Evaluation of the Effectiveness of ARTHRO -Distension Plus Intensive Mobilisation in Shoulder Capsulitis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Pain and disability using SPADI score at 2 weeks
Study Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness of ARTHRO distension plus intensive mobilisation in shoulder capsulitis.
Detailed Description
The aim of the study is to evaluate a treatment of shoulder capsulitis that associates ARTHRO distension and intensive mobilisation at 2, 6, 12, 26 and 52 weeks. It is a bicentric 87-month (inclusion: 74 months; follow up: 13 months) observer blind randomised clinical trial using 2 groups in parallel. The number of patients to be included is 66. The treatment that is evaluated associates ARTHRO distension followed by mobilisation of the shoulder 6 hours per day during 5 days, and then sessions of physiotherapy for 4 weeks. The control intervention is one intra-articular injection of corticosteroids and physiotherapy. The primary outcome is SPADI, namely pain and disability, at 2 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age ≥ 18 years
- •shoulder capsulitis
- •duration of symptoms ≥ 3 months
- •health insurance
Exclusion Criteria
- •cognitive disorders
- •Hypo coagulation
- •biological inflammatory syndrome
- •uncontrolled diabetes
- •XYLOCAINE allergy
- •pregnancy
- •unable to understand and to speak french
- •previous surgery of shoulder
- •shoulder infiltration or distension in the previous month
- •local contraindication to shoulder infiltration
Arms & Interventions
1
infiltration intra articular
Intervention: infiltration intra articular (Procedure)
2
ARTHRO distension plus intensive mobilisation
Intervention: ARTHRO distension plus intensive mobilisation (Procedure)
Outcomes
Primary Outcomes
Pain and disability using SPADI score at 2 weeks
Time Frame: at 2 weeks
Secondary Outcomes
No secondary outcomes reported