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Trial History Detail on 2014-12-08

CUHK_CCT00297

2011-09-08

Prospective

09100681

Health and Health Service Research Fund (HHSRF)

JC School of Public Health and Primary Care, The Chinese University of Hong Kong
The Chinese University of Hong Kong

Lek Yuen Health Center, Shatin, Hong Kong

Vincent Chi Ho, Chung

4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong

2252-8759

vchung@cuhk.edu.hk

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

Vincent Chi Ho, Chung

4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong

2252-8759

vchung@cuhk.edu.hk

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

Electroacupuncture and Wrist Splinting for Carpal Tunnel Syndrome: A Randomized Trial in Primary Care Setting

Electroacupuncture and Wrist Splinting for Carpal Tunnel Syndrome: A Randomized Trial in Primary Care Setting

Nil

Hong Kong

Yes

2010-09-14

Carpal Tunnel Syndrome (CTS)

Other

Electroacupuncture and Wrist Splinting

Night Splinting Plus Electroacupuncture Group: After baseline assessment, patient randomised to the night splint plus acupuncture group will receive a wrist splint with neutral positioning. A 20 minutes face to face structured education will also be provided. Patients will be instructed to wear the splint during the night during the trial period.
On top of night splinting, patients will receive 13 sessions of acupuncture over 17 weeks. Each patient will receive acupuncture on 8 fixed and traditional acupuncture points (TW-5, PC-7, HT-3, PC-3, SI-4, LI-5, LI-10 and LU-5) on the affected side (both sides will be treated for bilateral CTS but only outcomes from the dominant hand will be included in the analysis). The Chinese Medicine Practitioner (CMP) performing the acupuncture treatment will insert sterile, single-use filiform acupuncture needles, with a length of 10–30 mm and a diameter of 0.20 mm, with the aid of a guide tube at each of the points, after first disinfecting the skin and with the patient in decubitus. The puncture will be made in accordance with the standards of TCM, to a depth of 1–3 cm, depending on the thickness of the patients’ wrist, hand and forearm. The insertion will be followed by stimulation performed with bidirectional rotation actions of the needle sheath in order to produce the sensation known as De qi. Then, all acupoints will be subjected to 5 Hz electroacupuncture in the following combination: (1) TW-5 and PC-7, (2) SI-4 and LI-5, (3) LI-10 and LU-5, and (4) HT-3 and PC-3. The intensity (5-10 mA) will be adjusted to produce a muscle twitch that is acceptable to the patient. The electroacupuncture treatment will last for 20 minutes. The procedure will be standardized and documented according to the STRICTA requirement. Three CMP registered with the Chinese Medicine Council of Hong Kong will carry out the acupuncture treatment. All of them will have at least 3 years of clinical experience in practising acupuncture.

17 weeks

Night Splinting Plus Waiting List Group: After baseline assessment, patient randomised to the night splint plus acupuncture group will receive a wrist splint with neutral positioning. A 20 minutes face to face structured education will also be provided. Patients will be instructed to wear the splint during the night during the trial period.
Meanwhile, they will be assigned to an acupuncture waiting list, and acupuncture treatment will be offered to these patients after the fourth follow up (17 weeks after baseline assessment), if they wished to.

Patients aged 18-70 and fulfilling the Katz CTS hand diagram criteria of (1) Classic / Probable Symptoms or (2) Possible Symptoms. Eligible patients should also (3) have the ability to read and speak Chinese (Cantonese), and (4) agree to sign the Informed consent and (5) are willing to attend follow up and / or electroacupuncture sessions.

Patients with symptoms and signs of axonal loss and evident median nerve denervation, including (1) constant numbness, (2) loss of sensibility, and (3) thenar muscular atrophy or weakness will be excluded. Patients with secondary CTS caused by inflammatory arthropathy, coexisting cervical radical radiculopathy, polyneuropathy, diabetes mellitus, pregnancy, malignancy, hypothyroidism, alcoholism, rheumatoid arthritis, space-occupying lesions (tumours, hypertrophic synovial tissue, fracture callus, and osteophytes), infections, and familial neuropathy will also be excluded. In particular, cervical radiculopathy will be actively ruled out by assessing the existence of related symptoms and signs, including neck pain, reduced reflexes, less well demarcated dermatomal involvement, and positive Spurling’s test. Patients who received previous carpal tunnel release surgery, or have used warfarin, oral steroid, local steroid injection, night splint or acupuncture for CTS in the past 6 months, or other serious illnesses will be considered as ineligible.

18 years old

70 years old

Both Male and Female

Interventional

Randomized

Active

Single-blind

Parallel

2012-04-01

182

Complete

Boston Carpal Tunnel Questionnaire Scoring at 1,2,5 and 17 weeks

1. Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
2. A 0 to 10 point numerical rating scale to measure pain intensity.
3. Tip pinch strength (TPS)
4. Semmes-Weinstein monofilament testing (SWMT)
5. Dellon-modified Moberg pick-up test (DMMPUT)

No

2015-08-18

ChiCTR-TRC-11001655

2011-11-04


Yes

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