Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection
- Conditions
- Rehabilitation
- Interventions
- Other: sessions of shoulder rehabilitation
- Registration Number
- NCT03961802
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description systematic early rehabilitation sessions of shoulder rehabilitation systematic early rehabilitation
- Primary Outcome Measures
Name Time Method Disabilities of Shoulder, Arm and Hand Questionnaire (DASH) 6 months postoperatively (M6) The total score is reported. The score is between 0 and 100. The higher the score, the higher the disability.
- Secondary Outcome Measures
Name Time Method visual analog score for pain (M3, M6 and M12) 3, 6 and 12 months postoperatively (M3, M6 and M12) The reported score is between 0 and 10. The higher the score, the higher the pain.
evaluate the compliance of patients to rehabilitation 12 months postoperatively (M12) (% of rehabilitation sessions performed over 36 sessions)
Disabilities of Shoulder, Arm and Hand Questionnaire (DASH) 3 and 12 months postoperatively (M3 and M12) The total score is reported. The score is between 0 and 100. The higher the score, the higher the disability.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck cancer module (H&N35) 3, 6 and 12 months postoperatively (M3, M6 and M12) 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.goniometric measurement of flexion and abduction of the shoulder 3, 6 and 12 months postoperatively (M3, M6 and M12) 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.European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) 3, 6 and 12 months postoperatively (M3, M6 and M12) 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.
Trial Locations
- Locations (1)
Nantes University Hospital
🇫🇷Nantes, France