Clinical trial NCT03961802: Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection
Official title: Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Keywords: Rehabilitation
shoulder dysfunction
cervical lymph node dissection
head and neck cancer
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disabilities of Shoulder, Arm and Hand Questionnaire (DASH)
timeFrame: 6 months postoperatively (M6)
Secondary outcomes:
measure: Disabilities of Shoulder, Arm and Hand Questionnaire (DASH)
timeFrame: 3 and 12 months postoperatively (M3 and M12)
measure: visual analog score for pain (M3, M6 and M12)
timeFrame: 3, 6 and 12 months postoperatively (M3, M6 and M12)
measure: goniometric measurement of flexion and abduction of the shoulder
timeFrame: 3, 6 and 12 months postoperatively (M3, M6 and M12)
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
timeFrame: 3, 6 and 12 months postoperatively (M3, M6 and M12)
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
timeFrame: 3, 6 and 12 months postoperatively (M3, M6 and M12)
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
timeFrame: 3, 6 and 12 months postoperatively (M3, M6 and M12)
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck cancer module (H&N35)
timeFrame: 3, 6 and 12 months postoperatively (M3, M6 and M12)
measure: evaluate the compliance of patients to rehabilitation
timeFrame: 12 months postoperatively (M12)
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References: