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

NCT ID: NCT06574841

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-07
• Study Completion Date: 2025-01-27

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).

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Blood Flow Restriction Training

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.

Group Type: ACTIVE_COMPARATOR

Blood Flow Restriction training

Intervention Type: 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.

Conventional Physical therapy

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.

Group Type: EXPERIMENTAL

Blood Flow Restriction training

Intervention Type: 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.

Interventions

Blood Flow Restriction training

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.

Intervention Type: OTHER

Other Intervention Names

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

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed ElMelhat

Effect of BFR on Pain perception,Grip Strength and Nerve conductivity in CTS patients

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M El Melhat, Phd

Role: STUDY_DIRECTOR

Cairo University

Locations

Ahmed ElMelhat [aelmelhat]

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed M El Melhat, Phd

Role: CONTACT

ahmed.elmelhat@cu.edu.lb

01112595022

Layal N Kohl, DPT

Role: CONTACT

layalkohl1998@gmail.com

+961 76 554 707

Facility Contacts

Ahmed A [Elmelhat], Phd

Role: primary

ahmed.elmelhat@cu.edu.eg

01112595022

Layal N Kohl, DPT

Role: backup

layalkohl1998@gmail.com

+961 76 554 707

References

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.

Reference Type: RESULT

PMID: 31156448 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33196300 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32105522 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32631378 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32355236 (View on PubMed)

Other Identifiers

Blood Flow Restriction (BFR)

Identifier Type: -

Identifier Source: org_study_id