Lymphocyte profiles in patients with chronic low back pain enrolled in a clinical trial.

OBJECTIVE: Our earlier findings suggest that patients with musculoskeletal complaints have lower numbers and percentages of natural killer (NK) cells than asymptomatic subjects. This study examines patient lymphocyte profiles, as a secondary outcome measure, in a trial of manipulative therapies to treat chronic low back pain (LBP) of mechanical origin.
DESIGN: The patients were compared in a randomized controlled trial. Baseline measures were collected at the initial visit; all patients were scheduled for 11 treatments in 14 days. Treatment consisted of either a high-force, high-velocity, low-amplitude manipulation procedure; a low-force, high-velocity, low-amplitude procedure or a series of educational lectures on lower back pain. Posttreatment measures were collected at the final treatment session; follow-up measures were obtained 2 wk later.
SETTING: The study was conducted at a chiropractic teaching clinic in the suburban Chicago area. PARTICIPANTS: Individuals over 18 were eligible if they were new patients or repeat patients with a 6 month's hiatus, if the chief complaint was LBP of greater than 50 days' duration, if pain was elicited with palpation over one or more of the facet joints from the spinal levels between L1 and S1 and including the sacroiliac joints, and if there was absence of pain referral or if pain referral was only scleratogenous in nature. Criteria for excluding patients included hard neurologic signs, systemic disease potentially affecting the musculoskeletal system, contraindication to spinal manipulation such as osteoporosis, fracture or other bony pathology, or treatment with medication intended to relieve symptoms associated with their LBP. Eligibility was determined by a staff diagnostic team independent of the attending physician. Three hundred sixty-seven of 1,275 consecutive new patients met the eligibility criteria. Of these, 209 participated. These results are for 201 patients from whom flow cytometric data were obtained. OUTCOME MEASURES: Both absolute numbers and percentages of B-lymphocytes, T-lymphocytes, T-Helper (TH), T-Suppressor (TS) and NK lymphocytes were determined. Blood samples were collected at the same time that the primary outcome measures were obtained. Cells were stained with two-color monoclonal antibodies directed against specific cell surface antigens, and each lymphocyte subpopulation was quantified directly from lysed whole blood with a Coulter Epics Profile II flow cytometer.
RESULTS: Thirty-five patients dropped out before the follow-up visit and technical problems resulted in the loss of data from 17 more and the exclusion of some subpopulation data. In all, 148 cases were analyzed for B cells, 146 for TH, TS and NK cells and 138 for cells that carried both the NK and TS marker. A one-way analysis of variance revealed no significant differences in the lymphocyte profiles at baseline among the three groups. All subpopulation baseline values were within reported reference ranges for normal adult populations. However, the percentage of NK cells (9.1%) was below the published minimum critical value. A repeated measures analysis of variance was used to determine whether treatment effects changed over time, that is, treatment-time interaction. The cell types for which the interaction tests were at or near statistical significance were: TH cells (p = .0208), total T cell percent (p = .0928) and absolute total T cells (p = .0908). Interaction tests for differences in either percent or absolute counts of B cells, TS cells, or NK cells were not statistically significant.
CONCLUSIONS: This is the first report of lymphocyte profiles in patients with diagnosed chronic LBP. Our finding of a lower percentage of NK cells in these patients confirms our earlier finding that patients with musculoskeletal problems have a lower percentage of NK cells than do asymptomatic subjects. However, manipulative therapy was not shown to have a clinically significant effect on either the absolute n

RCT Entities:   Population Interventions Outcomes