Effect of Blood Flow Restriction on Pain Perception, Grip Strength and Nerve Conductivity in CTS Patients.

Not Applicable

Recruiting

• Conditions: Carpal Tunnel Syndrome

• Registration Number: NCT06574841
• Lead Sponsor: Cairo University

Brief Summary

The goal of this clinical trial is to investigate the effect of blood flow restriction (BFR) on pain perception, grip strength and nerve conductivity in patients suffering from carpal tunnel syndrome (CTS). The main question it aims to answer is:

Does performing blood flow restriction training decrease pain, improve grip strength and does not alter nerve conduction velocity in patients with (CTS)? The participants will be divided into two groups to be compared: Patients in the control group will receive the conventional physical therapy program only. In contrast, participants in the experimental group will receive blood flow restriction (BFR) training in addition to a conventional physical therapy program (which includes an orthotic device, tendon, and nerve-gliding exercises).

Detailed Description

Blood flow restriction (BFR) entails a training technique that partially limits arterial blood flow and completely restricts venous blood outflow within the active musculature during physical activity (Patterson SD, Hughes L, Warmington S, et al.). This method is thought to have begun in the 1970s through Dr. Yoshiaki Soto's Kaatsu resistance training. By restricting the outflow of blood from the limb, the resulting lack of oxygen creates conditions that stimulate muscle growth through cellular signaling and hormonal changes, resembling the effects of higher-intensity training with increased resistance (Wortman RJ, Brown SM, Savage-Elliott I, Finley ZJ, Mulcahey MK). Emerging studies indicate that Exercise-induced hypoalgesia (EIH) delineates a transient decrease in pain sensitivity subsequent to physical activity (Hughes, L., \& Patterson, S. D. (2020)). Moreover, research indicates that individuals diagnosed with carpal tunnel syndrome (CTS) typically exhibit reduced grip strength (Sasaki T, Makino K, Nimura A, et al). Furthermore, acute application of submaximal blood flow restriction (BFR) for approximately \~ 5 minutes does not influence the magnitude or timing of H wave responses (Mendonca, G.V., et al).

Thus, the investigators hypothesized that performing blood flow restriction training will decrease pain, improve grip strength and does not alter the nerve conduction velocity in patients with carpal tunnel syndrome (CTS).

Study Timeline

• Study Start: 2024-05-07
• Status Verified: 2024-08
• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28
• Primary Completion: 2024-12-18
• Study Completion: 2025-01-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. patients diagnosed by a physician according to the American Academy of Orthopedic Surgeon with carpal tunnel syndrome (CTS).
2. age:30-55 years old.
3. females.
4. positive clinical provocative tests for CTS (Tinel test and Phalen test).
5. subjects with a history of paresthesia, numbness, or pain in the median nerve distribution, night waking, and nocturnal pain.

Exclusion Criteria

1. subjects who had carpal tunnel release surgery.
2. subjects with cervical disc prolapse.
3. subjects with cervical spondylosis.
4. subjects with thoracic outlet syndrome (TOS).
5. subjects with diabetes.
6. subjects with gestational diabetes.
7. subjects with cardiovascular disorders.
8. subjects with hypertension.
9. pregnant women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Electromyography to evaluate median nerve abnormalities specifically within the wrist, assessing their severity, and ruling out other conditions that may imitate carpal tunnel syndrome.	Baseline and after 6 weeks	EMG activity for motor and sensory nerve conduction: 1. Electrode used for motor median nerve conduction positioned over the abductor pollicis brevis.; 2. Electrode used for sensory median nerve conduction positioned 2cm distally for the thumb, the index, middle, and ring finger.

Secondary Outcome Measures

Name	Time	Method
Grip Strength	Baseline and after 6 weeks	The JAMAR Hydraulic Hand Dynamometer, frequently utilized in research investigations, holds a powerful validation and is esteemed as the gold standard against which the efficacy of other devices is measured.
Numerical pain rating scale	Baseline and after 6 weeks	The numeric rating scale (NRS) is a widely utilized pain screening tool for assessing the severity of pain at a given moment, utilizing a scale from 0 to 10. Zero denotes the absence of pain, while 10 signifies the highest imaginable pain intensity.

Trial Locations

Locations (1)

Ahmed ElMelhat [aelmelhat]; 🇪🇬 Cairo, Egypt