Carpal Tunnel SyndromeNCT04828239
Acupuncture Versus Laser Acupuncture for Carpal Tunnel Syndrome
A study testing laser acupuncture and acupuncture in people with Carpal Tunnel Syndrome, run by Kuang Tien General Hospital at 1 site in Taiwan.
Trial summary
Carpal tunnel syndrome (CTS) results from the entrapment neuropathy of median nerve at the wrist, and most cases are idiopathic. So far, there are many treatments were developed (Surgical decompression, local injection of steroids, Wrist splints) but they are not fully satisfactory, other treatment modalities need to… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- laser acupuncture and acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Mar 2021to 20 Jun 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CTS diagnosis was based on the presence of at least one of the following symptoms
- numbness, tingling pain, or paresthesia in the median nerve distribution
- precipitation of these symptoms by repetitive hand activities, which could be relieved by resting, rubbing, and shaking the hand
- nocturnal awakening by such sensory symptoms.
- The diagnosis was often supported by a positive Tinel sign Confirmed by the presence of one or more of the following standard electrophysiologic criteria
- prolonged distal motor latency (DML) to the abductor pollicis brevis (APB) (abnormal Z4.7 ms, stimulation over the wrist, 8 cm proximal to the active electrode) (2) prolonged antidromic distal sensory latency (DSL) to the second digit (abnormal Z3.1 ms;stimulation over the wrist, 14 cm proximal to the active electrode) (3) prolonged antidromic wrist-palm sensory nerve conduction velocity (W-P SNCV) at a distance of 8 cm (W-P SNCV, abnormal <45 m/s).9-
Who cannot join
- Symptoms occurring less than 3 months before the study (to exclude patients who might have spontaneous resolution of symptoms)
- severe CTS that had progressed to visible muscle atrophy
- clinical or electrophysiologic evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as cervical radiculopathy, proximal median neuropathy, or significant polyneuropathy
- evidence of obvious underlying etiologic factors of CTS such as diabetes mellitus, rheumatoid arthritis, hypothyroidism (acromegaly), pregnancy, alcohol abuse or drug usage (steroids or drugs acting through the central nervous system), and suspected malignancy or inflammation or autoimmune disease documented as underlying causes of CTS
- cognitive impairment interfering with the subject's ability to follow instructions and describe symptoms
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kuang Tien Genreal Hospital
Taichung, 402
Li-Feng Lin, 0937165513
About this study
Official title: Institutional Review Board of Kuang Tien General Hospital
Carpal tunnel syndrome (CTS) results from the entrapment neuropathy of median nerve at the wrist, and most cases are idiopathic. So far, there are many treatments were developed (Surgical decompression, local injection of steroids, Wrist splints) but they are not fully satisfactory, other treatment modalities need to be further evaluated.
Both Acupuncture and laser acupuncture treatments for CTS have been reported. However, those studies still lack associated evidence to evaluate the efficacy of acupuncture and laser acupuncture.
The object of the study is to investigate the efficacy of acupuncture compared with laser acupuncture in patients with mild-to-moderate carpal tunnel syndrome (CTS). Nerve conduction studies (NCS) and global symptom score (GSS) assessment will apply to measure objective changes in this randomized, controlled study.
Read the detailed description
Both manual acupuncture and laser acupuncture treatments for CTS have been reported.
Laser acupuncture (LA) is defined as the stimulation of traditional acupuncture points by using low-level intensity. Its a noninvasive treatment than acupuncture for those patients had the potential risk for infection or people involving pain or fear of needles. So far, previous studies still lack associated evidence about comparisons between laser acupuncture and manual acupuncture to evaluate their efficacy. So the investigators would like to compare the efficacy of acupuncture treatment with laser acupuncture (LA) treatment in patients with idiopathic, mild-to-moderate carpal tunnel syndrome (CTS)
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- laser acupuncture, acupuncture, Sham laser acupuncture
- Keywords
- laser acupuncture, Carpal Tunnel Syndrome, manual acupuncture
- 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.
laser acupunctureDevice
Also called RJ-LASER, Germany
400 mW, near-infrared, continuous wavelength, 810 nm. about 24J/cm2
acupunctureOther
Needle type: C\&G, gauge and size: 0.25x40mm
Sham laser acupunctureDevice
Also called RJ-LASER, Germany
This laser pen is the same device with a red light was pasted on the acu-points in the same way, using the same protocol as for the active laser stimulation, but the laser apparatus was not switched on.
| Study group | Role | What they receive |
|---|---|---|
| Laser Acupuncture Group | Experimental | Acupuncture point: PC-6 and PC-7 laser pen is vertical to the points and with the pen at a distance of 0.5- cm from the skin., every point is treated for 1 min administrated over 4 weeks (2 sessions/wk) Receives: Device: laser acupuncture |
| Manual Acupuncture Group | Active comparator | Acupuncture point: PC-6 and PC-7 Responses elicited: de qi sensation Manual: twirling with lifting-thrusting method stimulation Needles retained for 30 min Needle type: C\&G, gauge and size: 0.25x40mm Receives: Other: acupuncture |
| Sham Laser Acupuncture Group | Sham comparator | Acupuncture point: PC-6 and PC-7 Sham laser pen is vertical to the points and with the pen at a distance of 0.5- cm from the skin., every point is treated for 1 min administrated over 4 weeks (2 sessions/wk) Receives: Device: Sham laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global symptom score
rated symptoms(Pain ,Numbness, paresthesia, Nocturnal awakening) from 0(no symptoms) to 10 (very severe symptoms)
Measured: Change from Baseline GSS at 2 weeks
Global symptom score
rated symptoms(Pain ,Numbness, paresthesia, Nocturnal awakening) from 0(no symptoms) to 10 (very severe symptoms)
Measured: Change from Baseline GSS at 4 weeks
Secondary outcomes (1)
Nerve conduction studies
calculate the median nerve transduction speed
Measured: Change from Baseline nerve conduction studies (NCS) at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start10 Mar 2021
- Primary completion20 May 2022 (estimated)
- Study completion20 Jun 2022 (estimated)
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
- Model description
- The recruited patients were randomly divided into two groups of ''Laser Acupuncture Group'' and ''Manual Acupuncture Group"
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuang Tien General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Feng Lin, Kuang Tien General Hospital
- Investigators
- Chun-Pai Yang, PhD, Principal investigator, Kuang Tien Genreal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828239
- Sponsor's protocol ID
- KTGH10946
- Status last verified
- Nov 2021
- First submitted
- 24 Mar 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institutional Review Board of Kuang Tien General Hospital
- ClinicalTrials.gov ID
- NCT04828239
- Acronym / sponsor ID
- KTGH10946
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- laser acupuncture, Carpal Tunnel Syndrome, manual acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kuang Tien General HospitalUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 20 May 2022 (estimated)
- Study completion
- 20 Jun 2022 (estimated)
- First posted
- 2 Apr 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.
Carpal tunnel syndrome (CTS) results from the entrapment neuropathy of median nerve at the wrist, and most cases are idiopathic. So far, there are many treatments were developed (Surgical decompression, local injection of steroids, Wrist splints) but they are not fully satisfactory, other treatment modalities need to be further evaluated.
Both Acupuncture and laser acupuncture treatments for CTS have been reported. However, those studies still lack associated evidence to evaluate the efficacy of acupuncture and laser acupuncture.
The object of the study is to investigate the efficacy of acupuncture compared with laser acupuncture in patients with mild-to-moderate carpal tunnel syndrome (CTS). Nerve conduction studies (NCS) and global symptom score (GSS) assessment will apply to measure objective changes in this randomized, controlled study.
Detailed description
Both manual acupuncture and laser acupuncture treatments for CTS have been reported.
Laser acupuncture (LA) is defined as the stimulation of traditional acupuncture points by using low-level intensity. Its a noninvasive treatment than acupuncture for those patients had the potential risk for infection or people involving pain or fear of needles. So far, previous studies still lack associated evidence about comparisons between laser acupuncture and manual acupuncture to evaluate their efficacy. So the investigators would like to compare the efficacy of acupuncture treatment with laser acupuncture (LA) treatment in patients with idiopathic, mild-to-moderate carpal tunnel syndrome (CTS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The recruited patients were randomly divided into two groups of ''Laser Acupuncture Group'' and ''Manual Acupuncture Group"
| Arm | Type | Receives |
|---|---|---|
| Laser Acupuncture Group | Experimental | Device: laser acupunctureAcupuncture point: PC-6 and PC-7 laser pen is vertical to the points and with the pen at a distance of 0.5- cm from the skin., every point is treated for 1 min administrated over 4 weeks (2 sessions/wk) |
| Manual Acupuncture Group | Active comparator | Other: acupunctureAcupuncture point: PC-6 and PC-7 Responses elicited: de qi sensation Manual: twirling with lifting-thrusting method stimulation Needles retained for 30 min Needle type: C\&G, gauge and size: 0.25x40mm |
| Sham Laser Acupuncture Group | Sham comparator | Device: Sham laser acupunctureAcupuncture point: PC-6 and PC-7 Sham laser pen is vertical to the points and with the pen at a distance of 0.5- cm from the skin., every point is treated for 1 min administrated over 4 weeks (2 sessions/wk) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- CTS diagnosis was based on the presence of at least one of the following symptoms
- numbness, tingling pain, or paresthesia in the median nerve distribution
- precipitation of these symptoms by repetitive hand activities, which could be relieved by resting, rubbing, and shaking the hand
- nocturnal awakening by such sensory symptoms.
- The diagnosis was often supported by a positive Tinel sign Confirmed by the presence of one or more of the following standard electrophysiologic criteria
Key exclusion criteria (5 listed)
- Symptoms occurring less than 3 months before the study (to exclude patients who might have spontaneous resolution of symptoms)
- severe CTS that had progressed to visible muscle atrophy
- clinical or electrophysiologic evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as cervical radiculopathy, proximal median neuropathy, or significant polyneuropathy
- evidence of obvious underlying etiologic factors of CTS such as diabetes mellitus, rheumatoid arthritis, hypothyroidism (acromegaly), pregnancy, alcohol abuse or drug usage (steroids or drugs acting through the central nervous system), and suspected malignancy or inflammation or autoimmune disease documented as underlying causes of CTS
- cognitive impairment interfering with the subject's ability to follow instructions and describe symptoms
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 |
|---|---|---|
| laser acupunctureAlso: RJ-LASER, Germany400 mW, near-infrared, continuous wavelength, 810 nm. about 24J/cm2 | Device | Laser Acupuncture Group |
| acupunctureNeedle type: C\&G, gauge and size: 0.25x40mm | Other | Manual Acupuncture Group |
| Sham laser acupunctureAlso: RJ-LASER, GermanyThis laser pen is the same device with a red light was pasted on the acu-points in the same way, using the same protocol as for the active laser stimulation, but the laser apparatus was not switched on. | Device | Sham Laser Acupuncture Group |
Primary outcome
Global symptom score
Time frame: Change from Baseline GSS at 2 weeks
rated symptoms(Pain ,Numbness, paresthesia, Nocturnal awakening) from 0(no symptoms) to 10 (very severe symptoms)
Global symptom score
Time frame: Change from Baseline GSS at 4 weeks
rated symptoms(Pain ,Numbness, paresthesia, Nocturnal awakening) from 0(no symptoms) to 10 (very severe symptoms)
1 secondary outcome
Nerve conduction studies
Time frame: Change from Baseline nerve conduction studies (NCS) at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: No
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Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
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Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
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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.
Chun-Pai Yang, PhD principal investigator
Kuang Tien Genreal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser acupuncture and acupuncture in people with Carpal Tunnel Syndrome, run by Kuang Tien General Hospital at 1 site in Taiwan.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Nov 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LI-FENG LIN, Bachelor (+88642662-5111 ext. 3109, u100030053@cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global symptom score (time frame: Change from Baseline GSS at 2 weeks). The study lists 2 primary outcomes in all. 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 30 Nov 2021.