Burn InjuryNCT05876442
Efficacy of EPSW Plus HILT on Carpal Tunnel Syndrome Post Burn Injury
A study testing Extracorporeal Shock Wave Therapy., High Intensity Laser Therapy and Traditional Physical Therapy Exercise Program in people with Burn Injury, run by Cairo University at 1 site in Egypt.
Trial summary
To study the effect of adding ESWT as a noninvasive short-term treatment plus high-level laser therapy for moderate carpal-tunnel syndrome post-burn injuries. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Burn Injury
- What is being tested?
- Extracorporeal Shock Wave Therapy., High Intensity Laser Therapy and Traditional Physical Therapy Exercise Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2023to 1 Jun 2024
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with carpal tunnel syndrome after thermal burn injuries.
- Patients will be diagnosed with median nerve conduction study and Phalen sign and tinel test.
- Patients age: 20 to 60 years
Who cannot join
- Patients with severe (absent sensory or motor waves) and mild (sensory nerve latency >3.5 ms at third digit) CTS according to EMG-NCV study.
- Conditions that could impact upon or impacted by outcome measures or laser intervention (e.g. hypothyroidism, cancer, active infection, pulmonary disease, acquired immunodeficiency syndrome, associated myopathy, myelopathy, history of neck and/or shoulder surgery, drugabuse, corticosteroids consumption, and pregnancy)
- Patients received continuous physical therapy or exercise during the previous two weeks or taking analgesic or anti-inflammatory drugs during the week prior to the baseline assessment
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University, Faculty of Physical Therapy
Cairo
Hadaya M Eladl, PhD, 00201281968332, hd_mos@yahoo.com
About this study
Official title: Efficacy of Extracorporeal Shock Wave Therapy Plus High-Intensity LaserTherapy on Carpal Tunnel Syndrome Post Burn Injury.
To study the effect of adding ESWT as a noninvasive short-term treatment plus high-level laser therapy for moderate carpal-tunnel syndrome post-burn injuries.
Read the detailed description
To study the effect of adding ESWT as a noninvasive short-term treatment plus high-level laser therapy for mild to moderate carpal tunnel syndrome post-burn injuries.
The effects of combining EPSW with High-intensity Laser Therapy for improving pain, Symptoms and function of motion, muscle strength, and quality of life in inpatients with carpal tunnel syndrome post-burn injuries
- Conditions
- Burn Injury
- Being tested
- Extracorporeal Shock Wave Therapy., High Intensity Laser Therapy, Traditional Physical Therapy Exercise Program
- Keywords
- Extracorporeal shock wave therapy, High Intensity Laser Therapy, Carpal Tunnel Syndrome
- Medical subject headings
- Burns, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave Therapy.Device
Patients will receive EPSW therapy at the area of the wrist for 5 minutes 1 time a week for 2 months.
High Intensity Laser TherapyDevice
High-intensity laser therapy at the area of the carpal bones for 5 minutes 2 times a week for two months..
Traditional Physical Therapy Exercise ProgramOther
30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. Followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night for two months.
| Study group | Role | What they receive |
|---|---|---|
| Group A: ESWT plus HILT in addition to Traditional Physical Therapy Exercise . | Experimental | patients will receive Extraporeal Shock wave therapy at the area of the wrist for 5 minutes 1 time a week for 2 months, then High-intensity laser therapy at the site of the carpal bones for 5 minutes 2 times a week. Then a program of traditional physical therapy exercises for post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. Followed by strengthening exercises for the wrist flexors, extensors, radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night. Receives: Device: Extracorporeal Shock Wave Therapy.; Device: High Intensity Laser Therapy; Other: Traditional Physical Therapy Exercise Program |
| Experimental: Group B: ESWT plus Traditional Physical Therapy Exercise . | Experimental | Patients will receive Extraporeal Shock wave therapy at the area of the wrist for 5 minutes 1 time a week for 2 months, Then a traditional physical therapy exercise program for the post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. They were followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night Receives: Device: Extracorporeal Shock Wave Therapy.; Other: Traditional Physical Therapy Exercise Program |
| Experimental: Group C:HILTplus Traditional Physical Therapy Exercise. | Experimental | patients will receive High-intensity laser therapy at the area of the carpal bones for 5 minutes 2 times a week for 2 monthes. Then a program of traditional physical therapy exercises for post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. Followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercises, and instructed to wear a wrist splint at night Receives: Device: High Intensity Laser Therapy; Other: Traditional Physical Therapy Exercise Program |
| Traditional Physical Therapy Exercise. | Active comparator | patients will receive a program of traditional physical therapy exercise for post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. They were followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night. Receives: Other: Traditional Physical Therapy Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity.
Intensity of pain will be measured by visual analogue scale at baseline and at the end of the 3months. Visual analogue scale is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best).Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity
Measured: 2 months
Secondary outcomes (3)
Symptoms and Functions.
Boston Carpal Tunnel Questionnaire (BCTQ) The BCTQ evaluates the severity of symptoms and the functional status of patients with carpal tunnel syndrome. The symptom severity scale (SSS) consists of 11 questions covering symptom severity including night and day numbness, pins and needles, pain, and muscle weakness and scores from 1 point (mildest) to 5 points (most severe). The functional status scale (FSS) consists of 8 points concerning the patient's problems in performing specific activities such as writing, holding a book, buttoning up the shirt, holding the phone, opening jam jar, doing hard house chores, taking a bath, carrying a shopping bag, and dressing ranging from 1 point (no difficulty with the activity) to 5 points (cannot perform the activity at all). The higher the score, the greater the severity of the symptoms, and the disability of the patient would be
Measured: 2 months
Median Nerve conduction Study
median nerve conduction study will be measured at the base line and at the end of the treatment period of two months.
Measured: 2 months
Muscle strength assessment
will be measured using the hand held daynamo-meter at the beginning and at the end of 2 months after treatment
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start20 May 2023
- Primary completion30 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadaya Mosaad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876442
- Sponsor's protocol ID
- P.T.REC/012/004498
- Status last verified
- Oct 2023
- First submitted
- 12 May 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extracorporeal Shock Wave Therapy Plus High-Intensity LaserTherapy on Carpal Tunnel Syndrome Post Burn Injury.
- ClinicalTrials.gov ID
- NCT05876442
- Acronym / sponsor ID
- P.T.REC/012/004498
- Conditions
- Burn Injury
- Keywords
- Extracorporeal shock wave therapy, High Intensity Laser Therapy, Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 25 May 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.
To study the effect of adding ESWT as a noninvasive short-term treatment plus high-level laser therapy for moderate carpal-tunnel syndrome post-burn injuries.
Detailed description
To study the effect of adding ESWT as a noninvasive short-term treatment plus high-level laser therapy for mild to moderate carpal tunnel syndrome post-burn injuries.
The effects of combining EPSW with High-intensity Laser Therapy for improving pain, Symptoms and function of motion, muscle strength, and quality of life in inpatients with carpal tunnel syndrome post-burn injuries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: ESWT plus HILT in addition to Traditional Physical Therapy Exercise . | Experimental | Device: Extracorporeal Shock Wave Therapy., Device: High Intensity Laser Therapy, Other: Traditional Physical Therapy Exercise Programpatients will receive Extraporeal Shock wave therapy at the area of the wrist for 5 minutes 1 time a week for 2 months, then High-intensity laser therapy at the site of the carpal bones for 5 minutes 2 times a week. Then a program of traditional physical therapy exercises for post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. Followed by strengthening exercises for the wrist flexors, extensors, radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night. |
| Experimental: Group B: ESWT plus Traditional Physical Therapy Exercise . | Experimental | Device: Extracorporeal Shock Wave Therapy., Other: Traditional Physical Therapy Exercise ProgramPatients will receive Extraporeal Shock wave therapy at the area of the wrist for 5 minutes 1 time a week for 2 months, Then a traditional physical therapy exercise program for the post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. They were followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night |
| Experimental: Group C:HILTplus Traditional Physical Therapy Exercise. | Experimental | Device: High Intensity Laser Therapy, Other: Traditional Physical Therapy Exercise Programpatients will receive High-intensity laser therapy at the area of the carpal bones for 5 minutes 2 times a week for 2 monthes. Then a program of traditional physical therapy exercises for post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. Followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercises, and instructed to wear a wrist splint at night |
| Traditional Physical Therapy Exercise. | Active comparator | Other: Traditional Physical Therapy Exercise Programpatients will receive a program of traditional physical therapy exercise for post-burn carpal tunnel syndrome for 30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. They were followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients diagnosed with carpal tunnel syndrome after thermal burn injuries.
- Patients will be diagnosed with median nerve conduction study and Phalen sign and tinel test.
- Patients age: 20 to 60 years
Key exclusion criteria (3 listed)
- Patients with severe (absent sensory or motor waves) and mild (sensory nerve latency >3.5 ms at third digit) CTS according to EMG-NCV study.
- Conditions that could impact upon or impacted by outcome measures or laser intervention (e.g. hypothyroidism, cancer, active infection, pulmonary disease, acquired immunodeficiency syndrome, associated myopathy, myelopathy, history of neck and/or shoulder surgery, drugabuse, corticosteroids consumption, and pregnancy)
- Patients received continuous physical therapy or exercise during the previous two weeks or taking analgesic or anti-inflammatory drugs during the week prior to the baseline assessment
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 |
|---|---|---|
| Extracorporeal Shock Wave Therapy.Patients will receive EPSW therapy at the area of the wrist for 5 minutes 1 time a week for 2 months. | Device | Experimental: Group B: ESWT plus Traditional Physical Therapy Exercise ., Group A: ESWT plus HILT in addition to Traditional Physical Therapy Exercise . |
| High Intensity Laser TherapyHigh-intensity laser therapy at the area of the carpal bones for 5 minutes 2 times a week for two months.. | Device | Experimental: Group C:HILTplus Traditional Physical Therapy Exercise., Group A: ESWT plus HILT in addition to Traditional Physical Therapy Exercise . |
| Traditional Physical Therapy Exercise Program30 minutes of stretching exercise for the wrist and carpal region with the fingers flexed and extended. Followed by strengthening exercises for the wrist flexors, extensors, and radial and ulnar deviation muscles. Mobilizing exercise, tendon gliding exercise, and instructed to wear a wrist splint at night for two months. | Other | Experimental: Group B: ESWT plus Traditional Physical Therapy Exercise ., Experimental: Group C:HILTplus Traditional Physical Therapy Exercise., Group A: ESWT plus HILT in addition to Traditional Physical Therapy Exercise ., Traditional Physical Therapy Exercise. |
Primary outcome
Pain Intensity.
Time frame: 2 months
Intensity of pain will be measured by visual analogue scale at baseline and at the end of the 3months. Visual analogue scale is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best).Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity
3 secondary outcomes
Symptoms and Functions.
Time frame: 2 months
Median Nerve conduction Study
Time frame: 2 months
Muscle strength assessment
Time frame: 2 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: Yes. Study results.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy., High Intensity Laser Therapy and Traditional Physical Therapy Exercise Program in people with Burn Injury, run by Cairo 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 3 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 25 Oct 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. 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 Hadaya M Eladl, PhD (00201281968332, hd_mos@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity. (time frame: 2 months). 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 25 Oct 2023.