Clinical trial NCT02369276: Safety Study of Musculoskeletal Ultrasonographic to Assess Disabilities Arm of Head and Neck Cancer Patient
Official title: Musculoskeletal Ultrasonographic Assessment for the Soft Tissue Injury of Ipsilateral Shoulder of Head and Neck Cancer Patient Following Selective Neck Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: neck dissection surgery
shoulder disability
musculoskeletal ultrasonography
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: head and neck cancer by Never-Sparing Selective Neck dissection, SND, the skin condition is stable, there is no wound, infection or inflammation metastasis. Exclusion criteria: (1) in head and neck cancer before surgery and there had been other nerves, bones, muscles, tendons, resulting in lesions of the shoulder pain disorders or a history of activity. (2) severe cognitive function can not meet the examiner. (3) age less than 20 years of age or over 65 years of age.

Brief summary: The investigators suppose: 1. SND may cause damage to the soft tissue around shoulder girdle. 2. The soft tissue injury may be related with the order of severity of wing scapula and duration after SND. The aims of this study are: 1. To assess the functional disabilities of shoulder and upper extremity in different time period after SND. 2. To evaluate the soft tissue lesion of shoulder with soft tissue ultrasonography to prove our hypothesis. This study is a two years, prospective, cross-section study. The investigators will enroll 80 HNC post SND within 3months, \>3- 6months,\> 6months -1 year, more than 1 year as four different groups, 20 patient in each group.

Detailed description: Lymph node metastasis is one the most important prognostic-factors in head and neck cancer(HNC). Radical neck dissection (RND) has been the standard surgical method for HNC with neck lymph nodes metastasis in past decades. This operation includes removal of the sternocleidomastoid muscle (SCM), internal jugular vein (IJV) all cervical lymph nodes on one side and spinal accessory nerve (SAN), leading to significant ipsilateral shoulder syndrome caused by SAN dysfunction and impact quality of life. Despite most clinics prefer to use the nerve-sparing selective neck dissection (SND) for patient with N0 or N1 nodal disease today, shoulder disability and pain were still reported from 31% to 40% after this procedure. However, most previous studies evaluated the shoulder disability only by functional evaluation, range of motion, and questionnaire. The short and long term adverse effect to soft tissue around shoulder girdle after SND has not been reported. The investigators suppose: 1. SND may cause damage to the soft tissue around shoulder girdle. 2. The soft tissue injury may be related with the order of severity of wing scapula and duration after SND. The aims of this study are: 1. To assess the functional disabilities of shoulder and upper extremity in different time period after SND. 2. To evaluate the soft tissue lesion of shoulder with soft tissue ultrasonography to prove our hypothesis. This study is a two years, prospective, cross-section study. The investigators will enroll 80 HNC post SND within 3months, \>3- 6months,\> 6months -1 year, more than 1 year as four different groups, 20 patient in each group. Evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand (DASH) questionnaire. Statistical analysis will perform by SPSS software (SPSS V 20. International Business Machines. USA).

Eligibility criteria: Inclusion Criteria:

head and neck cancer by Never-Sparing Selective Neck dissection, SND, the skin condition is stable, there is no wound, infection or inflammation metastasis.

Exclusion Criteria:

(1) in head and neck cancer before surgery and there had been other nerves, bones, muscles, tendons, resulting in lesions of the shoulder pain disorders or a history of activity. (2) severe cognitive function can not meet the examiner. (3) age less than 20 years of age or over 65 years of age.

Primary outcomes:
measure: 2-Item findings of musculoskeletal ultrasonography and elastography
timeFrame: baseline
Secondary outcomes:
measure: Range of motion
timeFrame: baseline
measure: Manual Muscle Test
timeFrame: baseline
measure: Pain Scale
timeFrame: baseline
measure: Disabilities of the Arm, Shoulder and Hand questionnaire（DASH）
timeFrame: baseline
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Niaonsung Hsiang
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chau-Peng Leong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Snow GB, Annyas AA, van Slooten EA, Bartelink H, Hart AA. Prognostic factors of neck node metastasis. Clin Otolaryngol Allied Sci. 1982 Jun;7(3):185-92. doi: 10.1111/j.1365-2273.1982.tb01581.x.
citation: Leemans CR, Tiwari R, Nauta JJ, van der Waal I, Snow GB. Recurrence at the primary site in head and neck cancer and the significance of neck lymph node metastases as a prognostic factor. Cancer. 1994 Jan 1;73(1):187-90. doi: 10.1002/1097-0142(19940101)73:13.0.co;2-j.
citation: Carenfelt C, Eliasson K. Occurrence, duration and prognosis of unexpected accessory nerve paresis in radical neck dissection. Acta Otolaryngol. 1980 Nov-Dec;90(5-6):470-3. doi: 10.3109/00016488009131750.
citation: Hillel AD, Kroll H, Dorman J, Medieros J. Radical neck dissection: a subjective and objective evaluation of postoperative disability. J Otolaryngol. 1989 Feb;18(1):53-61.
citation: Terrell JE, Welsh DE, Bradford CR, Chepeha DB, Esclamado RM, Hogikyan ND, Wolf GT. Pain, quality of life, and spinal accessory nerve status after neck dissection. Laryngoscope. 2000 Apr;110(4):620-6. doi: 10.1097/00005537-200004000-00016.
citation: Gordon SL, Graham WP 3rd, Black JT, Miller SH. Acessory nerve function after surgical procedures in the posterior triangle. Arch Surg. 1977 Mar;112(3):264-8. doi: 10.1001/archsurg.1977.01370030036005.
citation: Sobol S, Jensen C, Sawyer W 2nd, Costiloe P, Thong N. Objective comparison of physical dysfunction after neck dissection. Am J Surg. 1985 Oct;150(4):503-9. doi: 10.1016/0002-9610(85)90164-3.
citation: Leipzig B, Suen JY, English JL, Barnes J, Hooper M. Functional evaluation of the spinal accessory nerve after neck dissection. Am J Surg. 1983 Oct;146(4):526-30. doi: 10.1016/0002-9610(83)90246-5.
citation: Short SO, Kaplan JN, Laramore GE, Cummings CW. Shoulder pain and function after neck dissection with or without preservation of the spinal accessory nerve. Am J Surg. 1984 Oct;148(4):478-82. doi: 10.1016/0002-9610(84)90373-8.
citation: El Ghani F, Van Den Brekel MW, De Goede CJ, Kuik J, Leemans CR, Smeele LE. Shoulder function and patient well-being after various types of neck dissections. Clin Otolaryngol Allied Sci. 2002 Oct;27(5):403-8. doi: 10.1046/j.1365-2273.2002.00604.x.
citation: Inoue H, Nibu K, Saito M, Otsuki N, Ishida H, Onitsuka T, Fujii T, Kawabata K, Saikawa M. Quality of life after neck dissection. Arch Otolaryngol Head Neck Surg. 2006 Jun;132(6):662-6. doi: 10.1001/archotol.132.6.662.
citation: Cheng PT, Hao SP, Lin YH, Yeh AR. Objective comparison of shoulder dysfunction after three neck dissection techniques. Ann Otol Rhinol Laryngol. 2000 Aug;109(8 Pt 1):761-6. doi: 10.1177/000348940010900811.
citation: Kuntz AL, Weymuller EA Jr. Impact of neck dissection on quality of life. Laryngoscope. 1999 Aug;109(8):1334-8. doi: 10.1097/00005537-199908000-00030.
citation: Guldiken Y, Orhan KS, Demirel T, Ural HI, Yucel EA, Deger K. Assessment of shoulder impairment after functional neck dissection: long term results. Auris Nasus Larynx. 2005 Dec;32(4):387-91. doi: 10.1016/j.anl.2005.05.007. Epub 2005 Aug 1.
citation: van Wilgen CP, Dijkstra PU, van der Laan BF, Plukker JT, Roodenburg JL. Shoulder and neck morbidity in quality of life after surgery for head and neck cancer. Head Neck. 2004 Oct;26(10):839-44. doi: 10.1002/hed.20052.
citation: van Wouwe M, de Bree R, Kuik DJ, de Goede CJ, Verdonck-de Leeuw IM, Doornaert P, Leemans CR. Shoulder morbidity after non-surgical treatment of the neck. Radiother Oncol. 2009 Feb;90(2):196-201. doi: 10.1016/j.radonc.2008.11.003. Epub 2008 Dec 4.
citation: Tsuji T, Tanuma A, Onitsuka T, Ebihara M, Iida Y, Kimura A, Liu M. Electromyographic findings after different selective neck dissections. Laryngoscope. 2007 Feb;117(2):319-22. doi: 10.1097/01.mlg.0000249781.20989.5c.
citation: Ferlito A, Johnson JT, Rinaldo A, Pratt LW, Fagan JJ, Weir N, Suarez C, Folz BJ, Bien S, Towpik E, Leemans CR, Bradley PJ, Kowalski LP, Herranz J, Gavilan J, Olofsson J. European surgeons were the first to perform neck dissection. Laryngoscope. 2007 May;117(5):797-802. doi: 10.1097/MLG.0b013e3180325b59.
citation: Robbins KT, Medina JE, Wolfe GT, Levine PA, Sessions RB, Pruet CW. Standardizing neck dissection terminology. Official report of the Academy's Committee for Head and Neck Surgery and Oncology. Arch Otolaryngol Head Neck Surg. 1991 Jun;117(6):601-5. doi: 10.1001/archotol.1991.01870180037007.
citation: Brown H, Burns S, Kaiser CW. The spinal accessory nerve plexus, the trapezius muscle, and shoulder stabilization after radical neck cancer surgery. Ann Surg. 1988 Nov;208(5):654-61. doi: 10.1097/00000658-198811000-00019.
citation: Krause HR, Bremerich A, Herrmann M. The innervation of the trapezius muscle in connection with radical neck-dissection. An anatomical study. J Craniomaxillofac Surg. 1991 Feb;19(2):87-9. doi: 10.1016/s1010-5182(05)80613-4.
citation: Patten C, Hillel AD. The 11th nerve syndrome. Accessory nerve palsy or adhesive capsulitis? Arch Otolaryngol Head Neck Surg. 1993 Feb;119(2):215-20. doi: 10.1001/archotol.1993.01880140105016.
citation: Kalra N, Seitz AL, Boardman ND 3rd, Michener LA. Effect of posture on acromiohumeral distance with arm elevation in subjects with and without rotator cuff disease using ultrasonography. J Orthop Sports Phys Ther. 2010 Oct;40(10):633-40. doi: 10.2519/jospt.2010.3155.
citation: Remmler D, Byers R, Scheetz J, Shell B, White G, Zimmerman S, Goepfert H. A prospective study of shoulder disability resulting from radical and modified neck dissections. Head Neck Surg. 1986 Mar-Apr;8(4):280-6. doi: 10.1002/hed.2890080408.
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.
citation: Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
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.
citation: Kibler WB, Ludewig PM, McClure PW, Michener LA, Bak K, Sciascia AD. Clinical implications of scapular dyskinesis in shoulder injury: the 2013 consensus statement from the 'Scapular Summit'. Br J Sports Med. 2013 Sep;47(14):877-85. doi: 10.1136/bjsports-2013-092425. Epub 2013 Apr 11.
citation: Grassi W. Clinical evaluation versus ultrasonography: who is the winner? J Rheumatol. 2003 May;30(5):908-9. No abstract available.
citation: Dinnes J, Loveman E, McIntyre L, Waugh N. The effectiveness of diagnostic tests for the assessment of shoulder pain due to soft tissue disorders: a systematic review. Health Technol Assess. 2003;7(29):iii, 1-166. doi: 10.3310/hta7290.
citation: Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
citation: Martin RM, Fish DE. Scapular winging: anatomical review, diagnosis, and treatments. Curr Rev Musculoskelet Med. 2008 Mar;1(1):1-11. doi: 10.1007/s12178-007-9000-5.
citation: Ophir J, Cespedes I, Ponnekanti H, Yazdi Y, Li X. Elastography: a quantitative method for imaging the elasticity of biological tissues. Ultrason Imaging. 1991 Apr;13(2):111-34. doi: 10.1177/016173469101300201.
citation: Righetti R, Garra BS, Mobbs LM, Kraemer-Chant CM, Ophir J, Krouskop TA. The feasibility of using poroelastographic techniques for distinguishing between normal and lymphedematous tissues in vivo. Phys Med Biol. 2007 Nov 7;52(21):6525-41. doi: 10.1088/0031-9155/52/21/013. Epub 2007 Oct 16.
citation: Varghese T, Ophir J. Performance optimization in elastography: multicompression with temporal stretching. Ultrason Imaging. 1996 Jul;18(3):193-214. doi: 10.1177/016173469601800303.
citation: Drakonaki EE, Allen GM, Wilson DJ. Ultrasound elastography for musculoskeletal applications. Br J Radiol. 2012 Nov;85(1019):1435-45. doi: 10.1259/bjr/93042867.
citation: Grainger AJ. Highlights of the European Society of Musculoskeletal Radiology (ESSR) annual meeting 2010. Skeletal Radiol. 2011 Jan;40(1):137-9. doi: 10.1007/s00256-010-1030-1. No abstract available.