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

NCT04645056 | Unknown

• 1 other identifier: Rehabilitation thyroidectomy
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroidectomy

Keywords

Rehabilitation; Stretching; Otolaryngology; Quality of Life; Musculoskeletal Pain; Neck Pain; Voice Quality

Outcome Measures

Primary Outcomes (4)

• Short time quality of life (QoL)

  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).

  Short time QoL 1 week after surgery

• Short time quality of life (QoL)

  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).

  Short time QoL 2 weeks after surgery

• Short time quality of life (QoL)

  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).

  Short time QoL 4 weeks after surgery

• Short time quality of life (QoL)

  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).

  Short time QoL three months after surgery

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Stretching and Mobility exercises for neck and shoulder OTHER

9 specific stretching and mobility exercises performed 3 times every day the first 4 weeks after surgery.

Intervention group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator

Study Sites (1)

Department of ENT Head & Neck Surgery, Odense University Hospital, Denmark

Odense C, Fyn, 5000, Denmark

RECRUITING

Related Publications (12)

• Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.

  PMID: 16320034 BACKGROUND

• Ayhan H, Tastan S, Iyigun E, Ozturk E, Yildiz R, Gorgulu S. The Effectiveness of Neck Stretching Exercises Following Total Thyroidectomy on Reducing Neck Pain and Disability: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2016 Jun;13(3):224-31. doi: 10.1111/wvn.12136. Epub 2016 Jan 15.

  PMID: 26773539 BACKGROUND

• Benninger MS, Ahuja AS, Gardner G, Grywalski C. Assessing outcomes for dysphonic patients. J Voice. 1998 Dec;12(4):540-50. doi: 10.1016/s0892-1997(98)80063-5.

  PMID: 9988041 BACKGROUND

• Mishra A, Sabaretnam M, Chand G, Agarwal G, Agarwal A, Verma AK, Mishra SK. Quality of life (QoL) in patients with benign thyroid goiters (pre- and post-thyroidectomy): a prospective study. World J Surg. 2013 Oct;37(10):2322-9. doi: 10.1007/s00268-013-2133-3.

  PMID: 23838927 BACKGROUND

• Ryu J, Ryu YM, Jung YS, Kim SJ, Lee YJ, Lee EK, Kim SK, Kim TS, Kim TH, Lee CY, Park SY, Chung KW. Extent of thyroidectomy affects vocal and throat functions: a prospective observational study of lobectomy versus total thyroidectomy. Surgery. 2013 Sep;154(3):611-20. doi: 10.1016/j.surg.2013.03.011. Epub 2013 Aug 8.

  PMID: 23932596 BACKGROUND

• Sorensen JR, Printz T, Iwarsson J, Grontved AM, Dossing H, Hegedus L, Bonnema SJ, Godballe C, Mehlum CS. The Impact of Post-thyroidectomy Paresis on Quality of Life in Patients with Nodular Thyroid Disease. Otolaryngol Head Neck Surg. 2019 Oct;161(4):589-597. doi: 10.1177/0194599819855379. Epub 2019 Jun 11.

  PMID: 31184263 BACKGROUND

• Sorensen JR, Watt T, Cramon P, Dossing H, Hegedus L, Bonnema SJ, Godballe C. Quality of life after thyroidectomy in patients with nontoxic nodular goiter: A prospective cohort study. Head Neck. 2017 Nov;39(11):2232-2240. doi: 10.1002/hed.24886. Epub 2017 Sep 4.

  PMID: 28872214 BACKGROUND

• Vicente DA, Solomon NP, Avital I, Henry LR, Howard RS, Helou LB, Coppit GL, Shriver CD, Buckenmaier CC, Libutti SK, Shaha AR, Stojadinovic A. Voice outcomes after total thyroidectomy, partial thyroidectomy, or non-neck surgery using a prospective multifactorial assessment. J Am Coll Surg. 2014 Jul;219(1):152-63. doi: 10.1016/j.jamcollsurg.2014.03.019. Epub 2014 Mar 18.

  PMID: 24745621 BACKGROUND

• Watt T, Bjorner JB, Groenvold M, Cramon P, Winther KH, Hegedus L, Bonnema SJ, Rasmussen AK, Ware JE Jr, Feldt-Rasmussen U. Development of a Short Version of the Thyroid-Related Patient-Reported Outcome ThyPRO. Thyroid. 2015 Oct;25(10):1069-79. doi: 10.1089/thy.2015.0209. Epub 2015 Aug 26.

  PMID: 26214034 BACKGROUND

• Watt T, Cramon P, Frendl DM, Ware JE Jr; ThyQoL Group. Assessing health-related quality of life in patients with benign non-toxic goitre. Best Pract Res Clin Endocrinol Metab. 2014 Aug;28(4):559-75. doi: 10.1016/j.beem.2014.01.009. Epub 2014 Jan 28.

  PMID: 25047206 BACKGROUND

• Takamura Y, Miyauchi A, Tomoda C, Uruno T, Ito Y, Miya A, Kobayashi K, Matsuzuka F, Amino N, Kuma K. Stretching exercises to reduce symptoms of postoperative neck discomfort after thyroid surgery: prospective randomized study. World J Surg. 2005 Jun;29(6):775-9. doi: 10.1007/s00268-005-7722-3.

  PMID: 16078129 BACKGROUND

• Thorsen RT, Dossing H, Bonnema SJ, Brix TH, Godballe C, Sorensen JR. The Impact of Post-Thyroidectomy Neck Stretching Exercises on Neck Discomfort, Pressure Symptoms, Voice and Quality of Life: A Randomized Controlled Trial. World J Surg. 2022 Sep;46(9):2212-2222. doi: 10.1007/s00268-022-06610-0. Epub 2022 May 30.

  PMID: 35637354 DERIVED

MeSH Terms

Conditions

Musculoskeletal Pain; Neck Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Christian Godballe, Doctor

  Department of ENT Head & Neck Surgery, Odense University Hospital, Denmark

  STUDY DIRECTOR

Central Study Contacts

Rikke T Thorsen, Student

CONTACT

004560156686; rikke.taudal.thorsen2@rsyd.dk

Jesper R Soerensen, Doctor

CONTACT

Jesper.Roed.Sorensen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: November 25, 2020
• Study Start: April 28, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2022
• Last Updated: November 25, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)