Rehabilitation
Conditions
Keywords
Rehabilitation, shoulder dysfunction, cervical lymph node dissection, head and neck cancer
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.
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
OTHERsessions of shoulder rehabilitation
3 sessions of shoulder rehabilitation per week for 3 months (36 sessions)
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of Shoulder, Arm and Hand Questionnaire (DASH) | 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
| Measure | Time frame | Description |
|---|---|---|
| visual analog score for pain (M3, M6 and M12) | 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 | 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. |
| Disabilities of Shoulder, Arm and Hand Questionnaire (DASH) | 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. |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck cancer module (H&N35) | 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 | 12 months postoperatively (M12) | (% of rehabilitation sessions performed over 36 sessions) |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | 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. |
Countries
France
Outcome results
None listed