Carpal Tunnel SyndromeNCT06201520
The Effect of Acupuncture and Laser Acupuncture for Carpal Tunnel Syndrome
A study testing manual acupuncture, laser acupuncture and wrist splint in people with Carpal Tunnel Syndrome and Acupuncture, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Acupuncture and laser acupuncture treatments have been proven to be effective and safe treatments for carpal tunnel syndrome(CTS). However, there is still a lack of direct comparative studies of acupuncture and laser acupuncture in the treatment of CTS. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Acupuncture, Laser Acupuncture
- What is being tested?
- manual acupuncture, laser acupuncture and wrist splint
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2021to Feb 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with mild to moderate carpal tunnel syndrome diagnosed by neurophysiological examination
- symptoms of carpal tunnel syndrome such as pain and numbness
- those who are willing to sign informed consent form for subjects
Who cannot join
- (1) Those who have not signed the informed consent
- (2) Patients diagnosed with severe carpal tunnel syndrome
- (3) Those who have had a history of surgery on their hands and palms
- (4) Space-occupying lesions such as tumors, bone spurs, synovial membrane tissue hypertrophy, etc.
- (5) People with a history of diabetes, rheumatoid arthritis, and hypothyroidism (HbA1c>6.5, RF positive, Free T4, TSH in abnormal range)
- (6) Patients with end-stage renal disease
Show all 11Show fewer
- (7) Pregnant and alcoholic patients
- (8) Polyneuropathy patients
- (9) Clinical symptoms with C6~8 cervical radiculopathy
- (10) Those who are obviously infected
- (11) Those with a serious illness requiring hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupuncture and Laser Acupuncture for Carpal Tunnel Syndrome-A 3-arm, Randomized Sham Laser Acupuncture Controlled Study
Acupuncture and laser acupuncture treatments have been proven to be effective and safe treatments for carpal tunnel syndrome(CTS). However, there is still a lack of direct comparative studies of acupuncture and laser acupuncture in the treatment of CTS. A 3-arm, randomized controlled study in acupuncture, laser acupuncture study and sham laser acupuncture therapy was designed for patient with carpal tunnel syndrome. The Glabal symptom score (GSS), Boston Carpal Tunnel Questionnaire (BCTQ), neurophysiological study, morphological examination under ultrasonography will be evaluated before and after treatment. Comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of CTS will be explored.
Read the detailed description
The primary outcome will analyze the change of the Glabal symptom score (GSS) during intervention peroid. The secondary outcome will evaluate the neurophysiological study, morphological examination under ultrasonography before and after treatment. Comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of CTS will be explored.
- Conditions
- Carpal Tunnel Syndrome, Acupuncture, Laser Acupuncture
- Being tested
- manual acupuncture, laser acupuncture, sham laser acupuncture, wrist splint
- Keywords
- Carpal Tunnel Syndrome, Acupuncture, Laser 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.
manual acupunctureProcedure or surgery
manual acupuncture
laser acupunctureDevice
laser acupuncture therapy
sham laser acupunctureDevice
sham laser acupuncture
wrist splintDevice
wear wrist splint at night
| Study group | Role | What they receive |
|---|---|---|
| MA group (manual acupuncture group) | Experimental | Acupunctue Needle: 1 inch- 32 gauge（0.3x25 mm）for 20 min after De-qi Acupoints selection: PC4[Ximen], PC6[Neiguan], PC7[Daling], PC8[Laogong], HT2[Qingling], HT7[Shenmen], HT8[Shaofu], LU9[Taiyuan], LI11[Quchi] Receives: Procedure: manual acupuncture; Device: wrist splint |
| LA group (laser acupuncture group) | Experimental | laser acupuncture gruoup with LaserPen, 150 mW; wavelength, 810nm; area of probe, 0.03cm2; power density, 5W/cm2; pulsed wave; Nogier C frequency for 4 J each points The acupoints selection is the same as the MA group. Receives: Device: laser acupuncture; Device: wrist splint |
| SLA group (sham laser acupuncture group) | Sham comparator | sham laser acupuncture group is designed with the same acupoints selection and no energy output Receives: Device: sham laser acupuncture; Device: wrist splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Boston Carpal Tunnel Questionnaire(BCTQ) changes
The Boston Carpal Tunnel Questionnaire(BCTQ) is a questionnaire for CTS patients, which has been used widely in the world. It contains two parts. One part is the symptom severity scale (BCTQsss) which contains eleven questions about symptom severity, and another part is the function severity scale (BCTQfss) contains eight questions about functional status evaluation. Each selection option includes 1~5 to present different degrees of severity ("5" is the most severe). The max of BCTQsss is 55 and the min is 11. The max of BCTQfss is 40 and the min is 8. The higher scores mean a worse outcome.
Measured: from baseline to 3 months
Global symptoms score(GSS) changes
GSS is a questionnaire to evaluate the severity of five symptoms, including pain, numbness, paresthesias, weakness/ clumsy, and nocturnal awakening for CTS patients.
The score of pain, numbness, and paresthesias according to the magnitude: from 0 (nil) to 10 (most severe).
The score for weakness/ clumsiness is according to the severity: 0 (none); 2(mild); 3(moderate); 4(severe); 5(very severe).
The score for nocturnal awakening is according to how many times awaked in one week: 0(never); 2(once or twice); 4(three or four times); 6(five to seven times); 8(eight to ten times); 10(more than ten times).
The total score added up forms the GSS score. The minimum score is 0, and the maximum score is 50. The higher scores mean a worse outcome.
Measured: from baseline to 3 months
Secondary outcomes (4)
compound motor action potential(CMAP)
Nerve Electrophysiological examination of median nerve.The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including compound motor action potential(CMAP).
The unit of CMAP is millivolt (mV).
Measured: from baseline to 3 months
motor distal latency(MDL)
Nerve Electrophysiological examination of median nerve. The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including motor distal latency(MDL).
The unit of motor distal latency is millisecond (ms).
Measured: from baseline to 3 months
Sensory nerve action potential (SNAP)
Nerve Electrophysiological examination of median nerve. The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including Sensory nerve action potential (SNAP).
The unit of SNAP is also millivolt (mV).
Measured: from baseline to 3 months
sensory distal latency(SDL)
Nerve Electrophysiological examination of median nerve. The neurophysiological study of the median nerve will be recorded and compared before and after 15 sessions of treatments including sensory distal latency(SDL).
The unit of sensory distal latency is also millisecond (ms).
Measured: from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 May 2021
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201520
- Sponsor's protocol ID
- 201901768A3
- Status last verified
- Dec 2023
- First submitted
- 17 Aug 2021
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maeda Y, Kim H, Kettner N, Kim J, Cina S, Malatesta C, Gerber J, McManus C, Ong-Sutherland R, Mezzacappa P, Libby A, Mawla I, Morse LR, Kaptchuk TJ, Audette J, Napadow V. Rewiring the primary somatosensory cortex in carpal tunnel syndrome with acupuncture. Brain. 2017 Apr 1;140(4):914-927. doi: 10.1093/brain/awx015.
PubMed 28334999Hadianfard M, Bazrafshan E, Momeninejad H, Jahani N. Efficacies of Acupuncture and Anti-inflammatory Treatment for Carpal Tunnel Syndrome. J Acupunct Meridian Stud. 2015 Oct;8(5):229-35. doi: 10.1016/j.jams.2014.11.005. Epub 2014 Nov 29.
PubMed 26433799Chen CC, Wu YT, Su YC, Shen YP, Chen FP. Efficacy of laser acupuncture for carpal tunnel syndrome: A study protocol for a prospective double-blind randomized controlled trial. Medicine (Baltimore). 2019 Jul;98(30):e16516. doi: 10.1097/MD.0000000000016516.
PubMed 31348263
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture and Laser Acupuncture for Carpal Tunnel Syndrome-A 3-arm, Randomized Sham Laser Acupuncture Controlled Study
- ClinicalTrials.gov ID
- NCT06201520
- Acronym / sponsor ID
- 201901768A3
- Conditions
- Carpal Tunnel Syndrome, Acupuncture, Laser Acupuncture
- Keywords
- Carpal Tunnel Syndrome, Acupuncture, Laser Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 11 Jan 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.
Acupuncture and laser acupuncture treatments have been proven to be effective and safe treatments for carpal tunnel syndrome(CTS). However, there is still a lack of direct comparative studies of acupuncture and laser acupuncture in the treatment of CTS. A 3-arm, randomized controlled study in acupuncture, laser acupuncture study and sham laser acupuncture therapy was designed for patient with carpal tunnel syndrome. The Glabal symptom score (GSS), Boston Carpal Tunnel Questionnaire (BCTQ), neurophysiological study, morphological examination under ultrasonography will be evaluated before and after treatment. Comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of CTS will be explored.
Detailed description
The primary outcome will analyze the change of the Glabal symptom score (GSS) during intervention peroid. The secondary outcome will evaluate the neurophysiological study, morphological examination under ultrasonography before and after treatment. Comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of CTS will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MA group (manual acupuncture group) | Experimental | Procedure: manual acupuncture, Device: wrist splintAcupunctue Needle: 1 inch- 32 gauge（0.3x25 mm）for 20 min after De-qi Acupoints selection: PC4[Ximen], PC6[Neiguan], PC7[Daling], PC8[Laogong], HT2[Qingling], HT7[Shenmen], HT8[Shaofu], LU9[Taiyuan], LI11[Quchi] |
| LA group (laser acupuncture group) | Experimental | Device: laser acupuncture, Device: wrist splintlaser acupuncture gruoup with LaserPen, 150 mW; wavelength, 810nm; area of probe, 0.03cm2; power density, 5W/cm2; pulsed wave; Nogier C frequency for 4 J each points The acupoints selection is the same as the MA group. |
| SLA group (sham laser acupuncture group) | Sham comparator | Device: sham laser acupuncture, Device: wrist splintsham laser acupuncture group is designed with the same acupoints selection and no energy output |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with mild to moderate carpal tunnel syndrome diagnosed by neurophysiological examination
- symptoms of carpal tunnel syndrome such as pain and numbness
- those who are willing to sign informed consent form for subjects
Key exclusion criteria (11 listed)
- (1) Those who have not signed the informed consent
- (2) Patients diagnosed with severe carpal tunnel syndrome
- (3) Those who have had a history of surgery on their hands and palms
- (4) Space-occupying lesions such as tumors, bone spurs, synovial membrane tissue hypertrophy, etc.
- (5) People with a history of diabetes, rheumatoid arthritis, and hypothyroidism (HbA1c>6.5, RF positive, Free T4, TSH in abnormal range)
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 |
|---|---|---|
| manual acupuncturemanual acupuncture | Procedure or surgery | MA group (manual acupuncture group) |
| laser acupuncturelaser acupuncture therapy | Device | LA group (laser acupuncture group) |
| sham laser acupuncturesham laser acupuncture | Device | SLA group (sham laser acupuncture group) |
| wrist splintwear wrist splint at night | Device | LA group (laser acupuncture group), MA group (manual acupuncture group), SLA group (sham laser acupuncture group) |
Primary outcome
The Boston Carpal Tunnel Questionnaire(BCTQ) changes
Time frame: from baseline to 3 months
The Boston Carpal Tunnel Questionnaire(BCTQ) is a questionnaire for CTS patients, which has been used widely in the world. It contains two parts. One part is the symptom severity scale (BCTQsss) which contains eleven questions about symptom severity, and another part is the function severity scale (BCTQfss) contains eight questions about functional status evaluation. Each selection option includes 1~5 to present different degrees of severity ("5" is the most severe). The max of BCTQsss is 55 and the min is 11. The max of BCTQfss is 40 and the min is 8. The higher scores mean a worse outcome.
Global symptoms score(GSS) changes
Time frame: from baseline to 3 months
GSS is a questionnaire to evaluate the severity of five symptoms, including pain, numbness, paresthesias, weakness/ clumsy, and nocturnal awakening for CTS patients. The score of pain, numbness, and paresthesias according to the magnitude: from 0 (nil) to 10 (most severe). The score for weakness/ clumsiness is according to the severity: 0 (none); 2(mild); 3(moderate); 4(severe); 5(very severe). The score for nocturnal awakening is according to how many times awaked in one week: 0(never); 2(once or twice); 4(three or four times); 6(five to seven times); 8(eight to ten times); 10(more than ten times). The total score added up forms the GSS score. The minimum score is 0, and the maximum score is 50. The higher scores mean a worse outcome.
4 secondary outcomes
compound motor action potential(CMAP)
Time frame: from baseline to 3 months
motor distal latency(MDL)
Time frame: from baseline to 3 months
Sensory nerve action potential (SNAP)
Time frame: from baseline to 3 months
sensory distal latency(SDL)
Time frame: from baseline to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 28334999Maeda Y, Kim H, Kettner N, Kim J, Cina S, Malatesta C, Gerber J, McManus C, Ong-Sutherland R, Mezzacappa P, Libby A, Mawla I, Morse LR, Kaptchuk TJ, Audette J, Napadow V. Rewiring the primary somatosensory cortex in carpal tunnel syndrome with acupuncture. Brain. 2017 Apr 1;140(4):914-927. doi: 10.1093/brain/awx015.
- Results publication: PubMed 26433799Hadianfard M, Bazrafshan E, Momeninejad H, Jahani N. Efficacies of Acupuncture and Anti-inflammatory Treatment for Carpal Tunnel Syndrome. J Acupunct Meridian Stud. 2015 Oct;8(5):229-35. doi: 10.1016/j.jams.2014.11.005. Epub 2014 Nov 29.
- Results publication: PubMed 31348263Chen CC, Wu YT, Su YC, Shen YP, Chen FP. Efficacy of laser acupuncture for carpal tunnel syndrome: A study protocol for a prospective double-blind randomized controlled trial. Medicine (Baltimore). 2019 Jul;98(30):e16516. doi: 10.1097/MD.0000000000016516.
- 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.
Huang principal investigator
Chang Gung Memorial 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 manual acupuncture, laser acupuncture and wrist splint in people with Carpal Tunnel Syndrome and Acupuncture, run by Chang Gung Memorial 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 3 inclusion and 11 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 11 Jan 2024. 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?
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(BCTQ) changes (time frame: from baseline to 3 months). 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?
On the ClinicalTrials.gov record for NCT06201520, which also lists 3 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 11 Jan 2024.