Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection

Study Overview
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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.

Official Title
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Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection

Conditions
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Rehabilitation

Intervention / Treatment
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* Other: sessions of shoulder rehabilitation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: systematic early rehabilitation<br>systematic early rehabilitation | Other: sessions of shoulder rehabilitation<br>* 3 sessions of shoulder rehabilitation per week for 3 months (36 sessions)<br>|
| No Intervention: without systematic rehabilitation<br>without systematic rehabilitation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months postoperatively (M6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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: - operating scale, scale have a score between 0 and 100. A high score for this scale indicates the preservation of a good quality of life. | 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: - scale of generic symptoms. scale have a score between 0 and 100. A high score for this scale indicates the presence of symptoms acting as factors of deterioration of certain aspects of the quality of life. | 3, 6 and 12 months postoperatively (M3, M6 and M12) | 
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck cancer module (H&N35) | EORTC QLQ-H&N35 questionnaire evaluates the specific symptoms of patients with head and neck cancers. It consists of 35 items including 7 subscales . subscale scores are reported, All items and scales give a score between 0 and 100. For each subscale, a high score indicates the presence of a large number of specific symptoms, acting as factors of deterioration of certain aspects of the quality of life. | 3, 6 and 12 months postoperatively (M3, M6 and M12) | 
| evaluate the compliance of patients to rehabilitation | (% of rehabilitation sessions performed over 36 sessions) | 12 months postoperatively (M12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, shoulder dysfunction, cervical lymph node dissection, head and neck cancer