Anterior Cruciate Ligament RuptureNCT04393129
Central Sensitization Symptoms and Psychosocial Factors in Athletes After ACL Reconstruction
An observational study of Anterior Cruciate Ligament Rupture, run by University of Thessaly at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- How many people
- 39 participants
- Where
- 1 siteGreece
- Study dates
- 1 Oct 2019to 5 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Athletes that have suffered an ACL rupture and have undergone surgical reconstruction and rehabilitation, and have been cleared to return to sport.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Greece1 site
Clinical Exercise Physiology and Rehabilitation Laboratory
Lamia, Central Greece, 35100
About this study
Official title: Prevalence of Central Sensitization Symptoms and Psychosocial Factors in Athletes After ACL Reconstruction and Return to Play
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Return to play, Psychosocial, Central sensitization, Chronic pain, Athlete, Reconstruction, Rehabilitation
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At least 9 months post-operative
Secondary outcomes (3)
Willingness and ability to return to play
Anterior 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).
Measured: At least 9 months post-operative
Activity level
Tegner 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).
Measured: At least 9 months post-operative
Knee functional level
Knee 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).
Measured: At least 9 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Oct 2019
- Primary completion27 Feb 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Collaborators
- KAT General Hospital
- Responsible party
- Principal investigator, Eleni Kapreli, University of Thessaly
- Investigators
- Eleni Kapreli, Phd, Study chair, Physiotherapy Department, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393129
- Sponsor's protocol ID
- 2
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26783987Kuppens 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.
PubMed 28980347Lundberg 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.
PubMed 22191022Mayer 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.
PubMed 21951710Roos 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.
PubMed 14613558Sullivan 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.
PubMed 18536983Webster 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.
PubMed 19083699
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Central Sensitization Symptoms and Psychosocial Factors in Athletes After ACL Reconstruction and Return to Play
- ClinicalTrials.gov ID
- NCT04393129
- Acronym / sponsor ID
- 2
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Return to play, Psychosocial, Central sensitization, Chronic pain, Athlete, Reconstruction, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Collaborators
- KAT General Hospital
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Athletes that have suffered an ACL rupture and have undergone surgical reconstruction and rehabilitation, and have been cleared to return to sport.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptoms of Central Sensitization
Time frame: At least 9 months post-operative
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.
Pain intensity
Time frame: At least 9 months post-operative
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.
Pain Catastrophizing
Time frame: At least 9 months post-operative
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.
Kinesiophobia
Time frame: At least 9 months post-operative
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).
Sense of unfairness
Time frame: At least 9 months post-operative
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.
Illness Perception
Time frame: At least 9 months post-operative
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.
3 secondary outcomes
Willingness and ability to return to play
Time frame: At least 9 months post-operative
Activity level
Time frame: At least 9 months post-operative
Knee functional level
Time frame: At least 9 months post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Background: PubMed 26783987Craner 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.
- Background: PubMed 28980347Kuppens 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.
- Background: PubMed 22191022Lundberg 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.
- Background: PubMed 21951710Mayer 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.
- Background: PubMed 14613558Roos 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.
- Background: PubMed 18536983Sullivan 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.
- Background: PubMed 19083699Webster 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleni Kapreli, Phd study chair
Physiotherapy Department, University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Rupture, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of Central Sensitization (time frame: At least 9 months post-operative). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04393129, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.