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Completed

NCT Number: NCT03961802

Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection

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

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Key information

Conditions

Rehabilitation Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sessions of shoulder rehabilitation

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. evaluate the compliance of patients to rehabilitation

    Time frame: 12 months postoperatively (M12)

    (% of rehabilitation sessions performed over 36 sessions)

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: RESYSTE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 23, 2019
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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