Kinesiophobia After Anterior Cruciate Ligament Reconstruction.

ACL Injury Clinical Trial

Official title:

Kinesiophobia After Anterior Cruciate Ligament Reconstruction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762809
• Other study ID #: TUHST-1
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Tartu University Hospital
• Contact: Leho Rips, MD
• Phone: 5133474
• Email: leho.rips[@]kliinikum.ee
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anterior cruciate ligament (ACL) rupture is a serious trauma with long-term consequences to the athlete. Psychological and physiological factors may negatively affect patient recovery and increase reinjury rate after anterior cruciate ligament reconstruction (ACLR), and development of kinesiophobia is also possible.

Description:

Anterior cruciate ligament (ACL) rupture is a serious trauma with long-term consequences to the athlete. Return to sports at the pre-injury level after anterior cruciate ligament reconstruction (ACLR) is reported between 55 and 83%. Psychological and physiological factors can negatively affect patient recovery and increase reinjury rate after ACLR. In daily practice, surgeons and physiotherapists see athletes struggling to improve muscle strength and complaining of a lack of self-confidence and fear of reinjury during their progress to return to sports.

Kinesiophobia in ACLR patients is used to determine fear of pain, lack of self-confidence, and fear of reinjury. Patients with self-reported fear are less active, have decreased muscle function, and increased risk of a second ACL injury. Lower rates of return to sports are reported in athletes with kinesiophobia after ACLR. To measure kinesiophobia, the self-reported Tampa Scale of Kinesiophobia (TSK-17) test is widely used. The original TSK was developed and described by Miller et al. in 1991. In ACLR patients, the risk of developing fear was previously measured in a large systematic review of 2175 patients, in which 514 (24%) reported a psychological reason for not returning to sports.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients underwent ACLR by three orthopaedic surgeons at the Tartu University Hospital Sports Traumatology Centre between 2013 and 2019.

Exclusion Criteria:

• Patients with revision ACLR, bilateral ACLR, and postoperative infections were excluded from the study.

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries
• Kinesiophobia

Intervention

Diagnostic Test:
• Tampa Scale of Kinesiophobia (TSK-17)
The Tampa Scale of Kinesiophobia (TSK-17) was developed as a self-reported checklist to measure fear of pain during movement and fear of reinjury. The TSK-17 consists of 17 questions. Standardized answer options are given as a 4-point Likert scale, and each question is assigned a score from 1 to 4. A normalized score between 17 and 68 points is calculated. A score of 37 or over indicates kinesiophobia.
• Knee injury and Osteoarthritis Outcome Score (KOOS)
The KOOS consists of five subscales - Symptoms (S), Pain (P), Functional activities of daily living (ADL), Sport and Recreation Function (Sport/Rec) and Knee-Related Quality of life (QOL) - and total KOOS Outcome (O) scores. Standardized answer options are provided (5 Likert boxes), and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
• Oxford Knee Score (OKS) scoring
OKS consists of 12 questions. Standardized answer options are provided (5 Likert boxes), and each question is assigned a score from 0 to 4. A score of 40-48 indicates no symptoms or satisfactory joint function, 30-39 moderate knee arthritis, 20-29 moderate to severe knee arthritis, and 0-19 severe knee arthritis.
• Quadriceps and hamstring muscle isokinetic strength
Quadriceps and hamstring muscle strength at 60°/s and 180°/s were measured with an isokinetic dynamometer. For 180°/s, five trial and fifteen testing repetitions were used, and for 60°/s, three trial and three testing repetitions were used. The resting time between trial and testing was two minutes, between different speeds one minute, and between legs two minutes. The maximum peak torques were used in the statistical analysis.
• Single-leg hop test
The single-leg hop test (SLHT) for distance was used for lower limb functional testing. The test started with the participant standing on one leg, toes behind a marked line, and hands on hips throughout to avoid aiding the jump by swinging the arms. The participant was instructed to jump as far as possible and land on the same leg without losing balance. If the patient made contact with the ground with the contralateral limb, lost balance, or made additional hops after landing, the distance was not measured and the jump void. The distance was measured from the starting line to the heel of the leg being tested. For both legs, three trials and three jumps for maximal effort were allowed. The longest distance for both the left leg and the right leg were used in the statistical analysis.
• Y-balance test
The Y-balance test (YBT) (Move2Perform, United States) for anterior reach was used to measure dynamic balance. Participants performed three trials to familiarize themselves with the test, and then undertook three tests. The test started with the participant standing barefoot on the testing kit. The patients had to push a wooden box with the contralateral leg as far as possible with continuous movement and return to their starting position without losing balance. The longest distance achieved was used in the statistical analysis.
• Anthropometric measurements
Body mass (kg) and height (cm) were measured, and the body mass index (BMI) was calculated as kg/m2.

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu	Tartumaa

Sponsors (1)

Lead Sponsor	Collaborator
Tartu University Hospital

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KOOS	The primary variable of the study is the total KOOS score.	1 week
Secondary	Body mass index	Body mass (kg) and height (cm) were measured, and the body mass index (BMI) was calculated as kg/m2.	1 week
Secondary	Oxford Knee Score (OKS) scoring	OKS consists of 12 questions. Standardized answer options are provided (5 Likert boxes), and each question is assigned a score from 0 to 4. A score of 40-48 indicates no symptoms or satisfactory joint function, 30-39 moderate knee arthritis, 20-29 moderate to severe knee arthritis, and 0-19 severe knee arthritis.	1 week
Secondary	Tampa Scale of Kinesiophobia (TSK-17)	The Tampa Scale of Kinesiophobia (TSK-17) was developed as a self-reported checklist to measure fear of pain during movement and fear of reinjury. The TSK-17 consists of 17 questions. Standardized answer options are given as a 4-point Likert scale, and each question is assigned a score from 1 to 4. A normalized score between 17 and 68 points is calculated. A score of 37 or over indicates kinesiophobia.	1 week
Secondary	Quadriceps and hamstring muscle isokinetic strength	Quadriceps and hamstring muscle strength at 60°/s and 180°/s were measured with an isokinetic dynamometer. For 180°/s, five trial and fifteen testing repetitions were used, and for 60°/s, three trial and three testing repetitions were used. The resting time between trial and testing was two minutes, between different speeds one minute, and between legs two minutes. The maximum peak torques were used in the statistical analysis.	1 week
Secondary	Single-leg hop test	The single-leg hop test (SLHT) for distance was used for lower limb functional testing. The test started with the participant standing on one leg, toes behind a marked line, and hands on hips throughout to avoid aiding the jump by swinging the arms. The participant was instructed to jump as far as possible and land on the same leg without losing balance. If the patient made contact with the ground with the contralateral limb, lost balance, or made additional hops after landing, the distance was not measured and the jump void. The distance was measured from the starting line to the heel of the leg being tested. For both legs, three trials and three jumps for maximal effort were allowed. The longest distance for both the left leg and the right leg were used in the statistical analysis.	1 week
Secondary	Y-balance test	The Y-balance test (YBT) (Move2Perform, United States) for anterior reach was used to measure dynamic balance. Participants performed three trials to familiarize themselves with the test, and then undertook three tests. The test started with the participant standing barefoot on the testing kit. The patients had to push a wooden box with the contralateral leg as far as possible with continuous movement and return to their starting position without losing balance. The longest distance achieved was used in the statistical analysis.	1 week