NCT06113250

Brief 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

October 27, 2023

Last Update Submit

October 27, 2023

Conditions

Keywords

shortwave diathermy, ultrasound waves, extensor tendon reconstruction, pain, ROM, visual analque scale, goniometer

Outcome Measures

Primary Outcomes (2)

  • pain at extensor tendons

    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

    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

Study Arms (3)

shortwave diathermy

ACTIVE COMPARATOR
Device: shortwave diathermy

ultrasound waves

ACTIVE COMPARATOR
Device: ultrasound waves

therapeutic exercises

SHAM COMPARATOR
Device: shortwave diathermyDevice: ultrasound wavesOther: traditional physical therapy program

Interventions

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

shortwave diathermytherapeutic exercises

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

therapeutic exercisesultrasound waves

splinting, stretching exercises, strengthening exercises and range of motion (ROM) exercises

therapeutic exercises

Eligibility Criteria

Age22 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ranged from 20 to 30 years
  • After extensor tendon reconstruction surgeries
  • Gender: both male and female

You may not qualify if:

  • Photosensitivity
  • Sensory impairements
  • Intellectual disorders
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Abdelaziz A sherif

    Vice Dean for graduate studies and research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy for integumentary disorders, faculty of physical therapy, kafrelsheikh university

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 2, 2023

Study Start

July 5, 2023

Primary Completion

November 1, 2023

Study Completion

November 7, 2023

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations