Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection

Rehabilitation Clinical Trial

— RESYSTE  

Official title:

Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961802
• Other study ID #: RC17_0489
• Status: Completed
• Phase: N/A
• Start date: July 2, 2019
• Est. completion date: November 16, 2023

Study information

• Verified date: January 2024
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 16, 2023
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rehabilitation

Intervention

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

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	evaluate the compliance of patients to rehabilitation	(% of rehabilitation sessions performed over 36 sessions)	12 months postoperatively (M12)