CancerNCT05604235
Effectiveness of Oncological Physiotherapy on Painful Shoulder Cervical Ganglion in Head and Neck Cancer
A study testing Therapeutic upper limb strength exercise treatment and Treatment with passive and active mobilization of the upper limb. in people with Cancer and Shoulder Pain, run by University of Alcala at 3 sites in Spain.
Trial summary
Objective: To estimate whether oncological physiotherapy treatment with neurodynamic and kinesitherapy (passive and active) in patients with "painful shoulder due to accessory spinal nerve dissection" operated on for head and neck cancer is more effective than standard therapeutic exercise therapy with strength. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer, Shoulder Pain, Rehabilitation
- What is being tested?
- Therapeutic upper limb strength exercise treatment and Treatment with passive and active mobilization of the upper limb.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesSpain
- Study dates
- 15 Nov 2022to 15 Nov 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cancer located in the head and neck.
- Different types of cancer, undergoing cervical lymph node dissection between levels II and V, with pain and/or functional impotence in the shoulder.
Who cannot join
- Patients with bone metastases
- Patients with functional limitations in the shoulder prior to surgery or that can be demonstrated to be due to other causes.
- Patients who are minors
- Incident cases of painful shoulder in patients with
- Cervical level I lymph node dissection
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Centro Investigación Fisioterapia y Dolor
Alcalá de Henares, Madrid, 28805
Physiotherapy and Pain Institute
Alcalá de Henares, Madrid, 28805
Patricia Martinez Merinero
Alcalá de Henares, Madrid, 28806
About this study
Official title: Effectiveness of Oncological Physiotherapy With Neurodynamics and Kinesitherapy (Active+Passive) on Painful Shoulder Cervical Ganglion Post Cervical Evacuation in Head and Neck Cancer Due to Accessory Spinal Nerve of the Accessory Spinal Nerve
Objective: To estimate whether oncological physiotherapy treatment with neurodynamic and kinesitherapy (passive and active) in patients with "painful shoulder due to accessory spinal nerve dissection" operated on for head and neck cancer is more effective than standard therapeutic exercise therapy with strength.
Design: Randomized Clinical Trial (intervention study, no drugs). Two branches of rehabilitative treatment applied by oncological physiotherapist.
Read more
GROUP I: Treatment of passive and active mobilizations together with neurodynamics techniques.
GROUP II (or control group) Current treatment applied as gold standard, consisting of therapeutic strength exercise, which the patient will carry out under the supervision of the physiotherapist.
The frequency of both will be twice a week for two months.
Study subjects: Participants who underwent cervical ganglion dissection surgery for head and neck cancer, and who have, as a surgical sequela, a painful shoulder due to accessory spinal nerve injury.
Determinations: At baseline (t0), at one month (t1m) and at the end (t6m) will be measured, (1) the degree of pain of the participants through the pain scale (EVA), (2) the functionality of the shoulder, with the DASH scale and goniometry, (3) the quality of life with the QLQ H\&N35 questionnaire, (4) the strength with a hand dynamometer and (5) the degree of neurodynamics of the accessory spinal nerve with the neurodynamic test for this nerve.
Read the detailed description
Incident cases of painful shoulder due to accessory spinal nerve injury after cervical lymph node dissection in patients with head and neck cancer. Given that clinical data indicate that at least 60% of patients with cervical lymph node dissection have iatrogenic accessory spinal nerve damage, and that the sequelae significantly impair the patient's quality of life, an improvement in quality of life of up to 30% of the QLQ H\&N35 score is considered to be significant.
Participants will be selected through the Spanish Association Against Cancer's needs assessment and first impact service, which receives patients from different hospitals. The investigators will make a first appointment with patients likely to be included in the study to check whether they meet the inclusion/exclusion criteria and collect the necessary data.
The investigators will then proceed to randomization to one of the treatment arms. The planned time for the application of the therapy is 2 months. During the course of the clinical trial the participants will attend treatment twice or once a week with a session duration of approximately 30 minutes.
Participants will be seen three times at the oncological physiotherapy service of the AECC during the course of the study [t0, t1 and 6tf]. A first one as mentioned above, an intermediate one after one month and a last one at the end of the clinical trial 2 months after inclusion.
At each of the 3 visits, data on the different variables will be collected: the VAS scale, the QLQ H\&N35 quality of life questionnaire and the DASH questionnaire.
- Conditions
- Cancer, Shoulder Pain, Rehabilitation
- Being tested
- Therapeutic upper limb strength exercise treatment, Treatment with passive and active mobilization of the upper limb.
- Keywords
- cervical lymph node dissection, iatrogenic damage, spinal accessory nerve, physiotherapy
- Medical subject headings
- Neoplasms, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic upper limb strength exercise treatmentOther
A treatment with therapeutic strength exercises, twice a week, for two months, with a total of 10 exercises, with 20 repetitions each, aimed at improving the strength of the trapezius and sternocleidomastoid muscles mainly, as well as improving mobility in flexion, abduction and rotation of the affected upper limb. It will take approximately 30 minutes.
Treatment with passive and active mobilization of the upper limb.Other
A treatment with passive kinesitherapy, where the physiotherapist will perform the movements of flexion, abduction and rotation of the shoulder, without the patient's intervention; active kinesitherapy, where the patient will perform specifically prescribed movements, without weight, to improve the articular and muscular balance of the scapulo-humeral complex and neurodynamics, where mobilizations of the accessory spinal nerve will be performed through therapeutic exercise and manual neurodynamic therapy. This treatment will be carried out once a week for two months in 30-minute sessions.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic strength exercise group | Experimental | A treatment with therapeutic strength exercises, twice a week, for two months, with a total of 10 exercises, with 20 repetitions each, aimed at improving the strength of the trapezius and sternocleidomastoid muscles mainly, as well as improving mobility in flexion, abduction and rotation of the affected upper limb. The protocol will be carried out in approximately 30 minutes. Receives: Other: Therapeutic upper limb strength exercise treatment |
| Passive mobilization group | Experimental | A treatment with passive kinesitherapy, where the physiotherapist will perform the movements of flexion, abduction and rotation of the shoulder, without the patient's intervention; active kinesitherapy, where the patient will perform specifically prescribed movements, without weight, to improve the articular and muscular balance of the scapulohumeral complex and neurodynamics, where mobilisations of the accessory spinal nerve will be performed through therapeutic exercise and manual neurodynamic therapy. This treatment will be carried out once a week for two months in 30-minute sessions. Receives: Other: Treatment with passive and active mobilization of the upper limb. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eortc QLQ H&N35 questionnaire
The EORTC Quality of Life questionnaires are developed to assess the quality of life of cancer patients, includes 35 items and scales employ a 4-point response format (''not at all" to ''very much"). A higher score indicates better health
Measured: Change from baseline at 3 months
Secondary outcomes (3)
Visual analogue scale
The visual analogue scale (VAS) is a 10cm long line where 0 indicates no pain at all and 10 the worst pain imaginable. It is a tool that has shown good reliability values (r = 0.94).
Measured: Change from baseline at 3 months
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
It is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb
Measured: Change from baseline at 3 months
Handgrip strength test
Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. Handgrip strength will be measured by handgrip dynamometer (JAMAR). Low grip strength is associated with poor healthcare outcomes and
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start15 Nov 2022
- Primary completion15 Jun 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604235
- Sponsor's protocol ID
- CHUNSC_2021_91
- Status last verified
- Nov 2024
- First submitted
- 27 Oct 2022
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perez-Garcia R, Abuin-Porras V, Pecos-Martin D, Romero-Morales C. Effectiveness of Oncological Physiotherapy on Shoulder Dysfunction After Cervical Lymph Node Dissection in Head and Neck Cancer: A Pilot Randomized Controlled Trial. Medicina (Kaunas). 2025 Sep 10;61(9):1636. doi: 10.3390/medicina61091636.
PubMed 41011027
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Oncological Physiotherapy With Neurodynamics and Kinesitherapy (Active+Passive) on Painful Shoulder Cervical Ganglion Post Cervical Evacuation in Head and Neck Cancer Due to Accessory Spinal Nerve of the Accessory Spinal Nerve
- ClinicalTrials.gov ID
- NCT05604235
- Acronym / sponsor ID
- CHUNSC_2021_91
- Conditions
- Cancer, Shoulder Pain, Rehabilitation
- Keywords
- cervical lymph node dissection, iatrogenic damage, spinal accessory nerve, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 3 Nov 2022 (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.
Objective: To estimate whether oncological physiotherapy treatment with neurodynamic and kinesitherapy (passive and active) in patients with "painful shoulder due to accessory spinal nerve dissection" operated on for head and neck cancer is more effective than standard therapeutic exercise therapy with strength.
Design: Randomized Clinical Trial (intervention study, no drugs). Two branches of rehabilitative treatment applied by oncological physiotherapist.
GROUP I: Treatment of passive and active mobilizations together with neurodynamics techniques.
GROUP II (or control group) Current treatment applied as gold standard, consisting of therapeutic strength exercise, which the patient will carry out under the supervision of the physiotherapist.
The frequency of both will be twice a week for two months.
Study subjects: Participants who underwent cervical ganglion dissection surgery for head and neck cancer, and who have, as a surgical sequela, a painful shoulder due to accessory spinal nerve injury.
Determinations: At baseline (t0), at one month (t1m) and at the end (t6m) will be measured, (1) the degree of pain of the participants through the pain scale (EVA), (2) the functionality of the shoulder, with the DASH scale and goniometry, (3) the quality of life with the QLQ H\&N35 questionnaire, (4) the strength with a hand dynamometer and (5) the degree of neurodynamics of the accessory spinal nerve with the neurodynamic test for this nerve.
Detailed description
Incident cases of painful shoulder due to accessory spinal nerve injury after cervical lymph node dissection in patients with head and neck cancer. Given that clinical data indicate that at least 60% of patients with cervical lymph node dissection have iatrogenic accessory spinal nerve damage, and that the sequelae significantly impair the patient's quality of life, an improvement in quality of life of up to 30% of the QLQ H\&N35 score is considered to be significant.
Participants will be selected through the Spanish Association Against Cancer's needs assessment and first impact service, which receives patients from different hospitals. The investigators will make a first appointment with patients likely to be included in the study to check whether they meet the inclusion/exclusion criteria and collect the necessary data.
The investigators will then proceed to randomization to one of the treatment arms. The planned time for the application of the therapy is 2 months. During the course of the clinical trial the participants will attend treatment twice or once a week with a session duration of approximately 30 minutes.
Participants will be seen three times at the oncological physiotherapy service of the AECC during the course of the study [t0, t1 and 6tf]. A first one as mentioned above, an intermediate one after one month and a last one at the end of the clinical trial 2 months after inclusion.
At each of the 3 visits, data on the different variables will be collected: the VAS scale, the QLQ H\&N35 quality of life questionnaire and the DASH questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Therapeutic strength exercise group | Experimental | Other: Therapeutic upper limb strength exercise treatmentA treatment with therapeutic strength exercises, twice a week, for two months, with a total of 10 exercises, with 20 repetitions each, aimed at improving the strength of the trapezius and sternocleidomastoid muscles mainly, as well as improving mobility in flexion, abduction and rotation of the affected upper limb. The protocol will be carried out in approximately 30 minutes. |
| Passive mobilization group | Experimental | Other: Treatment with passive and active mobilization of the upper limb.A treatment with passive kinesitherapy, where the physiotherapist will perform the movements of flexion, abduction and rotation of the shoulder, without the patient's intervention; active kinesitherapy, where the patient will perform specifically prescribed movements, without weight, to improve the articular and muscular balance of the scapulohumeral complex and neurodynamics, where mobilisations of the accessory spinal nerve will be performed through therapeutic exercise and manual neurodynamic therapy. This treatment will be carried out once a week for two months in 30-minute sessions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with cancer located in the head and neck.
- Different types of cancer, undergoing cervical lymph node dissection between levels II and V, with pain and/or functional impotence in the shoulder.
Key exclusion criteria (5 listed)
- Patients with bone metastases
- Patients with functional limitations in the shoulder prior to surgery or that can be demonstrated to be due to other causes.
- Patients who are minors
- Incident cases of painful shoulder in patients with
- Cervical level I lymph node dissection
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 |
|---|---|---|
| Therapeutic upper limb strength exercise treatmentA treatment with therapeutic strength exercises, twice a week, for two months, with a total of 10 exercises, with 20 repetitions each, aimed at improving the strength of the trapezius and sternocleidomastoid muscles mainly, as well as improving mobility in flexion, abduction and rotation of the affected upper limb. It will take approximately 30 minutes. | Other | Therapeutic strength exercise group |
| Treatment with passive and active mobilization of the upper limb.A treatment with passive kinesitherapy, where the physiotherapist will perform the movements of flexion, abduction and rotation of the shoulder, without the patient's intervention; active kinesitherapy, where the patient will perform specifically prescribed movements, without weight, to improve the articular and muscular balance of the scapulo-humeral complex and neurodynamics, where mobilizations of the accessory spinal nerve will be performed through therapeutic exercise and manual neurodynamic therapy. This treatment will be carried out once a week for two months in 30-minute sessions. | Other | Passive mobilization group |
Primary outcome
Eortc QLQ H&N35 questionnaire
Time frame: Change from baseline at 3 months
The EORTC Quality of Life questionnaires are developed to assess the quality of life of cancer patients, includes 35 items and scales employ a 4-point response format (''not at all" to ''very much"). A higher score indicates better health
3 secondary outcomes
Visual analogue scale
Time frame: Change from baseline at 3 months
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Change from baseline at 3 months
Handgrip strength test
Time frame: Change from baseline at 3 months
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 20 Nov 2024.
- Derived from this study: PubMed 41011027Perez-Garcia R, Abuin-Porras V, Pecos-Martin D, Romero-Morales C. Effectiveness of Oncological Physiotherapy on Shoulder Dysfunction After Cervical Lymph Node Dissection in Head and Neck Cancer: A Pilot Randomized Controlled Trial. Medicina (Kaunas). 2025 Sep 10;61(9):1636. doi: 10.3390/medicina61091636.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic upper limb strength exercise treatment and Treatment with passive and active mobilization of the upper limb. in people with Cancer and Shoulder Pain, run by University of Alcala at 3 sites in Spain.
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 2 inclusion and 5 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Eortc QLQ H&N35 questionnaire (time frame: Change from baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05604235, which also lists 1 linked publication.
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 20 Nov 2024.