Passive Mobilisation of Region of Shoulder Joints for Hemiplegic Patient

Hemiplegia Clinical Trial

— ERIAMS  

Official title:

Measurement of the Analgesic Efficacy of Shoulder Mobilization in Hemiplegic Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02904148
• Other study ID #: 2015/CHU/09
• Status: Withdrawn
• Phase: N/A
• Start date: January 2020
• Est. completion date: September 2022

Study information

• Verified date: July 2019
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia

Intervention

Procedure:
• Shoulder mobilisation
early shoulder mobilisation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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