Psychosocial Factors, Lifestyle and Central Pain Processing as Potential Predictors of Outcome for Rotator Cuff Repair

NCT04946149 | Completed DMC

• 1 other identifier: ID2018-02089
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The influence of modifiable psychosocial and lifestyle factors and the role of central pain processing (CPP) on outcome after rotator cuff repair (RCR) is not well enough established to formulate holistic prognosis. Modern pain neuroscience emphasises to explain musculoskeletal shoulder pain biopsychosocially, which seems short when looking at the yearly RCR increase. This study will explore modifiable psychosocial and lifestyle factors and CPP as potential predictors for outcome after RCR.

Conditions

Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Keywords

rotator cuff repair; pain catastrophising; distress; psychological factors; expectations; sleep; central pain prossecing

Outcome Measures

Primary Outcomes (1)

• Western Ontario Rotator Cuff Index (WORC) change from preOP to 12 weeks postOP and preOP to 12months postOP

  This 21 - items self-reported questionnaire represents a quality of life measure in rotator cuff pathology. The WORC measures 5 dimensions (pain, sports/leisure, work, daily living, feelings) with 3-6 questions per domain, measured on a 100mm Visual Analogue Scale (VAS). Left endpoint equals "no" and right endpoint equals "extreme". The total WORC score ranges from 0 (best) to 2100 (worst) (21 items x 100mm). The minimal important difference (MID) is calculated at 300mm. The PROM is reported to have positive evidence for 5 psychometric properties; internal consistency, reliability, content validity, hypothesis testing and responsiveness.

  pre operative (T1), 12 Weeks postoperative (T2), 12 months postoperative (T3)

Secondary Outcomes (4)

• Constant-Murlex Score change from preOP to 12months postOP

  pre operative (T1), 12 months postoperative (T3)

• Maximum Pain on Numeric Rating Scale (NRS), change from preOP to 12 weeks postOP and preOP to 12months postOP

  pre operative (T1), 12 Weeks postoperative (T2), 12 months postoperative (T3)

• EQ-5D-5L, Euroqol 5dimensions, 5 levels, Quality of life measure, change from preOP to 12 weeks postOP and preOP to 12months postOP

  pre operative (T1), 12 Weeks postoperative (T2), 12 months postoperative (T3)

• Subjective Shoulder Value, change from preOP to 12 weeks postOP and preOP to 12months postOP

  pre operative (T1), 12 Weeks postoperative (T2),12 months postoperative (T3)

Other Outcomes (28)

• Potential predictor: Central pain processing: Central sensitization inventory

  pre operative (T1)

• Potential predictor: Central pain processing: Central sensitization inventory

  12 Weeks postoperative (T2)

• Potential predictor: Central pain processing: Central sensitization inventory

  12 months postoperative (T3)

Eligibility Criteria

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

Study Population

Adult musculoskelettal shoulder pain patients, scheduled for first time rotator cuff repair at the acute care hospital Kantonsspital Winterthur in Switzerland. Traumatic and non-traumatic origin of shoulder pain.

You may qualify if:

• Scheduled for elective arthroscopic RCR;
• First time RCR on the target shoulder;
• Completed primary and secondary outcome measures (Western Ontario Rotator Cuff Index (WORC), Constant Score, Maximum Pain on Numeric Rating Scale and EQ-5D-5L) from daily routine.

You may not qualify if:

• Changes of intra operative procedure (e.g. anything but RCR)
• Re-repair of tendon;
• No surgery;
• Other pain-related or neurological comorbidities that could interfere with pain measures;

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

Location

Related Publications (42)

• Coronado RA, Seitz AL, Pelote E, Archer KR, Jain NB. Are Psychosocial Factors Associated With Patient-reported Outcome Measures in Patients With Rotator Cuff Tears? A Systematic Review. Clin Orthop Relat Res. 2018 Apr;476(4):810-829. doi: 10.1007/s11999.0000000000000087.

  PMID: 29481342 BACKGROUND

• Vincent K, Leboeuf-Yde C, Gagey O. Are degenerative rotator cuff disorders a cause of shoulder pain? Comparison of prevalence of degenerative rotator cuff disease to prevalence of nontraumatic shoulder pain through three systematic and critical reviews. J Shoulder Elbow Surg. 2017 May;26(5):766-773. doi: 10.1016/j.jse.2016.09.060. Epub 2017 Jan 12.

  PMID: 28089260 BACKGROUND

• Bury J, Littlewood C. Rotator cuff disorders: a survey of current (2016) UK physiotherapy practice. Shoulder Elbow. 2018 Jan;10(1):52-61. doi: 10.1177/1758573217717103. Epub 2017 Jul 11.

  PMID: 29276538 BACKGROUND

• Jain NB, Higgins LD, Losina E, Collins J, Blazar PE, Katz JN. Epidemiology of musculoskeletal upper extremity ambulatory surgery in the United States. BMC Musculoskelet Disord. 2014 Jan 8;15:4. doi: 10.1186/1471-2474-15-4.

  PMID: 24397703 BACKGROUND

• Paloneva J, Lepola V, Aarimaa V, Joukainen A, Ylinen J, Mattila VM. Increasing incidence of rotator cuff repairs--A nationwide registry study in Finland. BMC Musculoskelet Disord. 2015 Aug 12;16:189. doi: 10.1186/s12891-015-0639-6.

  PMID: 26265152 BACKGROUND

• Novoa-Boldo A, Gulotta LV. Expectations Following Rotator Cuff Surgery. Curr Rev Musculoskelet Med. 2018 Mar;11(1):162-166. doi: 10.1007/s12178-018-9470-7.

  PMID: 29435813 BACKGROUND

• Henn RF 3rd, Kang L, Tashjian RZ, Green A. Patients' preoperative expectations predict the outcome of rotator cuff repair. J Bone Joint Surg Am. 2007 Sep;89(9):1913-9. doi: 10.2106/JBJS.F.00358.

  PMID: 17768186 BACKGROUND

• Lambers Heerspink FO, Dorrestijn O, van Raay JJ, Diercks RL. Specific patient-related prognostic factors for rotator cuff repair: a systematic review. J Shoulder Elbow Surg. 2014 Jul;23(7):1073-80. doi: 10.1016/j.jse.2014.01.001. Epub 2014 Apr 13.

  PMID: 24725900 BACKGROUND

• Cho CH, Song KS, Hwang I, Warner JJ. Does Rotator Cuff Repair Improve Psychologic Status and Quality of Life in Patients With Rotator Cuff Tear? Clin Orthop Relat Res. 2015 Nov;473(11):3494-500. doi: 10.1007/s11999-015-4258-1.

  PMID: 25791445 BACKGROUND

• Raman J, Walton D, MacDermid JC, Athwal GS. Predictors of outcomes after rotator cuff repair-A meta-analysis. J Hand Ther. 2017 Jul-Sep;30(3):276-292. doi: 10.1016/j.jht.2016.11.002. Epub 2017 Feb 23.

  PMID: 28237073 BACKGROUND

• Woollard JD, Bost JE, Piva SR, Kelley Fitzgerald G, Rodosky MW, Irrgang JJ. The ability of preoperative factors to predict patient-reported disability following surgery for rotator cuff pathology. Disabil Rehabil. 2017 Oct;39(20):2087-2096. doi: 10.1080/09638288.2016.1219396. Epub 2016 Aug 22.

  PMID: 27548366 BACKGROUND

• Thorpe AM, O'Sullivan PB, Mitchell T, Hurworth M, Spencer J, Booth G, Goebel S, Khoo P, Tay A, Smith A. Are Psychologic Factors Associated With Shoulder Scores After Rotator Cuff Surgery? Clin Orthop Relat Res. 2018 Oct;476(10):2062-2073. doi: 10.1097/CORR.0000000000000389.

  PMID: 30179945 BACKGROUND

• Noten S, Struyf F, Lluch E, D'Hoore M, Van Looveren E, Meeus M. Central Pain Processing in Patients with Shoulder Pain: A Review of the Literature. Pain Pract. 2017 Feb;17(2):267-280. doi: 10.1111/papr.12502. Epub 2016 Oct 14.

  PMID: 27739242 BACKGROUND

• Sanchis MN, Lluch E, Nijs J, Struyf F, Kangasperko M. The role of central sensitization in shoulder pain: A systematic literature review. Semin Arthritis Rheum. 2015 Jun;44(6):710-6. doi: 10.1016/j.semarthrit.2014.11.002. Epub 2014 Nov 13.

  PMID: 25523242 BACKGROUND

• Martinez-Calderon J, Meeus M, Struyf F, Miguel Morales-Asencio J, Gijon-Nogueron G, Luque-Suarez A. The role of psychological factors in the perpetuation of pain intensity and disability in people with chronic shoulder pain: a systematic review. BMJ Open. 2018 Apr 13;8(4):e020703. doi: 10.1136/bmjopen-2017-020703.

  PMID: 29654040 BACKGROUND

• Kusnanto H, Agustian D, Hilmanto D. Biopsychosocial model of illnesses in primary care: A hermeneutic literature review. J Family Med Prim Care. 2018 May-Jun;7(3):497-500. doi: 10.4103/jfmpc.jfmpc_145_17.

  PMID: 30112296 BACKGROUND

• Potter MQ, Wylie JD, Greis PE, Burks RT, Tashjian RZ. Psychological distress negatively affects self-assessment of shoulder function in patients with rotator cuff tears. Clin Orthop Relat Res. 2014 Dec;472(12):3926-32. doi: 10.1007/s11999-014-3833-1. Epub 2014 Jul 31.

  PMID: 25080266 BACKGROUND

• Dunn WR, Kuhn JE, Sanders R, An Q, Baumgarten KM, Bishop JY, Brophy RH, Carey JL, Harrell F, Holloway BG, Jones GL, Ma CB, Marx RG, McCarty EC, Poddar SK, Smith MV, Spencer EE, Vidal AF, Wolf BR, Wright RW; MOON Shoulder Group. 2013 Neer Award: predictors of failure of nonoperative treatment of chronic, symptomatic, full-thickness rotator cuff tears. J Shoulder Elbow Surg. 2016 Aug;25(8):1303-11. doi: 10.1016/j.jse.2016.04.030.

  PMID: 27422460 BACKGROUND

• Lawrence C, Zmistowski BM, Lazarus M, Abboud J, Williams G, Namdari S. Expectations of Shoulder Surgery Are Not Altered by Surgeon Counseling of the Patient. Joints. 2017 Aug 11;5(3):133-137. doi: 10.1055/s-0037-1605585. eCollection 2017 Sep.

  PMID: 29270541 BACKGROUND

• Cho CH, Jung SW, Park JY, Song KS, Yu KI. Is shoulder pain for three months or longer correlated with depression, anxiety, and sleep disturbance? J Shoulder Elbow Surg. 2013 Feb;22(2):222-8. doi: 10.1016/j.jse.2012.04.001. Epub 2012 Jun 26.

  PMID: 22738644 BACKGROUND

• Gwilym SE, Oag HC, Tracey I, Carr AJ. Evidence that central sensitisation is present in patients with shoulder impingement syndrome and influences the outcome after surgery. J Bone Joint Surg Br. 2011 Apr;93(4):498-502. doi: 10.1302/0301-620X.93B4.25054.

  PMID: 21464489 BACKGROUND

• Valencia C, Fillingim RB, Bishop M, Wu SS, Wright TW, Moser M, Farmer K, George SZ. Investigation of central pain processing in postoperative shoulder pain and disability. Clin J Pain. 2014 Sep;30(9):775-86. doi: 10.1097/AJP.0000000000000029.

  PMID: 24042347 BACKGROUND

• Lewis J, O'Sullivan P. Is it time to reframe how we care for people with non-traumatic musculoskeletal pain? Br J Sports Med. 2018 Dec;52(24):1543-1544. doi: 10.1136/bjsports-2018-099198. Epub 2018 Jun 25. No abstract available.

  PMID: 29941618 BACKGROUND

• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007 Oct 16;147(8):573-7. doi: 10.7326/0003-4819-147-8-200710160-00010.

  PMID: 17938396 BACKGROUND

• Buchbinder R, Page MJ, Huang H, Verhagen AP, Beaton D, Kopkow C, Lenza M, Jain NB, Richards B, Richards P, Voshaar M, van der Windt D, Gagnier JJ; Shoulder Core Outcome Set Special Interest Group. A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group. J Rheumatol. 2017 Dec;44(12):1880-1883. doi: 10.3899/jrheum.161123. Epub 2017 Jan 15.

  PMID: 28089972 BACKGROUND

• Huber W, Hofstaetter JG, Hanslik-Schnabel B, Posch M, Wurnig C. [Translation and psychometric testing of the Western Ontario Rotator Cuff Index (WORC) for use in Germany]. Z Orthop Ihre Grenzgeb. 2005 Jul-Aug;143(4):453-60. doi: 10.1055/s-2005-836677. German.

  PMID: 16118762 BACKGROUND

• Constant CR, Gerber C, Emery RJ, Sojbjerg JO, Gohlke F, Boileau P. A review of the Constant score: modifications and guidelines for its use. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):355-61. doi: 10.1016/j.jse.2007.06.022. Epub 2008 Jan 22. No abstract available.

  PMID: 18218327 BACKGROUND

• Maxwell S, Sterling M. An investigation of the use of a numeric pain rating scale with ice application to the neck to determine cold hyperalgesia. Man Ther. 2013 Apr;18(2):172-4. doi: 10.1016/j.math.2012.07.004. Epub 2012 Aug 11.

  PMID: 22892206 BACKGROUND

• Moloney N, Hall T, Doody C. An investigation of somatosensory profiles in work related upper limb disorders: a case-control observational study protocol. BMC Musculoskelet Disord. 2010 Jan 30;11:22. doi: 10.1186/1471-2474-11-22.

  PMID: 20113518 BACKGROUND

• Walton DM, Macdermid JC, Nielson W, Teasell RW, Reese H, Levesque L. Pressure pain threshold testing demonstrates predictive ability in people with acute whiplash. J Orthop Sports Phys Ther. 2011 Sep;41(9):658-65. doi: 10.2519/jospt.2011.3668. Epub 2011 Sep 1.

  PMID: 21885908 BACKGROUND

• Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.

  PMID: 21951710 BACKGROUND

• Scerbo T, Colasurdo J, Dunn S, Unger J, Nijs J, Cook C. Measurement Properties of the Central Sensitization Inventory: A Systematic Review. Pain Pract. 2018 Apr;18(4):544-554. doi: 10.1111/papr.12636. Epub 2017 Nov 20.

  PMID: 28851012 BACKGROUND

• Timmerman H, Steegers MAH, Huygen FJPM, Goeman JJ, van Dasselaar NT, Schenkels MJ, Wilder-Smith OHG, Wolff AP, Vissers KCP. Investigating the validity of the DN4 in a consecutive population of patients with chronic pain. PLoS One. 2017 Nov 30;12(11):e0187961. doi: 10.1371/journal.pone.0187961. eCollection 2017.

  PMID: 29190718 BACKGROUND

• Meyer K, Sprott H, Mannion AF. Cross-cultural adaptation, reliability, and validity of the German version of the Pain Catastrophizing Scale. J Psychosom Res. 2008 May;64(5):469-78. doi: 10.1016/j.jpsychores.2007.12.004.

  PMID: 18440399 BACKGROUND

• Klein EM, Brahler E, Dreier M, Reinecke L, Muller KW, Schmutzer G, Wolfling K, Beutel ME. The German version of the Perceived Stress Scale - psychometric characteristics in a representative German community sample. BMC Psychiatry. 2016 May 23;16:159. doi: 10.1186/s12888-016-0875-9.

  PMID: 27216151 BACKGROUND

• Broadbent E, Wilkes C, Koschwanez H, Weinman J, Norton S, Petrie KJ. A systematic review and meta-analysis of the Brief Illness Perception Questionnaire. Psychol Health. 2015;30(11):1361-85. doi: 10.1080/08870446.2015.1070851. Epub 2015 Aug 26.

  PMID: 26181764 BACKGROUND

• Leysen M, Nijs J, Meeus M, Paul van Wilgen C, Struyf F, Vermandel A, Kuppens K, Roussel NA. Clinimetric properties of illness perception questionnaire revised (IPQ-R) and brief illness perception questionnaire (Brief IPQ) in patients with musculoskeletal disorders: A systematic review. Man Ther. 2015 Feb;20(1):10-7. doi: 10.1016/j.math.2014.05.001. Epub 2014 May 14.

  PMID: 25435470 BACKGROUND

• Collins GH, Crawford SJ. Sarcocystis in goats: prevalence and transmission. N Z Vet J. 1978 Nov;26(11):288. doi: 10.1080/00480169.1978.34571. No abstract available.

  PMID: 109801 BACKGROUND

• Blackwell E, de Leon CF, Miller GE. Applying mixed regression models to the analysis of repeated-measures data in psychosomatic medicine. Psychosom Med. 2006 Nov-Dec;68(6):870-8. doi: 10.1097/01.psy.0000239144.91689.ca. Epub 2006 Nov 1.

  PMID: 17079709 BACKGROUND

• Edland SD, Ard MC, Sridhar J, Cobia D, Martersteck A, Mesulam MM, Rogalski EJ. Proof of concept demonstration of optimal composite MRI endpoints for clinical trials. Alzheimers Dement (N Y). 2016 Sep;2(3):177-181. doi: 10.1016/j.trci.2016.05.002.

  PMID: 28345017 BACKGROUND

• Schwank A, Struyf F, Struyf T, Mertens M, Gisi D, Benninger E, Meeus M. Psychosocial Factors, Sleep, and Central Pain Processing for Making a Prognosis About Recovery of Pain, Function, and Quality of Life After Rotator Cuff Repair: An Exploratory Longitudinal Study. J Orthop Sports Phys Ther. 2024 Aug;54(8):530-540. doi: 10.2519/jospt.2024.12398.

  PMID: 39096935 DERIVED

• Schwank A, Struyf T, Struyf F, Blazey P, Mertens M, Gisi D, Pisan M, Meeus M. Are psychosocial variables, sleep characteristics or central pain processing prognostic factors for outcome following rotator cuff repair? A protocol for a prospective longitudinal cohort study. BMJ Open. 2022 Aug 4;12(8):e058803. doi: 10.1136/bmjopen-2021-058803.

  PMID: 35926993 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries; Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Ariane Schwank, MSc

  Kantonsspital Winterthur KSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Specialist upper extremity, Physiotherapy / Physical Therapist, Master of Science

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 30, 2021
• Study Start: January 1, 2019
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

CH (1)