Passive Mobilisation of Region of Shoulder Joints for Hemiplegic Patient (ERIAMS)

Measurement of the Analgesic Efficacy of Shoulder Mobilization in Hemiplegic Patients

Hemiplegia is a high prevalence pathology with 1 per 1000 habitants in France. One of these complications is shoulder pain which affects about 35 to 70% of cases. The medical care of this complication is critical because it affects the patient's quality of life and also hinders participation in rehabilitation sessions slowing the recovery of independence in activities of daily living.

Literature confirmed the involvement of the scapula in the hemiplegic shoulder pain with his attitude pronounced lateral rotation. But no data to confirm that passive mobilization reduce shoulder pain.

Because no data available to permit us to determine the sample size we set-up this preliminary study to check if efficiency found in these preliminary data are consistent with an estimable real efficacy in a randomized trial feasible.

Study Overview

• Status: Withdrawn
• Conditions: Hemiplegia
• Intervention / Treatment: Procedure: Shoulder mobilisation

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hospitalized in Physical Medicine and Rehabilitation at Centre Hospitalier Universitaire Réunion (Site of Le Tampon)
• Having made a cerebrovascular accident between 30 and 3 days before inclusion
• with pain in the upper limb whose score with visual analogue scale is greater than or equal to 20 mm
• able to understand the question: "Do you have arm pain?"

Exclusion Criteria:

• with visual analogue scale score lower than 20 mm at the inclusion
• with aphasia of comprehension
• with medical contraindication for passive shoulder mobilisation (Shoulder fracture, dislocation,...)
• opposing to any mobilization
• with shoulder pathology previously known
• history of cerebrovascular accident prior 30 days before inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shoulder mobilisation; The shoulder mobilisation is performed daily by a physiotherapist for 45 days.	Procedure: Shoulder mobilisation; early shoulder mobilisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain evaluation with visual analogic scale	Proportion of patients reducing by at least 20 mm their score on the visual analogic scale (VAS) from baseline Day 45	Change of pain evaluation between Day 0 and Day 45

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Investigators: Principal Investigator: Andre Muller, MD, CHU de la Réunion

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia
• Other Study ID Numbers: 2015/CHU/09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No