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NCT Number: NCT06574841

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

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).

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Key information

Conditions

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

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • subjects who had carpal tunnel release surgery.
  • subjects with cervical disc prolapse.
  • subjects with cervical spondylosis.
  • subjects with thoracic outlet syndrome (TOS).
  • subjects with diabetes.
  • subjects with gestational diabetes.
  • subjects with cardiovascular disorders.
  • subjects with hypertension.
  • pregnant women.

Treatment and study plan

Blood Flow Restriction training

Other

BFR training done 3 sessions per week, each session includes low intensity of 20% to 30% of 1RM, 3 sets of 15 to 30 reps with a 30sec resting period done for 6 weeks.Moreover, nerve and tendon-gliding exercises consists of 10 reps with a 5-second hold, 3-5 times done daily for 5 weeks.

Other names: Nerve and tendon-gliding exercises with a customized volar orthotic device

Primary outcomes

  1. Electromyography to evaluate median nerve abnormalities specifically within the wrist, assessing their severity, and ruling out other conditions that may imitate carpal tunnel syndrome.

    Time frame: Baseline and after 6 weeks

    EMG activity for motor and sensory nerve conduction:

    • Electrode used for motor median nerve conduction positioned over the abductor pollicis brevis.
    • Electrode used for sensory median nerve conduction positioned 2cm distally for the thumb, the index, middle, and ring finger.

Secondary outcomes

  1. Grip Strength

    Time frame: 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.

  2. Numerical pain rating scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed M El Melhat, Phd

CONTACT

[email protected]

01112595022

Layal N Kohl, DPT

CONTACT

[email protected]

+961 76 554 707

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Blood Flow Restriction on Pain Perception, Grip Strength and Nerve Conductivity in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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