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Trial Title:
Efficacy of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome Post Mastectomy Lymphedema
NCT ID:
NCT06131515
Condition:
Carpal Tunnel Syndrome
Conditions: Official terms:
Carpal Tunnel Syndrome
Lymphedema
Breast Cancer Lymphedema
Syndrome
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Device
Intervention name:
extra corporeal shock wave therapy device
Description:
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
Arm group label:
Group A (experimental group)
Arm group label:
Group B (control group)
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.
Criteria for 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.
Gender:
Female
Minimum age:
40 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Khadra Mohamed Ali
Address:
City:
Cairo
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
shahira sami, A.lecturer
Phone:
01021986609
Email:
shahirasami6@cu.edu.eg
Contact backup:
Last name:
khadra mohamed ali, A.professor
Phone:
01098431152
Investigator:
Last name:
shahira sami, A.lecturer
Email:
Principal Investigator
Facility:
Name:
Shahira Sami
Address:
City:
Cairo
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
shahira sami, A.lecturer
Phone:
01021986609
Email:
shahirasami6@cu.edu.eg
Contact backup:
Last name:
khadra mohamed ali, A.professor
Phone:
01098431152
Investigator:
Last name:
khadra mohamed ali, A.professor
Email:
Sub-Investigator
Start date:
November 2023
Completion date:
December 2023
Lead sponsor:
Agency:
Cairo University
Agency class:
Other
Source:
Cairo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06131515
