Behavioral-graded activity compared with usual care after first-time disk surgery: Considerations of the design of a randomized clinical trial

Objective: To present the design of a trial on the effectiveness of a behav ioral-graded activity model. Design: Randomized clinical trial. Patients: Patients undergoing first-time lumbar disk surgery who still have low-back pain at the 6-week neurosurgical consultation. Interventions: A patient-tailored behavioral-graded activity program that i s based on operant therapy. The key elements of this program are baseline m easurements, goal-setting, and time-contingency. This program is compared w ith usual care in physiotherapy, which is pain-contingent. Outcome Measures: Primary measures are the patient's global impression of t he effect and their functional status. Secondary measures are kinesiophobia , catastrophizing, pain, main complaint, range of motion, and relapses. The direct and indirect costs will also be assessed. The effect measures are r ated before randomization and 3, 6, and 12 months later. Discussion: Several trials have been conducted on the effectiveness of beha vioral treatments. Subjects were always patients with chronic low-hack pain . In this trial, we apply such a treatment in patients after first-time dis k surgery in a primary care setting.