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

• ClinicalTrials.gov Identifier: NCT05604235
• Recruitment Status: Active, not recruiting
• First Posted: November 3, 2022
• Last Update Posted: May 3, 2024
• Sponsor: University of Alcala
• Information provided by (Responsible Party): Prof. Dr. Daniel Pecos Martín, University of Alcala

Tracking Information

• First Submitted Date: October 27, 2022
• First Posted Date: November 3, 2022
• Last Update Posted Date: May 3, 2024
• Actual Study Start Date: November 15, 2022
• Estimated Primary Completion Date: June 15, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 2, 2022)

Visual analogue scale [ Time Frame: Change from baseline at 6 months ]

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).

Original Primary Outcome Measures (submitted: November 2, 2022)

Visual analogue scale [ Time Frame: Change from baseline at 3 months ]

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).

Current Secondary Outcome Measures (submitted: November 2, 2022)

• Eortc QLQ H&N35 questionnaire [ Time Frame: Change from baseline at 6 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
• The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: Change from baseline at 6 months ]
  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

Original Secondary Outcome Measures (submitted: November 2, 2022)

• 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
• The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: Change from baseline at 3 months ]
  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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized clinical trial

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition

• Cancer
• Shoulder Pain
• Rehabilitation

Intervention

• Other: Therapeutic upper limb strength exercise treatment
  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.
• 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 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 Arms

• Experimental: Therapeutic strength exercise group
  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.
  Intervention: Other: Therapeutic upper limb strength exercise treatment
• Experimental: Passive mobilization group
  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.
  Intervention: Other: Treatment with passive and active mobilization of the upper limb.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 2, 2022): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 15, 2024
• Estimated Primary Completion Date: June 15, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT05604235
• Other Study ID Numbers: CHUNSC_2021_91
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Prof. Dr. Daniel Pecos Martín, University of Alcala
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Alcala
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Alcala
• Verification Date: May 2024