Ultra Phonophoresis With a Hyaluronic Acid-Containing Gel on Carpal Tunnel Syndrome Post Mastectomy.

NCT06538818 | Completed DMC

• 1 other identifier: P.T.REC/012/005219
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, 60 patients will be randomly assigned into two equal groups (30 patients for each group):

• Age range between 40-55 years.
• Female patients will participate in the study.
• All patients will have hormonal therapy at least for 6 weeks.
• All patients enrolled to the study will have their informed consent.
• Patient referred from physician by carpal tunnel syndrome. (B) Exclusion Criteria: The potential participants will be excluded if they meet one of the following criteria:
• Marked lymphedema.
• Steroid injection for CTS.
• Thrombosis propensity.
• Cervical radiculopathy.
• Brachial plexopathy

Conditions

Mastectomy; Carpal Tunnel Syndrome (CTS)

Outcome Measures

Primary Outcomes (4)

• Median nerve sensory and motor distal latency

  For assessing the Motor distal latency, the active recording electrode will be fastened on abductor pollicis brevis (APB) muscle and median nerve will be stimulated at wrist region with stimulator electrode, 8 cm proximal to the active electrode and then the distal latency will be recorded. Regarding the sensory distal latency, the recorder will be fastened on the third finger, and stimulator electrode will be placed 14 cm proximal to the recorder and will stimulate median nerve once at wrist and once at palm region, then distal latency will be recorded. Normal distal sensory latency of median nerve is of less than 3.6 and distal motor latency of median nerve less than 4.2. If only the sensory distal latency will long, patient has mild CTS, but if both sensory and motor distal latency will be long and denervation will not be observed in electromyography of APB, it is moderate CTS.

  3 weeks

• pain using a visual analogue scale (VAS)

  Intensity of pain is another outcome measure will be used to evaluate treatment. Adults use the visual analogue scale (VAS), a one-dimensional assessment tool, particularly for chronic pain. The VAS is a continuous scale that consists of a line that is either vertical (VVAS) or horizontal (HVAS), usually 10 cm long, and is supported by two verbal descriptors, one for each symptom intensity. The patients will be thoroughly briefed on the instructions, reporting timeline, and vocal description anchors prior to the measurement.

  3 weeks

• Baseline hydraulic hand dynamometer is used to measure hand grip strength

  . It is manufactured and serviced in the USA since 1978. It gives accurate grip strength readings without the subject being able to feel the handle move. The internationally accepted design ensures reliability, user convenience and measurement repeatability. Maximum reading remains until the unit is reset. The device comes with five position handles to improve comfort while using the dynamometer. The device Gauge is made of bourdon tube element with spring suspended movement that can viewed as pounds or kilograms.

  3 weeks

• Boston Carpal Tunnel Questionnaire (BCTQ):

  Patients with CTS can assess their level of dysfunction and symptom severity using the BCTQ .It has two measurement scales: the BCTQ-F, which measures functional status, and the BCTQ-S, which measures symptom severity. The BCTQ-S employs eleven questions on a five-point rating system from 1 (no symptoms) to 5 (severe symptoms) to assess the frequency and intensity of pain, numbness, weakness, and loss of dexterity. The average scores of the 11 questions are used to analyze the results. The BCTQ-F has eight questions that are scored on a five-point scale from 1 (no trouble) to 5 (cannot do at all owing to hand or wrist symptoms) to assess the degree of difficulty in carrying out daily chores. The average scores of the eight questions are used to analyze the results.

  3 weeks

Study Arms (2)

Study group

EXPERIMENTAL

This group will include 30 patients who will receive Ultra Phonophoresis with a hyaluronic acid-containing gel 5 sessions per week for 3 weeks in addition to their physical therapy program and medical treatment.

Device: Ultra Phonophoresis

Control group:

NO INTERVENTION

This group will include 30 patients who will receive only their traditional physical therapy program and medical treatment.

Interventions

Ultra Phonophoresis DEVICE

Therapeutic pulsed ultrasound using Phyaction UbMF ultrasound device in presence of a hyaluronic acid-containing gel will be applied gel pad over the wrist and along the course of median nerve at the carpal tunnel. The following parameters will be used: intensity of 1.0 W/em2 at a 1MHz frequency for 5 minutes and pulsed (25%) ultrasound waves to transfer the hyaluronic acid-containing gel. This therapy will be applied for 5 min/session, 5 d/wk, for 3 weeks. The following parameters will be used: * intensity of 1.0 W/cm2 * 1MHz frequency * pulsed (25%) * 5 min/session, 5 d/wk, for 3 weeks.

Study group

Eligibility Criteria

• Age: 40 Years - 55 Years
• Gender Eligibility Details: * All patients will have hormonal therapy at least for 6 weeks. * Patient referred from physician by carpal tunnel syndrome post mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age range between 40-55 years.
• Female patients will participate in the study.
• All patients will have hormonal therapy at least for 6 weeks.
• All patients enrolled to the study will have their informed consent.
• Patient referred from physician by carpal tunnel syndrome

You may not qualify if:

• Marked lymphedema.
• Steroid injection for CTS.
• Thrombosis propensity.
• Cervical radiculopathy.
• Brachial plexopathy

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy of surgery

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: September 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)