Stimulate Brain and Reduce Knee Pain Due to Degeneration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reduce Pain and Improve Quality of Life in Patient With Knee Osteoarthritis by Light, Sound and Brain Stimulation

NCT04321655

Knee Osteoarthritis

UNKNOWN NA

Transcranial Direct Current Stimulation and Yoga for Knee Osteoarthritis

NCT06228573

Knee Osteoarthritis

RECRUITING NA

Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms

NCT04375072

Osteo Arthritis Knee

COMPLETED NA

Effect of Cranial Stimulation and Acupuncture on Pain, Functional Capability and Cerebral Function in Osteoarthritis

NCT01747070

Osteoarthritis, Knee Chronic Pain

COMPLETED NA

Effects of tDCS in Elderly With Pain Due to Knee Osteoarthritis

NCT03117231

Osteoarthritis, Knee Chronic Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type OTHER

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)

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.

Group Type ACTIVE_COMPARATOR

Conventional Physiotherapy

Intervention Type OTHER

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type 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)

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

tDCS CPT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No