Panacea Index Logo

Command Palette

Search for a command to run...

Pain relief for osteoarthritis through combined treatment (PROACT): Protocol for a randomized controlled trial of mindfulness meditation combined with transcranial direct current stimulation in non-Hispanic black and white adults with knee osteoarthritis.

Contemporary clinical trials
November 1, 2020
Roger B Fillingim et al. (12 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, N.I.H., ExtramuralHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether combining mindfulness (Breathing and Attention Training) with transcranial direct current stimulation (tDCS) could enhance pain modulation, reduce clinical pain, and attenuate ethnic disparities in pain outcomes among adults with knee osteoarthritis.

Results Summary

The abstract does not report specific results, as the study is a proposed clinical trial. The outcomes to be measured include pain modulatory balance, pain-related brain function, clinical pain reduction, and ethnic differences in these effects.

Population

Non-Hispanic black (NHB) and non-Hispanic white (NHW) adults with knee osteoarthritis.

Effective Dosage

Not specified (intervention involves five 20-minute sessions of combined BAT and tDCS).

Duration

One week (five sessions).

Interactions

None mentioned

Extracted Claims (6)
InterventionDirectionEndpointPopulationDosageImpactClaim #
mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS)
increase
pain modulatory balance
NHBs and NHWs with knee OA
-
will test whether will enhance
#1
mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS)
increase
pain-related brain function
NHBs and NHWs with knee OA
-
will test whether will enhance
#2
mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS)
decrease
clinical pain
NHBs and NHWs with knee OA
-
will test whether will reduce
#3
mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS)
decrease
ethnic differences
NHBs and NHWs with knee OA
-
will test whether will attenuate
#4
mindfulness and tDCS treatments
increase
additive or synergistic effects when combined
-
-
will determine whether will show
#5
mindfulness and tDCS treatments
neutral
across ethnic/race groups
-
-
will determine whether treatment effects differ
#6
Abstract

Knee osteoarthritis (OA) is a leading cause of late life pain and disability, and non-Hispanic black (NHB) adults experience greater OA-related pain and disability than non-Hispanic whites (NHWs). Recent evidence implicates psychosocial stress, cognitive-attentional processes, and altered central pain processing as contributors to greater OA-related pain and disability among NHBs. To address these ethnic/race disparities, this clinical trial will test whether a mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS) will enhance pain modulatory balance and pain-related brain function, reduce clinical pain, and attenuate ethnic differences therein, among NHBs and NHWs with knee OA. Participants will complete assessments of clinical pain, function, psychosocial measures, and quantitative sensory testing (QST), including mechanical temporal summation and conditioned pain modulation. Neuroimaging will be performed to examine pain-related brain structure and function. Then, participants will be randomized to one of four groups created by crossing two BAT conditions (Real vs. Sham) with two tDCS conditions (Real vs. Sham). Participants will then undergo five treatment sessions during which the assigned BAT and tDCS interventions will be delivered concurrently for 20 min over one week. After the fifth intervention session, participants will undergo assessments of clinical pain and function, QST and neuroimaging identical to the pretreatment measures, and monthly follow-up assessments of pain will be conducted for three months. This will be the first study to determine whether mindfulness and tDCS treatments will show additive or synergistic effects when combined, and whether treatment effects differ across ethnic/race groups.

Medical Subject Headings (MeSH)
AdultHumansMeditationMindfulnessOsteoarthritis, KneePainRandomized Controlled Trials as TopicTranscranial Direct Current Stimulation
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations9
Citations/Year1.8
Relative Citation Ratio0.84
NIH Percentile43.9%
Research Impact Scores
APT Score0.50
Weight Score2.38
Normalized Score0.67
Related Supplements