Hand BurnNCT06371885
Shock Wave on Pillar Pain After Carpal Tunnel Release in Hand Burn
A study testing shock wave therapy and traditional physical therapy in people with Hand Burn and Carpal Tunnel Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
"In burn cases, the reported causes of CTS are increased volume of carpal tunnel content due to edema and synovitis, wrist hyperextension, tight dressing, fibrosis, and direct burn to the nerve. There are two types of pain that occur in the palm of the hand after carpal tunnel surgery: incisional pain and pillar pain. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Hand Burn, Carpal Tunnel Syndrome
- What is being tested?
- shock wave therapy and traditional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2023to 28 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range will be from 20 to 35 years.
- Patients who have upper limb burn with the percentage of the total body surface area ranging from 20 % to 25 % and diagnosed as a 2nd or 3rd degree burn and complicated with carpal tunnel syndrome post burn. The diagnosis will be confirmed by using electroneurographic (ENG) examination as well as by using physical examination which included Tinel's test and Phalen's test.
- All patients are non-smokers and are under own prescribed medications described by their physicians.
Who cannot join
- Sensory or motor neuropathy.
- Systemic inflammatory diseases.
- A history of surgery other than CTRS or trauma/fracture in the hand and hand-wrist region.
- Local infections at the hand level.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
"In burn cases, the reported causes of CTS are increased volume of carpal tunnel content due to edema and synovitis, wrist hyperextension, tight dressing, fibrosis, and direct burn to the nerve. There are two types of pain that occur in the palm of the hand after carpal tunnel surgery: incisional pain and pillar pain. The incision pain typically only lasts for a few days or weeks after surgery, while the pillar pain occurs on the sides of the incision in the thicker parts of the palm, called the thenar and hypothenar eminences. This is where the transverse ligament attaches to the carpal bones, forming the carpal tunnel.
So, in this study we will find out if shock wave therapy has therapeutic effect on pillar pain after carpal tunnel release in hand burn.
Read the detailed description
The development of CTS following burns is common and usually occurs due to thermal burns, owing to excessive edema in circumferential burns, extensive metabolic and inflammatory changes occur in response to burnCarpal tunnel release surgery is one of the most common procedures performed by hand surgeons. Pillar pain is a frequent symptom following carpal tunnel release. The pain is located at the base of the hand in the heel of the palm. The muscles at the thumb base (thenar eminence) and the muscles at the base of the small finger (hypothenar eminence) are the usual areas of tenderness. The palm is sore when pressed in these locations, marked with red asterisks in the photo.
Shock wave therapy is a physical therapy modality that involves the administration of high-intensity sound waves arising from sudden pressure changes to the body. Those changes result in strong waves that cause compression and tension leading to anesthesia of the nerve fibers through biochemical changes and reduced inflammation in the soft tissue. It is believed that the release of angiogenesis-related growth factors of the mechanism of action in the soft tissues after shock wave accelerates the formation of new vessels and increases oxygenation in the environment, resulting in accelerated tissue recovery.
So, in this study we will find out if shock wave therapy has therapeutic effect on pillar pain after carpal tunnel release in hand burn. In this single blind randomized clinical trial, Fifty- two patients who had upper limb burn with the percentage of the total body surface area ranging from 20 % to 25 % and diagnosed as a 2nd or 3rd degree burn complicated with carpal tunnel syndrome, their ages range between 20 and 35 years, will be recruited from the outpatient clinic of burn in Mansoura hospitals. The patients will be randomly assigned into two equal groups. Sock wave group and control group.
Shock wave therapy group:
This group will be composed of twenty-six patients who will managed by shock wave therapy one session per week, each ESWT session will involve 2,000 pulses of the focus probe at 4-bar pressure and 5 Hz frequency for twelve weeks in addition to the traditional physical therapy.
Control group:
This group will be composed of twenty-six patients who will only managed by the traditional physical therapying form of (10 minutes hot pack around wrist and forearm and 10 minutes of gentle stretching exercises for wrist joint, three sessions per week for twelve weeks.
The outcome measures will be assessed using Visual Analog Scale, Hand held dynamometer, and Michigan hand out Comes questionnaire before and after 12 weeks of intervention.
- Conditions
- Hand Burn, Carpal Tunnel Syndrome
- Being tested
- shock wave therapy, traditional physical therapy
- Keywords
- Carpal Tunnel Syndrome, Hand Burn, Pillar pain, Shock wave therapy
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shock wave therapyDevice
shock wave therapy will be applied one session per week, each ESWT session will involve 2,000 pulses of the focus probe at 4-bar pressure and 5 Hz frequency for twelve weeks
traditional physical therapyOther
the traditional physical therapy will be in form of (10 minutes hot pack around wrist and forearm and 10 minutes of gentle stretching exercises for wrist joint, three sessions per week for twelve weeks
| Study group | Role | What they receive |
|---|---|---|
| Shock wave therapy group | Active comparator | This group will be composed of twenty-six patients who will managed by shock wave therapy one session per week, each ESWT session will involve 2,000 pulses of the focus probe at 4-bar pressure and 5 Hz frequency for twelve weeks in addition to the traditional physical therapy in form of (10 minutes hot pack around wrist and forearm and 10 minutes of gentle stretching exercises for wrist joint, three sessions per week for twelve weeks. Receives: Device: shock wave therapy; Other: traditional physical therapy |
| Control group | Active comparator | This group will be composed of twenty-six patients who will only managed by the traditional physical therapy in form of (10 minutes hot pack around wrist and forearm and 10 minutes of gentle stretching exercises for wrist joint, three sessions per week for twelve weeks Receives: Other: traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
It is a pain rating scale. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm)
Measured: Change from baseline at twelve weeks after the intervention
Hand held dynamometer
It is a test to measure the maximum isometric strength of the hand and forearm muscles. Handgrip strength is important for any sport in which the hands are used for catching, throwing or lifting.
Measured: Change from baseline at twelve weeks after the intervention
Secondary outcomes (1)
Michigan hand out Comes questionnaire
t is a tool used to assess patients with hand disorders through the measurement of 6 health domains: overall hand function, activities of daily living (ADLs), pain, work performance, aesthetics, and patient satisfaction. The MHQ is a 57-item patient-reported outcome measure in hand surgery. The scale assesses six domains: overall hand function, activities of daily living, pain, work performance, aesthetics, and satisfaction with hand function. Each item is scored on a scale of 1 to 5. A domain score ranges from 0 (worst) to 100 (best), with higher scores indicating better hand function. However, the total score of a "pain domain" is reversed ("0 = best" to "100 = worst"), and therefore, a higher score in that domain indicates greater pain.
Measured: Change from baseline at twelve weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start10 Aug 2023
- Primary completion30 May 2024 (estimated)
- Study completion28 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand BurnStudies 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
- Model description
- Interventional (clinical trial)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohamed Ahmed Elsayeh, Cairo University
- Investigators
- Shaimaa MA El Sayeh, Study director, Lecturer at Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371885
- Sponsor's protocol ID
- P.T.REC/012/004646
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shock Wave on Pillar Pain After Carpal Tunnel Release in Hand Burn
- ClinicalTrials.gov ID
- NCT06371885
- Acronym / sponsor ID
- P.T.REC/012/004646
- Conditions
- Hand Burn, Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, Hand Burn, Pillar pain, Shock wave therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 28 Jun 2024 (estimated)
- First posted
- 17 Apr 2024 (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.
"In burn cases, the reported causes of CTS are increased volume of carpal tunnel content due to edema and synovitis, wrist hyperextension, tight dressing, fibrosis, and direct burn to the nerve. There are two types of pain that occur in the palm of the hand after carpal tunnel surgery: incisional pain and pillar pain. The incision pain typically only lasts for a few days or weeks after surgery, while the pillar pain occurs on the sides of the incision in the thicker parts of the palm, called the thenar and hypothenar eminences. This is where the transverse ligament attaches to the carpal bones, forming the carpal tunnel.
So, in this study we will find out if shock wave therapy has therapeutic effect on pillar pain after carpal tunnel release in hand burn.
Detailed description
The development of CTS following burns is common and usually occurs due to thermal burns, owing to excessive edema in circumferential burns, extensive metabolic and inflammatory changes occur in response to burnCarpal tunnel release surgery is one of the most common procedures performed by hand surgeons. Pillar pain is a frequent symptom following carpal tunnel release. The pain is located at the base of the hand in the heel of the palm. The muscles at the thumb base (thenar eminence) and the muscles at the base of the small finger (hypothenar eminence) are the usual areas of tenderness. The palm is sore when pressed in these locations, marked with red asterisks in the photo.
Shock wave therapy is a physical therapy modality that involves the administration of high-intensity sound waves arising from sudden pressure changes to the body. Those changes result in strong waves that cause compression and tension leading to anesthesia of the nerve fibers through biochemical changes and reduced inflammation in the soft tissue. It is believed that the release of angiogenesis-related growth factors of the mechanism of action in the soft tissues after shock wave accelerates the formation of new vessels and increases oxygenation in the environment, resulting in accelerated tissue recovery.
So, in this study we will find out if shock wave therapy has therapeutic effect on pillar pain after carpal tunnel release in hand burn. In this single blind randomized clinical trial, Fifty- two patients who had upper limb burn with the percentage of the total body surface area ranging from 20 % to 25 % and diagnosed as a 2nd or 3rd degree burn complicated with carpal tunnel syndrome, their ages range between 20 and 35 years, will be recruited from the outpatient clinic of burn in Mansoura hospitals. The patients will be randomly assigned into two equal groups. Sock wave group and control group.
Shock wave therapy group:
This group will be composed of twenty-six patients who will managed by shock wave therapy one session per week, each ESWT session will involve 2,000 pulses of the focus probe at 4-bar pressure and 5 Hz frequency for twelve weeks in addition to the traditional physical therapy.
Control group:
This group will be composed of twenty-six patients who will only managed by the traditional physical therapying form of (10 minutes hot pack around wrist and forearm and 10 minutes of gentle stretching exercises for wrist joint, three sessions per week for twelve weeks.
The outcome measures will be assessed using Visual Analog Scale, Hand held dynamometer, and Michigan hand out Comes questionnaire before and after 12 weeks of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Interventional (clinical trial)
| Arm | Type | Receives |
|---|---|---|
| Shock wave therapy group | Active comparator | Device: shock wave therapy, Other: traditional physical therapyThis group will be composed of twenty-six patients who will managed by shock wave therapy one session per week, each ESWT session will involve 2,000 pulses of the focus probe at 4-bar pressure and 5 Hz frequency for twelve weeks in addition to the traditional physical therapy in form of (10 minutes hot pack around wrist and forearm and 10 minutes of gentle stretching exercises for wrist joint, three sessions per week for twelve weeks. |
| Control group | Active comparator | Other: traditional physical therapyThis group will be composed of twenty-six patients who will only managed by the traditional physical therapy in form of (10 minutes hot pack around wrist and forearm and 10 minutes of gentle stretching exercises for wrist joint, three sessions per week for twelve weeks |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age range will be from 20 to 35 years.
- Patients who have upper limb burn with the percentage of the total body surface area ranging from 20 % to 25 % and diagnosed as a 2nd or 3rd degree burn and complicated with carpal tunnel syndrome post burn. The diagnosis will be confirmed by using electroneurographic (ENG) examination as well as by using physical examination which included Tinel's test and Phalen's test.
- All patients are non-smokers and are under own prescribed medications described by their physicians.
Key exclusion criteria (5 listed)
- Sensory or motor neuropathy.
- Systemic inflammatory diseases.
- A history of surgery other than CTRS or trauma/fracture in the hand and hand-wrist region.
- Local infections at the hand level.
- Pregnancy.
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 |
|---|---|---|
| shock wave therapyshock wave therapy will be applied one session per week, each ESWT session will involve 2,000 pulses of the focus probe at 4-bar pressure and 5 Hz frequency for twelve weeks | Device | Shock wave therapy group |
| traditional physical therapythe traditional physical therapy will be in form of (10 minutes hot pack around wrist and forearm and 10 minutes of gentle stretching exercises for wrist joint, three sessions per week for twelve weeks | Other | Control group, Shock wave therapy group |
Primary outcome
Visual Analog Scale
Time frame: Change from baseline at twelve weeks after the intervention
It is a pain rating scale. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm)
Hand held dynamometer
Time frame: Change from baseline at twelve weeks after the intervention
It is a test to measure the maximum isometric strength of the hand and forearm muscles. Handgrip strength is important for any sport in which the hands are used for catching, throwing or lifting.
1 secondary outcome
Michigan hand out Comes questionnaire
Time frame: Change from baseline at twelve weeks after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Hand Burn
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Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruitingObservational study
Validity and Reliability of Arabic Version of Michigan Hand Questionnaire in Assessment of Hand Function Post-burn
Burns
RecruitingObservational study
Turkish Adaptation and Validation of the Burnt Hand Outcome Tool (BHOT)
Hand Burn, Hand Injuries
RecruitingObservational study
Changes in Function of the Upper Limb With Physiotherapy
Burn of Upper Limb, Except Wrist and Hand
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.
Shaimaa MA El Sayeh study director
Lecturer at Faculty of Physical Therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shock wave therapy and traditional physical therapy in people with Hand Burn and Carpal Tunnel Syndrome, 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 5 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 17 Apr 2024. 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?
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?
Visual Analog Scale (time frame: Change from baseline at twelve weeks after the 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 17 Apr 2024.