Chronic Pain, Osteoarthritis, Knee
Conditions
Keywords
osteoarthritis, elderly, musculoskeletal pain, transcranial direct current stimulation
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.
Interventions
DEVICEActive 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.
DEVICESham 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
Sponsors
Spaulding Rehabilitation Hospital
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Pain Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Physical Function as measured through Lequesne Index | 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. |
| Changes in Patient Global Assessment | 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). |
| 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 | The investigators will use the Western Ontário and McMaster Universities Osteoarthritis Index (WOMAC) to assess changes in functional capacity. |
| Adverse Events | 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. |
| Changes in Mood | 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. |
| Changes in cognition | Up to 60 days after the end of stimulation | The safety of tDCS will be monitored by measuring changes in the MMSE. |
| Changes in Quality of Life | 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. |
| Timed Up and Go Test | Measured at baseline, 15, 30 and 60 days after the end of stimulation | The investigators will measure the walking speed of the subjects. |
| Changes Pain Pressure Threshold (PPT) | 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. |
| Changes in mechanical detection threshold as measured through Von-Frey monofilaments | 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. |
| Changes in mechanical pain threshold as measured through Von-Frey monofilaments | 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. |
| Descending Noxious Inhibitory Control (DNIC) | Measured at baseline, 15, 30 and 60 days after the end of stimulation | The investigators will monitore the central modulation of pain. |
| One leg standing balance test | 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. |
Countries
Brazil
Outcome results
None listed