Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection

NCT ID: NCT03961802

Last Updated: 2024-01-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-02

Study Completion Date

2023-11-16

Brief Summary

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A prospective, monocentric, controlled, randomized study of systematic early shoulder rehabilitation following cervical lymph node dissection for the prevention and treatment of shoulder dysfunction.

Detailed Description

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Pre-inclusion: information, collection of consent, collection of antecedents and biometric data, clinical examination (goniometric measurement and visual analogic scale of pain), collection of DASH, EORTC QLQ-C30 and H\&N35 questionnaires.

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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Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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systematic early rehabilitation

systematic early rehabilitation

Group Type EXPERIMENTAL

sessions of shoulder rehabilitation

Intervention Type OTHER

3 sessions of shoulder rehabilitation per week for 3 months (36 sessions)

without systematic rehabilitation

without systematic rehabilitation

Group Type NO_INTERVENTION

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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Proficiency in the oral and written French language
* unilateral or bilateral cervical lymph node dissection preserving the accessory spinal nerve
* Karnofsky index ≥ 80%
* Age ≥ 18 years

Exclusion Criteria

* cognitive disorders
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC17_0489

Identifier Type: -

Identifier Source: org_study_id

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