ClinicalTrials.Veeva

Menu

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

N

Nantes University Hospital (NUH)

Status

Completed

Conditions

Rehabilitation

Treatments

Other: sessions of shoulder rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT03961802
RC17_0489

Details and patient eligibility

About

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

Full 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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

systematic early rehabilitation
Experimental group
Description:
systematic early rehabilitation
Treatment:
Other: sessions of shoulder rehabilitation
without systematic rehabilitation
No Intervention group
Description:
without systematic rehabilitation

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems