Stimulate Brain and Reduce Knee Pain Due to Degeneration

Not Applicable

• Conditions: Knee Osteoarthritis
• Interventions: Other: Transcranial direct current stimulation; Other: Conventional Physiotherapy

• Registration Number: NCT04320875
• Lead Sponsor: Maharishi Markendeswar University (Deemed to be University)

Brief Summary

Osteoarthritis (OA) knee is chronic, slowly progressive, degenerative disease of joint which affects articular cartilage and accompanied by pain, swelling and loss of function . OA is often considered as the serious joint disease as it has negative impact on quality of life among elderly population, it is the major cause for the reduced mobility. At cental level, due to imbalance in endogenous pain modulation there is reduce capacity of brain to inhibit the pain. Therefore, dysregulation in the central modulation of pain further leads to maladaptive changes in the brain structure. Transcranial direct current stimulation is a non-invasive method to modulate the brain structure by using a week direct current applied through the scalp in painless way. Multi-session for prolonged time can induce neuroplastic changes in the brain.

The aim of the study is to demonstrate the effectiveness of tDCS in reducing the pain among patients with chronic knee OA and to modulate the plastic changes in brain structure.

A total of 80 patients with KOA will be recruited by the convenience sampling to participate in this two group pretest-posttest, double blinded randomized clinical study. After the demographics, recruited 80 patients with KOA will be randomly divided into two groups, transcranial direct current stimulation (tDCS) group and conventional physiotherapy (CPT) group with by block randomization. Patients with KOA in tDCS group will be provided with Active tDCS and conventional physiotherapy and CPT group will receive structured exercises protocol. Pre-post changes in the outcome measures will be documented at baseline and end of 8-week post intervention. Each session will last for approximately 30 minutes duration.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-01
• Study Start: 2022-10
• Primary Completion: 2023-09
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients diagnosed with clinical knee OA according to the diagnostic criteria of ACR were included in the study

Exclusion Criteria

• Unwillingness to participate in the study
• Recent history (within the last 3 months) of physical therapy to the same joint
• Recent history (within the last 3 months) of intra-articular procedure (injection and/or lavage) to the knee
• History of knee surgery/fracture
• Acute synovitis/arthritis including the infectious conditions
• Taking pain relief medications
• Any metal implantation near site of stimulation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcranial direct current stimulation (tDCS) group	Transcranial direct current stimulation	Fourty patients with KOA will receive structured tDCS (MA-tDCS, Walnut-Medical, Johnstown, PA) treatment. Two pair of sponge electrodes soaked with saline and fixed to head with elastic bands. The transcranial direct current stimulation will be applied by a constant current device with an intensity of 2mA
Conventional Physiotherapy (CPT) group	Conventional Physiotherapy	Individual with KOA will be educated on how to do the set of exercises correctly at their home during the first session. Consisted of nine exercises including muscle strengthening and flexibility training.

Primary Outcome Measures

Name	Time	Method
Digitalized pain pressure algometer (ALGO-DS-01)	Changes will be measured at baseline and end of 8 week intervention	Pain intensity will be measured using calibrated digitalized pain pressure algometer (ALGO-DS-01) in patients with KOA.

Secondary Outcome Measures

Name	Time	Method
Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)	Changes will be measured at baseline and end of 8 week intervention	The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC) will be used to evaluate the disease-specific self-reported symptoms of OA. This form is comprised of 24 questions in three categories including pain (5 questions), stiffness (2 questions), and physical function (17 questions)