Using shock wave therapy to treat carpal tunnel syndrome in women with lymphedema after mastectomy

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

This study is testing if shock wave therapy combined with physical therapy can help women with lymphedema after mastectomy who also have carpal tunnel syndrome feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 40 Years to 60 Years
• Sex: Female
• Sponsor: Cairo University (Academic / other)
• Locations: 2 sites (Cairo and 1 other locations)
• Trial ID: NCT06131515 on ClinicalTrials.gov

What this trial studies

This study involves 68 female patients aged 40 to 60 who experience carpal tunnel syndrome symptoms and have upper extremity lymphedema following mastectomy. Participants will be randomly divided into two groups: one receiving extracorporeal shock wave therapy combined with physical therapy exercises, and the other receiving a sham treatment with the same physical therapy regimen. The treatment duration is set for four weeks, with weekly sessions of shock wave therapy and bi-weekly physical therapy exercises. Informed consent will be obtained from all participants, ensuring their rights are protected throughout the study.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 40-60 with carpal tunnel syndrome symptoms lasting at least three months and unilateral or bilateral lymphedema following mastectomy.

Not a fit: Patients who do not have carpal tunnel syndrome or those with other underlying conditions affecting their hands may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate symptoms of carpal tunnel syndrome in women suffering from lymphedema after mastectomy.

How similar studies have performed: While there is limited data on the specific combination of treatments used in this study, similar approaches have shown promise in managing carpal tunnel syndrome.

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.

Where this trial is running

Cairo and 1 other locations

• Khadra Mohamed Ali — Cairo, Egypt (Recruiting)
• Shahira Sami — Cairo, Egypt (Recruiting)

Study contacts

• Principal investigator: shahira sami — Cairo University
• Study coordinator: shahira sami, A.lecturer

Conditions Carpal Tunnel Syndrome