RehabilitationRESYSTENCT03961802
Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection
A study testing sessions of shoulder rehabilitation in people with Rehabilitation, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation
- What is being tested?
- sessions of shoulder rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2019to 16 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- minors
- majors under guardianship
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
A prospective, monocentric, controlled, randomized study of systematic early shoulder rehabilitation following cervical lymph node dissection for the prevention and treatment of shoulder dysfunction.
Read the 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.
- Conditions
- Rehabilitation
- Being tested
- sessions of shoulder rehabilitation
- Keywords
- Rehabilitation, shoulder dysfunction, cervical lymph node dissection, head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sessions of shoulder rehabilitationOther
3 sessions of shoulder rehabilitation per week for 3 months (36 sessions)
| Study group | Role | What they receive |
|---|---|---|
| systematic early rehabilitation | Experimental | systematic early rehabilitation Receives: Other: sessions of shoulder rehabilitation |
| without systematic rehabilitation | No intervention | without systematic rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months postoperatively (M6)
Secondary outcomes (8)
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.
Measured: 3 and 12 months postoperatively (M3 and M12)
visual analog score for pain (M3, M6 and M12)
The reported score is between 0 and 10. The higher the score, the higher the pain.
Measured: 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:
- 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3, 6 and 12 months postoperatively (M3, M6 and M12)
evaluate the compliance of patients to rehabilitation
(% of rehabilitation sessions performed over 36 sessions)
Measured: 12 months postoperatively (M12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start2 Jul 2019
- Primary completion16 Nov 2023
- Study completion16 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961802
- Sponsor's protocol ID
- RC17_0489
- Acronym
- RESYSTE
- Status last verified
- Jan 2024
- First submitted
- 8 Mar 2019
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection
- ClinicalTrials.gov ID
- NCT03961802
- Acronym / sponsor ID
- RESYSTE / RC17_0489
- Conditions
- Rehabilitation
- Keywords
- Rehabilitation, shoulder dysfunction, cervical lymph node dissection, head and neck cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| systematic early rehabilitation | Experimental | Other: sessions of shoulder rehabilitationsystematic early rehabilitation |
| without systematic rehabilitation | No intervention | –without systematic rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sessions of shoulder rehabilitation3 sessions of shoulder rehabilitation per week for 3 months (36 sessions) | Other | systematic early rehabilitation |
Primary outcome
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.
8 secondary outcomes
Disabilities of Shoulder, Arm and Hand Questionnaire (DASH)
Time frame: 3 and 12 months postoperatively (M3 and M12)
visual analog score for pain (M3, M6 and M12)
Time frame: 3, 6 and 12 months postoperatively (M3, M6 and M12)
goniometric measurement of flexion and abduction of the shoulder
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 3, 6 and 12 months postoperatively (M3, M6 and M12)
evaluate the compliance of patients to rehabilitation
Time frame: 12 months postoperatively (M12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sessions of shoulder rehabilitation in people with Rehabilitation, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of Shoulder, Arm and Hand Questionnaire (DASH) (time frame: 6 months postoperatively (M6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.