Effectiveness of Oncological Physiotherapy on Painful Shoulder Cervical Ganglion in Head and Neck Cancer

NCT05604235 | Completed

• 1 other identifier: CHUNSC_2021_91
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer; Shoulder Pain; Rehabilitation

Keywords

cervical lymph node dissection; iatrogenic damage; spinal accessory nerve; physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

  Change from baseline at 3 months

Secondary Outcomes (3)

• Visual analogue scale

  Change from baseline at 3 months

• The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

  Change from baseline at 3 months

• Handgrip strength test

  Change from baseline at 3 months

Study Arms (2)

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.

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.

Other: Treatment with passive and active mobilization of the upper limb.

Interventions

Therapeutic upper limb strength exercise treatment OTHER

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.

Therapeutic strength exercise group

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.

Passive mobilization group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (3)

Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28805, Spain

Location

Physiotherapy and Pain Institute

Alcalá de Henares, Madrid, 28805, Spain

Location

Patricia Martinez Merinero

Alcalá de Henares, Madrid, 28806, Spain

Location

Related Publications (1)

• 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.

  PMID: 41011027 DERIVED

MeSH Terms

Conditions

Neoplasms; Shoulder Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 3, 2022
• Study Start: November 15, 2022
• Primary Completion: June 15, 2024
• Study Completion: November 15, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)