Clinical trial NCT04393129: Central Sensitization Symptoms and Psychosocial Factors in Athletes After ACL Reconstruction
Official title: Prevalence of Central Sensitization Symptoms and Psychosocial Factors in Athletes After ACL Reconstruction and Return to Play
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Rupture
Keywords: Return to play
Psychosocial
Central sensitization
Chronic pain
Athlete
Reconstruction
Rehabilitation
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: KAT General Hospital
First posted: 2020-05-19
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: This is an observational, cross-sectional study. For the purposes of the study a sample group was selected from a clinic specialised in ACL reconstruction and rehabilitation based in Athens, Greece. Patients of the specific clinic had received the same surgical technique and rehabilitation protocol. Ability to return to sport was examined 9 months after surgery and approval was given according to the rehabilitation progress. A list of eligible study subjects was formed and, after inclusion and exclusion criteria were screened for, they were invited to participate in the study. Study participants, after having declared consent and passed the criteria were asked to answer the study questionnaires. Communication with participants was done through telephone and email, and all questionnaires were completed online.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. adolescent age (\<18 years of age),
2. diagnosis of cancer of any stage,
3. diagnosis of psychiatric, neurological or autoimmune disease or syndrome,
4. past musculoskeletal injuries, including fractures, joints dislocation, ligament and tendon tears and
5. 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).

Primary outcomes:
measure: Symptoms of Central Sensitization
timeFrame: At least 9 months post-operative
measure: Pain intensity
timeFrame: At least 9 months post-operative
measure: Pain Catastrophizing
timeFrame: At least 9 months post-operative
measure: Kinesiophobia
timeFrame: At least 9 months post-operative
measure: Sense of unfairness
timeFrame: At least 9 months post-operative
measure: Illness Perception
timeFrame: At least 9 months post-operative
Secondary outcomes:
measure: Willingness and ability to return to play
timeFrame: At least 9 months post-operative
measure: Activity level
timeFrame: At least 9 months post-operative
measure: Knee functional level
timeFrame: At least 9 months post-operative
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: Clinical Exercise Physiology and Rehabilitation Laboratory
state: Sterea Ellada
Study officials:
affiliation: Physiotherapy Department, University of Thessaly
name: Eleni Kapreli, Phd
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.