Carpal TunnelNCT04603274
Efficacy of Electroacupuncture in Carpal Tunnel Syndrome
A study testing 8 sessions of electroacupuncture to the upper limb with carpal tunnel syndrome in people with Carpal Tunnel and Carpal Tunnel Syndrome, run by Aretaieion University Hospital at 2 sites in Greece.
Trial summary
The aim of this clinical study is to assess the effectiveness of electroacupuncture in reducing the severity of symptoms, in improving limb function, in improving the aesthetic and motor conduction of the median nerve and in reducing its cross-sectional area at the inlet of the carpal tunnel in patients with carpal… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carpal Tunnel, Carpal Tunnel Syndrome, Pain
- What is being tested?
- 8 sessions of electroacupuncture to the upper limb with carpal tunnel syndrome
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Jul 2020to 31 Dec 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- paraesthesia, numbness, pain in the area of distribution of the median nerve
- worsening of symptoms at night or with repeated movements of the wrist
- aesthetic or/and motor deficits in the area of distribution of the median nerve
- Median sensory nerve conduction velocity (SNCV), first digit to wrist <42 m/s
- Median distal motor latency (DML), wrist to thenar eminence >4 ms.
- Difference between the median and radial sensory latencies to the thumb ≥ 0,5 ms.
- Median palmar peak latency (PL)> 2,2 ms and in comparison to ulnar palmar peak latency ≥ 0,4 ms.
- Median versus Ulnar - Lumbrical - Interossei studies (Difference between the median 2nd lumbrical \& ulnar 1st palmar interosseous distal latency, >0,5 ms).
Who cannot join
- age<18 years
- absence of the above electrophysiological criteria
- diagnosis of another disease during the electrophysiological test
- patients with severe carpal tunnel syndrome to be operated on
- thenar muscle atrophy
- previous carpal tunnel release surgery
Show all 14Show fewer
- local steroid injections in the last 3 months
- clinical active rheumatic disease
- diabetic polyneuropathy
- alcoholism
- neurological disease affecting the upper extremity (stroke, multiple sclerosis, amyotrophic lateral sclerosis, cervical radiculopathy, polyneuropathy)
- contraindications to electroacupuncture: pacemaker, epilepsy, skin disorders in the upper extremities
- no consent to the study
- language or communications barriers
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Pain Clinic of Aretaieion University Hospital
Athens, 11528
Laboratory of Musculoskeletal Physiotherapy of University of West Attica
Athens, 12243
About this study
Official title: Efficacy of Electroacupuncture in Carpal Tunnel Syndrome: a Clinical, Electrophysiologic and Ultrasonographic Study
The aim of this clinical study is to assess the effectiveness of electroacupuncture in reducing the severity of symptoms, in improving limb function, in improving the aesthetic and motor conduction of the median nerve and in reducing its cross-sectional area at the inlet of the carpal tunnel in patients with carpal tunnel syndrome. All upper extremities diagnosed with carpal tunnel syndrome will be treated with electroacupuncture for 8 sessions. Clinical, electrophysiological and ultrasonography outcome measures will be evaluated before and after the intervention, to assess the result.
Read the detailed description
Carpal tunnel syndrome (CTS) is the most common mononeuritis, with a significant burden on both patients and public health. For mild and moderate cases, conservative methods, including immobilization, corticosteroid injections, oral medications and physical therapy have been suggested as appropriate treatments, with mixed results. Acupuncture and related therapies has been used worldwide over the last few years in the management of CTS, with generally positive results. However, more studies will be needed to assess the role of acupuncture as an independent therapeutic modality to CTS.
This is a clinical study that will be conducted in the pain clinic at the department of Anaesthesiology of Aretaieion University Hospital as well as in the Laboratory of Musculoskeletal Physiotherapy of University of West Attica, with which there is a cooperation agreement. All recruited participants will be treated with the same acupuncture protocol at the limb that will be diagnosed with carpal tunnel syndrome. If the patients are diagnosed with bilateral CTS, both wrists will be treated. Clinical, electrophysiological and ultrasonography outcomes will be measured before and after the intervention.
In order to record the possible influence of psychosomatic characteristics, the Greek version of the Hospital Anxiety \& Depression (HAD) Scale will be used before the treatment. As a result the anxiety and the depression of the participants will be quantified with a simple clinical tool.
All participants will accept 8 sessions of electroacupuncture, 2 days a week for 1 month by experienced physicians.
All participants in the study will be evaluated 3-7 days before and 3-7 days after the treatment protocol with clinical, electrophysiological and ultrasonographical outcome measures. In patients with bilateral symptoms, each limb will be assessed separately.
- Being tested
- 8 sessions of electroacupuncture to the upper limb with carpal tunnel syndrome
- Medical subject headings
- Median Neuropathy, Carpal Tunnel Syndrome, Pain, Somatoform Disorders, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8 sessions of electroacupuncture to the upper limb with carpal tunnel syndromeProcedure or surgery
All participants will accept 8 sessions of electroacupuncture, 2 days a week for 1 month by experienced physicians. Acupuncture sterile disposable needles 0,25x 0,25 mm will be inserted for 20 minutes at specific acupuncture points to all patients. Electrical stimulation will be applied at specific acupuncture points for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| upper extremity diagnosed with carpal tunnel syndrome | Other | 8 sessions of electroacupuncture, 2 days a week for 1 month by experienced physicians Receives: Procedure: 8 sessions of electroacupuncture to the upper limb with carpal tunnel syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in Symptom Severity Scale (SSS) of -the Greek- Boston carpal tunnel questionnaire (BCTQ)
The Boston carpal tunnel questionnaire (BCTQ) is an easy, disease-specific measurement of self-reported symptom severity and functional status for carpal tunnel syndrome (CTS). It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and the Functional Status Scale (FSS) containing 8 questions. Each scale using a five-point rating score generates a final score which ranges from 1 to 5, with the higher indicating greater disability. We will use the Greek version of the BCTQ, which had been examined for reliability and validity and responsiveness before and after the intervention.
Measured: 3-7 days after the treatment protocol
Secondary outcomes (9)
change from baseline in Functional Status Scale (FSS) of -the Greek- Boston carpal tunnel questionnaire (BCTQ)
The Boston carpal tunnel questionnaire (BCTQ) is an easy, disease-specific measurement of self-reported symptom severity and functional status for carpal tunnel syndrome (CTS). It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and the Functional Status Scale (FSS) containing 8 questions. Each scale using a five-point rating score generates a final score which ranges from 1 to 5, with the higher indicating greater disability. We will use the Greek version of the BCTQ, which had been examined for reliability and validity and responsiveness before and after the intervention.
Measured: 3-7 days after the treatment protocol
change from baseline in Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) will be used to measure the severity of pain induced by carpal tunnel syndrome before and after the intervention. Zero is the minimum score and ten is the maximum score for pain.
Measured: 3-7 days after the treatment protocol
change from baseline in median sensory nerve conduction velocity (SNCV)
Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography
Measured: 3-7 days after the treatment protocol
change from baseline in median distal motor latency (DML)
Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography
Measured: 3-7 days after the treatment protocol
change from baseline in median sensory nerve action potential (SNAP)
Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography
Measured: 3-7 days after the treatment protocol
change from baseline in cross sectional area of the median nerve
The Cross sectional area (CSA) of the median nerve at the inlet of carpal tunnel (at the level of pisiform and scaphoid bone) will be measured before and after treatment by the Sonosite edge Ultrasound machine (6 MHz- 15 MHz linear probe)
Measured: 3-7 days after the treatment protocol
adverse events
number of patients who develop adverse events
Measured: 3-7 days after the treatment protocol
number of patients who require medication throughout treatment
need for additional medication throughout treatment
Measured: 3-7 days after the treatment protocol
change from baseline in distal sensory latency (DSL) of the median nerve
Change from baseline of electrophysiological parameters will be assessed after the treatment by using Keypoint electromyography
Measured: 3-7 days after the treatment protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Carpal TunnelStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of West Attica, Lilian Voudouri Foundation
- Responsible party
- Principal investigator, Dr Kassiani Theodoraki, Aretaieion University Hospital
- Investigators
- Kassiani Theodoraki, PhD, DESA, Principal investigator, Aretaieion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603274
- Sponsor's protocol ID
- 233/30-06-2020 electroacup
- Status last verified
- Jan 2022
- First submitted
- 18 Oct 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bougea A, Zambelis T, Voskou P, Katsika PZ, Tzavara C, Kokotis P, Karandreas N. Reliability and Validation of the Greek Version of the Boston Carpal Tunnel Questionnaire. Hand (N Y). 2018 Sep;13(5):593-599. doi: 10.1177/1558944717725379. Epub 2017 Aug 20.
PubMed 28825339Graham B, Peljovich AE, Afra R, Cho MS, Gray R, Stephenson J, Gurman A, MacDermid J, Mlady G, Patel AT, Rempel D, Rozental TD, Salajegheh MK, Keith MW, Jevsevar DS, Shea KG, Bozic KJ, Adams J, Evans JM, Lubahn J, Ray WZ, Spinner R, Thomson G, Shaffer WO, Cummins DS, Murray JN, Mohiuddin M, Mullen K, Shores P, Woznica A, Linskey E, Martinez Y, Sevarino K. The American Academy of Orthopaedic Surgeons Evidence-Based Clinical Practice Guideline on: Management of Carpal Tunnel Syndrome. J Bone Joint Surg Am. 2016 Oct 19;98(20):1750-1754. doi: 10.2106/JBJS.16.00719. No abstract available.
PubMed 27869627Jablecki CK, Andary MT, Floeter MK, Miller RG, Quartly CA, Vennix MJ, Wilson JR; American Association of Electrodiagnostic Medicine; American Academy of Neurology; American Academy of Physical Medicine and Rehabilitation. Practice parameter: Electrodiagnostic studies in carpal tunnel syndrome [RETIRED]. Report of the American Association of Electrodiagnostic Medicine, American Academy of Neurology, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2002 Jun 11;58(11):1589-92. doi: 10.1212/wnl.58.11.1589. No abstract available.
PubMed 12058083Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.
PubMed 8245050McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. doi: 10.1017/s0033291700009934.
PubMed 3078045Michopoulos I, Douzenis A, Kalkavoura C, Christodoulou C, Michalopoulou P, Kalemi G, Fineti K, Patapis P, Protopapas K, Lykouras L. Hospital Anxiety and Depression Scale (HADS): validation in a Greek general hospital sample. Ann Gen Psychiatry. 2008 Mar 6;7:4. doi: 10.1186/1744-859X-7-4.
PubMed 18325093Milone MT, Karim A, Klifto CS, Capo JT. Analysis of Expected Costs of Carpal Tunnel Syndrome Treatment Strategies. Hand (N Y). 2019 May;14(3):317-323. doi: 10.1177/1558944717743597. Epub 2017 Nov 22.
PubMed 29166787Padua L, LoMonaco M, Gregori B, Valente EM, Padua R, Tonali P. Neurophysiological classification and sensitivity in 500 carpal tunnel syndrome hands. Acta Neurol Scand. 1997 Oct;96(4):211-7. doi: 10.1111/j.1600-0404.1997.tb00271.x.
PubMed 9325471Snaith RP, Zigmond AS. The hospital anxiety and depression scale. Br Med J (Clin Res Ed). 1986 Feb 1;292(6516):344. doi: 10.1136/bmj.292.6516.344. No abstract available.
PubMed 3080166Wu IX, Lam VC, Ho RS, Cheung WK, Sit RW, Chou LW, Zhang Y, Leung TH, Chung VC. Acupuncture and related interventions for carpal tunnel syndrome: systematic review. Clin Rehabil. 2020 Jan;34(1):34-44. doi: 10.1177/0269215519877511. Epub 2019 Sep 26.
PubMed 31556315Ntoutsouli AM, Georgoudis G, Papapostolou A, Karavis M, Petrou DD, Vadalouca A, Theodoraki K. Effects of electroacupuncture on carpal tunnel syndrome: a clinical, electrophysiological and ultrasonographical pilot study. Acupunct Med. 2025 Aug;43(4):198-207. doi: 10.1177/09645284251363989. Epub 2025 Aug 4.
PubMed 40760926
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Electroacupuncture in Carpal Tunnel Syndrome: a Clinical, Electrophysiologic and Ultrasonographic Study
- ClinicalTrials.gov ID
- NCT04603274
- Acronym / sponsor ID
- 233/30-06-2020 electroacup
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Collaborators
- University of West Attica, Lilian Voudouri Foundation
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Oct 2020 (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 aim of this clinical study is to assess the effectiveness of electroacupuncture in reducing the severity of symptoms, in improving limb function, in improving the aesthetic and motor conduction of the median nerve and in reducing its cross-sectional area at the inlet of the carpal tunnel in patients with carpal tunnel syndrome. All upper extremities diagnosed with carpal tunnel syndrome will be treated with electroacupuncture for 8 sessions. Clinical, electrophysiological and ultrasonography outcome measures will be evaluated before and after the intervention, to assess the result.
Detailed description
Carpal tunnel syndrome (CTS) is the most common mononeuritis, with a significant burden on both patients and public health. For mild and moderate cases, conservative methods, including immobilization, corticosteroid injections, oral medications and physical therapy have been suggested as appropriate treatments, with mixed results. Acupuncture and related therapies has been used worldwide over the last few years in the management of CTS, with generally positive results. However, more studies will be needed to assess the role of acupuncture as an independent therapeutic modality to CTS.
This is a clinical study that will be conducted in the pain clinic at the department of Anaesthesiology of Aretaieion University Hospital as well as in the Laboratory of Musculoskeletal Physiotherapy of University of West Attica, with which there is a cooperation agreement. All recruited participants will be treated with the same acupuncture protocol at the limb that will be diagnosed with carpal tunnel syndrome. If the patients are diagnosed with bilateral CTS, both wrists will be treated. Clinical, electrophysiological and ultrasonography outcomes will be measured before and after the intervention.
In order to record the possible influence of psychosomatic characteristics, the Greek version of the Hospital Anxiety \& Depression (HAD) Scale will be used before the treatment. As a result the anxiety and the depression of the participants will be quantified with a simple clinical tool.
All participants will accept 8 sessions of electroacupuncture, 2 days a week for 1 month by experienced physicians.
All participants in the study will be evaluated 3-7 days before and 3-7 days after the treatment protocol with clinical, electrophysiological and ultrasonographical outcome measures. In patients with bilateral symptoms, each limb will be assessed separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| upper extremity diagnosed with carpal tunnel syndrome | Other | Procedure: 8 sessions of electroacupuncture to the upper limb with carpal tunnel syndrome8 sessions of electroacupuncture, 2 days a week for 1 month by experienced physicians |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- paraesthesia, numbness, pain in the area of distribution of the median nerve
- worsening of symptoms at night or with repeated movements of the wrist
- aesthetic or/and motor deficits in the area of distribution of the median nerve
- Median sensory nerve conduction velocity (SNCV), first digit to wrist <42 m/s
- Median distal motor latency (DML), wrist to thenar eminence >4 ms.
Key exclusion criteria (14 listed)
- age<18 years
- absence of the above electrophysiological criteria
- diagnosis of another disease during the electrophysiological test
- patients with severe carpal tunnel syndrome to be operated on
- thenar muscle atrophy
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 |
|---|---|---|
| 8 sessions of electroacupuncture to the upper limb with carpal tunnel syndromeAll participants will accept 8 sessions of electroacupuncture, 2 days a week for 1 month by experienced physicians. Acupuncture sterile disposable needles 0,25x 0,25 mm will be inserted for 20 minutes at specific acupuncture points to all patients. Electrical stimulation will be applied at specific acupuncture points for 20 minutes. | Procedure or surgery | upper extremity diagnosed with carpal tunnel syndrome |
Primary outcome
change from baseline in Symptom Severity Scale (SSS) of -the Greek- Boston carpal tunnel questionnaire (BCTQ)
Time frame: 3-7 days after the treatment protocol
The Boston carpal tunnel questionnaire (BCTQ) is an easy, disease-specific measurement of self-reported symptom severity and functional status for carpal tunnel syndrome (CTS). It has two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and the Functional Status Scale (FSS) containing 8 questions. Each scale using a five-point rating score generates a final score which ranges from 1 to 5, with the higher indicating greater disability. We will use the Greek version of the BCTQ, which had been examined for reliability and validity and responsiveness before and after the intervention.
9 secondary outcomes
change from baseline in Functional Status Scale (FSS) of -the Greek- Boston carpal tunnel questionnaire (BCTQ)
Time frame: 3-7 days after the treatment protocol
change from baseline in Visual Analogue Scale (VAS)
Time frame: 3-7 days after the treatment protocol
change from baseline in median sensory nerve conduction velocity (SNCV)
Time frame: 3-7 days after the treatment protocol
change from baseline in median distal motor latency (DML)
Time frame: 3-7 days after the treatment protocol
change from baseline in median sensory nerve action potential (SNAP)
Time frame: 3-7 days after the treatment protocol
change from baseline in cross sectional area of the median nerve
Time frame: 3-7 days after the treatment protocol
adverse events
Time frame: 3-7 days after the treatment protocol
number of patients who require medication throughout treatment
Time frame: 3-7 days after the treatment protocol
change from baseline in distal sensory latency (DSL) of the median nerve
Time frame: 3-7 days after the treatment protocol
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 1 Feb 2022.
- Background: PubMed 28825339Bougea A, Zambelis T, Voskou P, Katsika PZ, Tzavara C, Kokotis P, Karandreas N. Reliability and Validation of the Greek Version of the Boston Carpal Tunnel Questionnaire. Hand (N Y). 2018 Sep;13(5):593-599. doi: 10.1177/1558944717725379. Epub 2017 Aug 20.
- Background: PubMed 27869627Graham B, Peljovich AE, Afra R, Cho MS, Gray R, Stephenson J, Gurman A, MacDermid J, Mlady G, Patel AT, Rempel D, Rozental TD, Salajegheh MK, Keith MW, Jevsevar DS, Shea KG, Bozic KJ, Adams J, Evans JM, Lubahn J, Ray WZ, Spinner R, Thomson G, Shaffer WO, Cummins DS, Murray JN, Mohiuddin M, Mullen K, Shores P, Woznica A, Linskey E, Martinez Y, Sevarino K. The American Academy of Orthopaedic Surgeons Evidence-Based Clinical Practice Guideline on: Management of Carpal Tunnel Syndrome. J Bone Joint Surg Am. 2016 Oct 19;98(20):1750-1754. doi: 10.2106/JBJS.16.00719. No abstract available.
- Background: PubMed 12058083Jablecki CK, Andary MT, Floeter MK, Miller RG, Quartly CA, Vennix MJ, Wilson JR; American Association of Electrodiagnostic Medicine; American Academy of Neurology; American Academy of Physical Medicine and Rehabilitation. Practice parameter: Electrodiagnostic studies in carpal tunnel syndrome [RETIRED]. Report of the American Association of Electrodiagnostic Medicine, American Academy of Neurology, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2002 Jun 11;58(11):1589-92. doi: 10.1212/wnl.58.11.1589. No abstract available.
- Background: PubMed 8245050Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.
- Background: PubMed 3078045McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. doi: 10.1017/s0033291700009934.
- Background: PubMed 18325093Michopoulos I, Douzenis A, Kalkavoura C, Christodoulou C, Michalopoulou P, Kalemi G, Fineti K, Patapis P, Protopapas K, Lykouras L. Hospital Anxiety and Depression Scale (HADS): validation in a Greek general hospital sample. Ann Gen Psychiatry. 2008 Mar 6;7:4. doi: 10.1186/1744-859X-7-4.
- Background: PubMed 29166787Milone MT, Karim A, Klifto CS, Capo JT. Analysis of Expected Costs of Carpal Tunnel Syndrome Treatment Strategies. Hand (N Y). 2019 May;14(3):317-323. doi: 10.1177/1558944717743597. Epub 2017 Nov 22.
- Background: PubMed 9325471Padua L, LoMonaco M, Gregori B, Valente EM, Padua R, Tonali P. Neurophysiological classification and sensitivity in 500 carpal tunnel syndrome hands. Acta Neurol Scand. 1997 Oct;96(4):211-7. doi: 10.1111/j.1600-0404.1997.tb00271.x.
- Background: PubMed 3080166Snaith RP, Zigmond AS. The hospital anxiety and depression scale. Br Med J (Clin Res Ed). 1986 Feb 1;292(6516):344. doi: 10.1136/bmj.292.6516.344. No abstract available.
- Background: PubMed 31556315Wu IX, Lam VC, Ho RS, Cheung WK, Sit RW, Chou LW, Zhang Y, Leung TH, Chung VC. Acupuncture and related interventions for carpal tunnel syndrome: systematic review. Clin Rehabil. 2020 Jan;34(1):34-44. doi: 10.1177/0269215519877511. Epub 2019 Sep 26.
- Derived from this study: PubMed 40760926Ntoutsouli AM, Georgoudis G, Papapostolou A, Karavis M, Petrou DD, Vadalouca A, Theodoraki K. Effects of electroacupuncture on carpal tunnel syndrome: a clinical, electrophysiological and ultrasonographical pilot study. Acupunct Med. 2025 Aug;43(4):198-207. doi: 10.1177/09645284251363989. Epub 2025 Aug 4.
- Individual participant dataSharing planned: No
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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.
Kassiani Theodoraki, PhD, DESA principal investigator
Aretaieion University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8 sessions of electroacupuncture to the upper limb with carpal tunnel syndrome in people with Carpal Tunnel and Carpal Tunnel Syndrome, run by Aretaieion University Hospital at 2 sites in Greece.
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 8 inclusion and 14 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 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
change from baseline in Symptom Severity Scale (SSS) of -the Greek- Boston carpal tunnel questionnaire (BCTQ) (time frame: 3-7 days after the treatment protocol). 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 NCT04603274, which also lists 11 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 1 Feb 2022.