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

August 18, 2016 updated by: You-Jen Tang, Taipei Medical University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • triamcinolone Acetonide
Drug: XYLOCAINE
xylocaine(20mg/ml) 0.5 ml
Other Names:
  • 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))

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain assessed on visual analog scale
Time Frame: 24 weeks
24 weeks
Boston Carpal Tunnel Syndrome Questionaire
Time Frame: 24 weeks
24 weeks
The 6-item CTS symptoms scale
Time Frame: 24 weeks
24 weeks
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 )
24 weeks
hand grip power
Time Frame: 24 weeks
Jamar Hand grip Dynamometer as the measuring tool
24 weeks
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame: 24 weeks
24 weeks
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).
24 weeks
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)].
24 weeks
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)].
24 weeks
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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

August 8, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 17, 2016

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201605074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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