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

Asir John Samuel

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Other: Transcranial Direct Current Stimulation (tDCS); Other: Ibuprofen Gel Phonophoresis (IGP); Other: High Intensity LASER Therapy (HILT); Other: Conventional Physiotherapy (CPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04321655

U1111-1248-7814 (Other Identifier)

MMDU/IEC/110P

Details and patient eligibility

About

Patients affected with osteoarthritis knee have associated with pain and inflammation of the joint capsule, impaired muscular stabilization, decrease range of motion and functional disability. Laser therapy, phonophoresis, transcranial direct current stimulation (tDCS) and conventional physiotherapy exercises has innumerable benefits to the patients with knee osteoarthritis (KOA).However, it is still not clear which treatment is effective among them in rehabilitating the patients with chronic knee osteoarthritis (KOA). Aim is to establish the benefits of High intensity Laser therapy, phonophoresis, tDCS and conventional physiotherapy in the treatment of patient with chronic KOA living in the hilly terrain. A total of 160 patients with chronic KOA will be recruited by the simple random sampling (random number generator) to participate in randomized, double blind randomized controlled, study. Recruited patients with chronic KOA will be randomly divided into four groups, high intensity-laser therapy (HILT) group, ibuprofen gel phonophoresis (IGP) group, transcranial direct current stimulation (tDCS) group and conventional physiotherapy (CPT) group. Duration of the treatment will be 8 minutes in one session/knee joint for HILT and IGP and 30 minutes in one session for tDCS each day for 3 days/week for 8 weeks. Thus, each patient with chronic KOA will receive 24 sessions in total. The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC), Digitalized pain pressure algometer (ALGO-DS-01) and 36-Item Short Form Health Survey (SF-36) questionnaire are the outcome measures will be recorded at baseline, end of 8-week post-intervention period.

Enrollment: 160 estimated patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with clinical chronic knee OA according to the diagnostic criteria of American College of Rheumatology (ACR) were included in the study
• Age between 45-70
• Both sex male and female

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,
• Presence of malignancy,
• Pregnancy
• Taking pain relief medications
• Any metal implants near the site of stimulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups

High Intensity LASER Therapy group (HILT)

Experimental group

Description:

Forty patients with chronic KOA in HILT group will received Class IV LASER therapy. A Class IV LASER emits power more than 500 milliwatt (mW) .

Treatment:

Other: High Intensity LASER Therapy (HILT)

Ibuprofen gel phonophoresis (IGP) group

Experimental group

Description:

Patients with chronic KOA in ibuprofen gel phonophoresis (IGP) group will administered with continuous ultrasound set at a frequency of 1 megahertz (MHz) and an intensity of 1 W/cm2 was applied on a circular basis.

Treatment:

Other: Ibuprofen Gel Phonophoresis (IGP)

Transcranial direct current stimulation (tDCS) group

Experimental group

Description:

Fourty patients with chronic 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 (tDCS)

Conventional physiotherapy group (CPT)

Active Comparator group

Description:

Individual with chronic KOA will be educated on how to do the set of exercises correctly at their home during the first session. All the groups will receive the same, standardized exercise protocol for KOA which consisted of nine exercises including muscle strengthening and flexibility training.

Treatment:

Other: Conventional Physiotherapy (CPT)