindfulness Inventory (FMI) is a 14-item instrument. Respondents indicate their experiences relating to the items on a 4-point Likert scale (rarely, occasionally, fairly often and almost always), and the total score is calculated by adding all the scores on the 14 items of the FMI. Total scores range from 14-56, with higher scores indicating higher levels of mindfulness.

Group	Value	95% CI
tDCS With Mindfulness-based Meditation	41.13	± 5.60
Sham tDCS With Sham Meditation	36.40	± 7.01

Psychosocial Symptoms as Assessed by the Freiburg Mindfulness Inventory (FMI) Secondary · 2 weeks

The Freiburg Mindfulness Inventory (FMI) is a 14-item instrument. Respondents indicate their experiences relating to the items on a 4-point Likert scale (rarely, occasionally, fairly often and almost always), and the total score is calculated by adding all the scores on the 14 items of the FMI. Total scores range from 14-56, with higher scores indicating higher levels of mindfulness.

Group	Value	95% CI
tDCS With Mindfulness-based Meditation	42.67	± 6.98
Sham tDCS With Sham Meditation	38.93	± 7.43

Sponsor's own description

The purpose of this study is to determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation for pain in older adults with knee osteoarthritis (OA).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.