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Effectiveness of the Godelieve Denys-Struyf (GDS) method in patients with low back pain: a cluster randomized controlled trial
Diaz-Arribas MJ, Kovacs FM, Royuela A, Fernandez-Serrano M, Gutierrez-Fernandez L, san Martin-Pariente O, Abraira V, Ramos-Sanchez M, Llorca-Palomera R, Pardo-Hervas P, Gestoso M, Sanchez-Gil GC, Elena-Lucas MA, Paniagua-de-la-Calle R, Castellanos-Lopez I, Garcia-Heredia MA, Ceron-Sanz AM, Victoria-Gonzalez B, Monsalve-Martin C, Duque-Heras JM, Juanes-Hernandez MJ, Saura-Conti J, Soto-Saez JL, Roman-Moraleda C, Ruiz-Arias C, Martin-Mora B, Escolano-Garcia R, Cantero-Bengoechea JS, Garcia-Lopez E, Lopez-Pelegrin A, Padilla-Martin E, Martinez-Rodriguez M, Casillas-Martin J, Jerez-Vazquez J, Barrientos-Gomez L, for the Spanish Back Pain Research Network
Physical Therapy 2015 Mar;95(3):319-336
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: The Godelieve Denys-Struyf method (GDS) is a motor learning intervention which may be applied in group or individualized sessions. OBJECTIVE: To compare the effectiveness of: a) routine physiotherapy, b) group GDS (GDS-G) sessions, c) group and individualized GDS (GDS-I) sessions. DESIGN: Cluster randomized controlled trial. SETTING: 21 Primary Care Physical Therapy Units ("clusters") of the Spanish National Health Service (SNHS). PATIENTS: 461patients with sub-acute and chronic low back pain (LBP). INTERVENTIONS: Clusters were randomized into three groups. All received medical treatment and a 15 min group education session on active management. Additional interventions were; "control", fifteen 40 min. sessions of transcutaneous electrical nerve stimulation, microwave and standardized exercises; "GDS-G", eleven 50 min group GDS sessions; "GDS-I", the same 11 sessions plus four 50-min individualized GDS sessions. MEASUREMENTS: Primary outcomes: LBP, pain referred down to the leg (RP) (separate pain intenstiy numeric rating scales), and disability (Roland-Morris Questionnaire -- RMQ), at baseline and 2, 6 and 12 months later. Secondary outcomes: Use of medication and self-reported health (mental (MCS) and physical (PCS) component summaries of SF-12). Separate linear mixed models for LBP, RP and disability were developed to adjust for potential confounders. Randomization, outcome assessment and data analyses were blinded. RESULTS: At 12 months, disability improved 0.7 (95% CI -0.4 to 1.8) RMQ points in the control group, 1.5 (0.4 to 2.7) in the GDS-I group (p = 0.252) and 2.2 (1.2 to 3.2) in the GDS-G group (p = 0.024). There were no differences in pain. LIMITATIONS: The amount of exercise was smaller in the control group. GDS-I sessions were provided by junior physiotherapists. CONCLUSIONS: Disability improvement was slightly higher with group GDS sessions than with the program routinely used in PT units within the SNHS. Adding individualized GDS sessions eliminates this advantage. Further studies should compare GDS with other types of exercise.

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