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Central Sensitization Symptoms and Psychosocial Factors in Athletes After ACL Reconstruction

Prevalence of Central Sensitization Symptoms and Psychosocial Factors in Athletes After ACL Reconstruction and Return to Play

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04393129
Enrollment
39
Registered
2020-05-19
Start date
2019-10-01
Completion date
2020-03-05
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Rupture

Keywords

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

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.

Interventions

None listed

Sponsors

KAT General Hospital
CollaboratorOTHER
University of Thessaly
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Symptoms of Central SensitizationAt least 9 months post-operativeThe 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.
Pain intensityAt least 9 months post-operativeThe 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.
Pain CatastrophizingAt least 9 months post-operativePain 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.
KinesiophobiaAt least 9 months post-operativeKinesiophobia 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).
Sense of unfairnessAt least 9 months post-operativeSense 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.
Illness PerceptionAt least 9 months post-operativeBrief 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.

Secondary

MeasureTime frameDescription
Willingness and ability to return to playAt least 9 months post-operativeAnterior Cruciate Ligament - Return to Sport after Injury (ACL-RSI) questionnaire was used to assess willingness and ability to return to play. The ACl-RSI scale focuses on three main psychosocial areas, emotions, confidence and risk appraisal, that can affect willingness and ability to return to sport safely. The scale has high internal consistency, Cronbach's alpha 0.96 and inter-item correlations were high with a mean of 0.69 (min 0.49, max 0.83) (Webster et al. 2008). The ACL-RSI consists of a unidimensional 12-question scale that measures the three psychosocial domains mentioned above, 5 questions focus on emotions, 5 on confidence in performance and 2 on risk appraisal. The questions are answered on a scale from 0 to 100 in 10-point increments and the total score is represented by the mean total of the answers' given (Webster et al. 2008).
Activity levelAt least 9 months post-operativeTegner Activity Scale (TAS) was used to assess the activity level. Activity level and level of sports participation of athletes recovering from ACL is most often measured by self-report and the Tegner Activity Scale (TAS) or by a combination of the above (Neeb et al. 1997). The TAS is a grades activity based on work and sport activities. The TAS consists of a numerical scale (0-10) followed by a sentence describing each level of activity. The subjects is asked to choose the number that best describes their activity level. A higher score indicates a higher activity level. Test retest validity has been found to be acceptable (ICC\> 0.70) and internal validity was measured to be a=0.72 (Cronbach). Specifically, the TAS has been tested in the ACL population and seems to demonstrate acceptable psychometric parameters (Briggs et al. 2009).
Knee functional levelAt least 9 months post-operativeKnee injury and Osteoarthritis Outcome Score (KOOS) was used to assess knee functional level. It is a knee specific measuring instrument which was originally developed in order to evaluate both the short-term and long-term consequences of a knee injury. The KOOS questionnaire consists of five subgroups referring to pain, symptoms, activities of daily living, sports and recreation functionality and quality of life. In total there are 42 questions and It has been validated on the anterior cruciate ligament reconstruction population and is considered most appropriate for this study since it assesses sport and recreation functionality (Roos and Lohmander 2003).

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026