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

BackgroundFrozen 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 AimThis 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. MethodsThis prospective cohort study will follow the STROBE guidelines. Adults aged 40-65 years diagnosed with primary FS will be recruited. Inclusion criteria include [&ge;]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 ConclusionThis 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) PrimaryTo 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 O_LIadult population ([&ge;] 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 C_LIO_LIable to understand and speak Italian C_LIO_LIhave no contraindication for the use of corticosteroids C_LI Exclusion Criteria O_LIpatients with shoulder fractures during the last year C_LIO_LIpatients with rotator cuff repair in the previous year C_LIO_LIpatients with shoulder surgery procedures during the last year C_LIO_LIpatients with shoulder dislocation during the previous year C_LIO_LIpatients with actual serious specific shoulder disorders (i.e., tumour, infection) C_LIO_LIpatients with actual severe psychiatric diagnosed disorders that prevent study participation C_LI Study Duration Each subjects 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 O_TBL View this table: org.highwire.dtl.DTLVardef@1004a1aorg.highwire.dtl.DTLVardef@11d95org.highwire.dtl.DTLVardef@13d4c49org.highwire.dtl.DTLVardef@15b5783org.highwire.dtl.DTLVardef@1ce9085_HPS_FORMAT_FIGEXP M_TBL O_FLOATNOTABLE 1:C_FLOATNO O_TABLECAPTIONSCHEDULE OF STUDY PROCEDURES C_TABLECAPTION C_TBL 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