Carpal Tunnel SyndromeNCT06574841
Effect of Blood Flow Restriction on Pain Perception, Grip Strength and Nerve Conductivity in CTS Patients.
A study testing Blood Flow Restriction training in people with Carpal Tunnel Syndrome and Blood Flow Restriction (BFR) Training Effects, run by Ahmed ElMelhat at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Carpal Tunnel Syndrome, Blood Flow Restriction (BFR) Training Effects
- What is being tested?
- Blood Flow Restriction training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- subjects with cardiovascular disorders.
- subjects with hypertension.
- pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Blood Flow Restriction on Pain Perception, Grip Strength and Nerve Conductivity in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial.
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).
Read the 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. 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. Emerging studies indicate that Exercise-induced hypoalgesia (EIH) delineates a transient decrease in pain sensitivity subsequent to physical activity. Moreover, research indicates that individuals diagnosed with carpal tunnel syndrome (CTS) typically exhibit reduced grip strength Furthermore, acute application of submaximal blood flow restriction (BFR) for approximately 5 minutes does not influence the magnitude or timing of H wave responses.
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).
- Being tested
- Blood Flow Restriction training
- Keywords
- Carpal Tunnel Syndrome, Blood Flow Restriction.
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction trainingOther
Also called Nerve and tendon-gliding exercises with a customized volar orthotic device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Blood Flow Restriction training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: Baseline and after 6 weeks
Secondary outcomes (2)
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.
Measured: Baseline and after 6 weeks
Numerical pain rating scale
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.
Measured: Baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Oct 2024
- Primary completion18 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed ElMelhat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed ElMelhat, Cairo University
- Investigators
- Ahmed M El Melhat, Phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574841
- Sponsor's protocol ID
- Blood Flow Restriction (BFR)
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31156448Wortman 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.
PubMed 33196300Hughes 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.
PubMed 32105522Sasaki 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.
PubMed 32631378Mendonca 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.
PubMed 32355236
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blood Flow Restriction on Pain Perception, Grip Strength and Nerve Conductivity in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06574841
- Acronym / sponsor ID
- Blood Flow Restriction (BFR)
- Keywords
- Carpal Tunnel Syndrome, Blood Flow Restriction.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ahmed ElMelhatUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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. Emerging studies indicate that Exercise-induced hypoalgesia (EIH) delineates a transient decrease in pain sensitivity subsequent to physical activity. Moreover, research indicates that individuals diagnosed with carpal tunnel syndrome (CTS) typically exhibit reduced grip strength Furthermore, acute application of submaximal blood flow restriction (BFR) for approximately 5 minutes does not influence the magnitude or timing of H wave responses.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction Training | Active comparator | Other: Blood Flow Restriction trainingBlood 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. |
| Conventional Physical therapy | Experimental | Other: Blood Flow Restriction trainingIt 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. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction trainingAlso: Nerve and tendon-gliding exercises with a customized volar orthotic deviceBFR 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 | Blood Flow Restriction Training, Conventional Physical therapy |
Primary outcome
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: 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.
2 secondary outcomes
Grip Strength
Time frame: Baseline and after 6 weeks
Numerical pain rating scale
Time frame: Baseline and after 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Results publication: PubMed 31156448Patterson 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.
- Results publication: PubMed 33196300Wortman 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.
- Results publication: PubMed 32105522Hughes 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.
- Results publication: PubMed 32631378Sasaki 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.
- Results publication: PubMed 32355236Mendonca 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.
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M El Melhat, Phd study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction training in people with Carpal Tunnel Syndrome and Blood Flow Restriction (BFR) Training Effects, run by Ahmed ElMelhat at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06574841, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.