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Completed

NCT Number: NCT03117231

Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Chronic Pain Joint Diseases Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daniela Tavares

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Changes in Pain Scale

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

    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)

Secondary outcomes

  1. Changes in Quality of Life

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

    The investigators will use the 12-Item Short Form Health Survey (SF-12) to assess changes in quality of life.

  2. Changes in Physical Function as measured through Lequesne Index

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

    The investigators will use the Lequesne Index to assess changes in functional capacity.

  3. Changes in Patient Global Assessment

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

    Modifications in the patient global assessment will be evaluated by measuring changes in the Visual Analogue Scale (VAS).

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

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

    The investigators will use the Western Ontário and McMaster Universities Osteoarthritis Index (WOMAC) to assess changes in functional capacity.

  5. Adverse Events

    Time frame: Up to 60 days after the end of stimulation

    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.

  6. Changes in Mood

    Time frame: Up to 60 days after the end of stimulation

    The safety of tDCS will be monitored by measuring changes in the Visual Analog Mood Scale.

  7. Changes in cognition

    Time frame: Up to 60 days after the end of stimulation

    The safety of tDCS will be monitored by measuring changes in the MMSE.

  8. One leg standing balance test

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

    The investigators will analyse how long time the subject can stay stand on one foot to analise those balance.

  9. Timed Up and Go Test

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

    The investigators will measure the walking speed of the subjects.

  10. Changes Pain Pressure Threshold (PPT)

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

    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.

  11. Changes in mechanical detection threshold as measured through Von-Frey monofilaments

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

    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.

  12. Changes in mechanical pain threshold as measured through Von-Frey monofilaments

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

    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.

  13. Descending Noxious Inhibitory Control (DNIC)

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

    The investigators will monitore the central modulation of pain.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Spaulding Rehabilitation Hospital

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2017
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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