Extensor Tendon ReconstructionPhase 2NCT06113250
Effect of Shortwave Diathermy Versus Ultrasound Waves on Increasing ROM and Decreasing Pain After Extensor Tendon Reconstruction
A Phase 2 study testing shortwave diathermy, ultrasound waves and traditional physical therapy program in people with Extensor Tendon Reconstruction, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Extensor Tendon Reconstruction
- What is being tested?
- shortwave diathermy, ultrasound waves and traditional physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2023to 7 Nov 2023
- Phase
- Phase 2
- 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 22 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ranged from 20 to 30 years
- After extensor tendon reconstruction surgeries
- Gender: both male and female
Who cannot join
- Photosensitivity
- Sensory impairements
- Intellectual disorders
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511
About this study
Official title: 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
- Conditions
- Extensor Tendon Reconstruction
- Being tested
- shortwave diathermy, ultrasound waves, traditional physical therapy program
- Keywords
- shortwave diathermy, ultrasound waves, extensor tendon reconstruction, pain, ROM, visual analque scale, goniometer
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shortwave diathermyDevice
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 wavesDevice
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
traditional physical therapy programOther
splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises
| Study group | Role | What they receive |
|---|---|---|
| shortwave diathermy | Active comparator | Not described Receives: Device: shortwave diathermy |
| ultrasound waves | Active comparator | Not described Receives: Device: ultrasound waves |
| therapeutic exercises | Sham comparator | Not described Receives: Device: shortwave diathermy; Device: ultrasound waves; Other: traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain at extensor tendons
visual analque scale is a 10 point line is used to quantify amount of pain at extensor tendon of hand
Measured: pain is measured before starting study and after 2 months of intervention
finger flexion ROM
goniometer is digital tool is used to measure range of finger flexion of hand
Measured: flexion range of finger is measured before starting study and after 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start5 Jul 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion7 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensor Tendon ReconstructionStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 60 male and female patients will participate in the study are divided into 3 groups (20 in each group). They will be randomly assigned to three equal groups: Group (A): twenty patients will receive shortwave diathermy and traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises). Group (B): twenty patients will receive ultrasound waves and traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises). Group (C): twenty patients will receive only traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Yousef Zidane, Kafrelsheikh University
- Investigators
- Abdelaziz A sherif, Principal investigator, Vice Dean for graduate studies and research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113250
- Sponsor's protocol ID
- KFSIRB200-29
- Status last verified
- Oct 2023
- First submitted
- 27 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shortwave Diathermy Versus Ultrasound Waves on Increasing Rom and Decreasing Pain After Extensor Tendon Reconstruction
- ClinicalTrials.gov ID
- NCT06113250
- Acronym / sponsor ID
- KFSIRB200-29
- Conditions
- Extensor Tendon Reconstruction
- Keywords
- shortwave diathermy, ultrasound waves, extensor tendon reconstruction, pain, ROM, visual analque scale, goniometer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 7 Nov 2023 (estimated)
- First posted
- 2 Nov 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 60 male and female patients will participate in the study are divided into 3 groups (20 in each group). They will be randomly assigned to three equal groups: Group (A): twenty patients will receive shortwave diathermy and traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises). Group (B): twenty patients will receive ultrasound waves and traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises). Group (C): twenty patients will receive only traditional physical therapy program (splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises)
| Arm | Type | Receives |
|---|---|---|
| shortwave diathermy | Active comparator | Device: shortwave diathermy |
| ultrasound waves | Active comparator | Device: ultrasound waves |
| therapeutic exercises | Sham comparator | Device: shortwave diathermy, Device: ultrasound waves, Other: traditional physical therapy program |
Who may qualify
- Ages
- 22 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ranged from 20 to 30 years
- After extensor tendon reconstruction surgeries
- Gender: both male and female
Key exclusion criteria (4 listed)
- Photosensitivity
- Sensory impairements
- Intellectual disorders
- Pregnant women
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 |
|---|---|---|
| shortwave diathermyShortwave 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 | shortwave diathermy, therapeutic exercises |
| ultrasound wavesUltrasound 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 | Device | therapeutic exercises, ultrasound waves |
| traditional physical therapy programsplinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises | Other | therapeutic exercises |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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.
Abdelaziz A sherif principal investigator
Vice Dean for graduate studies and research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing shortwave diathermy, ultrasound waves and traditional physical therapy program in people with Extensor Tendon Reconstruction, run by Kafrelsheikh University at 1 site in Egypt.
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 3 inclusion and 4 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 2 Nov 2023. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain at extensor tendons (time frame: pain is measured before starting study and after 2 months of intervention). The study lists 2 primary outcomes in all. 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 2 Nov 2023.