Stimulate Brain and Reduce Knee Pain Due to Degeneration

September 30, 2021 updated by: Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)

Stimulate Brain to Reduce Pain Among Patients With Knee Osteoarthritis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial direct current stimulation (tDCS) group
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
Other: Transcranial direct current stimulation
Anode electrode -C3/C4 (International 10-20 electroencephalogram system), contralateral side of the most affected knee) Cathode electrode- contralateral supraorbital area. 2 mA intensity for 20 minutes, one session/day for 3 days/week for 8 weeks)
Other Names:
  • tDCS
Active Comparator: Conventional Physiotherapy (CPT) group
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.
Other: Conventional Physiotherapy
  1. Warm-up exercises: Walking at the usual speed on a flat surface for 10 min ( 3sets X10 Reps X 3 min rest in between)
  2. Hamstring and calf gentle stretches. ( 3sets X10 Reps X 3 min rest in between)
  3. Straight leg raise (SLR) ( 3sets X10 Reps X 3 min rest in between)
  4. Quadriceps setting ( 3sets X10 Reps X 3 min rest in between)
  5. Pillow squeeze ( 3sets X10 Reps X 3 min rest in between)
  6. Heel raise ( 3sets X10 Reps X 3 min rest in between)
  7. One leg balance ( 3sets X10 Reps X 3 min rest in between)
  8. Step ups ( 3sets X10 Reps X 3 min rest in between)
  9. Quadriceps strengthening exercises ( 3sets X10 Reps X 3 min rest in between)
Other Names:
  • CPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Changes will be measured at baseline and end of 8 week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)
Time Frame: 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)
Changes will be measured at baseline and end of 8 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maharishi Markendeswar University (Deemed to be University)

Investigators

  • Principal Investigator: Asir J Samuel, Ph.D, Maharishi Markandeshwar Medical College and Hospital
  • Study Director: Adarsh K Srivastav, MPT, Maharishi Markandeshwar Medical College and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 25, 2020

Study Record Updates

Last Update Posted (Actual)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMDU/IEC/108P
  • U1111-1249-2403 (Other Identifier: Universal Trial Number (UTN) by WHO ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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