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

NCT06131515 | Unknown DMC

• 1 other identifier: 1582017
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group A (experimental group)

EXPERIMENTAL

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

Group B (control group)

EXPERIMENTAL

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

Interventions

extra corporeal shock wave therapy device 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 A (experimental group); Group B (control group)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.
• Sensory loss with numbness in the regions of the hand innervated by the median nerve;
• Impaired motor function with atrophy of the median nerve-innervated thenar muscles.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Khadra Mohamed Ali

Cairo, Egypt

RECRUITING

Shahira Sami

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• shahira sami

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shahira sami, A.lecturer

CONTACT

01021986609; shahirasami6@cu.edu.eg

shahira sami

CONTACT

01021986609; shahirasami6@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: November 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: after 6 months of study

Locations

EG (2)