Clinical trial NCT06131515: Efficacy of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome Post Mastectomy Lymphedema
Official title: Efficacy of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome Post Mastectomy Lymphedema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 68
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Nerve conduction studies
timeFrame: 4weeks
measure: Limb volume
timeFrame: 4weeks
measure: Visual analogue scale (VAS)
timeFrame: 4weeks
measure: Boston Carpal Tunnel Questionnaire (BCTQ)
timeFrame: 4weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Khadra Mohamed Ali
city: Cairo
country: Egypt
facility: Shahira Sami
Study officials:
affiliation: Cairo University
name: shahira sami
role: PRINCIPAL_INVESTIGATOR
References: