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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Baseline and after 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Grip Strength | 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. | Baseline and after 6 weeks |
| Numerical pain rating scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed M El Melhat, Phd | Contact | 01112595022 | ahmed.elmelhat@cu.edu.lb | |
| Layal N Kohl, DPT | Contact | +961 76 554 707 | layalkohl1998@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed M El Melhat, Phd | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmed ElMelhat [aelmelhat] | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31156448 | Result | 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. | |
| 33196300 |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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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. |
| Baseline and after 6 weeks |
| 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. |
| 32105522 | 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. |
| 32631378 | 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. |
| 32355236 | 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. |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |