Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection
NCT ID: NCT03961802
Last Updated: 2024-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2019-07-02
2023-11-16
Brief Summary
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Detailed Description
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Surgical intervention (J0) and randomization into 2 groups:
Group 1 - systematic early rehabilitation Group 2 - without systematic rehabilitation
M3, M6, M12: collection of complications, adjuvant treatments, number of physiotherapy sessions performed, clinical examination (goniometric measurement and visual analogic scale of pain), collection of DASH, EORTC QLQ- C30 and H\&N35 questionnaires.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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systematic early rehabilitation
systematic early rehabilitation
sessions of shoulder rehabilitation
3 sessions of shoulder rehabilitation per week for 3 months (36 sessions)
without systematic rehabilitation
without systematic rehabilitation
No interventions assigned to this group
Interventions
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sessions of shoulder rehabilitation
3 sessions of shoulder rehabilitation per week for 3 months (36 sessions)
Eligibility Criteria
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Inclusion Criteria
* unilateral or bilateral cervical lymph node dissection preserving the accessory spinal nerve
* Karnofsky index ≥ 80%
* Age ≥ 18 years
Exclusion Criteria
* predictable difficulties in compliance with treatment and/or follow-up
* pre-existing pathology involving shoulder and its mobility, independent of head and neck cancer
* comorbidity preventing rehabilitation of the shoulder
* time to start rehabilitation after 6 weeks postoperatively
* pregnant women
* minors
* majors under guardianship
* refusal to participate in the study
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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Nantes University Hospital
Nantes, , France
Countries
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Other Identifiers
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RC17_0489
Identifier Type: -
Identifier Source: org_study_id
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