These interviews included questions about details of the back pain episode, medications and other therapies used, tests performed, work and compensation status, demographic data, and income level. Outcome data included responses to the 23-item Roland-Morris Back Disability Questionnaire.15 We also asked when the patients considered they were able to perform their usual daily activities after the back pain. Patient satisfaction was assessed on how well the physician communicated, listened, gave information and explained the cause of back pain, whether a detailed history was taken and the back examined carefully, and if advice was given on pain management, prevention, and activities of sleeping and sitting (yes/no responses). Other satisfaction items (overall treatment, pain relief provided, and patient abilities to walk, socialize, and work) were rated on a 5-point Likert scale (poor, fair, good, very good, or excellent). This was subsequently adapted to a dichotomous response. Clinical and utilization data were obtained from charts in the physicians’ offices to allow validation of survey variables.
The randomized trial of the effectiveness of limited manual therapy was started in 1995, 12 months after the closure of the cohort study. Patients were recruited by 31 generalist physicians (13 from the earlier cohort study and 18 volunteers from the 630 physicians on the North Carolina physician master file). The same inclusion and exclusion criteria from the cohort study were used except that the acceptable age range was 21 to 65 (compared with 75 years) and patients had no osteopenia, severe arthritis, morbid obesity, or neurological deficits and had not received previous manual therapy by the physician. These additional exclusion criteria were necessary to avoid possible adverse effects of manual therapy in the presence of disease and to eliminate patient bias of a preference for manual therapy based on previous experience.
For each arm of the study, after the first office visit the identical telephone interview questions and schedule used in the cohort study were implemented for up to 8 weeks. Chart abstraction methods and variables were also identical except that additional data were collected on the specifics of manual therapy given at each visit.
Two sequential weekend workshops with a refresher session for each of the 31 physicians (developed and given to 9 physicians per workshop by 3 family physicians skilled in manual therapy) were implemented before the start of the clinical trial. The purpose was to train these physicians in quality care for low back pain (explained to patients as enhanced care—the control arm) and in standardized limited manual therapy (the main component of the intervention arm).13 The term “enhanced care” was developed to minimize the impression for patients during randomization that they might either receive something special (manual therapy) or just routine care—both options needed to appear to be special to reduce placebo bias.
Training for the enhanced low back pain care arm included physician education in (1) the directed history and physical examination using Agency for Health Care Policy and Research (AHCPR) guidelines,16 (2) review of the efficacy of imaging and laboratory testing, (3) review of the efficacy of treatment modalities, and (4) use of specially designed patient handouts emphasizing progressive exercises, daily activities, and early return to function.
Training for the limited manual therapy arm included the enhanced low back pain skills plus:
- manual therapy, consisting of: (1) principles of manual therapy and explanatory models, (2) instruction in motion testing, and (3) instruction in limited manual therapy skills (soft-tissue, muscle energy, and high-velocity low-amplitude techniques involving psoas and piriformis muscles—lumbar spine, lumbosacral junction, and sacroiliac joints)
- workshop training and demonstrated competence in low back care on simulated patients
- guidance and practice in integrating limited manual therapy into the office visit
- education and practice in recruiting patients and in the procedures of random assignment of those patients to the control (enhanced care) arm or the manual therapy arm
After training, the physicians returned to their practices and worked on their newly learned skill for approximately 3 months before enrolling patients. At an agreed time they began to enroll patients and randomized them to enhanced care or enhanced care plus limited manual therapy using a blinded method.
Analysis
Using the patients of the 13 physicians active in both the original cohort study and the subsequent randomized trial of limited manual therapy, we compared outcomes between 3 groups of patients: (1) those whose usual care was only observed in the earlier cohort study, (2) those receiving enhanced care (control arm) in the randomized trial, and (3) those receiving enhanced care plus manual therapy (intervention arm) in the randomized trial. The major variables included in the analyses were age, sex, education, household income, duration of low back pain episode for more than 2 weeks, presence of sciatica, workers’ compensation status, and the Work Adaptation, Partnership, Growth, Affection, and Resolve Survey (a measure of job satisfaction).16 In each of the studies, outcome measures from repeated interviews included data on functional status over time and pain levels. Data on satisfaction with care, return to work, and time to functional and complete recovery were obtained either at 8 weeks or when the patients were better. The main outcome measures were the Roland-Morris adaptation of the Sickness Impact Profile (a 23-item scale with high scores indicating significant dysfunction), patients’ report of being all better or functionally better, and the date they were able to return to performing their usual daily activities.10,14 Patient satisfaction measures were based on the scale developed by Cherkin and colleagues.8 The patient was the unit of analysis.