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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02904148
Other study ID # 2015/CHU/09
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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 RĂ©union (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 Design


Related Conditions & MeSH terms


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
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