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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06371885
• Other study ID #: P.T.REC/012/004646
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: June 28, 2024

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: June 28, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns
• Carpal Tunnel Syndrome
• Hand Burn

Intervention

Device:
• 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

Other:
• 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

Locations

Country	Name	City	State
Egypt	Shaimaa Mohamed Ahmed El Sayeh	Cairo	New Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Change from baseline at twelve weeks after the intervention
Primary	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.	Change from baseline at twelve weeks after the intervention
Secondary	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.	Change from baseline at twelve weeks after the intervention