Recruitment Methods and Costs for a Randomized, Placebo-Controlled Trial of Chiropractic Care for Lumbar Spinal Stenosis: A Single-Site Pilot Study

Abstract 

Objective

The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis.

Methods

This randomized, placebo-controlled pilot study investigated the efficacy of different amounts of total treatment dosage over 6 weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects were recruited for this study through several media venues, focusing on successful and cost-effective strategies. Included in our efforts were radio advertising, newspaper advertising, direct mail, and various other low-cost initiatives.

Results

Of the 1211 telephone screens, 60 responders (5.0%) were randomized into the study. The most successful recruitment method was radio advertising, generating more than 64% of the calls (776 subjects). Newspaper and magazine advertising generated approximately 9% of all calls (108 subjects), and direct mail generated less than 7% (79 subjects). The total direct cost for recruitment was $40 740 or $679 per randomized patient. The costs per randomization were highest for direct mail ($995 per randomization) and lowest for newspaper/magazine advertising ($558 per randomization).

Conclusions

Success of recruitment methods may vary based on target population and location. Planning of recruitment efforts is essential to the success of any clinical trial.

Key Indexing Terms: Patient Selection, Patient Participation, Chiropractic, Complementary Therapies, Low Back Pain, Spinal Stenosis