Carpal Tunnel SyndromeNCT04949373
High Intensity Laser Therapy in Carpal Tunnel Syndrome
A study testing High-intensity laser therapy (HILT) in people with Carpal Tunnel Syndrome and Entrapment Neuropathy, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This research aims to investigate the effect of high-intensity laser therapy on pain, function, nerve conduction studies and grip strength in patients with idiopathic carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Entrapment Neuropathy, Median Neuropathy
- What is being tested?
- High-intensity laser therapy (HILT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 15 Nov 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild or moderate idiopathic carpal tunnel syndrome (clinically diagnosed and electrophysiologically confirmed CTS)
Who cannot join
- Diabetes mellitus,hypothyroidism, rheumatic diseases, acromegaly
- Polyneuropathy,
- Ipsilateral brachial plexopathy and traumatic nerve injury of the upper extremity
- Previous injection into the carpal tunnel and physical therapy within in the preceding 6 months
- Pregnancy
- History of malignancy
- Patients with cochlear implants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University
Center, Afyonkarahi̇sar, 03200
About this study
Official title: Evaluation of the Efficacy of High Intensity Laser (HILT) Therapy in Idiopathic Carpal Tunnel Syndrome
This research aims to investigate the effect of high-intensity laser therapy on pain, function, nerve conduction studies and grip strength in patients with idiopathic carpal tunnel syndrome.
Read the detailed description
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy, and it causes numbness and tingling in the hand, atrophy and muscle weakness in the later stages. Any condition that increases the volume of the carpal tunnel and narrows the diameter of the tunnel may increase the compression of the median nerve under the transverse carpal ligament and cause symptoms. In majority of cases, no cause can be found and it is called "idiopathic".
While the diagnosis of CTS is made by the patient's history and physical examination methods, the diagnosis is confirmed with use of electrophysiological examination. Physical therapy, non-steroidal anti-inflammatory drug use, local steroid injection, hand-wrist rest splint, nerve/tendon gliding exercises; Physiotherapy modalities such as therapeutic ultrasound and laser are among the conservative treatment methods of CTS. Despite the effectiveness of surgery in the treatment of severe CTS cases, as is known, surgical treatment is not without risk. Therefore, mild to moderate CTS is treated conservatively.
Laser therapy is one of the physical therapy modalities, low-intensity laser therapy (LILT), whose biological effects occur secondary to direct photochemical effect and are not the result of thermal effects. High-intensity laser therapy (HILT), which has been widely used recently, is frequently used since it has small and slow light absorption from chromophores. HILT is not a concentrated light, but it diffuses in all directions (scattering phenomenon). This supports the wider effectiveness of HILT. HILT also has effects such as increased mitochondrial oxidative reactions, increased production of adenosine triphosphate, RNA and DNA (photochemical effect), increased tissue stimulation (photobiological), and reduced pain and inflammation. HILT, which has recently found many uses in musculoskeletal diseases, can affect a wider and deeper area in the tissues compared to the widely used LILT. Although there are many studies on the effectiveness of LILT therapy in CTS, there are few trials to study the effectiveness of HILT on clinical and electrophysiological parameters in CTS.
This investigation is designed as double-blind prospective sham controlled randomized study.
Participants were randomized into 2 groups: 1) HILT + nerve/tendon gliding exercises + rest splint and 2) Sham HILT+ nerve/tendon gliding exercises + rest splint
- Conditions
- Carpal Tunnel Syndrome, Entrapment Neuropathy, Median Neuropathy, Musculoskeletal Diseases
- Being tested
- High-intensity laser therapy (HILT), Sham High-intensity laser therapy (sham HILT)
- Keywords
- Carpal Tunnel Syndrome, Median Neuropathy, High intensity laser therapy, Nerve conduction studies, Hand function
- Medical subject headings
- Carpal Tunnel Syndrome, Charcot-Marie-Tooth Disease, Median Neuropathy, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity laser therapy (HILT)Device
High intensity laser therapy-Patients will receive pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of three weeks, and one session per day for a total of 15 sessions. A 3-phase treatment program will be performed on each session.
Other: Tendon and nerve gliding exercises will be performed three times a day with 10 repetitions each time for 3 weeks. Exercises will be performed by a trained physiotherapist.
Other: Rest splint(at night) Participants will be splinted in neutral position with standard cotton-polyester splints.The patients will be encouraged to use the splints during nighttime for 12 weeks.
Sham High-intensity laser therapy (sham HILT)Device
Sham high intensity laser therapy-Participants will receive pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of three weeks, and one session per day for a total of 15 sessions.
Other: Tendon and nerve gliding exercises will be performed three times a day with 10 repetitions each time for 3 weeks. Exercises will be performed by a trained physiotherapist.
Other: Rest splint(at night) Participants will be splinted in neutral position with standard cotton-polyester splints.The patients will be encouraged to use the splints during nighttime for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HILT+nerve/tendon gliding exercise+rest splint | Experimental | Patients will receive pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for three weeks (one session per day for a total of 15 sessions). A 3-phase treatment program will be performed in each session, and a physiotherapist will then apply nerve/tendon gliding exercises program to the patients once daily. The patients will use rest splint at night. Receives: Device: High-intensity laser therapy (HILT) |
| Sham HILT+nerve/tendon gliding exercise+rest splint | Sham comparator | Patients will receive sham laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for three weeks (one session per day for a total of 15 sessions). A 3-phase treatment program will be performed in each session, and a physiotherapist will then apply nerve/tendon gliding exercises program to the patients once daily . The patients will use rest splint at night. Receives: Device: Sham High-intensity laser therapy (sham HILT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Boston carpal tunnel questionnaire: 0(Baseline), Change from Baseline at 3rd and 12th weeks
This questionnaire determines CTS-specific symptom severity and functional outcome using a scale for each. Symptom severity subgroup is determined using 11 questions scored from 1 to 5 and one can get 55 points at most. The higher the score, the higher the symptom severity. The function subgroup questions the difficulty of 8 functional activities scored from 1 to 5 and one can get 40 points at most. The higher the score, the worse the functional capacity.
Measured: 0(Baseline) and at 3rd and 12th weeks
Secondary outcomes (6)
Visual analogue scale (VAS) [ Time Frame: 0(Baseline), Change from Baseline VAS at 3rd and 12th weeks ]
Pain intensity will be measured with visual analogue scale (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
Measured: 0(Baseline) and at 3rd and 12th weeks
Median nerve distal motor latency.Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks
The compound muscle action potential amplitude(CMAP) will be obtained via surface electrodes placed on the abductor pollicis brevis muscle. The active recording electrode will be placed on the muscle belly and the reference electrode will be placed on the tendon insertion. The median nerve will be stimulated 8 cm proximal to the active recording electrode. Distal motor latencies will be measured from the onset of stimulus artifact to the onset of the CMAP.
Measured: 0(Baseline) and at 3rd and 12th weeks
Sensory nerve conduction velocity Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks
Sensory nerve action potential amplitudes (SNAP) will be obtained using an orthodromic method and recorded by surface electrodes placed at the wrist The median nerves will be stimulated at the proximal and distal interphalangeal joints of the index finger . Distal sensory latencies will be measured from the onset of the stimulus artifact to the onset of the SNAP. Sensory nerve conduction velocity will be calculated dividing the distance by the distal sensory latency.
Measured: 0(Baseline) and at 3rd and 12th weeks
Median nerve compound muscle action potential amplitude (CMAP): Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks
The CMAPs will be obtained via surface electrodes placed on the abductor pollicis brevis muscle. The active recording electrode will be placed on the muscle belly, and the reference electrode will be placed on the tendon insertion. The median nerve will be stimulated 8 cm proximal to the active recording electrode. The amplitude of CMAP will be measured from baseline to negative peak.
Measured: 0(Baseline) and at 3rd and 12th weeks
Median sensory nerve action potential amplitudes: Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks
Sensory nerve action potential amplitudes (SNAP) will be obtained using an orthodromic method and recorded by surface electrodes placed at the wrist The median nerves will be stimulated at the proximal and distal interphalangeal joints of the index finger and palm . Distal sensory latencies will be measured from the onset of the stimulus artifact to the onset of the SNAP.
Measured: 0(Baseline) and at 3rd and 12th weeks
Grip strength: Time Frame:0(Baseline), Change from Baseline at 3rd and 12th weeks
In the evaluation of grip strength, a hand dynamometer (JAMAR) will be used for grip strength and a pinchmeter will be used for the evaluation of the pulp to pulp grip. The patient will perform three consecutive tests while sitting with their shoulder abducted and neutrally rotated, elbow flexed at 90°, and forearm and wrist in neutral position.The best of these measurements will be recorded in kilograms.
Measured: 0(Baseline) and at 3rd and 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Jun 2021
- Primary completion27 Jun 2022
- Study completion15 Nov 2022
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selma Eroğlu, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949373
- Sponsor's protocol ID
- Afyonkarahisar Health Sciences
- Status last verified
- Nov 2022
- First submitted
- 25 Jun 2021
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bekhet AH, Ragab B, Abushouk AI, Elgebaly A, Ali OI. Efficacy of low-level laser therapy in carpal tunnel syndrome management: a systematic review and meta-analysis. Lasers Med Sci. 2017 Aug;32(6):1439-1448. doi: 10.1007/s10103-017-2234-6. Epub 2017 Jun 5.
PubMed 28580494Dundar U, Turkmen U, Toktas H, Ulasli AM, Solak O. Effectiveness of high-intensity laser therapy and splinting in lateral epicondylitis; a prospective, randomized, controlled study. Lasers Med Sci. 2015 Apr;30(3):1097-107. doi: 10.1007/s10103-015-1716-7. Epub 2015 Jan 23.
PubMed 25614134Guner A, Altan L, Kasapoglu Aksoy M. The effectiveness of the low-power laser and kinesiotaping in the treatment of carpal tunnel syndrome, a pilot study. Rheumatol Int. 2018 May;38(5):895-904. doi: 10.1007/s00296-018-4020-6. Epub 2018 Mar 28.
PubMed 29594333Ezzati K, Laakso EL, Salari A, Hasannejad A, Fekrazad R, Aris A. The Beneficial Effects of High-Intensity Laser Therapy and Co-Interventions on Musculoskeletal Pain Management: A Systematic Review. J Lasers Med Sci. 2020 Winter;11(1):81-90. doi: 10.15171/jlms.2020.14. Epub 2020 Jan 18.
PubMed 32099632Yagci I, Elmas O, Akcan E, Ustun I, Gunduz OH, Guven Z. Comparison of splinting and splinting plus low-level laser therapy in idiopathic carpal tunnel syndrome. Clin Rheumatol. 2009 Sep;28(9):1059-65. doi: 10.1007/s10067-009-1213-0. Epub 2009 Jun 21.
PubMed 19544043
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of High Intensity Laser (HILT) Therapy in Idiopathic Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04949373
- Acronym / sponsor ID
- Afyonkarahisar Health Sciences
- Conditions
- Carpal Tunnel Syndrome, Entrapment Neuropathy, Median Neuropathy, Musculoskeletal Diseases
- Keywords
- Carpal Tunnel Syndrome, Median Neuropathy, High intensity laser therapy, Nerve conduction studies, Hand function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 2 Jul 2021 (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.
This research aims to investigate the effect of high-intensity laser therapy on pain, function, nerve conduction studies and grip strength in patients with idiopathic carpal tunnel syndrome.
Detailed description
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy, and it causes numbness and tingling in the hand, atrophy and muscle weakness in the later stages. Any condition that increases the volume of the carpal tunnel and narrows the diameter of the tunnel may increase the compression of the median nerve under the transverse carpal ligament and cause symptoms. In majority of cases, no cause can be found and it is called "idiopathic".
While the diagnosis of CTS is made by the patient's history and physical examination methods, the diagnosis is confirmed with use of electrophysiological examination. Physical therapy, non-steroidal anti-inflammatory drug use, local steroid injection, hand-wrist rest splint, nerve/tendon gliding exercises; Physiotherapy modalities such as therapeutic ultrasound and laser are among the conservative treatment methods of CTS. Despite the effectiveness of surgery in the treatment of severe CTS cases, as is known, surgical treatment is not without risk. Therefore, mild to moderate CTS is treated conservatively.
Laser therapy is one of the physical therapy modalities, low-intensity laser therapy (LILT), whose biological effects occur secondary to direct photochemical effect and are not the result of thermal effects. High-intensity laser therapy (HILT), which has been widely used recently, is frequently used since it has small and slow light absorption from chromophores. HILT is not a concentrated light, but it diffuses in all directions (scattering phenomenon). This supports the wider effectiveness of HILT. HILT also has effects such as increased mitochondrial oxidative reactions, increased production of adenosine triphosphate, RNA and DNA (photochemical effect), increased tissue stimulation (photobiological), and reduced pain and inflammation. HILT, which has recently found many uses in musculoskeletal diseases, can affect a wider and deeper area in the tissues compared to the widely used LILT. Although there are many studies on the effectiveness of LILT therapy in CTS, there are few trials to study the effectiveness of HILT on clinical and electrophysiological parameters in CTS.
This investigation is designed as double-blind prospective sham controlled randomized study.
Participants were randomized into 2 groups: 1) HILT + nerve/tendon gliding exercises + rest splint and 2) Sham HILT+ nerve/tendon gliding exercises + rest splint
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HILT+nerve/tendon gliding exercise+rest splint | Experimental | Device: High-intensity laser therapy (HILT)Patients will receive pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for three weeks (one session per day for a total of 15 sessions). A 3-phase treatment program will be performed in each session, and a physiotherapist will then apply nerve/tendon gliding exercises program to the patients once daily. The patients will use rest splint at night. |
| Sham HILT+nerve/tendon gliding exercise+rest splint | Sham comparator | Device: Sham High-intensity laser therapy (sham HILT)Patients will receive sham laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for three weeks (one session per day for a total of 15 sessions). A 3-phase treatment program will be performed in each session, and a physiotherapist will then apply nerve/tendon gliding exercises program to the patients once daily . The patients will use rest splint at night. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild or moderate idiopathic carpal tunnel syndrome (clinically diagnosed and electrophysiologically confirmed CTS)
Key exclusion criteria (7 listed)
- Diabetes mellitus,hypothyroidism, rheumatic diseases, acromegaly
- Polyneuropathy,
- Ipsilateral brachial plexopathy and traumatic nerve injury of the upper extremity
- Previous injection into the carpal tunnel and physical therapy within in the preceding 6 months
- Pregnancy
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 |
|---|---|---|
| High-intensity laser therapy (HILT)High intensity laser therapy-Patients will receive pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of three weeks, and one session per day for a total of 15 sessions. A 3-phase treatment program will be performed on each session. Other: Tendon and nerve gliding exercises will be performed three times a day with 10 repetitions each time for 3 weeks. Exercises will be performed by a trained physiotherapist. Other: Rest splint(at night) Participants will be splinted in neutral position with standard cotton-polyester splints.The patients will be encouraged to use the splints during nighttime for 12 weeks. | Device | HILT+nerve/tendon gliding exercise+rest splint |
| Sham High-intensity laser therapy (sham HILT)Sham high intensity laser therapy-Participants will receive pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of three weeks, and one session per day for a total of 15 sessions. Other: Tendon and nerve gliding exercises will be performed three times a day with 10 repetitions each time for 3 weeks. Exercises will be performed by a trained physiotherapist. Other: Rest splint(at night) Participants will be splinted in neutral position with standard cotton-polyester splints.The patients will be encouraged to use the splints during nighttime for 12 weeks. | Device | Sham HILT+nerve/tendon gliding exercise+rest splint |
Primary outcome
The Boston carpal tunnel questionnaire: 0(Baseline), Change from Baseline at 3rd and 12th weeks
Time frame: 0(Baseline) and at 3rd and 12th weeks
This questionnaire determines CTS-specific symptom severity and functional outcome using a scale for each. Symptom severity subgroup is determined using 11 questions scored from 1 to 5 and one can get 55 points at most. The higher the score, the higher the symptom severity. The function subgroup questions the difficulty of 8 functional activities scored from 1 to 5 and one can get 40 points at most. The higher the score, the worse the functional capacity.
6 secondary outcomes
Visual analogue scale (VAS) [ Time Frame: 0(Baseline), Change from Baseline VAS at 3rd and 12th weeks ]
Time frame: 0(Baseline) and at 3rd and 12th weeks
Median nerve distal motor latency.Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks
Time frame: 0(Baseline) and at 3rd and 12th weeks
Sensory nerve conduction velocity Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks
Time frame: 0(Baseline) and at 3rd and 12th weeks
Median nerve compound muscle action potential amplitude (CMAP): Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks
Time frame: 0(Baseline) and at 3rd and 12th weeks
Median sensory nerve action potential amplitudes: Time Frame: 0(Baseline), Change from Baseline at 3rd and 12th weeks
Time frame: 0(Baseline) and at 3rd and 12th weeks
Grip strength: Time Frame:0(Baseline), Change from Baseline at 3rd and 12th weeks
Time frame: 0(Baseline) and at 3rd and 12th 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 22 Nov 2022.
- Background: PubMed 28580494Bekhet AH, Ragab B, Abushouk AI, Elgebaly A, Ali OI. Efficacy of low-level laser therapy in carpal tunnel syndrome management: a systematic review and meta-analysis. Lasers Med Sci. 2017 Aug;32(6):1439-1448. doi: 10.1007/s10103-017-2234-6. Epub 2017 Jun 5.
- Background: PubMed 25614134Dundar U, Turkmen U, Toktas H, Ulasli AM, Solak O. Effectiveness of high-intensity laser therapy and splinting in lateral epicondylitis; a prospective, randomized, controlled study. Lasers Med Sci. 2015 Apr;30(3):1097-107. doi: 10.1007/s10103-015-1716-7. Epub 2015 Jan 23.
- Background: PubMed 29594333Guner A, Altan L, Kasapoglu Aksoy M. The effectiveness of the low-power laser and kinesiotaping in the treatment of carpal tunnel syndrome, a pilot study. Rheumatol Int. 2018 May;38(5):895-904. doi: 10.1007/s00296-018-4020-6. Epub 2018 Mar 28.
- Background: PubMed 32099632Ezzati K, Laakso EL, Salari A, Hasannejad A, Fekrazad R, Aris A. The Beneficial Effects of High-Intensity Laser Therapy and Co-Interventions on Musculoskeletal Pain Management: A Systematic Review. J Lasers Med Sci. 2020 Winter;11(1):81-90. doi: 10.15171/jlms.2020.14. Epub 2020 Jan 18.
- Background: PubMed 19544043Yagci I, Elmas O, Akcan E, Ustun I, Gunduz OH, Guven Z. Comparison of splinting and splinting plus low-level laser therapy in idiopathic carpal tunnel syndrome. Clin Rheumatol. 2009 Sep;28(9):1059-65. doi: 10.1007/s10067-009-1213-0. Epub 2009 Jun 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity laser therapy (HILT) in people with Carpal Tunnel Syndrome and Entrapment Neuropathy, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
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 1 inclusion and 7 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 22 Nov 2022. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
The Boston carpal tunnel questionnaire: 0(Baseline), Change from Baseline at 3rd and 12th weeks (time frame: 0(Baseline) and at 3rd and 12th 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 NCT04949373, 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 22 Nov 2022.