WHAT IS THE IMPACT OF SELF-EFFICACY, DEPRESSION, ANXIETY, BELIEFS AND PERCEPTION, AND SLEEP QUALITY ON PAIN, DISABILITY, AND QUALITY OF LIFE IN PATIENTS WITH FS? THE PERSPECTIVE FS-PSY-II COHORT STUDY
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Background
Frozen shoulder (FS) is a painful and disabling condition that significantly impairs daily activities, sleep, and quality of life. 1–5 Beyond structural limitations, FS also involves psychological and behavioural factors such as altered pain beliefs, anxiety, and mood changes. 6,7 Traditional biomedical models, which separate physical from psychological aspects of illness, often fail to address persistent pain effectively. 8 FS is not exclusively linked to tissue pathology, as emotional and cognitive components also contribute to symptom intensity. 8,9 Despite increasing awareness of the biopsychosocial nature of FS among specialists, these perspectives are not consistently applied in general practice. 10 However, the broader psychosocial dimensions of FS remain underrepresented in clinical research. 11
Aim
This study aims to investigate whether psychological variables, including self-efficacy, depression, anxiety, pain beliefs, and sleep quality, affect pain, disability, and quality of life after 3 months in patients with FS.
Methods
This prospective cohort study will follow the STROBE guidelines. Adults aged 40–65 years diagnosed with primary FS will be recruited. Inclusion criteria include ≥50% restriction in external rotation compared to the unaffected shoulder, and <25% restriction in at least two other planes. Exclusion criteria include prior shoulder surgery, serious comorbidities, or psychiatric conditions interfering with participation. Conservative treatment will include corticosteroid injections, mobilization, stretching, and therapeutic exercise. Patient-reported outcome measures (PROMs) (shoulder Pain and Disability Index - SPADI for shoulder-specific disability, Numeric Rating Scale - NRS for daily and nighttime pain, EQ-5D-5L for quality of life assessment) and psychological variables will be administered at baseline and at 3 months using validated PROMs for self-efficacy, depression, anxiety, pain beliefs, and sleep quality.Primary analysis will examine the relationship between baseline psychological variables and improvement in SPADI using multivariable regression, adjusting for gender and comorbidities. Descriptive statistics, normality tests, and multiple imputation will be used as appropriate. Analyses will be performed with R.
Discussion and Conclusion
This study will provide new evidence on how psychological factors influence FS recovery. The findings may support a more integrated and patient-centred approach to treatment, promoting both physical and psychological rehabilitation strategies.
Study Objective(s) Primary
To determine if improvement disability (via SPADI), daily and nighttime pain (through NRS) and Quality of life (via EUROQoL 5D-5L), at 3 months is influenced by self-efficacy, depression, anxiety, beliefs and perception, sleep quality in FS patients.
Study Design Prospective cohort study
Subject Population key criteria for Inclusion and Exclusion Inclusion Criteria
adult population (≥ 40 < 65 years old) with FS.FS is defined as range of motion restriction in external rotation at arm by side on the affected limb > 50% with respect to the contralateral limb, restriction <25% in two other planes at least. Moreover, symptoms must remain stable or worsted in the last one month 2
able to understand and speak Italian
have no contraindication for the use of corticosteroids
Exclusion Criteria
patients with shoulder fractures during the last year
patients with rotator cuff repair in the previous year
patients with shoulder surgery procedures during the last year
patients with shoulder dislocation during the previous year
patients with actual serious specific shoulder disorders (i.e., tumour, infection)
patients with actual severe psychiatric diagnosed disorders that prevent study participation
Study Duration
Each subject’s participation will last up to 3 months; the whole study will be of 12 months.
Study Phases Screening
Screening for eligibility: the patients will be screened for inclusion and exclusion criteria and will be informed about the study procedures and aims. All patients will sign a written informed consent to the study.
Study Treatment Follow-Up
The treatment will be the best choice up to date highlighted in the literature (corticosteroid infiltrations, mobilization, stretching, exercises) 2, 12–14 and no added intervention will be administered.
Different study’ time points will be as shown in Table 1 and at the end of the treatment at 3 months, the interview will be conducted online via questionnaire completion
Efficacy Evaluations
Primary evaluation measurements will be used to assess the change in disability, pain and quality of life at 3 months. Evidence showed that an important improve in clinical variables is gained in about 3 months from the start of the treatment and continued until 1 year 15–16
