Clinical trial NCT03117231: Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on Knee Osteoarthritis Pain in Elderly Subjects With Defective Endogenous Pain-Inhibitory System: Protocol for a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Chronic Pain
Keywords: osteoarthritis
elderly
musculoskeletal pain
transcranial direct current stimulation
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Spaulding Rehabilitation Hospital
First posted: 2017-04-17
Enrollment: 104
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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%

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in Pain Scale
timeFrame: Measured at baseline and up to 60 days after the end of stimulation
Secondary outcomes:
measure: Changes in Quality of Life
timeFrame: Measured at baseline, 15, 30 and 60 days after the of stimulation
measure: Changes in Physical Function as measured through Lequesne Index
timeFrame: Measured at baseline, 15, 30, and 60 days after the end of stimulation
measure: Changes in Patient Global Assessment
timeFrame: Measured at baseline, 15, 30 and 60 after the end of stimulation
measure: Changes in Physical Function as measured through Western Ontário and McMaster Universities Osteoarthritis Index
timeFrame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
measure: Adverse Events
timeFrame: Up to 60 days after the end of stimulation
measure: Changes in Mood
timeFrame: Up to 60 days after the end of stimulation
measure: Changes in cognition
timeFrame: Up to 60 days after the end of stimulation
measure: One leg standing balance test
timeFrame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
measure: Timed Up and Go Test
timeFrame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
measure: Changes Pain Pressure Threshold (PPT)
timeFrame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
measure: Changes in mechanical detection threshold as measured through Von-Frey monofilaments
timeFrame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
measure: Changes in mechanical pain threshold as measured through Von-Frey monofilaments
timeFrame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
measure: Descending Noxious Inhibitory Control (DNIC)
timeFrame: Measured at baseline, 15, 30 and 60 days after the end of stimulation
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Daniela Tavares
state: SP
Study officials:
References:
citation: 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.
citation: 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.