Physiotherapy and Capsulitis

Overview

Multicenter randomised study, on parallel groups to compare recovery of functional amplitude following shoulder dilatation with auto rehabilitation in one group and physiotherapy in the other group.

Full Title of Study: “Physiotherapy Versus Self Rehabilitation After Shoulder Dilatation for Primary Idiopathic Capsulitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2013

Interventions

  • Other: Self rehabilitation
  • Other: Self rehabilitation plus physiotherapy

Arms, Groups and Cohorts

  • Active Comparator: Self rehabilitation
    • Self rehabilitation
  • Experimental: Self rehabilitation plus physiotherapy
    • Self rehabilitation plus physiotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Function of the shoulder joint (Score de Constant)
    • Time Frame: 12 months post shoulder dilatation

Secondary Measures

  • Pain Visual Analogue Scale (at evening, rest, and at movement)
    • Time Frame: 12 months post shoulder dilatation

Participating in This Clinical Trial

Inclusion Criteria

  • Primary idiopathic phase 2 capsulitis – Diagnosis of capsulitis confirmed by shoulder dilatation – Patients between 18 and 70 years of age Exclusion Criteria:

  • Secondary capsulitis – Shoulder pain of other etiology – Cognitive disorders – Patients less than 18 years, and more than 70 years of age

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hopital Foch
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bernard BOISAUBERT, MD, Study Chair, Hôpital FOCH 40, rue Worth 92150 Suresnes
    • Louis FRANCESCHI, MD, Principal Investigator, IMM – 42, boulevard Jourdan 75014 Paris

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