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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 45 to 70 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

No sites are listed yet.

About this study

Conditions

Knee Osteoarthritis

Being tested

High Intensity LASER Therapy (HILT), Ibuprofen Gel Phonophoresis (IGP), Transcranial Direct Current Stimulation (tDCS), Conventional Physiotherapy (CPT)

Keywords

Knee osteoarthritis, uphill, incline walking, degeneration, laser therapy, ultrasound, tDCS

Medical subject headings

Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• High Intensity LASER Therapy (HILT)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)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)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 (CPT)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)

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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)

   Measured: Changes will be measured at baseline and end of 8 week intervention

2. 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.

   Measured: Changes will be measured at baseline and end of 8 week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted25 Mar 2020
2. Study start1 Apr 2022 (estimated)
3. Primary completion31 Oct 2022 (estimated)
4. Study completion2 Aug 2023 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (4)Papers the sponsor has linked to this study.
• Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.