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Stimulate Brain and Reduce Knee Pain Due to Degeneration

M

Maharishi Markendeswar University (Deemed to be University)

Status

Unknown

Conditions

Knee Osteoarthritis

Treatments

Other: Transcranial direct current stimulation
Other: Conventional Physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04320875
MMDU/IEC/108P
U1111-1249-2403 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

45 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

Transcranial direct current stimulation (tDCS) group
Experimental group
Description:
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
Treatment:
Other: Transcranial direct current stimulation
Conventional Physiotherapy (CPT) group
Active Comparator group
Description:
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.
Treatment:
Other: Conventional Physiotherapy

Trial contacts and locations

0

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Central trial contact

Asir J Samuel, Ph.D; Adarsh K Srivastav, MPT

Data sourced from clinicaltrials.gov

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