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

NCT06574841 | Recruiting

• 1 other identifier: Blood Flow Restriction (BFR)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome, Blood Flow Restriction.

Outcome Measures

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.

  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.

  Baseline and after 6 weeks

Secondary Outcomes (2)

• Grip Strength

  Baseline and after 6 weeks

• Numerical pain rating scale

  Baseline and after 6 weeks

Study Arms (2)

Blood Flow Restriction Training

ACTIVE COMPARATOR

Blood flow restriction resistance exercise (BFR-RE) involves partially restricting arterial blood flow and fully restricting venous blood flow in the active limb during exercise, utilizing loads typically set at 20% to 30% of an individual's maximum repetition (1RM). It will conduct 3-5 sets until concentric failure is achieved, each set will contain 15-30 repetitions. Moreover, rest periods will range from 30 to 60 seconds and 3 sessions per week will be performed.

Other: Blood Flow Restriction training

Conventional Physical therapy

EXPERIMENTAL

It consists of the application of a neural custom volar orthotic device to be worn at night and during strenuous daytime activities. Moreover,exercises required patients to assume five different finger postures during tendon-gliding activities: Straight, Hook Fist, Duck Position, Straight Fist, and Full Fist. As well as, six different postures during nerve-gliding activites: Wrist positioned neutrally with flexed thumb and fingers, Wrist maintained neutrally with extended thumb and fingers, Extended wrist and fingers with the thumb in a neutral position, Extended wrist, fingers, and thumb, Extended wrist, fingers, and thumb with forearm supination, and Extended wrist, fingers, and thumb with forearm supination, accompanied by gentle stretching of the thumb by the therapist. All will be done 10rep x 5 sec hold, 3-5 times daily for 5 weeks.

Other: Blood Flow Restriction training

Interventions

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.

Also known as: Nerve and tendon-gliding exercises with a customized volar orthotic device

Blood Flow Restriction Training; Conventional Physical therapy

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed ElMelhat [aelmelhat]

Cairo, Egypt

RECRUITING

Related Publications (5)

• Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.

  PMID: 31156448 RESULT

• Wortman RJ, Brown SM, Savage-Elliott I, Finley ZJ, Mulcahey MK. Blood Flow Restriction Training for Athletes: A Systematic Review. Am J Sports Med. 2021 Jun;49(7):1938-1944. doi: 10.1177/0363546520964454. Epub 2020 Nov 16.

  PMID: 33196300 RESULT

• Hughes L, Patterson SD. The effect of blood flow restriction exercise on exercise-induced hypoalgesia and endogenous opioid and endocannabinoid mechanisms of pain modulation. J Appl Physiol (1985). 2020 Apr 1;128(4):914-924. doi: 10.1152/japplphysiol.00768.2019. Epub 2020 Feb 27.

  PMID: 32105522 RESULT

• Sasaki T, Makino K, Nimura A, Suzuki S, Kuroiwa T, Koyama T, Okawa A, Terada H, Fujita K. Assessment of grip-motion characteristics in carpal tunnel syndrome patients using a novel finger grip dynamometer system. J Orthop Surg Res. 2020 Jul 6;15(1):245. doi: 10.1186/s13018-020-01773-9.

  PMID: 32631378 RESULT

• Mendonca GV, Mouro M, Vila-Cha C, Pezarat-Correia P. Nerve conduction during acute blood-flow restriction with and without low-intensity exercise Nerve conduction and blood-flow restriction. Sci Rep. 2020 Apr 30;10(1):7380. doi: 10.1038/s41598-020-64379-5.

  PMID: 32355236 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Blood Flow Restriction Therapy

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Ahmed M El Melhat, Phd

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed M El Melhat, Phd

CONTACT

01112595022; ahmed.elmelhat@cu.edu.lb

Layal N Kohl, DPT

CONTACT

+961 76 554 707; layalkohl1998@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect of BFR on Pain perception,Grip Strength and Nerve conductivity in CTS patients

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: May 7, 2024
• Primary Completion: December 18, 2024
• Study Completion: January 27, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

EG (1)