Central Sensitization Symptoms and Psychosocial Factors in Athletes After ACL Reconstruction

NCT04393129 | Completed

• 1 other identifier: 2
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The main research objective of this study is whether athletes who have sustained an anterior cruciate ligament injury, experience chronic nociplastic pain and psychosocial factors, including kinesiophobia and pain catastrophizing, after having been through ACL reconstruction surgery and rehabilitation and have returned to sport.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

Return to play; Psychosocial; Central sensitization; Chronic pain; Athlete; Reconstruction; Rehabilitation

Outcome Measures

Primary Outcomes (6)

• Symptoms of Central Sensitization

  The Central Sensitization Inventory (CSI) was used to assess symptoms of central sensitization. CSI was developed as a tool to evaluate somatic and emotional complaints associated with central sensitization syndrome. The CSI consists of 25 questions and can be divided in four sections that focus on physical symptoms, emotional distress, headache and jaw symptoms and urological symptoms (Mayer et al. 2012). Each question is answered on a 0-4 scale by choosing the intensity that best describes their symptoms or emotions. The individual answers are added to form a total score that can range from 0 to 100.

  At least 9 months post-operative

• Pain intensity

  The Numerical Rating Scale (NRS) was used to assess pain intensity. NRS has been widely used to measure and assess pain levels in adults, including chronic pain patients (Hawker et al. 2011). The scale consists of a segmented numeric version of the Visual Analog Scale (VAS) in which subjects choose a number (0-10) that best describes their pain intensity.

  At least 9 months post-operative

• Pain Catastrophizing

  Pain catastrophizing was assessed by the Pain Catastrophizing Scale (PCS). PCS was created in an effort to measure inability to cope with pain due to catastrophizing. The scale was developed on the construct that catastrophizing involves three subsequent dimensions, rumination, magnification and helplessness (Craner et al. 2016). It is a self-report questionnaire which includes 13 items about the above three dimensions of pain catastrophizing. Every item is answered on a Likert scale ranging from 0 to 4. A final total score will range between 0 and 52 points with minimal detectable change being 9 points.

  At least 9 months post-operative

• Kinesiophobia

  Kinesiophobia was assessed using the Tampa Scale for Kinesiophobia (TSK). TSK is a questionnaire which consists of 17 questions and is used to assess fear of movement and re injury. The questions are answered by choosing the statement that most accurately represents the subjects state, these answers vary from "strongly agree" to "strongly disagree". The final score of the questionnaire will range from 17-68 and is made up by scoring each answer in a Likert scale (Lundberg et al. 2011).

  At least 9 months post-operative

• Sense of unfairness

  Sense of unfairness was examined by using the Inequality Experience Questionnaire (IEQ) which is a 12-item scale that asks participants to indicate the frequency with which they experience different thoughts concerning the sense of unfairness corelated to their injury on a five-point scale ranging from 0 (never) to 4 (all the time). The IEQ yields two factors that have been labeled severity/irreparability of loss and blame/unfairness. The IEQ has been shown to be internally reliable (Sullivan et al. 2008). The IEQ total score is measured by summing responses to all 12 items.

  At least 9 months post-operative

• Illness Perception

  Brief Illness Perception Questionnaire (B-IPQ) was used to assess illness perception. The B-IPQ is a very commonly used tool to assess the subject's perception of their illness. In total it consists of 9 items which are scored on a 0-10 scale apart from the final item which is an open-ended question.

  At least 9 months post-operative

Secondary Outcomes (3)

• Willingness and ability to return to play

  At least 9 months post-operative

• Activity level

  At least 9 months post-operative

• Knee functional level

  At least 9 months post-operative

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Athletes that have suffered an ACL rupture and have undergone surgical reconstruction and rehabilitation, and have been cleared to return to sport.

You may qualify if:

• knowledge of Greek language,
• surgically reconstructed ACL tear on one limb only,
• successful completion of rehabilitation program,
• medical permission to return to sport,
• returned to previous sport for at least 6 months period
• athlete of a lower limb loading sport.

You may not qualify if:

• adolescent age (\<18 years of age),
• diagnosis of cancer of any stage,
• diagnosis of psychiatric, neurological or autoimmune disease or syndrome,
• past musculoskeletal injuries, including fractures, joints dislocation, ligament and tendon tears and
• chronic musculoskeletal injuries (tendinopathies, shin splints, shoulder impingement etc.). Chronic pain is defined as pain persisting for at least 3 months, of intensity at least 3 on the VAS scale for most days per week (Kuppens et al. 2018).

Sponsors & Collaborators

• University of Thessaly: lead
• KAT General Hospital: collaborator

Study Sites (1)

Clinical Exercise Physiology and Rehabilitation Laboratory

Lamia, Central Greece, 35100, Greece

Location

Related Publications (7)

• Craner JR, Gilliam WP, Sperry JA. Rumination, Magnification, and Helplessness: How do Different Aspects of Pain Catastrophizing Relate to Pain Severity and Functioning? Clin J Pain. 2016 Dec;32(12):1028-1035. doi: 10.1097/AJP.0000000000000355.

  PMID: 26783987 BACKGROUND

• Kuppens K, Hans G, Roussel N, Struyf F, Fransen E, Cras P, Van Wilgen CP, Nijs J. Sensory processing and central pain modulation in patients with chronic shoulder pain: A case-control study. Scand J Med Sci Sports. 2018 Mar;28(3):1183-1192. doi: 10.1111/sms.12982. Epub 2017 Oct 4.

  PMID: 28980347 BACKGROUND

• Lundberg M, Grimby-Ekman A, Verbunt J, Simmonds MJ. Pain-related fear: a critical review of the related measures. Pain Res Treat. 2011;2011:494196. doi: 10.1155/2011/494196. Epub 2011 Nov 15.

  PMID: 22191022 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

• Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.

  PMID: 14613558 BACKGROUND

• Sullivan MJ, Adams H, Horan S, Maher D, Boland D, Gross R. The role of perceived injustice in the experience of chronic pain and disability: scale development and validation. J Occup Rehabil. 2008 Sep;18(3):249-61. doi: 10.1007/s10926-008-9140-5. Epub 2008 Jun 7.

  PMID: 18536983 BACKGROUND

• Webster KE, Feller JA, Lambros C. Development and preliminary validation of a scale to measure the psychological impact of returning to sport following anterior cruciate ligament reconstruction surgery. Phys Ther Sport. 2008 Feb;9(1):9-15. doi: 10.1016/j.ptsp.2007.09.003. Epub 2007 Nov 5.

  PMID: 19083699 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Chronic Pain

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eleni Kapreli, Phd

  Physiotherapy Department, University of Thessaly

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 19, 2020
• Study Start: October 1, 2019
• Primary Completion: February 27, 2020
• Study Completion: March 5, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

GR (1)