Knee Acute and Chronic PainIFT & SWDNCT04148768
Acute Effect of Inferential Therapy (IFT) and Short Wave Diathermy (SWD) on Balance in Subjects With Knee Pain
A study testing Inferential therapy and short wave diathermy in people with Knee Acute and Chronic Pain, run by King Khalid University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Knee Acute and Chronic Pain
- What is being tested?
- Inferential therapy and short wave diathermy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 30 Nov 2019to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-specific Knee pain,
- osteoarthritis,
- chronic ACL and meniscus injury,
- patellofemoral knee pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
snehil dixit, PHD contact
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Khalid University
Abhā, 'Asir Region
SNEHIL DIXIT, PhD, snehil@kku.edu.sa
Irshad Hameed, PhD, iabdulhamed@kku.edu.sa
About this study
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
Read more
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.
Read the 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.
- Conditions
- Knee Acute and Chronic Pain
- Being tested
- Inferential therapy, short wave diathermy
- Keywords
- Knee pain, osteoarthritis,, patello-femoral pain,, Anetrior cruciate repair, Balance, Dynamic and static balance, Proprioception
- Medical subject headings
- Chronic Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferential therapyDevice
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 diathermyDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Inferential therapy | Active comparator | 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 Receives: Device: Inferential therapy |
| Shortwave diathermy | Active comparator | 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 Receives: Device: short wave diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Y balance test Score
More condensed form of star excursion test. Used to evaluate dynamic balance
Measured: Change is being evaluated from Baseline and at 4 week
Secondary outcomes (1)
Visual analogue scale
Pain values from 0-10 on a scale 0 means no pain 10 means maximum unbearable pain
Measured: Change is being evaluated from Baseline and at 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start30 Nov 2019
- Primary completion27 Apr 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Acute and Chronic PainStudies 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention SWD \& IFT: 4 SESSIONS OF TREATMENT and measurement of balance
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Khalid University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Snehil Dixit, King Khalid University
- Investigators
- snehil dixit, PhD, Principal investigator, King Khalid University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148768
- Sponsor's protocol ID
- (ECM#2019-55)-( HAPO-06-B-001)
- Acronym
- IFT & SWD
- Status last verified
- Feb 2021
- First submitted
- 29 Oct 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Inferential Therapy (IFT) and Short Wave Diathermy (SWD) on Balance in Subjects With Knee Pain
- ClinicalTrials.gov ID
- NCT04148768
- Acronym / sponsor ID
- IFT & SWD / (ECM#2019-55)-( HAPO-06-B-001)
- Conditions
- Knee Acute and Chronic Pain
- Keywords
- Knee pain, osteoarthritis,, patello-femoral pain,, Anetrior cruciate repair, Balance, Dynamic and static balance, Proprioception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King Khalid UniversityUniversity, hospital or other
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 27 Apr 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention SWD \& IFT: 4 SESSIONS OF TREATMENT and measurement of balance
| Arm | Type | Receives |
|---|---|---|
| Inferential therapy | Active comparator | Device: Inferential therapyInterferential 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 |
| Shortwave diathermy | Active comparator | Device: short wave diathermy4 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 |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-specific Knee pain,
- osteoarthritis,
- chronic ACL and meniscus injury,
- patellofemoral knee pain
Key exclusion criteria (8 listed)
- Recent major surgeries within 6 months,
- Limb Length discrepancies, amputation,
- any musculoskeletal or neurological limitation preventing evaluation,
- vitamin deficiency (B12),
- neuropathy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inferential therapyInterferential 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. | Device | Inferential therapy |
| short wave diathermySWD: 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) | Device | Shortwave diathermy |
Primary outcome
Y balance test Score
Time frame: Change is being evaluated from Baseline and at 4 week
More condensed form of star excursion test. Used to evaluate dynamic balance
1 secondary outcome
Visual analogue scale
Time frame: Change is being evaluated from Baseline and at 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
snehil dixit, PHD contact
snehil dixit, PhD principal investigator
King Khalid University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferential therapy and short wave diathermy in people with Knee Acute and Chronic Pain, run by King Khalid University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact snehil dixit, PHD (+966559105324), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Y balance test Score (time frame: Change is being evaluated from Baseline and at 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.