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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Egypt
    • Kafr El Sheikh Governorate
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age ranged from 20 to 30 years
  2. After extensor tendon reconstruction surgeries
  3. Gender: both male and female

Exclusion Criteria:

  1. Photosensitivity
  2. Sensory impairements
  3. Intellectual disorders
  4. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: shortwave diathermy
Device: 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
Device: 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
Device: 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
Device: 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
Other: traditional physical therapy program
splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kafrelsheikh University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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