Dataset Information

Recruitment and enrollment for the simultaneous conduct of 2 randomized controlled trials for patients with subacute and chronic low back pain at a CAM research center.

ABSTRACT:

Objective

To describe recruitment and enrollment experiences of 2 low back pain (LBP) randomized controlled trials (RCTs).

Design

Descriptive report.

Setting

Chiropractic research center in the midwest United States that is not a fee-for-service clinic.

Participants

Both trials enrolled participants with subacute or chronic LBP without neurologic signs who had not received spinal manipulative care during the previous month. For study 1 we screened 1940 potential participants to enroll 192 participants (89 women and 103 men), mean age 40.0 +/- 9.4 years (range, 21-54 years). For study 2 we screened 1849 potential participants to enroll 240 participants (105 women and 135 men) at least 55 years old (mean, 63.1 +/- 6.7 years).

Interventions

Study 1 randomly assigned participants to 2 weeks of 2 different chiropractic techniques or a wait list control group. Study 2 randomly assigned participants to 6 weeks of 2 different chiropractic techniques or medical care consisting of 3 provider visits for medications.

Outcome measures

Recruitment source costs and yield, and baseline characteristics of enrolled versus nonparticipants were recorded.

Results

We conducted 3789 telephone screens for both trials to enroll 432 (11%) participants, at a cost in excess of $156,000 for recruitment efforts. The cost per call for all callers averaged $41, ranging from $4 to $300 based on recruitment method; for enrolled participants, the cost per call was $361, ranging from $33 to $750. Direct mail efforts accounted for 62% of all callers, 57% for enrolled participants, and had the second lowest cost per call for recruitment efforts.

Conclusions

It is important that complementary and alternative medicine (CAM) research can be successfully conducted at CAM institutions. However, the costs associated with recruitment efforts for studies conducted at CAM institutions may be higher than expected and many self-identified participants are users of the CAM therapy. Therefore, strategies for efficient recruitment methods and targeting nonusers of CAM therapies should be developed early for CAM trials.

SUBMITTER: Hondras MA

PROVIDER: S-EPMC3116528 | biostudies-literature | 2008 Oct

REPOSITORIES: biostudies-literature

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Publications

Recruitment and enrollment for the simultaneous conduct of 2 randomized controlled trials for patients with subacute and chronic low back pain at a CAM research center.

Hondras Maria A MA Long Cynthia R CR Haan Andrea G AG Spencer Lori Byrd LB Meeker William C WC

Journal of alternative and complementary medicine (New York, N.Y.) 20081001 8

<h4>Objective</h4>To describe recruitment and enrollment experiences of 2 low back pain (LBP) randomized controlled trials (RCTs).<h4>Design</h4>Descriptive report.<h4>Setting</h4>Chiropractic research center in the midwest United States that is not a fee-for-service clinic.<h4>Participants</h4>Both trials enrolled participants with subacute or chronic LBP without neurologic signs who had not received spinal manipulative care during the previous month. For study 1 we screened 1940 potential part ...[more]

PMID: 18990046

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Project description:BackgroundLow back pain (LBP) is a common musculoskeletal condition and a major cause of disability worldwide. Previous studies have found associations of biomarkers with pain and pain-related disability in LBP patients. This study aimed to explore the association between serum biomarkers and pain and disability in patients with acute or subacute axial LBP.MethodsThis study was ancillary to a parent randomized controlled trial. Enrolled participants were randomized into three intervention groups: one of two types of spinal manipulation or medical care. In the parent study, 107 adults who experienced a new episode of LBP within 3 months prior to enrollment were recruited. For this study, 90 of these 107 participants consented to have blood samples obtained, which were drawn immediately before the beginning of treatment. Seven biomarkers were chosen based on previous literature and analyzed. Clinical outcomes were pain and Oswestry Disability Index (ODI) evaluated at baseline and 4 weeks. Spearman's |r| was used to study the association of initial levels of each biomarker with pain and ODI scores at baseline and with changes in outcome scores from baseline to 4 weeks (end of treatment) within each intervention group.ResultsAt baseline, 4 of 7 biomarkers had an association with pain that was |r| ≥ .20: neuropeptide Y (NPY) (r = 0.23, p = .028), E-Selectin (r = 0.22, p = .043), vitamin D ((r = - 0.32, p = .002), and c-reactive protein (CRP) (r = 0.37, p = .001). No baseline biomarker had an association with disability that was |r| ≥ 0.20. For the correlations of baseline biomarkers with 4-week change in outcomes, vitamin D showed a correlation with change in disability and/or pain (|r| ≥ 0.20, p > .05) in manipulation-related groups, while CRP, NPY, and E-selectin along with TNFα, Substance P and RANTES showed at least one correlation with change in pain or disability (|r| ≥ 0.20, p > .05) in at least one of the treatment groups.ConclusionsIn 90 LBP patients, the analyzed biomarkers, especially vitamin D, represent a small set of potential candidates for further research aimed at individualizing patient care. Overall, the associations investigated in the current study are an initial step in identifying the direct mechanisms of LBP and predicting outcomes of manipulation-related treatments or medical care.Trial registrationClinicalTrials.gov Identifier: NCT01211613, Date of Registration: September 29, 2010, https://clinicaltrials.gov/ct2/show/NCT01211613?term=schneider&cond=Low+Back+Pain&cntry=US&state=US%3APA&draw=2&rank=1.

Project description:BackgroundPatients with back and neck pain are often seen in primary care and it is important to provide them with tailored interventions based on risk stratification/triage. The STarT Back Screening Tool (SBT) is a widely used screening questionnaire which has not yet been validated for a population with back and/or neck pain with short duration. Our aim was to compare the concurrent validity of the SBT and the short form of the ÖMPSQ including psychometric properties and clinical utility in a primary care setting.MethodsPatients who applied for physiotherapy by direct access (January 2013 to January 2014) at 35 primary care centers in south Sweden, with acute or subacute back and/or neck pain, aged 18-67 years, who were not currently on sick leave or had been on sick leave less than 60 days were asked to complete the SBT and ÖMPSQ-short questionnaire (n = 329). We used the Spearman's rank correlations to study correlations, cross tabulation and Cohen's kappa to analyze agreement of patient classification. Clinical utility was described as clinician scoring miscalculations and misclassifications of total and/or subscale scores.ResultsCompleted SBT (9-items) and ÖMPSQ-short (10-items) data were available for 315/329 patients respectively. The statistical correlation for SBT and ÖMPSQ-short total scores was moderately strong (0.62, p < 0.01). In subgroup analyses, the correlations were 0.69 (p < 0.01) for males and 0.57 (p < 0.01) for females. The correlations were lower among older age groups, especially females over 50 years (0.21, p = 0.11). Classification to high or low risk for long-term pain and disability had moderate agreement (κ = 0.42). Observed classification agreement was 70.2%. The SBT had fewer miscalculations (13/315) than the ÖMPSQ-short (54/315).ConclusionsThe correlation between the SBT and the ÖMPSQ-short scores were moderately strong for individuals with acute or subacute back and/or neck pain. SBT seemed to be clinically feasible to use in clinical practice. We therefore suggest that SBT can be used for individuals with both BP and/or NP in primary care settings but it is important to be aware of that SBT's agreement with the ÖMPSQ-short was poor among females aged over 50 years.Trial registrationClinicalTrials.gov ID: NCT02609750 Registered: November 18, 2015.

Dataset Information

Recruitment and enrollment for the simultaneous conduct of 2 randomized controlled trials for patients with subacute and chronic low back pain at a CAM research center.

Objective

Design

Setting

Participants

Interventions

Outcome measures

Results

Conclusions

Publications

Recruitment and enrollment for the simultaneous conduct of 2 randomized controlled trials for patients with subacute and chronic low back pain at a CAM research center.

Similar Datasets

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