Clinical trial NCT05604235: Effectiveness of Oncological Physiotherapy on Painful Shoulder Cervical Ganglion in Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Shoulder Pain
Rehabilitation
Keywords: cervical lymph node dissection
iatrogenic damage
spinal accessory nerve
physiotherapy
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Eortc QLQ H&N35 questionnaire
timeFrame: Change from baseline at 3 months
Secondary outcomes:
measure: Visual analogue scale
timeFrame: Change from baseline at 3 months
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Change from baseline at 3 months
measure: Handgrip strength test
timeFrame: Change from baseline at 3 months
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Centro Investigación Fisioterapia y Dolor
state: Madrid
city: Alcalá de Henares
country: Spain
facility: Physiotherapy and Pain Institute
state: Madrid
city: Alcalá de Henares
country: Spain
facility: Patricia Martinez Merinero
state: Madrid
Study officials:
References: