Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection (RESYSTE)

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

Study Overview

• Status: Completed
• Conditions: Rehabilitation
• Intervention / Treatment: Other: sessions of shoulder rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: systematic early rehabilitation	Other: sessions of shoulder rehabilitation; 3 sessions of shoulder rehabilitation per week for 3 months (36 sessions)
No Intervention: without systematic rehabilitation

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2019
• Primary Completion (Actual): November 16, 2023
• Study Completion (Actual): November 16, 2023

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; head and neck cancer; cervical lymph node dissection; shoulder dysfunction
• Other Study ID Numbers: RC17_0489

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No