Pain Clinical Trial
Official title:
Efficacy of Electroacupuncture in Carpal Tunnel Syndrome: a Clinical, Electrophysiologic and Ultrasonographic Study
Verified date | January 2022 |
Source | Aretaieion University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
Greece | Laboratory of Musculoskeletal Physiotherapy of University of West Attica | Athens | |
Greece | Pain Clinic of Aretaieion University Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
Aretaieion University Hospital | Lilian Voudouri Foundation, University of West Attica |
Greece,
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. — View Citation
Graham 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. — View Citation
Jablecki 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. 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. — View Citation
Levine 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. — View Citation
McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. Review. — View Citation
Michopoulos 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. — View Citation
Milone 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. — View Citation
Padua 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. — View Citation
Snaith RP, Zigmond AS. The hospital anxiety and depression scale. Br Med J (Clin Res Ed). 1986 Feb 1;292(6516):344. — View Citation
Wu 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3-7 days after the treatment protocol | |
Secondary | 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. | 3-7 days after the treatment protocol | |
Secondary | 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. | 3-7 days after the treatment protocol | |
Secondary | 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 | 3-7 days after the treatment protocol | |
Secondary | 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 | 3-7 days after the treatment protocol | |
Secondary | 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 | 3-7 days after the treatment protocol | |
Secondary | 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) | 3-7 days after the treatment protocol | |
Secondary | adverse events | number of patients who develop adverse events | 3-7 days after the treatment protocol | |
Secondary | number of patients who require medication throughout treatment | need for additional medication throughout treatment | 3-7 days after the treatment protocol | |
Secondary | 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 | 3-7 days after the treatment protocol |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Terminated |
NCT04356352 -
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
|
Phase 2/Phase 3 | |
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04466111 -
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
|
||
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05868122 -
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
|
Phase 3 | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
Enrolling by invitation |
NCT06087432 -
Is PNF Application Effective on Temporomandibular Dysfunction
|
N/A | |
Completed |
NCT05508594 -
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
|
Phase 2/Phase 3 | |
Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Completed |
NCT02913027 -
Can We Improve the Comfort of Pelvic Exams?
|
N/A | |
Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
|
Phase 4 | |
Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
|