Objectives: To assess the feasibility of patient recruitment, the ability o
f patients and clinicians to comply with study protocols, and the use of da
ta collection instruments to collect cost-effectiveness data, and to obtain
variability estimates for sample-size calculations for a full-scale trial.
Study Design: Prospective, observer-blinded, pilot randomized clinical tria
l.
Setting: Primary contact chiropractic and medical clinics.
Patients: Ages 20 to 65 years, with low back-related radiating leg pain (sc
iatica).
Outcome Measures: Self-report questionnaires were administered at baseline
and 3 and 12 weeks after randomization. The measures included leg and back
pain severity, frequency and bothersomeness of symptoms, leg/back disabilit
y, medication use, global improvement, satisfaction and health care utiliza
tion.
Interventions: Medical care, chiropractic care, and epidural steroid inject
ions.
Results: A total of 706 persons were screened by phone to deter mine initia
l eligibility. Of these, over 90% of those persons contacted did not meet t
he entrance criteria. The most common reason for disqualification was that
the duration of the complaint was longer than 3 months. Twenty patients wer
e randomized into the study. All 3 groups showed substantial improvements i
n the main patient-rated outcomes at the end of the 12-week intervention ph
ase. For leg pain, back pain, frequency and bothersomeness of leg symptoms,
and Roland-Morris disability score, the percent improvement varied from 50
% to 84%, and the corresponding effect sizes ranged from 0.8 to 2.2. Bother
someness of leg symptoms was the most responsive outcome associated with th
e largest magnitude of effect size. All within-group changes from baseline
were statistically significant (P <.01). No between-group comparisons were
planned or performed because of the insufficient sample size and high risk
of committing type I and type II errors.
Conclusions: Pilot studies such as these are important for the determinatio
n of the feasibility of conducting costly, larger scale trials. Recruitment
for a full-scale study of sciatica of 1 to 12 weeks duration is not feasib
le, given the methods used in this pilot study. Our results do indicate, ho
wever, that there are substantial numbers of patients with sciatica more ch
ronic in nature who would be interested in participating in a similar study
. In addition, collaboration with a local health maintenance organization w
ould likely facilitate clinician referrals and optimize the recruitment pro
cess. Patient and provider compliance was high in the pilot study, which in
dicates that most study protocols are feasible. Additionally, we were able
to collect complete outcomes data, including those regarding health care us
e. A suggested modification by investigators and outside consultants has re
sulted in the replacement of the medication group with a minimal interventi
on control group tie, self-care advice). As a result, a second pilot study
of patients with sciatica of more than 1 weeks duration has been planned be
fore a full-scale trial is attempted.