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

NCT ID: NCT06131515

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2023-12-31

Brief Summary

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.

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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 Type: EXPERIMENTAL

extra corporeal shock wave therapy device

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

extra corporeal shock wave therapy device

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Shahira Sami

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

shahira sami

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Khadra Mohamed Ali

Cairo, , Egypt

Site Status: RECRUITING

Shahira Sami

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

shahira sami, A.lecturer

Role: CONTACT

shahirasami6@cu.edu.eg

01021986609

shahira sami

Role: CONTACT

shahirasami6@cu.edu.eg

01021986609

Facility Contacts

shahira sami, A.lecturer

Role: primary

shahirasami6@cu.edu.eg

01021986609

khadra mohamed ali, A.professor

Role: backup

01098431152

shahira sami, A.lecturer

Role: primary

shahirasami6@cu.edu.eg

01021986609

khadra mohamed ali, A.professor

Role: backup

01098431152

Other Identifiers

1582017

Identifier Type: -

Identifier Source: org_study_id