Acupuncture for chronic neck pain: a pilot for a randomised controlled trial

Salter, G. C.

Roman, M.

Bland, J. M.

MacPherson, H.

2006

7(1)

99-

RCT

Acu + Usual Care Versus Usual Care

Acupressure

Acupuncture

Exercise

Individualized Acupuncture Protocol

Massage

Neck Pain

Pain

Pilot Study

RCT

Restricted Modalities, Acupuncture + Other

Usual Care Control, Multimodality

TCM Acupuncture Style

Traditional Diagnosis Based Point Selection

Trigger Point Acupuncture Style

ABSTRACT: BACKGROUND: Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. METHODS: Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture (up to 10 treatments over 3 months) as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ) at 3 months. The primary analysis was to determine the sample size for the full scale study. RESULTS: Of the 227 patients with neck pain identified from the GP database, 28 (12.3%) consenting patients were eligible to participate in the pilot and 24 (10.5%) were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients). CONCLUSIONS: This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for neck pain. Trial Registration: ISRCTN06223266

Neck Pain

<1/WK

24

12 Weeks