Efficacy of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome Post Mastectomy Lymphedema

Sixty eight female patients who had symptoms of carpal tunnel syndromesuch as wrist pain or numbness and paraesthesia and had lymphedema of an upper extremity.Their ages will be ranged from 40 to 60 years. The participants will be selected from Out Patient clinic of Faculty of Physical Therapy, Cairo University and randomly distributed into two equal groups.Duration of treatment for 4weeks.All subjects signed an informed consent form, and the rights of subjects were protected.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: extra corporeal shock wave therapy device

Detailed Description

In this study the patients will be randomly assigned into two equal groups(34 patients for each group)Group A (experimental group):This group includes 34female patients who will receive extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide skin care and manual lymph drainage 2 sessions per week for 4 weeks. Group B (control group):

This group includes 34female patients who will receive shame extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide exercises, skin care and manual lymph drainage 2 sessions per week for 4 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: shahira sami, A.lecturer; Phone Number: 01021986609; Email: shahirasami6@cu.edu.eg
• Study Contact Backup: Name: shahira sami; Phone Number: 01021986609; Email: shahirasami6@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Khadra Mohamed Ali
    • Contact: shahira sami, A.lecturer; Phone Number: 01021986609; Email: shahirasami6@cu.edu.eg
    • Contact: khadra mohamed ali, A.professor; Phone Number: 01098431152
    • Principal Investigator: shahira sami, A.lecturer
  • Cairo, Egypt
    • Recruiting
    • Shahira Sami
    • Contact: shahira sami, A.lecturer; Phone Number: 01021986609; Email: shahirasami6@cu.edu.eg
    • Contact: khadra mohamed ali, A.professor; Phone Number: 01098431152
    • Sub-Investigator: khadra mohamed ali, A.professor

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

All participants could be considered and enrolled if they conformed to the diagnosis of CTS, with clinical symptoms for at least 3 months.

The clinical symptoms and signs for the diagnosis of CTS were as follows:

1. Paresthesias and painful swelling with weakness of the affected hand, exacerbated while sleeping or by repetitive use of the wrist, which would be relieved by shaking the hand with postural change.
2. Sensory loss with numbness in the regions of the hand innervated by the median nerve;
3. Impaired motor function with atrophy of the median nerve-innervated thenar muscles.
4. Positive Tinel's sign.

The subject selection will be according to the following criteria:

• Female patient their age range between 40-60 years.
• Symptoms of CTS as pain, tingling sensation for at least 3 months.
• Unilateral or bilateral Lymphedema following mastectomy
• All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

• The potential participants will be excluded if they meet one of the following criteria:
• Local infections at the hand level.
• Patients with prior medical histories of cardiac arrhythmias.
• Patient with venous thrombosis.
• Areas of skin with lesions and impaired sensation
• Other diseases that cause significant swelling.
• During pregnancy and breastfeeding.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (experimental group); This group includes 34female patients who will receive extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide skin care and manual lymph drainage 2 sessions per week for 4 weeks.	Device: extra corporeal shock wave therapy device; Patients were seated in a relaxed position with their forearm and finger placed on the table. The median nerve was identified at the pisiform level of the proximal carpal tunnel, with the palm facing upwards. rESWT was delivered with the Physio Shock Wave Therapy system .The rESWT probe was located and oriented perpendicularly on the median nerve, and treatment comprised graduated shots at a bar pressure of 4 and a pulse repetition frequency of 5Hz for each patient ( The treated area was parallel to the median nerve from the pisiform level to 2 cm proximal to the inlet of the carpal tunnel with equal diffusion of 800, 900, 1000, 1100 shots from first to fourth session respectively. The procedure was painless, and there was no need for additional anesthesia or analgesia. In the control group, sham rESWT just made the same sound without energy emission
Experimental: Group B (control group); This group includes 34female patients who will receive shame extra corporeal shock wave therapy one session per week for 4 weeks in addition to physical therapy exercises (including carpal bone mobilization, nerve glide exercises, skin care and manual lymph drainage 2 sessions per week for 4 weeks.	Device: extra corporeal shock wave therapy device; Patients were seated in a relaxed position with their forearm and finger placed on the table. The median nerve was identified at the pisiform level of the proximal carpal tunnel, with the palm facing upwards. rESWT was delivered with the Physio Shock Wave Therapy system .The rESWT probe was located and oriented perpendicularly on the median nerve, and treatment comprised graduated shots at a bar pressure of 4 and a pulse repetition frequency of 5Hz for each patient ( The treated area was parallel to the median nerve from the pisiform level to 2 cm proximal to the inlet of the carpal tunnel with equal diffusion of 800, 900, 1000, 1100 shots from first to fourth session respectively. The procedure was painless, and there was no need for additional anesthesia or analgesia. In the control group, sham rESWT just made the same sound without energy emission

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nerve conduction studies	For assessing the motor response, the recorder electrode on abductor pollicis brevis muscle and median nerve was stimulated at wrist region with stimulator electrode, 8 cm proximal to the active electrode , and the distal latency was recorded. Regarding the sensory response, the recorder was fastened on the third finger, and stimulator electrode was placed 14 cm proximal to the recorder and stimulated median nerve at wrist and at palm region, then distal latency was recorded. If only the SNAP distal latency was long, patient had mild CTS, but if both SNAP and CMAP distal latency were long and denervation was not observed in electromyography of APB, it was moderate CTS	4weeks
Limb volume	Upper limb volumes were calculated from circumference measurements taken at 5cm intervals from the dorsum of the wrist to the axilla. Volume was calculated from circumference using the established formula	4weeks
Visual analogue scale (VAS)	The VAS uses a straight 10-centimeter line with one end being 'no pain' and on the other end the 'worst imaginable pain'. The patient chooses a spot on the line then places a perpendicular line to indicate their pain level within the last 24 hours.	4weeks
Boston Carpal Tunnel Questionnaire (BCTQ)	The BCTQ is used to evaluate symptom severity and dysfunction in patients with CTS .It contains 2 measurement scales: a symptom severity scale (BCTQ-S) and a functional status scale (BCTQ-F). The BCTQ-S uses 11 questions to evaluate the intensity and frequency of pain, numbness, weakness and loss of dexterity on a five-point scale ranging from 1 (no symptoms) to 5 (severe symptoms). The results are interpreted as the average scores of the 11 questions. The BCTQ-F has 8 questions to evaluate the level of difficulty in performing daily tasks, each rated on a five-point scale ranging from 1 (no difficulty) to 5 (cannot do at all due to hand or wrist symptoms). The results are interpreted as the average scores of the 8 questions	4weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: shahira sami, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Lymphatic Diseases; Postoperative Complications; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Lymphedema; Carpal Tunnel Syndrome; Breast Cancer Lymphedema
• Other Study ID Numbers: 1582017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: after 6months we will share the study protocol and informed consent.
• IPD Sharing Time Frame: after 6 months of study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

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