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The Impact of Post-thyroidectomy Neck Stretching Exercises on Improving Short Term Quality of Life

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ClinicalTrials.gov Identifier: NCT04645056
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : November 25, 2020
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
University of Southern Denmark

Brief Summary:

The project deals with patients undergoing surgery in the neck due to benign tumor in the thyroid gland in order to remove pressure symptoms.

The background of the project is a recent series of studies (Sorensen, Watt et al. 2017) (Sorensen, Watt et al. 2017), showing that patients are very adversely affected by a reduced voice function and pain the neck/shoulders in the first weeks and months after the operation. In general, the patients quality of life is impaired in this period. Due to this, it is relevant to seek ways to reduce the discomfort symptoms after the operation by performing simple and specific chosen stretching exercises for the muscles in the neck and shoulders.

The patients in the project are randomly divided into two groups, and both groups are answering questionnaires after 1,2, 4 weeks and after 3 months regarding their short time quality of life focusing on voice function and pain in the neck and shoulders. The patients in the intervention group are instructed in stretching and mobility exercises for neck and shoulder starting the day after surgery and they are supposed to perform them every day in four weeks after surgery. The control group are not performing these exercises and are not informed that there concurrently is an intervention going on. In this way the questionnaires can be compared in the end.

The hypothesis is that short time quality of life including voice function and pain the neck and shoulder can be improved for this group of patients with these specific stretching and mobility exercises. The project is of great clinical relevance and can in case of confirmed hypothesis be applied in clinical practice immediately benefitting the patients undergoing surgery.


Condition or disease Intervention/treatment Phase
Thyroidectomy Other: Stretching and Mobility exercises for neck and shoulder Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be recruited for this randomized controlled clinical study the day after surgery. Participants are randomized into two groups using a randomization scheme according to whether the surgery is performed in a week with an even or uneven number (e.g. week number 42 or 43 within a given year). A designated person with no impact on the decision of surgical procedure will handle the randomization and recruitment (the project owner).

The patients are randomized to either intervention with nine specific and carefully selected neck stretching exercises or to the control group without any intervention.

Before discharge, both groups are instructed to perform either stretching exercises or to no intervention, respectively, the four postoperative weeks. A follow-up phone call will be made approximately one week after discharge to ensure patient adherence.

Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Impact of Post-thyroidectomy Neck Stretching Exercises on Improving Short Term Quality of Life: A Randomized Prospective Clinical Trial
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group

a. Intervention Group: Neck stretching and movement

The patient starts the stretching exercises the morning after surgery with instructions from a trained professional at the department. The patient is informed that the stretching exercises will not affect the surgical wound. The patient is instructed in performing five repetitions of each of the following nine exercises three times each day in four weeks:

  1. Relax shoulders and neck sufficiently
  2. Look down - Stretching and movement
  3. Look to each side - movement
  4. Lower the head to each side - stretching
  5. Lower the head diagonally to each side - stretching
  6. Small nod movements
  7. Lift the shoulders - movement
  8. Roll the shoulders - movement
  9. Lift the arms - movement

The first stretching session is observed by the instructor who gives feedback and correct the exercises, if necessary. Furthermore, the patient is given a training brochure.

Other: Stretching and Mobility exercises for neck and shoulder
9 specific stretching and mobility exercises performed 3 times every day the first 4 weeks after surgery.

No Intervention: Control group
b. Control group The patients in the control group are not instructed in any intervention but are answering completely similar questionnaires as the intervention group.



Primary Outcome Measures :
  1. Short time quality of life (QoL) [ Time Frame: Short time QoL 1 week after surgery ]
    Short time quality of life including voice quality and pain in neck and shoulders measured in specific questionnaires answered before and 4 times after surgery (2 weeks before, 1,2,4 weeks and 3 months after surgery).

  2. Short time quality of life (QoL) [ Time Frame: Short time QoL 2 weeks after surgery ]
    Short time quality of life including voice quality and pain in neck and shoulders measured in specific questionnaires answered before and 4 times after surgery (2 weeks before, 1,2,4 weeks and 3 months after surgery).

  3. Short time quality of life (QoL) [ Time Frame: Short time QoL 4 weeks after surgery ]
    Short time quality of life including voice quality and pain in neck and shoulders measured in specific questionnaires answered before and 4 times after surgery (2 weeks before, 1,2,4 weeks and 3 months after surgery).

  4. Short time quality of life (QoL) [ Time Frame: Short time QoL three months after surgery ]
    Short time quality of life including voice quality and pain in neck and shoulders measured in specific questionnaires answered before and 4 times after surgery (2 weeks before, 1,2,4 weeks and 3 months after surgery).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Patients undergoing either hemi- or total thyroidectomy for a benign thyroid disease

Exclusion Criteria:

  • Pre-operative recurrent laryngeal nerve palsy
  • Pre-operative voice disorder requiring treatment by surgery or speech language pathology
  • Previous neck surgery including thyroid surgery
  • Patients under the age of 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645056


Contacts
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Contact: Rikke T Thorsen, Student 004560156686 rikke.taudal.thorsen2@rsyd.dk
Contact: Jesper R Soerensen, Doctor Jesper.Roed.Sorensen@rsyd.dk

Locations
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Denmark
Department of ENT Head & Neck Surgery, Odense University Hospital, Denmark Recruiting
Odense C, Fyn, Denmark, 5000
Contact: Rikke T Thorsen, Student    60156686    rikkett@hotmail.com   
Contact: Jesper R Soerensen, Doctor, phd       jesper.roed.sorensen@rsyd.dk   
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Investigators
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Study Director: Christian Godballe, Doctor Department of ENT Head & Neck Surgery, Odense University Hospital, Denmark
Additional Information:
Publications:

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Responsible Party: University of Southern Denmark
ClinicalTrials.gov Identifier: NCT04645056    
Other Study ID Numbers: Rehabilitation thyroidectomy
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Southern Denmark:
Rehabilitation
Stretching
Otolaryngology
Quality of Life
Musculoskeletal Pain
Neck Pain
Voice Quality