- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06113250
Effect of Shortwave Diathermy Versus Ultrasound Waves on Increasing ROM and Decreasing Pain After Extensor Tendon Reconstruction
October 27, 2023 updated by: Ibrahim Yousef Zidane, Kafrelsheikh University
Effect of Shortwave Diathermy Versus Ultrasound Waves on Increasing Rom and Decreasing Pain After Extensor Tendon Reconstruction
tendon injuries can result in long-term sequelae, including chronic pain and mobility restrictions, and may warrant surgery.
Ultrasound is sound with a frequency above 20,000 Hertz (Hz) and is undetectable by the human ear.
Ultrasound waves are generated by a piezoelectric effect caused by vibration of crystals within the head of the wand/probe.
The sound waves that pass through the skin cause vibration of the local tissue.
This can cause a deep heating locally.
ultrasound can provide several benefits for treating strains, sprains, tissue healing andpain.n
Shortwave diathermy is a high frequency current that is obtained by a discharging condenser through inductance of low ohmic resistance.
When this high frequency current passes into the tissues, it produces heat into the tissues.
PSWD heats a much larger area than ultrasound does, making it ideal to heat larger joints, such as the elbow, shoulder, hip, knee, and ankle.
This work aims to compare between the effect of shortwave diathermy versus ultrasound waves on increasing ROM and decreasing pain after extensor tendon reconstruction.
Sixty adults patients of both sex, aged from 20 to 30 years, with extensor tendon injuries participated in this study after reconstruction surgeries.
They were randomly categorized into three groups of equal numbers.
Group A received Pulsed shortwave diathermy and traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises), group B received ultrasound waves and traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises, while group C received only traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises).
Pain and finger flexion range of motion will be measured before and after two months of intervention.
Data and results will be statistically analyzed to give conclusions
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kafr El Sheikh Governorate
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Kafr Ash Shaykh, Kafr El Sheikh Governorate, Egypt, 33511
- Faculty of Physical Therapy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age ranged from 20 to 30 years
- After extensor tendon reconstruction surgeries
- Gender: both male and female
Exclusion Criteria:
- Photosensitivity
- Sensory impairements
- Intellectual disorders
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: shortwave diathermy
|
Shortwave diathermy (SWD) is a modality that produces heat by converting electromagnetic energy into thermal energy.
pulsed shortwave diathermy (PSWD), uses high-frequency electromagnetic waves to heat tissues up to 5 cm deep.
Heat is produced by the resistance of tissue to the passage of energy.
Although it heats to the same depth as 1-MHz ultrasound, PSWD heats a much larger area than ultrasound does, making it ideal to heat larger joints, such as the elbow, shoulder, hip, knee, and ankle
|
|
Active Comparator: ultrasound waves
|
Ultrasound is sound with a frequency above 20,000 Hertz (Hz) and is undetectable by the human ear.
However, clinical ultrasound uses much high frequencies of between 1 and 20 megahertz (MHz) and sometimes up to 75 MHz in specialized areas such as dermatology and ophthalmology.
Clinically, ultrasound is used for a number of applications ranging from visualizing structures to allow safe insertion of lines and catheters to diagnostic imaging including the assessment of the movement of cardiac Production of ultrasound waves is the first part of the clinical ultrasound process.
Ultrasound is generated by piezoelectric crystals.
These crystalline materials contain randomly oriented electric dipoles, and when a force is applied that deforms the crystal, the dipoles are rearranged and a net charge induced across the crystal
|
|
Sham Comparator: therapeutic exercises
|
Shortwave diathermy (SWD) is a modality that produces heat by converting electromagnetic energy into thermal energy.
pulsed shortwave diathermy (PSWD), uses high-frequency electromagnetic waves to heat tissues up to 5 cm deep.
Heat is produced by the resistance of tissue to the passage of energy.
Although it heats to the same depth as 1-MHz ultrasound, PSWD heats a much larger area than ultrasound does, making it ideal to heat larger joints, such as the elbow, shoulder, hip, knee, and ankle
Ultrasound is sound with a frequency above 20,000 Hertz (Hz) and is undetectable by the human ear.
However, clinical ultrasound uses much high frequencies of between 1 and 20 megahertz (MHz) and sometimes up to 75 MHz in specialized areas such as dermatology and ophthalmology.
Clinically, ultrasound is used for a number of applications ranging from visualizing structures to allow safe insertion of lines and catheters to diagnostic imaging including the assessment of the movement of cardiac Production of ultrasound waves is the first part of the clinical ultrasound process.
Ultrasound is generated by piezoelectric crystals.
These crystalline materials contain randomly oriented electric dipoles, and when a force is applied that deforms the crystal, the dipoles are rearranged and a net charge induced across the crystal
splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain at extensor tendons
Time Frame: pain is measured before starting study and after 2 months of intervention
|
visual analque scale is a 10 point line is used to quantify amount of pain at extensor tendon of hand
|
pain is measured before starting study and after 2 months of intervention
|
|
finger flexion ROM
Time Frame: flexion range of finger is measured before starting study and after 2 months
|
goniometer is digital tool is used to measure range of finger flexion of hand
|
flexion range of finger is measured before starting study and after 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abdelaziz A sherif, Vice Dean for graduate studies and research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2023
Primary Completion (Estimated)
November 1, 2023
Study Completion (Estimated)
November 7, 2023
Study Registration Dates
First Submitted
October 27, 2023
First Submitted That Met QC Criteria
October 27, 2023
First Posted (Actual)
November 2, 2023
Study Record Updates
Last Update Posted (Actual)
November 2, 2023
Last Update Submitted That Met QC Criteria
October 27, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-29
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Extensor Tendon Reconstruction
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-
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