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Trial record 19 of 427 for:    Taipei Medical University Hospital

Assessment of the Effectiveness of Ultrasound-guided Acupuncture in the Management of Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT02870673
Recruitment Status : Unknown
Verified August 2016 by You-Jen Tang, Taipei Medical University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 17, 2016
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
You-Jen Tang, Taipei Medical University Hospital

Brief Summary:

In clinical practice, carpal tunnel syndrome (CTS) is the common disease of peripheral neuropathy and usually happened to female, mid-age population, overweight persons, and those who overused their hands for work or production. Some research claimed this might be correlated to anatomical characteristics such as the longer anteroposterior diameter or smaller cross section area of the wrist. Preliminary symptoms often start with sensory domain (pain, tingling, paresthesia and especially night awakening due to symptoms mentioned above) and then progress to motor domain (thenar muscle atrophy and clumsiness) if left untreated.

Depending on the severity, patient's willingness and convenience, there are many options for CTS. For those whose symptoms are mild to moderate, conservative therapies are usually the first choice, including physiotherapies, local injection and night splints. Local steroid is proven to be effective to relieve the symptoms of CTS shortly up to 3 months. However, the effects will decline gradually and repetitive injections is suggestive. The patients with severe symptoms which comprise thenar muscle atrophy will be advised to receive decompression surgery.the surgery can alleviate the illness with high success rate up to 70%. Unfortunately, there are still patients who will relapse or undergo side effects, for example, finger weakness.

In recent years, acupuncture researches focused on CTS intervention have been outgrowing and promising. Whereas, there are still lack of evidence which stands for the therapeutic effects comparing with local steroid injection. This limits the built-up of suspect mechanism of acupuncture intervention for CTS.

This is a preliminary, randomized and single-blinded study which started since 2016 and last for a year. The investigators utilize ultrasound to guide the depth of needle penetration which prevents unnecessarily tissues injury such as artery or dry needle injury. This procedure also guarantees the needles lie directly on the upper surface of the median nerve. One group will receive electrical stimulation and another won't. The investigators use electromyography, cross-section area of median nerve, visual analog scale, Boston Carpal Tunnel Syndrome Questionnaire, six-item scale, The disabilities of the arm, shoulder and hand score and Jamar grip dynamometer as outcome measurements. The results gathered from two experimental groups will be compared with the data from the control group whose participants only receiving local steroid injection once in the first week. The participants are all above 18 years old and complain of illness for a least 3 months without any surgery or local injection for a least 1 year. The investigators set up strict exclusive criteria and sample size estimation is 70.


Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: SHINCORT Drug: XYLOCAINE Device: sham electroacupuncture Device: electroacupuncture Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Effectiveness of Ultrasound-guided Acupuncture in the Management of Carpal Tunnel Syndrome
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017


Arm Intervention/treatment
Active Comparator: Injection of Shincort 0.5 ml and Xylocaine 0.5ml mixture

In the first week of recruitment, this group will receive the local injection around the distal wrist crease with mixture of Shincort Inj(10mg/ml) 0.5 ml and xylocaine(20mg/ml) 0.5 ml only one time.

The ultrasound-guided procedure is performed by the orthopedic physician.

Drug: SHINCORT
triamcinolone Acetonide (10mg/ml) 0.5 ml
Other Name: triamcinolone Acetonide

Drug: XYLOCAINE
xylocaine(20mg/ml) 0.5 ml
Other Name: XYLOCAINE IV INJECTION

Experimental: sham electroacupuncture

In this group, the participants receive acupuncture treatment and only 2 minutes electrical stimulation.

Each needle insertion depth and position are confirmed by the ultrasound. The procedure makes sure that needle pin is directly placed on the median nerve and prevent nerve penetration. Then the electrical stimulator is connected to the needles as cathode and anode and is turned on to the intensity which can induce thenar muscle contraction or reach the upper limit of the participant. After 2 minutes, the stimulator will turn off spontaneously and the participant will not be informed.

The whole course will cost 20 minutes after needles are pulled out. Every participant is asked to receive 1 treatment per week in the consecutive 3 months(total 12 times).

Device: sham electroacupuncture
1.5 inches 32 gauze stainless steel needles Transcutaneous electrical nerve stimulation machine (MODEL-05B(6))

Experimental: electroacupuncture

In this group, the participants receive acupuncture treatment and 20 minutes electrical stimulation.

Each needle insertion depth and position are confirmed by the ultrasound. The procedure makes sure that needle pin is directly placed on the median nerve and prevent nerve penetration. Then the electrical stimulator is connected to the needles as cathode and anode and is turned on to the intensity which can induce thenar muscle contraction or reach the upper limit of the participant.

The whole course will cost 20 minutes after needles are pulled out. Every participant is asked to receive 1 treatment per week in the consecutive 3 months(total 12 times).

Device: electroacupuncture
1.5 inches 32 gauze stainless steel needles Transcutaneous electrical nerve stimulation machine (MODEL-05B(6))




Primary Outcome Measures :
  1. pain assessed on visual analog scale [ Time Frame: 24 weeks ]
  2. Boston Carpal Tunnel Syndrome Questionaire [ Time Frame: 24 weeks ]
  3. The 6-item CTS symptoms scale [ Time Frame: 24 weeks ]
  4. cross sectional area(CSA) of the median nerve [ Time Frame: 24 weeks ]
    CSA of the median nerve below the distal wrist crease which is measured by the ultrasound(transverse view )

  5. hand grip power [ Time Frame: 24 weeks ]
    Jamar Hand grip Dynamometer as the measuring tool

  6. The Disabilities of the Arm, Shoulder and Hand (DASH) Score [ Time Frame: 24 weeks ]
  7. compound muscle action potential(CMAP) [ Time Frame: 24 weeks ]
    The CMAP is a summated voltage response from the individual muscle fibre action potentials and measured in millivolts (mV).

  8. Wrist-palm sensory nerve conduction velocity(Wrist-palm SNCV) [ Time Frame: 24 weeks ]
    Wrist-palm SNCV (m/s) = distance between stimulation site 1 and site 2 (mm)/[latency wrist- latency palm(ms)].

  9. motor nerve conduction velocity(MNCV) [ Time Frame: 24 weeks ]
    MNCV (m/s) = distance between stimulation site 1 and site 2 (mm)/[latency site 2 - latency site 1 (ms)].

  10. sensory nerve action potential(SNAP) [ Time Frame: 24 weeks ]
    The sensory nerve action potential (SNAP) is obtained by electrically stimulating sensory fibres and recording the nerve action potential at a point further along that nerve.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All participants are must above 20 years old,
  2. All participants are willing to join and can be cooperated with all the interviews and examinations.
  3. The symptoms are compatible with carpal tunnel syndrome, including numbness, pain, paresthesia, tingling, burning sensation over a least 2 fingers and hand motor limitation which are dominated by median nerve.These symptoms have to sustain for more than 3 months and be diagnosed by electromyography, physical examination and physicians.
  4. Those who underwent local injection including glucose, steroid or anaphylaxis will be recruited if the treatments finished more than a year.

Exclusion Criteria:

  1. symptoms due to radiculopathy (When the patient also complains of symptoms radiating to the elbow or neck movement pain, the orthopedic doctor will make the definite diagnosis. )
  2. Those who underwent decompression surgery.
  3. CTS due to traumatic injury (confirmed by image)
  4. Those who underwent local injection within a year.
  5. CTS due to rheumatoid arthritis
  6. CTS due to cancer
  7. CTS due to peripheral artery occlusive disease
  8. Those who have past history of psychosis.
  9. Pregnancy(every woman will be confirmed by urine pregnancy test)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870673


Contacts
Contact: You-Jen Tang, MD +886932182791 9502060@gmail.com

Sponsors and Collaborators
Taipei Medical University Hospital

Responsible Party: You-Jen Tang, Principal Investigator, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT02870673     History of Changes
Other Study ID Numbers: N201605074
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by You-Jen Tang, Taipei Medical University Hospital:
acupuncture
electrical stimulation
carpal tunnel syndrome

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Lidocaine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants