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

Primary Purpose

Knee Acute and Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Inferential therapy
short wave diathermy
Sponsored by
King Khalid University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Acute and Chronic Pain focused on measuring Knee pain, osteoarthritis,, patello-femoral pain,, Anetrior cruciate repair, Balance, Dynamic and static balance, Proprioception

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King Khalid UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Inferential therapy

Shortwave diathermy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Y balance test Score
More condensed form of star excursion test. Used to evaluate dynamic balance

Secondary Outcome Measures

Visual analogue scale
Pain values from 0-10 on a scale 0 means no pain 10 means maximum unbearable pain

Full Information

First Posted
October 29, 2019
Last Updated
February 8, 2021
Sponsor
King Khalid University
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1. Study Identification

Unique Protocol Identification Number
NCT04148768
Brief Title
Acute Effect of Inferential Therapy (IFT) and Short Wave Diathermy (SWD) on Balance in Subjects With Knee Pain
Acronym
IFT & SWD
Official Title
Acute Effect of Inferential Therapy (IFT) and Short Wave Diathermy (SWD) on Balance in Subjects With Knee Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
April 27, 2021 (Anticipated)
Study Completion Date
June 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Khalid University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Acute and Chronic Pain
Keywords
Knee pain, osteoarthritis,, patello-femoral pain,, Anetrior cruciate repair, Balance, Dynamic and static balance, Proprioception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention SWD & IFT: 4 SESSIONS OF TREATMENT and measurement of balance
Masking
Participant
Masking Description
Participants will not be aware of the treatment groups given to them.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inferential therapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Shortwave diathermy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Inferential therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
short wave diathermy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Y balance test Score
Description
More condensed form of star excursion test. Used to evaluate dynamic balance
Time Frame
Change is being evaluated from Baseline and at 4 week
Secondary Outcome Measure Information:
Title
Visual analogue scale
Description
Pain values from 0-10 on a scale 0 means no pain 10 means maximum unbearable pain
Time Frame
Change is being evaluated from Baseline and at 4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-specific Knee pain, osteoarthritis, chronic ACL and meniscus injury, patellofemoral knee pain Exclusion Criteria: Recent major surgeries within 6 months, Limb Length discrepancies, amputation, any musculoskeletal or neurological limitation preventing evaluation, vitamin deficiency (B12), neuropathy, cancer-related patients, rheumatoid arthritis, Osteoporosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
snehil dixit, PHD
Phone
+966559105324
First Name & Middle Initial & Last Name or Official Title & Degree
snehil dixit, PhD
Phone
+966559105324
Email
snehil@kku.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
snehil dixit, PhD
Organizational Affiliation
King Khalid University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Khalid University
City
Abha
State/Province
Aseer
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SNEHIL DIXIT, PhD
Email
snehil@kku.edu.sa
First Name & Middle Initial & Last Name & Degree
Irshad Hameed, PhD
Email
iabdulhamed@kku.edu.sa

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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