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

"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.

Study Overview

• Status: Active, not recruiting
• Conditions: Carpal Tunnel Syndrome; Hand Burn
• Intervention / Treatment: Device: shock wave therapy; Other: traditional physical therapy

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • New Cairo
    • Cairo, New Cairo, Egypt, 02
      • Shaimaa Mohamed Ahmed El Sayeh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Shaimaa MA El Sayeh, Lecturer at faculty of physical therapy, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): June 28, 2024

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Carpal Tunnel Syndrome; Shock wave therapy; Pillar pain; Hand Burn
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Burns; Carpal Tunnel Syndrome
• Other Study ID Numbers: P.T.REC/012/004646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No