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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04148768
Other study ID # (ECM#2019-55)-( HAPO-06-B-001)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 30, 2019
Est. completion date June 15, 2021

Study information

Verified date February 2021
Source King Khalid University
Contact snehil dixit, PHD
Phone +966559105324
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: The Y balance test is a dynamic test that requires strength, flexibility, and proprioception. It is a measure of dynamic balance that provides a significant challenge to athletes and physically active individuals. The test can be used to assess physical performance, but can also be used to screen deficits in dynamic postural control due to musculoskeletal injuries (e.g. chronic ankle instability), to identify athletes at greater risk for lower extremity injury, as well as during the rehabilitation of orthopedic injuries in healthy active adults Objective: To know the effect of 4 sessions of treatment by interferential therapy (IFT) 15-20 minutes, and SWD 15 min on the balance and dynamic postural component using Y balance test Methods: Subjects will be randomized into IFT and laser group (n=20 each). After the first session, the balance component will be measured pre-post-intervention. Outcome assessment: Y Balance tests score.


Description:

Objective: To know the effect of 4 sessions of treatment by interferential therapy, and SWD on the balance and dynamic postural component using Y balance test Methods: Study design: Random sampling through lottery methods Blinding: Participants were not aware of the group they were in Allocation concealment: Not done Inclusion criteria: Physical assessment of the knee joint participants complains of pain, osteoarthritis, Patellofemoral knee pain syndrome, pain due to altered biomechanics of knee joints (structural and functional) Exclusion criteria: History of previous surgeries, participants on steroids, Vitamin deficiencies, osteoporosis, open wounds, recurrent ACL repair, Affliction due to metastasis or post-cancer patients Treatment specifications: Duration of intervention: Treatment will continue for 4 sessions/week, with each session lasting 15-20 minutes. Intervention: Experimental group-1: Interferential therapy will be given to the patients with knee pain for 4 sessions for 15-20 minutes and the examination of the balance will be done with Y balance tests Pre-Post. 4 electrodes methods placed diagonally to each other creating a beat frequency at the center. Intensity to the percieved tolerable limits. The 'medium frequency' currents (medium frequency in electromedical terms is usually considered to be 1KHz-100KHz). These medium frequency currents, passed through the tissues simultaneously, where they are set up so that their paths cross & they literally interfere with each other. This interaction gives rise to an interference current (or beat frequency) which has the characteristics of low-frequency stimulation Experimental group-2: SWD will be given to the patients with knee pain for 4 sessions for 10-15 minutes with Continuous Mode and intensity: comfortable warmth, timing 15 mins and examination of the balance will be done with Y balance tests Pre-Post. Technical specification : Technical specification of Generator frequency: 27.12 MHz, ± 0.6% Output power: continuous High-Frequency max. 400 W, pulsed High-Frequency max. 1000 W (peak) Pulse duration: ca. 400 µs Pulse repetition frequency: 15-200 Hz adjustable in 10 steps Mains supply: 230-240 V / 50 Hz Mains voltage variation: approx. ± 10% Current consumption: approx. 6 Ampere (at 230 V) Dimensions (width, without arms): 56x43x92.5 cm Length electrode arms: 93 cm Weight: ca. 80 kg.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 15, 2021
Est. primary completion date April 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 68 Years
Eligibility Inclusion Criteria: 1. Non-specific Knee pain, 2. osteoarthritis, 3. chronic ACL and meniscus injury, 4. patellofemoral knee pain Exclusion Criteria: 1. Recent major surgeries within 6 months, 2. Limb Length discrepancies, amputation, 3. any musculoskeletal or neurological limitation preventing evaluation, 4. vitamin deficiency (B12), 5. neuropathy, 6. cancer-related patients, 7. rheumatoid arthritis, 8. Osteoporosis

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Inferential therapy
Interferential therapy(IFT) utilises two of these medium frequency currents, passed through the tissues simultaneously, where they are set up so that their paths cross & they literally interfere with each other - hence another term that has been used in the past but appears to be out of favour at the moment - Interference Current Therapy. This interaction gives rise to an interference current (or beat frequency) which has the characteristics of low-frequency stimulation.
short wave diathermy
SWD: Technical specification of Generator frequency: 27.12 MHz, ± 0.6% Output power: continuous High-Frequency max. 400 W, pulsed High-Frequency max. 1000 W (peak) Pulse duration: ca. 400 µs Pulse repetition frequency: 15-200 Hz adjustable in 10 steps Mains supply: 230-240 V / 50 Hz Mains voltage variation: approx. ± 10% Current consumption: approx. 6 Ampere (at 230 V)

Locations

Country Name City State
Saudi Arabia King Khalid University Abha Aseer

Sponsors (1)

Lead Sponsor Collaborator
King Khalid University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Y balance test Score More condensed form of star excursion test. Used to evaluate dynamic balance Change is being evaluated from Baseline and at 4 week
Secondary Visual analogue scale Pain values from 0-10 on a scale 0 means no pain 10 means maximum unbearable pain Change is being evaluated from Baseline and at 4 week