Carpal Tunnel SyndromeNCT05904561
Effect of Low Level Laser Therapy Versus Pulsed Ultrasound
A study testing low level laser therapy in people with Carpal Tunnel Syndrome and POSTPARTUM CARPAL TUNNEL SYNDROME, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Carpal tunnel syndrome (CTs), the most common entrapment neuropathy of the upper extremity, is caused by compression of the median nerve as it travels through the carpal tunnel. CTs was clinically diagnosed in more than half of women (62%). Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Carpal Tunnel Syndrome, POSTPARTUM CARPAL TUNNEL SYNDROME
- What is being tested?
- low level laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 20 Aug 2023
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postpartum women with mild to moderate carpal tunnel syndrome will participate in this study.
- Their ages will range from 25 to 35 years old.
- Their BMI will be ranged from 25 to 30 Kg/m2.
- The electrophysiological evidence of mild or moderate median nerve lesion at wrist (mild: sensory nerve conduction velocity slow on finger/wrist measurement, sensory nerve latency >3.5 ms, normal terminal motor latency; moderate: sensory potential preserved with motor slowing, distal motor latency to abductor pollicis brevis (APB) < 6.5 ms) (Bland, 2000 and Dumitru and Zwarts, 2002).
- Positive phalen's test.
- Positive tinel's test.
- Unilateral or bilateral carpal tunnel affection will be included.
Who cannot join
- History of brachial plexopathy or malignancy.
- Radial, ulnar neuropathy, proximal median neuropathy or polyneuropathy.
- Previous wrist surgery or steroid injection for carpal tunnel syndrome.
- History of trauma, fracture, deformity or inflammation in the wrist, such as rheumatoid arthritis.
- Coagulation abnormalities, pregnancy, fever and infections.
- Skin disease and skin cancer.
- Spots, birthmarks or tattoos over the work points.
- Pacemaker and implementable medical devices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low Level Laser Therapy Versus Pulsed Ultrasound on Postpartum Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTs), the most common entrapment neuropathy of the upper extremity, is caused by compression of the median nerve as it travels through the carpal tunnel.
CTs was clinically diagnosed in more than half of women (62%). Neurophysiological evaluation diagnosed that CTs in around half of women (43%) was positive in one hand at least, also, it was reported that about half of women with CTs during pregnancy still complained of CTs symptoms one year after delivery.
Read the detailed description
Carpal tunnel syndrome pain and discomfort during postpartum period may interfere with the mother ability to successfully breastfeed due to increased physical load on the mother's hands and repetitive need for flexion during breastfeeding and carrying of the baby.
Observation of peripheral oedema in about 80% of pregnant women, especially in the period of third trimester is common, it is due to hormonal changes that cause reduction of venous return, fluid retention which decrease the carpal tunnel diameter and increase compression of the median nerve. Also, increase production of relaxin hormone leads to relaxation of the transverse carpal ligament and flattening of it that increase compression of the median nerve.
Symptoms of CTs differ from tingling, numbness and palmar side pain in radial 3.5 fingers. Typically, at night, patients are awakened by a numb hand. Complaints like decrease in hand strength, difficulty of holding things and dropping are common. Sensory distribution, median nerve hypoesthesia, positive provocative tests and atrophy or weakness of the thenar muscles may be shown in physical examination.
Nerve conduction study (NCS) has been showed as the gold standard in the diagnosis of CTs since it provides information about the physiological health of median nerve over the carpal tunnel. NCS measures sensory and motor nerve action potential which determines the severity of nerve entrapment.
Conservative treatment of CTs includes; local steroid injection, non-steroidal anti-inflammatory drugs, splinting, modification of activity, physical therapy modalities like ultrasound, low level laser therapy and stretching exercises.
Low level Laser therapy (LLLT) has analgesic and anti- inflammatory effect. Also, LLL improves the metabolic processes and increases protein synthesis that improves blood flow, blood vessel health and cell regeneration.
- Being tested
- low level laser therapy
- 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.
low level laser therapyRadiation
Also called pulsed ultrasound waves
comparing between the effect of low level laser therapy (LLLT) and pulsed ultrasound on post-partum carpal tunnel syndrome. All interventions that were pre-specified to be administered as part of the protocol, even if a particular intervention is not "of interest
| Study group | Role | What they receive |
|---|---|---|
| Group (A) (Study group A) | Active comparator | It will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive low level laser therapy, for 10 minutes, three times per week for 4 weeks (total of 12 sessions), in addition to wrist exercises and home advices. Receives: Radiation: low level laser therapy |
| Group (B) (study group B) | Experimental | It will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive pulsed ultrasound therapy, for 10 minutes, three times per week for 4 weeks (total of 12 sessions), in addition to wrist exercises and home advices Receives: Radiation: low level laser therapy |
| Group (C) (control): | Active comparator | It will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive wrist exercises (strengthening exercises for thenar muscles, wrist flexors. Extensors, grip strengthening, stretching, nerve glide, neurodynamic technique and tendon glide) for 15 minutes, three times per week for 4 weeks (total of 12 sessions) and home advices only. Receives: Radiation: low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
measure pain intensity for each woman in all groups (A, B and C). The VAS is usually presented as a 10-cm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." Its simplicity, reliability and validity, as well as its ratio scale properties make the VAS the optimal tool for describing pain intensity
Measured: From base line to 4 weeks from starting the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Apr 2023
- Primary completion1 Aug 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Afaf Mohammed, Assist.Prof., Study chair, Department of physical Therapy for Women's Health, Faculty of Physical Therapy Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904561
- Sponsor's protocol ID
- Mai Mahmoud Abdelmonem
- Status last verified
- Aug 2023
- First submitted
- 1 Jun 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Level Laser Therapy Versus Pulsed Ultrasound on Postpartum Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05904561
- Acronym / sponsor ID
- Mai Mahmoud Abdelmonem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 15 Jun 2023 (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.
Carpal tunnel syndrome (CTs), the most common entrapment neuropathy of the upper extremity, is caused by compression of the median nerve as it travels through the carpal tunnel.
CTs was clinically diagnosed in more than half of women (62%). Neurophysiological evaluation diagnosed that CTs in around half of women (43%) was positive in one hand at least, also, it was reported that about half of women with CTs during pregnancy still complained of CTs symptoms one year after delivery.
Detailed description
Carpal tunnel syndrome pain and discomfort during postpartum period may interfere with the mother ability to successfully breastfeed due to increased physical load on the mother's hands and repetitive need for flexion during breastfeeding and carrying of the baby.
Observation of peripheral oedema in about 80% of pregnant women, especially in the period of third trimester is common, it is due to hormonal changes that cause reduction of venous return, fluid retention which decrease the carpal tunnel diameter and increase compression of the median nerve. Also, increase production of relaxin hormone leads to relaxation of the transverse carpal ligament and flattening of it that increase compression of the median nerve.
Symptoms of CTs differ from tingling, numbness and palmar side pain in radial 3.5 fingers. Typically, at night, patients are awakened by a numb hand. Complaints like decrease in hand strength, difficulty of holding things and dropping are common. Sensory distribution, median nerve hypoesthesia, positive provocative tests and atrophy or weakness of the thenar muscles may be shown in physical examination.
Nerve conduction study (NCS) has been showed as the gold standard in the diagnosis of CTs since it provides information about the physiological health of median nerve over the carpal tunnel. NCS measures sensory and motor nerve action potential which determines the severity of nerve entrapment.
Conservative treatment of CTs includes; local steroid injection, non-steroidal anti-inflammatory drugs, splinting, modification of activity, physical therapy modalities like ultrasound, low level laser therapy and stretching exercises.
Low level Laser therapy (LLLT) has analgesic and anti- inflammatory effect. Also, LLL improves the metabolic processes and increases protein synthesis that improves blood flow, blood vessel health and cell regeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (A) (Study group A) | Active comparator | Radiation: low level laser therapyIt will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive low level laser therapy, for 10 minutes, three times per week for 4 weeks (total of 12 sessions), in addition to wrist exercises and home advices. |
| Group (B) (study group B) | Experimental | Radiation: low level laser therapyIt will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive pulsed ultrasound therapy, for 10 minutes, three times per week for 4 weeks (total of 12 sessions), in addition to wrist exercises and home advices |
| Group (C) (control): | Active comparator | Radiation: low level laser therapyIt will be consisted of 16 women complaining from mild to moderate Carpel Tunnel Syndrome after 6 weeks from delivery diagnosed by electrophysiological study. They will receive wrist exercises (strengthening exercises for thenar muscles, wrist flexors. Extensors, grip strengthening, stretching, nerve glide, neurodynamic technique and tendon glide) for 15 minutes, three times per week for 4 weeks (total of 12 sessions) and home advices only. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Postpartum women with mild to moderate carpal tunnel syndrome will participate in this study.
- Their ages will range from 25 to 35 years old.
- Their BMI will be ranged from 25 to 30 Kg/m2.
- The electrophysiological evidence of mild or moderate median nerve lesion at wrist (mild: sensory nerve conduction velocity slow on finger/wrist measurement, sensory nerve latency >3.5 ms, normal terminal motor latency; moderate: sensory potential preserved with motor slowing, distal motor latency to abductor pollicis brevis (APB) < 6.5 ms) (Bland, 2000 and Dumitru and Zwarts, 2002).
- Positive phalen's test.
Key exclusion criteria (8 listed)
- History of brachial plexopathy or malignancy.
- Radial, ulnar neuropathy, proximal median neuropathy or polyneuropathy.
- Previous wrist surgery or steroid injection for carpal tunnel syndrome.
- History of trauma, fracture, deformity or inflammation in the wrist, such as rheumatoid arthritis.
- Coagulation abnormalities, pregnancy, fever and infections.
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 |
|---|---|---|
| low level laser therapyAlso: pulsed ultrasound wavescomparing between the effect of low level laser therapy (LLLT) and pulsed ultrasound on post-partum carpal tunnel syndrome. All interventions that were pre-specified to be administered as part of the protocol, even if a particular intervention is not "of interest | Radiation | Group (A) (Study group A), Group (B) (study group B), Group (C) (control): |
Primary outcome
Pain Intensity
Time frame: From base line to 4 weeks from starting the treatment
measure pain intensity for each woman in all groups (A, B and C). The VAS is usually presented as a 10-cm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." Its simplicity, reliability and validity, as well as its ratio scale properties make the VAS the optimal tool for describing pain intensity
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 25 Aug 2023.
- Individual participant dataSharing planned: Undecided
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.
Afaf Mohammed, Assist.Prof. study chair
Department of physical Therapy for Women's Health, Faculty of Physical Therapy 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 low level laser therapy in people with Carpal Tunnel Syndrome and POSTPARTUM CARPAL TUNNEL SYNDROME, run by Egymedicalpedia 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 7 inclusion and 8 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 25 Aug 2023. 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?
Pain Intensity (time frame: From base line to 4 weeks from starting the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2023.