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

NCT ID: NCT02870673

Last Updated: 2016-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-09-30

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

SHINCORT

Intervention Type: DRUG

triamcinolone Acetonide (10mg/ml) 0.5 ml

XYLOCAINE

Intervention Type: DRUG

xylocaine(20mg/ml) 0.5 ml

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).

Group Type: EXPERIMENTAL

sham electroacupuncture

Intervention Type: DEVICE

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

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).

Group Type: EXPERIMENTAL

electroacupuncture

Intervention Type: DEVICE

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

Interventions

SHINCORT

triamcinolone Acetonide (10mg/ml) 0.5 ml

Intervention Type: DRUG

XYLOCAINE

xylocaine(20mg/ml) 0.5 ml

Intervention Type: DRUG

sham electroacupuncture

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

Intervention Type: DEVICE

electroacupuncture

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

Intervention Type: DEVICE

Other Intervention Names

triamcinolone Acetonide; XYLOCAINE IV INJECTION

Eligibility 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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

You-Jen Tang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

You-Jen Tang, MD

Role: CONTACT

9502060@gmail.com

+886932182791

Other Identifiers

N201605074

Identifier Type: -

Identifier Source: org_study_id