Combined Effect of Hypnotic-Cognitive Therapy With Therapeutic Exercise on Quality of Life in Individuals With Fibromyalgia: A Randomized Controlled Trial Protocol.

BACKGROUND

A multidisciplinary approach is viewed as the primary treatment strategy for fibromyalgia (FM). Therapeutic exercise is an important component of this approach. Hypnotic cognitive therapy (HYP-CT), a relatively new intervention strategy, has not traditionally been incorporated in FM treatment, although it has shown beneficial effects in other chronic pain conditions. This study aims to investigate the potential benefits of a combined approach that incorporates HYP-CT with therapeutic exercise in the rehabilitation of individuals with FM.

MATERIALS AND

METHODS

One hundred and four individuals with FM (≥ 1 year) and meeting eligibility criteria will be randomly allocated to one of two 12-week treatment groups: (1) therapeutic exercises plus HYP-CT or (2) therapeutic exercise plus patient attention. Usual pharmacological treatment will be offered to all participants. The primary outcome measure will be the quality of life (QOL) assessed by the Fibromyalgia Impact Questionnaire Revised (FIQR). Secondary outcomes will include sleep disturbance, fatigue, pressure sensitivity and muscle endurance, as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance scale-short form, PROMIS fatigue short form, Pain Pressure Threshold (PPT), and muscle endurance test, respectively. Outcomes will be assessed at baseline, at post-treatment (12 weeks following randomisation) and at 24 weeks following randomisation.

PLANNED OUTCOMES: This study explores the feasibility of a novel and holistic approach in the field of rehabilitation of individuals with FM, with the aim of informing future research and clinical practice.

TRIAL REGISTRATION: CTRI/2025/07/091248.