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

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ClinicalTrials.gov Identifier: NCT03961802
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Rehabilitation Other: sessions of shoulder rehabilitation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: systematic early rehabilitation
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
without systematic rehabilitation



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961802


Locations
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France
Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03961802     History of Changes
Other Study ID Numbers: RC17_0489
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:
Rehabilitation
shoulder dysfunction
cervical lymph node dissection
head and neck cancer