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

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-08-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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High Intensity LASER Therapy group (HILT)

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) .

Group Type EXPERIMENTAL

High Intensity LASER Therapy (HILT)

Intervention Type OTHER

The total energy will be delivered to the patient during one session will be 1,250 J through three phases of treatment.

1. Initial phase (710 and 810 mJ (millijoule)/cm2 for a total of 500 J)
2. Intermediate phase (handpiece will be applied on the joint line just proximal to the medial and lateral tibial condyles with 25 J, a fluency of 610 mJ/cm2, and a time of 14 s for each point and a total of 250 J)
3. Final phase (same as the initial phase (500 J) except that scanning will be slow manual scanning ) The application time for all three phases will be approximately 15 min with the total energy delivered to the patient during one session of 1,250 J

Ibuprofen gel phonophoresis (IGP) group

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.

Group Type EXPERIMENTAL

Ibuprofen Gel Phonophoresis (IGP)

Intervention Type OTHER

Continuous ultrasound set at a frequency of 1 MHz and an intensity of 1 W/cm2 was applied on a circular basis. (8 min/ one session each day for 3 days/week for 8 weeks).

Transcranial direct current stimulation (tDCS) group

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

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type OTHER

Anode electrode -C3/C4 (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 group (CPT)

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.

Group Type ACTIVE_COMPARATOR

Conventional Physiotherapy (CPT)

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

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High Intensity LASER Therapy (HILT)

The total energy will be delivered to the patient during one session will be 1,250 J through three phases of treatment.

1. Initial phase (710 and 810 mJ (millijoule)/cm2 for a total of 500 J)
2. Intermediate phase (handpiece will be applied on the joint line just proximal to the medial and lateral tibial condyles with 25 J, a fluency of 610 mJ/cm2, and a time of 14 s for each point and a total of 250 J)
3. Final phase (same as the initial phase (500 J) except that scanning will be slow manual scanning ) The application time for all three phases will be approximately 15 min with the total energy delivered to the patient during one session of 1,250 J

Intervention Type OTHER

Ibuprofen Gel Phonophoresis (IGP)

Continuous ultrasound set at a frequency of 1 MHz and an intensity of 1 W/cm2 was applied on a circular basis. (8 min/ one session each day for 3 days/week for 8 weeks).

Intervention Type OTHER

Transcranial Direct Current Stimulation (tDCS)

Anode electrode -C3/C4 (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 (CPT)

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

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No