Prospective

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

Yes

2010-09-14

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 customized, fabricated wrist splint positioning the wrist in neutral (0°) and the Metacarpophalangeal joints from 0° to 10° of flexion. A 20 minutes face to face structured education will also be provided according to a published study. These will be provided by a trained occupational therapist with research experience. Patients will be instructed to wear the splint during the night for 5 weeks. The reasons for this is that (1) symptoms are often worse at night, (2)compliance at night is higher than during the day and (3) splinting may interfere with daily activity. Their weekly compliance with splint wearing instruction will be measured by a brief question at each follow up (wearing splint weekly for: 0-1 nights, 2-3 nights, 4-5 nights, 6-7 nights). Voltaren 25 mg three times a day as needed will be allowed as an additional medication and their consumption will be recorded at each follow up.
The acupuncture treatment procedure is designed base on fMRI evaluation studies of acupuncture for CTS patients performed by Napadow et al. Their protocol of acupuncture treatment is showed to demonstrate beneficial neurological responses amongst CTS patients. These responses include pain killing action via the activation of hypothalamus and deactivation in the amygdala, as well as beneficial cortical plasticity manifested by more focused digital representations. By synthesising the Napadow protocol and a review on recent TCM literature, we have devised the following acupuncture treatment plan. On top of night splinting, patients will receive 13 sessions of acupuncture over 5 weeks, (3 sessions / week at the first 3 weeks, and 2 sessions / week at the subsequent 2 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. Electroacupuncture will be conducted by KWD 808 I electroacupuncture device. (http://www.mayfairmed.com/web/chi/showpro.asp?product=EY3334).
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. To ensure standardization of acupuncture treatment, they will be co-piloting the documented procedure on 15 patients. Treatment compliance will be monitored by attendance to acupuncture appointment. Patient will be advised not to seek any other alternative treatment (including any TCM / WM treatment or physiotherapy) during the trial period. They will be encouraged to seek medical attention at the trial clinic (LYHC), if needed. In this case, patients will be referred to a doctor that is blinded to treatment assignment and patients’ self disclosure of allocation status will be actively discouraged. Use of other any additional treatment will be recorded by questionnaire during follow ups.

17 weeks

Night Splinting Plus Waiting List for Electroacupuncture Group
Patient randomised to night splint plus waiting list group will receive custom splints and structured education as described in section 5.1, after baseline assessment. Similarly, their weekly compliance with splint wearing instruction will be measured by a brief question at each follow up (wearing splint weekly for: 0-1 nights, 2-3 nights, 4-5 nights, 6-7 nights). Voltaren 25 mg three times a day as needed will be allowed as an additional medication and their consumption will be recorded at each follow up. 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. They will be advised not to seek any other alternative treatment (including any TCM / WM treatment or physiotherapy) during the trial period. If necessary, they will be encouraged to seek medical attention at the trial clinic (LYHC). In this case, patients will be referred to a doctor that is blinded to treatment assignment and patients’ self disclosure of allocation status will be actively discouraged. Use of other any additional treatment will be recorded by questionnaire during follow ups.

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

Randomized

Active

Single-blind

Parallel

No

Yes

Nil