Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117231
• Other study ID #: Tavares1
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: September 2019
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Active Transcranial Direct Current Stimulation (tDCS)
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.
• Sham Transcranial Direct Current Stimulation (tDCS)
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

Locations

Country	Name	City	State
Brazil	Daniela Tavares	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in Quality of Life	The investigators will use the 12-Item Short Form Health Survey (SF-12) to assess changes in quality of life.	Measured at baseline, 15, 30 and 60 days after the of stimulation
Secondary	Changes in Physical Function as measured through Lequesne Index	The investigators will use the Lequesne Index to assess changes in functional capacity.	Measured at baseline, 15, 30, and 60 days after the end of stimulation
Secondary	Changes in Patient Global Assessment	Modifications in the patient global assessment will be evaluated by measuring changes in the Visual Analogue Scale (VAS).	Measured at baseline, 15, 30 and 60 after the end of stimulation
Secondary	Changes in Physical Function as measured through Western Ontário and McMaster Universities Osteoarthritis Index	The investigators will use the Western Ontário and McMaster Universities Osteoarthritis Index (WOMAC) to assess changes in functional capacity.	Measured at baseline, 15, 30 and 60 days after the end of stimulation
Secondary	Adverse Events	Subjects will complete a questionnaire, after each session, to assess potential adverse events of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale.	Up to 60 days after the end of stimulation
Secondary	Changes in Mood	The safety of tDCS will be monitored by measuring changes in the Visual Analog Mood Scale.	Up to 60 days after the end of stimulation
Secondary	Changes in cognition	The safety of tDCS will be monitored by measuring changes in the MMSE.	Up to 60 days after the end of stimulation
Secondary	One leg standing balance test	The investigators will analyse how long time the subject can stay stand on one foot to analise those balance.	Measured at baseline, 15, 30 and 60 days after the end of stimulation
Secondary	Timed Up and Go Test	The investigators will measure the walking speed of the subjects.	Measured at baseline, 15, 30 and 60 days after the end of stimulation
Secondary	Changes Pain Pressure Threshold (PPT)	Changes in the pain pressure threshold will be analyzed in order to determine whether anodal transcranial direct current stimulation is effective in increasing the pain pressure threshold in subjects with osteoarthritis knee pain.	Measured at baseline, 15, 30 and 60 days after the end of stimulation
Secondary	Changes in mechanical detection threshold as measured through Von-Frey monofilaments	Changes in the mechanical detection threshold (MDT) will be measured through calibrated Von-Frey monofilaments in order to determine whether anodal transcranial direct current stimulation is effective in increasing the mechanical detection threshold of subjects with osteoarthritis knee pain.	Measured at baseline, 15, 30 and 60 days after the end of stimulation
Secondary	Changes in mechanical pain threshold as measured through Von-Frey monofilaments	Changes in the mechanical pain threshold (MDT) will be measured through calibrated Von-Frey monofilaments in order to determine whether anodal transcranial direct current stimulation is effective in increasing the mechanical pain threshold of subjects with osteoarthritis knee pain.	Measured at baseline, 15, 30 and 60 days after the end of stimulation
Secondary	Descending Noxious Inhibitory Control (DNIC)	The investigators will monitore the central modulation of pain.	Measured at baseline, 15, 30 and 60 days after the end of stimulation