Predicting outcome in frozen shoulder (shoulder capsulitis) in presence of comorbidity as measured with subjective health complaints and neuroticism.

BACKGROUND: There is a substantive lack of knowledge about comorbidity in patients with frozen shoulder. The aim of this study was to investigate whether subjective health complaints and Neuroticism would predict treatment outcome in patients diagnosed with frozen shoulder as measured by the Shoulder Pain and Disability Index (SPADI) and change in SPADI. METHODS: A total of 105 patients with frozen shoulder were recruited for a randomised controlled trial, where 69 were in the intervention group and received intraarticular corticosteroid injections and 36 patients served as control group. The SPADI was used as the outcome measure after 8 weeks, and change in SPADI from baseline to 8 weeks as a measure of rate of recovery. To examine comorbidities, all participants completed the Subjective Health Complaints (SHC) questionnaire with its five subscales, and the Neuroticism (N) component of the Eysenck Personality Questionnaire Revised. Multiple regression analysis was performed with the baseline comorbidity variables that correlated significantly with SPADI after 8 weeks, and with change in SPADI from baseline to 8 weeks, controlling for the variables intervention, age, gender and duration of pain. RESULTS: In this study, patients with frozen shoulder had little comorbidity as measured with SHC and scored normally with respect to Neuroticism. Only the Pseudoneurology subscale in SHC correlated significantly with SPADI and had significant predictive power (p < 0.001) for the outcome at 8 weeks. The intervention group exhibited significant statistical predictive power (p < 0.001) for the treatment outcome as measured by a change in SPADI from baseline to 8 weeks. Being female also had some predictive significance for change in SPADI (p < 0.005). CONCLUSION: Psychometric parameters as measured by the Pseudoneurology subscale in SHC questionnaire did predict the treatment outcome in frozen shoulder as measured by SPADI at 8 weeks, but not by change in SPADI from baseline to 8 weeks. One may conclude that psychometric parameters may affect symptoms, but do not predict the rate of recovery in frozen shoulder. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT01570985 .

Adhesive capsulitis of the shoulder, treatment with corticosteroid, corticosteroid with distension or treatment-as-usual; a randomised controlled trial in primary care.

BACKGROUND: Optimal management for adhesive shoulder capsulitis (frozen shoulder) is currently unclear. We intended to explore whether treatment by intra-articular injections with corticosteroid and distension is more effective than treating with corticosteroids alone or treatment-as-usual in a primary care setting in Norway. METHODS: In this prospective randomised intention to treat parallel study, 106 patients were block randomised to three groups; 36 (analysed 35) receiving steroid injection and Lidocaine (IS), 34 receiving steroid and additional saline as distension (ISD) and 36 had treatment-as-usual (TAU). Intervention groups received four injections within 8 weeks, assessed on 1st visit, at the 4th and 8th week. Outcomes were Shoulder Pain and Disability Index (SPADI), Numerical pain rating scale (NPRS) and passive range of motion (PROM). Postal assessment was repeated after 1 year for SPADI. Patients in the IS and ISD groups were "blinded" for intervention received and the assessor was "blinded" to group allocation. RESULTS: At baseline there were no differences between groups in outcome measures. There were no statistical significant differences between the intervention groups in SPADI, NPRS and PROM at baseline, at short-term (4-and 8 weeks) or long-term (12 months). There were statistically significant differences (p < 0.01) in change scores at short-term for SPADI when comparing the IS and TAU groups (-20.8; CI-28.9 to -12.7), and the ISD and TAU groups (-21.7; CI-29.4 to -14.0), respectively for NPRS (-2.0; CI-2.8 to -1.1 and -2.2; CI-3.0 to -1.4), and for PROM, but not at long-term for SPADI (p > 0.05). Effect size (ES) at 8 weeks was large between both injection groups and TAU (ES 1.2). At 12 months ES was reduced to 0.3 and 0.4 respectively. Transitory side effects as flushing and after-pain were reported by 14 % in intervention groups. CONCLUSION: This intention to treat RCT in primary care indicates that four injections with corticosteroid with or without distension, given with increasing intervals during 8 weeks, were better than treatment-as-usual in treatment of adhesive shoulder capsulitis. However, in the long run no difference was found between any of the groups, indicating that natural healing takes place independent of treatment or not. TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov/ identifier: NCT01570985.

Passive range of motion in patients with adhesive shoulder capsulitis, an intertester reliability study over eight weeks.

BACKGROUND: Measuring range of motion (ROM) in the shoulder joint is important for the diagnosis and monitoring of change over time. To what degree passive ROM can be trusted as a reliable outcome measure was examined as part of an on-going randomized controlled trial for patients with shoulder capsulitis. The aim of this study was to examine intertester reliability of passive ROM in the shoulder joint over a period of eight weeks in patients with adhesive capsulitis stage II. METHODS: Fifty patients with a clinical diagnosis of adhesive shoulder capsulitis were examined by two independent testers. A predefined protocol was used for measuring passive range of motion with an inclinometer, a plurimeter, in both affected and non-affected shoulders three times; at the start of the study and after 4 and 8 weeks. RESULTS: Very good to excellent intertester agreements were found for most parameters for the affected arm at all three test points. The intraclass correlation coefficient (ICC 2.1) values ranged from 0.76 to 0.98, i.e. from very reliable to excellent. The measurement error was in general small for the affected arm (5°-7°). ICCs were slightly lower for the non-affected arm at 8 weeks, but with acceptable measurement errors. CONCLUSIONS: Intertester reliability between two testers was very good at three visits over a time period of eight weeks using a plurimeter to measure passive range of motion in patients with adhesive shoulder capsulitis. This method can reliably determine passive range of motion in this patient population and be a reliable outcome measure.