Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2020

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: systematic early rehabilitation
    • systematic early rehabilitation
  • No Intervention: without systematic rehabilitation
    • without systematic rehabilitation

Clinical Trial Outcome Measures

Primary Measures

  • Disabilities of Shoulder, Arm and Hand Questionnaire (DASH)
    • Time Frame: 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 Measures

  • Disabilities of Shoulder, Arm and Hand Questionnaire (DASH)
    • Time Frame: 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.
  • visual analog score for pain (M3, M6 and M12)
    • Time Frame: 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.
  • goniometric measurement of flexion and abduction of the shoulder
    • Time Frame: 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)
    • Time Frame: 3, 6 and 12 months postoperatively (M3, M6 and M12)
    • 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.
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
    • Time Frame: 3, 6 and 12 months postoperatively (M3, M6 and M12)
    • 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.
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
    • Time Frame: 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.
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck cancer module (H&N35)
    • Time Frame: 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.
  • evaluate the compliance of patients to rehabilitation
    • Time Frame: 12 months postoperatively (M12)
    • (% of rehabilitation sessions performed over 36 sessions)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nantes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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