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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: High Intensity LASER Therapy (HILT); Other: Ibuprofen Gel Phonophoresis (IGP); Other: Transcranial Direct Current Stimulation (tDCS); Other: Conventional Physiotherapy (CPT)

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vipin Saini, Ph.D; Phone Number: +918059930160; Email: vipinsaini31@rediffmail.com
• Study Contact Backup: Name: Asir J Samuel, MPT, Ph.D; Phone Number: +918059930222; Email: asirjohnsamuel@mmumullana.org

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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) .	Other: 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.; Initial phase (710 and 810 mJ (millijoule)/cm2 for a total of 500 J); 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); 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
EXPERIMENTAL: 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.	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).
EXPERIMENTAL: 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	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)
ACTIVE_COMPARATOR: 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.	Other: Conventional Physiotherapy (CPT); Warm-up exercises: Walking at the usual speed on a flat surface for 10 min ( 3sets X10 Reps X 3 min rest in between); Hamstring and calf gentle stretches. ( 3sets X10 Reps X 3 min rest in between); Straight leg raise (SLR) ( 3sets X10 Reps X 3 min rest in between); Quadriceps setting ( 3sets X10 Reps X 3 min rest in between); Pillow squeeze ( 3sets X10 Reps X 3 min rest in between); Heel raise ( 3sets X10 Reps X 3 min rest in between); One leg balance ( 3sets X10 Reps X 3 min rest in between); Step ups ( 3sets X10 Reps X 3 min rest in between); Quadriceps strengthening exercises ( 3sets X10 Reps X 3 min rest in between)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digitalized pain pressure algometer	Pain intensity will be measured using calibrated digitalized pain pressure algometer (ALGO-DS-01) in patients with KOA. Sensor digital algometer is force gauge with computer size which is highly accurate. The ALGO-DS-01 is chosen for the assessment of pain for Mechanical sacroiliac joint dysfunction, which is a reliable and valid tool for assessing sacroiliac joint dysfunction. The inter rater reliability of pressure pain algometer was demonstrated to be moderate to good reliability with interclass correlation coefficient (ICC) of (0.62-0.84)	Changes will be measured at baseline and end of 8 week intervention
Western Ontario and Mc Master Universities Osteoarthritis Index	The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC) will be was used to evaluate the disease-specific self-reported symptoms of OA.48 This form is comprised of 24 questions in three categories including pain (5 questions), stiffness (2 questions), and physical function (17 questions). These 24 items are presented in a five-point Likert (0-4) scale, where higher scores indicate the higher intensity of the related symptom. The minimal clinical important difference of WOMAC at 2 month of intervention is found to be, 14.1 The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.	Changes will be measured at baseline and end of 8 week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
36-Item Short Form Health Survey	The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life (QoL). The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). SF-36 is used to assess QoL in patient with KOA. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Changes will be measured at baseline and end of 8 week intervention

Collaborators and Investigators

• Sponsor: Asir John Samuel
• Collaborators: Maharishi Markendeswar University (Deemed to be University)
• Investigators: Principal Investigator: Adarsh K Srivastav, MPT, Maharishi Markandeshwar Medical College and Hospital; Study Chair: Asir J Samuel, MPT, Ph.D, Maharishi Markandeshwar Medical College and Hospital; Study Director: Vipin Saini, Ph.D, Maharishi Markandeshwar Medical College and Hospital

Publications and helpful links

General Publications

• Chang WJ, Bennell KL, Hodges PW, Hinman RS, Young CL, Buscemi V, Liston MB, Schabrun SM. Addition of transcranial direct current stimulation to quadriceps strengthening exercise in knee osteoarthritis: A pilot randomised controlled trial. PLoS One. 2017 Jun 30;12(6):e0180328. doi: 10.1371/journal.pone.0180328. eCollection 2017.
• Stiglic-Rogoznica N, Stamenkovic D, Frlan-Vrgoc L, Avancini-Dobrovic V, Vrbanic TS. Analgesic effect of high intensity laser therapy in knee osteoarthritis. Coll Antropol. 2011 Sep;35 Suppl 2:183-5.
• Coskun Benlidayi I, Gokcen N, Basaran S. Comparative short-term effectiveness of ibuprofen gel and cream phonophoresis in patients with knee osteoarthritis. Rheumatol Int. 2018 Oct;38(10):1927-1932. doi: 10.1007/s00296-018-4099-9. Epub 2018 Jul 12.
• Srivastav AK, Sharma N, Samuel AJ. tDCS combined with cognitive training in a patient with chronic traumatic head injury. Neurophysiol Clin. 2020 Apr;50(2):133-134. doi: 10.1016/j.neucli.2020.02.004. Epub 2020 Mar 5. No abstract available.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2022
• Primary Completion (ANTICIPATED): October 31, 2022
• Study Completion (ANTICIPATED): August 2, 2023

Study Registration Dates

• First Submitted: March 17, 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: tDCS; ultrasound; laser therapy; Knee osteoarthritis; degeneration; uphill; incline walking
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: MMDU/IEC/110P; U1111-1248-7814 (OTHER: 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