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Effects of a patient-centered graded exposure intervention added to manual therapy for women with chronic pelvic pain: a randomized controlled trial
Ariza-Mateos MJ, Cabrera-Martos I, Ortiz-Rubio A, Torres-Sanchez I, Rodriguez-Torres J, Valenza MC
Archives of Physical Medicine and Rehabilitation 2019 Jan;100(1):9-16
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*

OBJECTIVE: To explore the effects of a 6-week patient-centered graded exposure intervention added to manual therapy in women with chronic pelvic pain (CPP) and fear of movement/(re)injury. DESIGN: Prospective three-armed randomized controlled trial. SETTING: Faculty of Health Sciences. PARTICIPANTS: A total of forty-nine women with CPP and substantial fear of movement were randomly allocated to one of three groups: (1) patient-centered graded exposure intervention added to manual therapy, (2) manual therapy or (3) control group. INTERVENTIONS: The 6-week intervention consisted of 12 sessions in the group receiving manual therapy and 6 additional sessions of graded exposure therapy in the group receiving both interventions. MAIN MEASURES: Primary outcomes were fear-avoidance behavior assessed using the Fear-Avoidance Behavior Questionaire and pain interference and severity evaluated with the Brief Pain Inventory. The secondary outcome was disability evaluated with the Oswestry Disability Index. All the variables were assessed in a blinded manner at baseline, after the treatment, and at 3-month follow-up. RESULTS: Our results show interaction effects (p < 0.05) for all the outcomes. Graded exposure added to manual therapy is distinctly superior to manual therapy alone in maintaining improvements for long-term fear-avoidance behavior and physical functioning. CONCLUSIONS: Graded exposure added to manual therapy is a promising approach with long-term effects for women with CPP and fear of movement/(re)injury.

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