Acute Effect of Inferential Therapy (IFT) and Short Wave Diathermy (SWD) on Balance in Subjects With Knee Pain (IFT & SWD)

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Acute and Chronic Pain
• Intervention / Treatment: Device: Inferential therapy; Device: short wave diathermy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: snehil dixit, PHD; Phone Number: +966559105324
• Study Contact Backup: Name: SNEHIL DIXIT, PHD; Phone Number: +966559105324; Email: snehil@kku.edu.sa

Study Locations

• Saudi Arabia
  • Aseer
    • Abha, Aseer, Saudi Arabia
      • Recruiting
      • King Khalid University
      • Contact: SNEHIL DIXIT, PhD; Email: snehil@kku.edu.sa
      • Contact: Irshad Hameed, PhD; Email: iabdulhamed@kku.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inferential therapy; Interferential therapy will be given using 4 electrode methods. 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. Pre-Post Y balance test will be used after 4 sessions to measure the improvement in balance in the population	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.
Active Comparator: Shortwave diathermy; 4 sessions of treatment will be given to the participants with SWD. Pre-post Y balance test will be used to measure balance in the population	Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: King Khalid University
• Investigators: Principal Investigator: SNEHIL DIXIT, PhD, King Khalid University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2019
• Primary Completion (Anticipated): April 27, 2021
• Study Completion (Anticipated): June 15, 2021

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Balance; Knee pain; Proprioception; osteoarthritis,; patello-femoral pain,; Anetrior cruciate repair; Dynamic and static balance
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: (ECM#2019-55)-( HAPO-06-B-001)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No