Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection

Nantes University Hospital120 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

120

Conditions

Rehabilitation

Interventions

sessions of shoulder rehabilitationOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Nantes University Hospital

Nantes, France

Outcomes

Primary Outcomes

Disabilities of Shoulder, Arm and Hand Questionnaire (DASH)

The total score is reported. The score is between 0 and 100. The higher the score, the higher the disability.

Time frame: 6 months postoperatively (M6)

Secondary Outcomes

Disabilities of Shoulder, Arm and Hand Questionnaire (DASH)

The total score is reported. The score is between 0 and 100. The higher the score, the higher the disability.

Time frame: 3 and 12 months postoperatively (M3 and M12)

visual analog score for pain (M3, M6 and M12)

The reported score is between 0 and 10. The higher the score, the higher the pain.

Time frame: 3, 6 and 12 months postoperatively (M3, M6 and M12)

goniometric measurement of flexion and abduction of the shoulder

Goniometric measurement will be performed using a Rippstein's Plurimeter, with standardized position and movement for each measurement: * Sitting on a chair, the bust is straight, arm hanging down the body. * The plurimeter is placed on the distal part of the arm. * The flexion is in the sagittal plane around a transverse axis in the frontal plane. * The abduction is in the frontal plane around an anteroposterior axis contained in the sagittal plane.

Time frame: 3, 6 and 12 months postoperatively (M3, M6 and M12)

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

EORTC QLQ-C30 questionnaire has 30 questions and includes the following scale: \- health and overall quality of life, scale have a score between 0 and 100. A high score indicates the preservation of a good quality of life.

Time frame: 3, 6 and 12 months postoperatively (M3, M6 and M12)

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

Data from ClinicalTrials.gov

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