Skip to main content
. 2013 Sep 10;2013(9):CD009796. doi: 10.1002/14651858.CD009796.pub2

Castel 2009.

Methods Study setting: Europe (Spain). SIngle centre, recruitment in university pain clinic, outpatient based
Study design: Parallel
Duration therapy: 12 weeks
Follow‐up: None  
Analysis: T‐tests and Chi2 analysis to compare treatment conditions in demographic and pre‐treatment outcome variables, paired t‐tests to evaluate changes in each condition treatment, univariate analyses to compare between treatments, percentage of patients that experienced a significant change in pain intensity was evaluated, cut‐off of 30% accepted as indicator of clinically important improvement, evaluation of Pearson correlation between hypnotisability and pre‐post‐treatment differences
Participants Patients: Treatment Group: 18 patients, 94% female, race not reported, mean age 43.0 years; pain duration 10.2 (10.7) years
Control Group: 12 patients, 86% female, race not reported, mean age 49.6 years; pain duration 7.1 (5.6) years
Inclusion: ACR 1990 criteria for FM, age between 18 years and less than 60 years, having a minimum of 6 months history of chronic pain, having at least 6 years of education
Exclusion: One or more additional severe chronic medical pain conditions, significant suicidal ideation, severe psychopathology (e. g. psychosis), moderate to severe cognitive impairment, presence of pending litigation
Interventions Treatment Group: CBT, group: didactic presentation of information about FMS and theory of pain perception, relaxation training, cognitive restructuring, assertiveness training, behavioral goal setting, problem solving, training in outcome generalization, maintenance of gains, audio CD of a relaxation exercise to listen to at home (1.5h/week), total: 18h
Control Group: TAU: Pharmacological treatment including analgesics, antidepressants, sedatives, myorelaxants
Comedication allowed: Standard medication management
Other Cotherapies: Not reported
Outcomes Primary Outcomes
Self reported pain: Numeric Pain Rating Scale (NPRS) 0‐10 NR
Self reported negative mood: FIQ depression 0‐10; Data provided on request
Self reported disability: FIQ physical impairment 0‐10; Data provided on request
Acceptability: Total dropout rate
Secondary Outcomes
Self reported self efficacy pain: Not assessed
Self reported fatigue: FIQ fatigue 0‐10; data provided on request
Self reported sleep problems: Not assessed
Self reported disease‐specific health‐related quality of life: FIQ total 0‐100
Notes 1. Study arm CBT plus hypnosis (not used for comparison)
2.Reasons for dropout: Not reported
3. Attendance rates: Not reported
4. Responder analysis: None
5. Funding sources and declaration of interest of the primary researchers: No details reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No detailed information
Allocation concealment (selection bias) Unclear risk No detailed information
Incomplete outcome data (attrition bias) 
 All outcomes High risk No Intention‐to‐treat analysis
Selective reporting (reporting bias) Low risk All outcomes reported or provided on request
Blinding of outcome assessor Unclear risk No detailed information