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

NCT06371885 | Active Not Recruiting

• 1 other identifier: P.T.REC/012/004646
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Burn; Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; Hand Burn; Pillar pain; Shock wave therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Michigan hand out Comes questionnaire

  Change from baseline at twelve weeks after the intervention

Study Arms (2)

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.

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

Other: traditional physical therapy

Interventions

shock wave therapy 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

Shock wave therapy group

traditional physical therapy 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; Shock wave therapy group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Shaimaa Mohamed Ahmed El Sayeh

Cairo, New Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Shaimaa MA El Sayeh

  Lecturer at Faculty of Physical Therapy, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double mask for both groups (participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy

Model Details: Interventional (clinical trial)

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 17, 2024
• Study Start: August 10, 2023
• Primary Completion: May 30, 2024
• Study Completion: June 28, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)