Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis

NCT03117231 | Completed

• 1 other identifier: Tavares1
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate if anodal tDCS stimulation over M1 may decrease chronic knee OA pain in elderly subjects with defective CPM. In addition, this trial will help to investigate the role of central sensitization in knee OA and evaluate how tDCS stimulation may affect it.

Conditions

Osteoarthritis, Knee; Chronic Pain

Keywords

osteoarthritis; elderly; musculoskeletal pain; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Changes in Pain Scale

  Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with chronic pain due to knee osteoarthritis, as measured by changes in the Brief Pain Inventory (BPI)

  Measured at baseline and up to 60 days after the end of stimulation

Secondary Outcomes (13)

• Changes in Quality of Life

  Measured at baseline, 15, 30 and 60 days after the of stimulation

• Changes in Physical Function as measured through Lequesne Index

  Measured at baseline, 15, 30, and 60 days after the end of stimulation

• Changes in Patient Global Assessment

  Measured at baseline, 15, 30 and 60 after the end of stimulation

• Changes in Physical Function as measured through Western Ontário and McMaster Universities Osteoarthritis Index

  Measured at baseline, 15, 30 and 60 days after the end of stimulation

• Adverse Events

  Up to 60 days after the end of stimulation

Study Arms (2)

Active tDCS

EXPERIMENTAL

Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.

Device: Active Transcranial Direct Current Stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

Subjects will undergo low-intensity transcranial electrical stimulation for 20 minutes.

Device: Sham Transcranial Direct Current Stimulation (tDCS)

Interventions

Active Transcranial Direct Current Stimulation (tDCS) DEVICE

Subjects will undergo 15 sessions of tDCS stimulation, 1x per day at 20 minutes per session, of up to 2mA. During active stimulation, the current will be active for the full 20 minutes.

Active tDCS

Sham Transcranial Direct Current Stimulation (tDCS) DEVICE

Subjects will undergo 15 sessions of tDCS stimulation, 1x per day at 20 minutes per session, of up to 2mA. However, during sham stimulation (placebo) the current will not be active for the full 20 minutes

Sham tDCS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals \> 60 years old, of both genders.
• Diagnosis of primary knee osteoarthritis with chronic pain self-reported.
• Be able to sign the informed consent to participate in the study.
• Chronic pain (over the past 6 months) of at least 4 on a 0-10 VAS scale on average.
• Reduction on VAS (visual analogic scale) during CPM (conditioned pain modulation) \< 10%

You may not qualify if:

• Contraindications to transcranial brain stimulation, i.e. implanted brain medical devices or implanted brain metallic devices.
• Severe acute or chronic decompensated disease.
• Cognitive and behavioral impairment.
• Epilepsy.
• History of fractures in the lower limbs and/or spine in the last 6 months.
• Use of carbamazepine within the past 6 months as self-reported.
• Severe depression (with a score of \>30 in the Beck Depression Inventory)
• History of syncope.
• Traumatic brain injury with residual neurological deficits.
• History of alcohol abuse within the past 6 months as self-reported.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Spaulding Rehabilitation Hospital: collaborator

Study Sites (1)

Daniela Tavares

São Paulo, São Paulo, Brazil

Location

Related Publications (2)

• Tavares DRB, Okazaki JEF, Santana MVA, Pinto ACPN, Tutiya KK, Gazoni FM, Pinto CB, Santos FC, Fregni F, Trevisani VFM. Motor cortex transcranial direct current stimulation effects on knee osteoarthritis pain in elderly subjects with dysfunctional descending pain inhibitory system: A randomized controlled trial. Brain Stimul. 2021 May-Jun;14(3):477-487. doi: 10.1016/j.brs.2021.02.018. Epub 2021 Mar 5.

  PMID: 33684598 DERIVED

• Tavares DRB, Okazaki JEF, Rocha AP, Santana MVA, Pinto ACPN, Civile VT, Santos FC, Fregni F, Trevisani VFM. Effects of Transcranial Direct Current Stimulation on Knee Osteoarthritis Pain in Elderly Subjects With Defective Endogenous Pain-Inhibitory Systems: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 29;7(10):e11660. doi: 10.2196/11660.

  PMID: 30373731 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain; Osteoarthritis; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Geriatrician

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 17, 2017
• Study Start: March 15, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: September 9, 2019

Record last verified: 2019-09

Locations

BR (1)