Recruitment methods and costs for a randomized, placebo-controlled trial of chiropractic care for lumbar spinal stenosis: a single-site pilot study.
ABSTRACT The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis.
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.
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).
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.
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ABSTRACT: OBJECTIVE: The purpose of this study was to quantify lumbar zygapophyseal (Z) joint space separation (gapping) in low back pain (LBP) subjects after spinal manipulative therapy (SMT) or side-posture positioning (SPP). METHODS: This was a controlled mechanisms trial with randomization and blinding. Acute LBP subjects (N = 112; four n = 28 magnetic resonance imaging [MRI] protocol groups) had 2 MRI appointments (initial enrollment and after 2 weeks of chiropractic treatment, receiving 2 MRI scans of the L4/L5 and L5/S1 Z joints at each MRI appointment. After the first MRI scan of each appointment, subjects were randomized (initial enrollment appointment) or assigned (after 2 weeks of chiropractic treatment appointment) into SPP (nonmanipulation), SMT (manipulation), or control MRI protocol groups. After SPP or SMT, a second MRI was taken. The central anterior-posterior joint space was measured. Difference between most painful side anterior-posterior measurements taken postintervention and preintervention was the Z joint "gapping difference." Gapping differences were compared (analysis of variance) among protocol groups. Secondary measures of pain (visual analog scale, verbal numeric pain rating scale) and function (Bournemouth questionnaire) were assessed. RESULTS: Gapping differences were significant at the first (adjusted, P = .009; SPP, 0.66 ± 0.48 mm; SMT, 0.23 ± 0.86; control, 0.18 ± 0.71) and second (adjusted, P = .0005; SPP, 0.65 ± 0.92 mm; SMT, 0.89 ± 0.71; control, 0.35 ± 0.32) MRI appointments. Verbal numeric pain rating scale differences were significant at first MRI appointment (P = .04) with SMT showing the greatest improvement. Visual analog scale and Bournemouth questionnaire improved after 2 weeks of care in all groups (both P < .0001). CONCLUSIONS: Side-posture positioning showed greatest gapping at baseline. After 2 weeks, SMT resulted in greatest gapping. Side-posture positioning appeared to have additive therapeutic benefit to SMT.Journal of manipulative and physiological therapeutics 05/2013; 36(4). DOI:10.1016/j.jmpt.2013.04.003 · 1.25 Impact Factor
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ABSTRACT: To measure the impact of newspaper advertising across Scotland on patient interest, and subsequent recruitment into the Standard Care versus Celecoxib Outcome Trial (SCOT) - a clinical trial investigating the cardiovascular safety of non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis. Newspaper advertisements about the SCOT trial were placed sequentially in regional and national Scottish newspapers. The number of phone calls as a result of exposure to the advertisements, and ongoing study recruitment rates were recorded before, during and after the advertising campaign. To enroll in SCOT individuals had to be registered with a participating GP practice. The total cost for the advertising campaign was £46,250 and 320 phone calls were received as a result of individuals responding to the newspaper advertisements. 172 individuals were identified as possibly suitable to be included in the study however only 36 were registered at participating GP practices, 17 completed a screening visit and 15 finally randomised into the study. The average cost per respondent individual was £144 and the average cost per randomised patient was £3083. Analysis of recruitment rate trends showed that there was no impact of the newspaper advertising campaign on increasing recruitment into SCOT. Advertisements placed in local and national newspapers were not an effective recruitment strategy for the SCOT trial. The advertisements attracted relatively small numbers of respondents, many of whom did not meet study inclusion criteria or were not registered at a participating GP practice.British Journal of Clinical Pharmacology 11/2013; 77(6). DOI:10.1111/bcp.12262 · 3.69 Impact Factor
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ABSTRACT: Objective The purpose of this pilot clinical trial was to assess the feasibility of recruiting older adults with lumbar spinal stenosis (LSS) into a clinical trial that used different dosages of flexion-distraction manipulation. Methods This randomized controlled trial used a 4-group design. Three groups consisted of chiropractic flexion-distraction manipulation applied at different dosages (8, 12, or 18 treatments). The fourth group was given 8 treatments of placebo care. Feasibility measures included recruitment goals, adherence to various treatment schedules, credibility of the placebo treatment, and rates of adverse events. The primary outcome measure was the Swiss Spinal Stenosis Questionnaire, a validated self-report of LSS symptom severity and physical function. Results The recruitment and adherence goals of the study were met with a total of 60 subjects randomized (n = 15 per group) and most subjects attending at least 75% of their scheduled visits. No adverse events were reported by any of the subjects in the trial. Our placebo treatment did not appear to be credible; most subjects correctly guessed that they were receiving a placebo treatment. Between-group effect size estimates were small, indicating larger samples are needed for future studies. Conclusion This pilot study showed that it is feasible to recruit patients with LSS and that most subjects will adhere to a 6-week treatment schedule. The information gained from this trial will be useful to inform the design of larger trials.Journal of Manipulative and Physiological Therapeutics 07/2014; 37(6). DOI:10.1016/j.jmpt.2014.05.005 · 1.25 Impact Factor