Shock Wave on Pillar Pain After Carpal Tunnel Release in Hand Burn

NCT ID: NCT06371885

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2024-06-28

Brief 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. 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.

Conditions

Hand Burn; Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 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.

Group Type: ACTIVE_COMPARATOR

shock wave therapy

Intervention Type: DEVICE

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 therapy

Intervention Type: OTHER

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

Control group

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

Group Type: ACTIVE_COMPARATOR

traditional physical therapy

Intervention Type: OTHER

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

Interventions

shock wave therapy

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

Intervention Type: DEVICE

traditional physical therapy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Shaimaa Mohamed Ahmed Elsayeh

Lecturer of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaimaa MA El Sayeh

Role: STUDY_DIRECTOR

Lecturer at Faculty of Physical Therapy, Cairo University

Locations

Shaimaa Mohamed Ahmed El Sayeh

Cairo, New Cairo, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004646

Identifier Type: -

Identifier Source: org_study_id