OBJECTIVE: To present the design of a trial on the effectiveness of a behavioral-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 is based on operant therapy. The key elements of this program are baseline measurements, goal-setting, and time-contingency. This program is compared with usual care in physiotherapy, which is pain-contingent. OUTCOME MEASURES: Primary measures are the patient's global impression of the 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 rated before randomization and 3, 6, and 12 months later. DISCUSSION: Several trials have been conducted on the effectiveness of behavioral treatments. Subjects were always patients with chronic low-back pain. In this trial, we apply such a treatment in patients after first-time disk surgery in a primary care setting.
RCT Entities:
OBJECTIVE: To present the design of a trial on the effectiveness of a behavioral-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 is based on operant therapy. The key elements of this program are baseline measurements, goal-setting, and time-contingency. This program is compared with usual care in physiotherapy, which is pain-contingent. OUTCOME MEASURES: Primary measures are the patient's global impression of the 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 rated before randomization and 3, 6, and 12 months later. DISCUSSION: Several trials have been conducted on the effectiveness of behavioral treatments. Subjects were always patients with chronic low-back pain. In this trial, we apply such a treatment in patients after first-time disk surgery in a primary care setting.
Authors: R W J G Ostelo; H C W de Vet; M W Berfelo; M R Kerckhoffs; J W S Vlaeyen; P M J C Wolters; P A van den Brandt Journal: Eur Spine J Date: 2003-09-23 Impact factor: 3.134
Authors: William M M Levack; Mark Weatherall; E Jean C Hay-Smith; Sarah G Dean; Kathryn McPherson; Richard J Siegert Journal: Cochrane Database Syst Rev Date: 2015-07-20
Authors: Camiel De Bruijn; Rob de Bie; Jacques Geraets; Marielle Goossens; Albère Köke; Wim van den Heuvel; Geert van der Heijden; Geert-Jan Dinant Journal: BMC Fam Pract Date: 2005-02-16 Impact factor: 2.497
Authors: Pim A J Luijsterburg; Arianne P Verhagen; Raymond W J G Ostelo; Hans J M M van den Hoogen; Wilco C Peul; Cees J J Avezaat; Bart W Koes Journal: BMC Musculoskelet Disord Date: 2004-11-09 Impact factor: 2.362