title: Adhesive capsulitis of the shoulder, treatment with corticosteroid, corticosteroid with distension or treatment-as-usual; a randomised controlled trial in primary care.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov, https://clinicaltrials.gov/ identifier: NCT01570985.
authors.affiliation: Research Group, Section for General Practice, Department of Global Health and Primary Care, University of Bergen, Kalfarveien 31, N-5018, Bergen, Norway. satya.sharma@uib.no.
authors.forename: Satya Pal
authors.initials: SP
authors.lastname: Sharma
authors.affiliation: Research Group, Section for General Practice, Department of Global Health and Primary Care, University of Bergen, Kalfarveien 31, N-5018, Bergen, Norway.
authors.forename: Anders
authors.initials: A
authors.lastname: Bærheim
authors.affiliation: Physiotherapy Research Group, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
authors.forename: Rolf
authors.initials: R
authors.lastname: Moe-Nilssen
authors.affiliation: Physiotherapy Research Group, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.|Department of Occupational Therapy, Physiotherapy and Radiography, Bergen University College, Bergen, Norway.
authors.forename: Alice
authors.initials: A
authors.lastname: Kvåle
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D000779:Anesthetics, Local / Q000008:administration & dosage / Q000627:therapeutic use*; D002062:Bursitis / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007270:Injections, Intra-Articular; D008012:Lidocaine / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009664:Norway; D010147:Pain Measurement; D011320:Primary Health Care / Q000379:methods*; D011446:Prospective Studies; D016059:Range of Motion, Articular; D012785:Shoulder Joint / Q000502:physiology; D020069:Shoulder Pain / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000779:Anesthetics, Local; D008012:Lidocaine
keywords: Adhesive capsulitis; Corticosteroid; Distension; Frozen shoulder