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A prospective, monocentric, controlled, randomized study of systematic early shoulder rehabilitation following cervical lymph node dissection for the prevention and treatment of shoulder dysfunction.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| systematic early rehabilitation | Experimental | systematic early rehabilitation |
|
| without systematic rehabilitation | No Intervention | without systematic rehabilitation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sessions of shoulder rehabilitation | Other | 3 sessions of shoulder rehabilitation per week for 3 months (36 sessions) |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Nantes | 44093 | France |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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:
| 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) |