Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors
Primary Purpose
Oral Cancer
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
motor control therapy
regular physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Oral Cancer focused on measuring oral cancer, shoulder dysfunction, quality of life, motor control, strengthening exercise
Eligibility Criteria
Inclusion Criteria:
- Willing to sign the inform consent
- Sufficiently communicate in the Chinese language
- Be able to follow instructions
- Newly diagnosed oral cancer
- Spinal accessory shoulder dysfunction
Exclusion Criteria:
- Pregnant or breast-feeding woman
- Cognitively impaired
- Central nervous disease
- Distant metastasis or recurrence
- A history of shoulder pain or known shoulder pathology
- Unable to communicate or comprehend the questionnaires
Sites / Locations
- Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental group
control group
Arm Description
motor control therapy
regular physical therapy
Outcomes
Primary Outcome Measures
shoulder pain
Visual Analog Scale, the *total* range = 0-10
shoulder joint range of motion
abduction measured by goniometer
shoulder function
the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure for upper extremity function
maximal isometric muscle strength
measurement for the upper trapezius, middle trapezius, lower trapezius and serrates anterior at the moment of SEMG
Secondary Outcome Measures
surface electromyography (SEMG)
measure the muscle activities of the upper trapezius, middle trapezius, lower trapezius and serrates anterior
quality of life C-30
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30
quality of life H&N35
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35
return to work
duration between return-to-work and operation
Full Information
NCT ID
NCT03545100
First Posted
May 22, 2018
Last Updated
July 14, 2020
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03545100
Brief Title
Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors
Official Title
Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
February 6, 2020 (Actual)
Study Completion Date
February 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. The probability of shoulder dysfunction after neck dissection is as high as 70%. Rehabilitation effects on shoulder function for head and neck survivors are needed for further studied.The purpose of this randomized clinical trial is to explore the effects of rehabilitation for shoulder function in oral cancer survivors.
Detailed Description
Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. The probability of shoulder dysfunction after neck dissection is as high as 70%. Rehabilitation effects on shoulder function for head and neck survivors are needed for further studied.
The purpose of this randomized clinical trial is to explore the effects of rehabilitation for shoulder function in oral cancer survivors. We will recruit 60 newly diagnosed oral cancer subjects through the plastic surgeon's referral from April 2018 to March 2020. The participants will be randomized separated into experimental or control group. Each group would receive regular physical therapy for shoulder function (i.e., transcutaneous electrical stimulation, shoulder joint range of motion exercise, scapular muscle strengthening training). Experimental group would be supplemented by motor control therapy targeting the scapular muscle progressive resistance exercise (exercise plus manual therapy).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer
Keywords
oral cancer, shoulder dysfunction, quality of life, motor control, strengthening exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
motor control therapy
Arm Title
control group
Arm Type
Active Comparator
Arm Description
regular physical therapy
Intervention Type
Other
Intervention Name(s)
motor control therapy
Intervention Description
scapular muscle progressive resistive exercise(PRE)
Intervention Type
Other
Intervention Name(s)
regular physical therapy
Intervention Description
transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE
Primary Outcome Measure Information:
Title
shoulder pain
Description
Visual Analog Scale, the *total* range = 0-10
Time Frame
1 year
Title
shoulder joint range of motion
Description
abduction measured by goniometer
Time Frame
1 year
Title
shoulder function
Description
the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure for upper extremity function
Time Frame
1 year
Title
maximal isometric muscle strength
Description
measurement for the upper trapezius, middle trapezius, lower trapezius and serrates anterior at the moment of SEMG
Time Frame
1 year
Secondary Outcome Measure Information:
Title
surface electromyography (SEMG)
Description
measure the muscle activities of the upper trapezius, middle trapezius, lower trapezius and serrates anterior
Time Frame
1 year
Title
quality of life C-30
Description
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30
Time Frame
1 year
Title
quality of life H&N35
Description
European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35
Time Frame
1 year
Title
return to work
Description
duration between return-to-work and operation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing to sign the inform consent
Sufficiently communicate in the Chinese language
Be able to follow instructions
Newly diagnosed oral cancer
Spinal accessory shoulder dysfunction
Exclusion Criteria:
Pregnant or breast-feeding woman
Cognitively impaired
Central nervous disease
Distant metastasis or recurrence
A history of shoulder pain or known shoulder pathology
Unable to communicate or comprehend the questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yueh-Hsia Chen, Master
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
20014446
Citation
Wong CH, Wei FC. Microsurgical free flap in head and neck reconstruction. Head Neck. 2010 Sep;32(9):1236-45. doi: 10.1002/hed.21284.
Results Reference
result
PubMed Identifier
15979480
Citation
Lutz BS, Wei FC. Microsurgical workhorse flaps in head and neck reconstruction. Clin Plast Surg. 2005 Jul;32(3):421-30, vii. doi: 10.1016/j.cps.2005.02.006.
Results Reference
result
PubMed Identifier
23358022
Citation
Neligan PC. Head and neck reconstruction. Plast Reconstr Surg. 2013 Feb;131(2):260e-269e. doi: 10.1097/PRS.0b013e3182778938.
Results Reference
result
PubMed Identifier
24909649
Citation
Pauloski BR, Rademaker AW, Logemann JA, Discekici-Harris M, Mittal BB. Comparison of swallowing function after intensity-modulated radiation therapy and conventional radiotherapy for head and neck cancer. Head Neck. 2015 Nov;37(11):1575-82. doi: 10.1002/hed.23796. Epub 2014 Aug 1.
Results Reference
result
PubMed Identifier
24817237
Citation
Sheikh A, Shallwani H, Ghaffar S. Postoperative shoulder function after different types of neck dissection in head and neck cancer. Ear Nose Throat J. 2014 Apr-May;93(4-5):E21-6.
Results Reference
result
PubMed Identifier
20623305
Citation
van der Molen L, van Rossum MA, Burkhead LM, Smeele LE, Rasch CR, Hilgers FJ. A randomized preventive rehabilitation trial in advanced head and neck cancer patients treated with chemoradiotherapy: feasibility, compliance, and short-term effects. Dysphagia. 2011 Jun;26(2):155-70. doi: 10.1007/s00455-010-9288-y. Epub 2010 Jul 11.
Results Reference
result
PubMed Identifier
22422558
Citation
Eades M, Murphy J, Carney S, Amdouni S, Lemoignan J, Jelowicki M, Nadler M, Chasen M, Gagnon B. Effect of an interdisciplinary rehabilitation program on quality of life in patients with head and neck cancer: review of clinical experience. Head Neck. 2013 Mar;35(3):343-9. doi: 10.1002/hed.22972. Epub 2012 Mar 16.
Results Reference
result
PubMed Identifier
22864015
Citation
McGarvey AC, Osmotherly PG, Hoffman GR, Chiarelli PE. Impact of neck dissection on scapular muscle function: a case-controlled electromyographic study. Arch Phys Med Rehabil. 2013 Jan;94(1):113-9. doi: 10.1016/j.apmr.2012.07.017. Epub 2012 Aug 1.
Results Reference
result
PubMed Identifier
24658376
Citation
Hsieh LC, Chen JW, Wang LY, Tsang YM, Shueng PW, Liao LJ, Lo WC, Lin YC, Tseng CF, Kuo YS, Jhuang JY, Tien HJ, Juan HF, Hsieh CH. Predicting the severity and prognosis of trismus after intensity-modulated radiation therapy for oral cancer patients by magnetic resonance imaging. PLoS One. 2014 Mar 21;9(3):e92561. doi: 10.1371/journal.pone.0092561. eCollection 2014.
Results Reference
result
PubMed Identifier
24478217
Citation
Wetzels JW, Merkx MA, de Haan AF, Koole R, Speksnijder CM. Maximum mouth opening and trismus in 143 patients treated for oral cancer: a 1-year prospective study. Head Neck. 2014 Dec;36(12):1754-62. doi: 10.1002/hed.23534. Epub 2014 Jan 30.
Results Reference
result
PubMed Identifier
21794962
Citation
Lee R, Slevin N, Musgrove B, Swindell R, Molassiotis A. Prediction of post-treatment trismus in head and neck cancer patients. Br J Oral Maxillofac Surg. 2012 Jun;50(4):328-32. doi: 10.1016/j.bjoms.2011.06.009. Epub 2011 Jul 26.
Results Reference
result
PubMed Identifier
22108231
Citation
Stubblefield MD. Radiation fibrosis syndrome: neuromuscular and musculoskeletal complications in cancer survivors. PM R. 2011 Nov;3(11):1041-54. doi: 10.1016/j.pmrj.2011.08.535.
Results Reference
result
PubMed Identifier
21541945
Citation
Chan JY, Lua LL, Starmer HH, Sun DQ, Rosenblatt ES, Gourin CG. The relationship between depressive symptoms and initial quality of life and function in head and neck cancer. Laryngoscope. 2011 Jun;121(6):1212-8. doi: 10.1002/lary.21788. Epub 2011 May 3.
Results Reference
result
PubMed Identifier
12988177
Citation
EWING MR, MARTIN H. Disability following radical neck dissection; an assessment based on the postoperative evaluation of 100 patients. Cancer. 1952 Sep;5(5):873-83. doi: 10.1002/1097-0142(195209)5:53.0.co;2-4. No abstract available.
Results Reference
result
PubMed Identifier
19260131
Citation
Carr SD, Bowyer D, Cox G. Upper limb dysfunction following selective neck dissection: a retrospective questionnaire study. Head Neck. 2009 Jun;31(6):789-92. doi: 10.1002/hed.21018.
Results Reference
result
PubMed Identifier
11754498
Citation
Dijkstra PU, van Wilgen PC, Buijs RP, Brendeke W, de Goede CJ, Kerst A, Koolstra M, Marinus J, Schoppink EM, Stuiver MM, van de Velde CF, Roodenburg JL. Incidence of shoulder pain after neck dissection: a clinical explorative study for risk factors. Head Neck. 2001 Nov;23(11):947-53. doi: 10.1002/hed.1137.
Results Reference
result
PubMed Identifier
15459926
Citation
Erisen L, Basel B, Irdesel J, Zarifoglu M, Coskun H, Basut O, Tezel I, Hizalan I, Onart S. Shoulder function after accessory nerve-sparing neck dissections. Head Neck. 2004 Nov;26(11):967-71. doi: 10.1002/hed.20095.
Results Reference
result
PubMed Identifier
21537629
Citation
Lima LP, Amar A, Lehn CN. Spinal accessory nerve neuropathy following neck dissection. Braz J Otorhinolaryngol. 2011 Mar-Apr;77(2):259-62. doi: 10.1590/s1808-86942011000200017.
Results Reference
result
PubMed Identifier
20299249
Citation
Umeda M, Shigeta T, Takahashi H, Oguni A, Kataoka T, Minamikawa T, Shibuya Y, Komori T. Shoulder mobility after spinal accessory nerve-sparing modified radical neck dissection in oral cancer patients. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Jun;109(6):820-4. doi: 10.1016/j.tripleo.2009.11.027. Epub 2010 Mar 17.
Results Reference
result
PubMed Identifier
25540485
Citation
Ishigaki T, Yamanaka M, Hirokawa M, Tai K, Ezawa Y, Samukawa M, Tohyama H, Sugawara M. Rehabilitation Exercises to Induce Balanced Scapular Muscle Activity in an Anti-gravity Posture. J Phys Ther Sci. 2014 Dec;26(12):1871-4. doi: 10.1589/jpts.26.1871. Epub 2014 Dec 25.
Results Reference
result
PubMed Identifier
17606671
Citation
Cools AM, Dewitte V, Lanszweert F, Notebaert D, Roets A, Soetens B, Cagnie B, Witvrouw EE. Rehabilitation of scapular muscle balance: which exercises to prescribe? Am J Sports Med. 2007 Oct;35(10):1744-51. doi: 10.1177/0363546507303560. Epub 2007 Jul 2.
Results Reference
result
PubMed Identifier
22076101
Citation
Andersen CH, Zebis MK, Saervoll C, Sundstrup E, Jakobsen MD, Sjogaard G, Andersen LL. Scapular muscle activity from selected strengthening exercises performed at low and high intensities. J Strength Cond Res. 2012 Sep;26(9):2408-16. doi: 10.1519/JSC.0b013e31823f8d24.
Results Reference
result
PubMed Identifier
21820276
Citation
Cricchio M, Frazer C. Scapulothoracic and scapulohumeral exercises: a narrative review of electromyographic studies. J Hand Ther. 2011 Oct-Dec;24(4):322-33; quiz 334. doi: 10.1016/j.jht.2011.06.001. Epub 2011 Aug 5.
Results Reference
result
PubMed Identifier
22947240
Citation
Worsley P, Warner M, Mottram S, Gadola S, Veeger HE, Hermens H, Morrissey D, Little P, Cooper C, Carr A, Stokes M. Motor control retraining exercises for shoulder impingement: effects on function, muscle activation, and biomechanics in young adults. J Shoulder Elbow Surg. 2013 Apr;22(4):e11-9. doi: 10.1016/j.jse.2012.06.010. Epub 2012 Sep 1.
Results Reference
result
PubMed Identifier
23431215
Citation
McGarvey AC, Osmotherly PG, Hoffman GR, Chiarelli PE. Scapular muscle exercises following neck dissection surgery for head and neck cancer: a comparative electromyographic study. Phys Ther. 2013 Jun;93(6):786-97. doi: 10.2522/ptj.20120385. Epub 2013 Feb 21.
Results Reference
result
PubMed Identifier
18457329
Citation
McNeely ML, Parliament MB, Seikaly H, Jha N, Magee DJ, Haykowsky MJ, Courneya KS. Effect of exercise on upper extremity pain and dysfunction in head and neck cancer survivors: a randomized controlled trial. Cancer. 2008 Jul 1;113(1):214-22. doi: 10.1002/cncr.23536.
Results Reference
result
PubMed Identifier
21904699
Citation
Brown KE, Stickler L. Shoulder pain and dysfunction secondary to neural injury. Int J Sports Phys Ther. 2011 Sep;6(3):224-33.
Results Reference
result
PubMed Identifier
20222043
Citation
McGarvey AC, Chiarelli PE, Osmotherly PG, Hoffman GR. Physiotherapy for accessory nerve shoulder dysfunction following neck dissection surgery: a literature review. Head Neck. 2011 Feb;33(2):274-80. doi: 10.1002/hed.21366.
Results Reference
result
PubMed Identifier
15172646
Citation
Shepherd KL, Fisher SE. Prospective evaluation of quality of life in patients with oral and oropharyngeal cancer: from diagnosis to three months post-treatment. Oral Oncol. 2004 Aug;40(7):751-7. doi: 10.1016/j.oraloncology.2004.01.018.
Results Reference
result
PubMed Identifier
12361079
Citation
Schliephake H, Jamil MU. Prospective evaluation of quality of life after oncologic surgery for oral cancer. Int J Oral Maxillofac Surg. 2002 Aug;31(4):427-33. doi: 10.1054/ijom.2001.0194.
Results Reference
result
PubMed Identifier
25613348
Citation
Barrios R, Bravo M, Gil-Montoya JA, Martinez-Lara I, Garcia-Medina B, Tsakos G. Oral and general health-related quality of life in patients treated for oral cancer compared to control group. Health Qual Life Outcomes. 2015 Jan 23;13:9. doi: 10.1186/s12955-014-0201-5.
Results Reference
result
PubMed Identifier
25931658
Citation
McNeely ML, Parliament MB, Seikaly H, Jha N, Magee DJ, Haykowsky MJ, Courneya KS. Sustainability of outcomes after a randomized crossover trial of resistance exercise for shoulder dysfunction in survivors of head and neck cancer. Physiother Can. 2015 Winter;67(1):85-93. doi: 10.3138/ptc.2014-13O.
Results Reference
result
PubMed Identifier
23720248
Citation
Ch'ng S, Oates J, Gao K, Foo K, Davies S, Brunner M, Clark JR. Prospective quality of life assessment between treatment groups for oral cavity squamous cell carcinoma. Head Neck. 2014 Jun;36(6):834-40. doi: 10.1002/hed.23387. Epub 2013 Sep 2.
Results Reference
result
PubMed Identifier
25042422
Citation
McGarvey AC, Hoffman GR, Osmotherly PG, Chiarelli PE. Maximizing shoulder function after accessory nerve injury and neck dissection surgery: A multicenter randomized controlled trial. Head Neck. 2015 Jul;37(7):1022-31. doi: 10.1002/hed.23712. Epub 2014 Jul 11.
Results Reference
result
PubMed Identifier
26138607
Citation
Chan JY, Wong ST, Chan RC, Wei WI. Shoulder Dysfunction after Selective Neck Dissection in Recurrent Nasopharyngeal Carcinoma. Otolaryngol Head Neck Surg. 2015 Sep;153(3):379-84. doi: 10.1177/0194599815590589. Epub 2015 Jul 2.
Results Reference
result
PubMed Identifier
11246689
Citation
Cranney A, Welch V, Wells G, Adachi J, Shea B, Simon L, Tugwell P. Discrimination of changes in osteoporosis outcomes. J Rheumatol. 2001 Feb;28(2):413-21.
Results Reference
result
PubMed Identifier
11246687
Citation
Beaton DE, Bombardier C, Katz JN, Wright JG, Wells G, Boers M, Strand V, Shea B. Looking for important change/differences in studies of responsiveness. OMERACT MCID Working Group. Outcome Measures in Rheumatology. Minimal Clinically Important Difference. J Rheumatol. 2001 Feb;28(2):400-5.
Results Reference
result
PubMed Identifier
25224592
Citation
Canis M, Weiss BG, Ihler F, Hummers-Pradier E, Matthias C, Wolff HA. Quality of life in patients after resection of pT3 lateral tongue carcinoma: Microvascular reconstruction versus primary closure. Head Neck. 2016 Jan;38(1):89-94. doi: 10.1002/hed.23862. Epub 2015 Jun 16.
Results Reference
result
PubMed Identifier
10071296
Citation
Bjordal K, Hammerlid E, Ahlner-Elmqvist M, de Graeff A, Boysen M, Evensen JF, Biorklund A, de Leeuw JR, Fayers PM, Jannert M, Westin T, Kaasa S. Quality of life in head and neck cancer patients: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. J Clin Oncol. 1999 Mar;17(3):1008-19. doi: 10.1200/JCO.1999.17.3.1008.
Results Reference
result
PubMed Identifier
12625522
Citation
Chie WC, Hong RL, Lai CC, Ting LL, Hsu MM. Quality of life in patients of nasopharyngeal carcinoma: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and the EORTC QLQ-H&N35. Qual Life Res. 2003 Feb;12(1):93-8. doi: 10.1023/a:1022070220328.
Results Reference
result
PubMed Identifier
10772298
Citation
Sherman AC, Simonton S, Adams DC, Vural E, Owens B, Hanna E. Assessing quality of life in patients with head and neck cancer: cross-validation of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Head and Neck module (QLQ-H&N35). Arch Otolaryngol Head Neck Surg. 2000 Apr;126(4):459-67. doi: 10.1001/archotol.126.4.459.
Results Reference
result
PubMed Identifier
34412536
Citation
Chen YH, Huang CY, Liang WA, Lin CR, Chao YH. Effects of Conscious Control of Scapular Orientation in Oral Cancer Survivors With Scapular Dyskinesis: A Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211040827. doi: 10.1177/15347354211040827.
Results Reference
derived
Learn more about this trial
Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors
We'll reach out to this number within 24 hrs