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Clinical Trials/NCT04320875
NCT04320875
Unknown
N/A

Stimulate Brain to Reduce Pain Among Patients With Knee Osteoarthritis

Maharishi Markendeswar University (Deemed to be University)0 sites80 target enrollmentOctober 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Maharishi Markendeswar University (Deemed to be University)
Enrollment
80
Primary Endpoint
Digitalized pain pressure algometer (ALGO-DS-01)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2022
End Date
March 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Maharishi Markendeswar University (Deemed to be University)
Responsible Party
Principal Investigator
Principal Investigator

Asir John Samuel

Associate Professor

Maharishi Markendeswar University (Deemed to be University)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Digitalized pain pressure algometer (ALGO-DS-01)

Time Frame: 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 Outcomes

  • Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)(Changes will be measured at baseline and end of 8 week intervention)

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