Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy

Patellar Tendinopathy Clinical Trial

Official title:

Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03694730
• Other study ID #: 1217479
• Status: Completed
• Phase: N/A
• Start date: March 11, 2018
• Est. completion date: April 15, 2020

Study information

• Verified date: March 2021
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study will evaluate the feasibility of pain-guided activity modification during rehabilitation for patellar tendinopathy. The information provided will be utilized to conduct a larger randomized clinical trial to determine if there is a difference in recovery from patellar tendinopathy during rehabilitation between individuals that use pain-guided activity modification and those that halt all painful activities. Recovery from patellar tendinopathy will be assessed using pain ratings, tendon-specific outcome measures, tendon structure, tendon mechanical properties, and muscle function.

Description:

Patellar tendinopathy is a chronic, degenerative condition of the patellar tendon that results in pain, altered tendon structure, functional impairments, decreased sports performance, and lost playing time. It commonly affects jumping athletes in sports such as volleyball and basketball. The prevalence of patellar tendinopathy is high, with 11.8-14.4% of recreational and 32-45% of elite volleyball and basketball players reporting symptoms. Although many athletes will seek treatment, 27-49% will experience re-injury and over half of those injured will retire from their sport of choice due to recurrent symptoms. Additionally, the absence of symptoms does not ensure full recovery of tendon health and function, which may contribute to the high rates of recurrence.

Exercise therapy for the treatment of patellar tendinopathy is supported by the highest level of evidence. However, exercise therapy has been found to be ineffective if the patients continue with full sports participation. On the other hand, it is unclear if it is necessary for athletes to completely halt physical activities while undergoing treatment. Absence from sport due to injury has been associated with increased anxiety, depression, and decreased self-esteem. Therefore, it is of interest to maintain sports participation, as long as it does not interfere with injury recovery.

In a randomized controlled trial (RCT) the investigators evaluated if continued running and jumping during treatment with an Achilles tendon-loading strengthening program had an effect on the outcome in patients with Achilles tendinopathy. In this study the investigators found that there were no detrimental effects of being physically active when the level of activity was guided by a pain-monitoring model. However, the impact of pain-guided activity modification has not been investigated in patellar tendinopathy. The proposed pilot study will determine if continued activity, using a pain-monitoring model, is feasible during treatment for patients with patellar tendinopathy. Furthermore, the investigators will evaluate if there is a negative effect on recovery of symptoms, tendon structure and mechanical properties, and functional recovery when adding continued physical activity compared to rest during exercise therapy treatment. To achieve this objective, the investigators will conduct a RCT comparing patients with patellar tendinopathy that are allowed to continue sports participation during treatment, using a pain-monitoring model, to those that are not allowed to participate in activities that cause pain.

Aim 1 is to evaluate feasibility by examining compliance and satisfaction with continued sports participation, guided by a pain-monitoring model, compared to refraining from sports participation during treatment. This will provide critical information to determine if a larger randomized clinical trial is feasible and if the study protocol needs to be modified. Aim 2 is to evaluate if there is a difference in change over time in symptoms, tendon structure and mechanical properties, and function between the two interventions.

This study will be the first to evaluate continued sports participation, guided by a pain-monitoring model, during rehabilitation in patients with patellar tendinopathy. The results from this study will play a critical role in achieving the long-term research goal of understanding of how to develop tailored treatments for patients with tendon injury. Ultimately this work will inform clinician recommendations regarding activity modification and potentially, limit the negative psychosocial impacts of the injury.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

Inclusion Criteria:

• Physically active individuals with a diagnosis of patellar tendinopathy

Exclusion Criteria:

• Injury that limits ability to participate in testing

• History of knee surgery within the last 6 months.

• Injection, shockwave, tenotomy or Ten-X to the patellar tendon within the last 6 months.

Related Conditions & MeSH terms

• Jumper's Knee
• Patellar Tendinitis
• Patellar Tendinopathy
• Patellar Tendinosis
• Patellar Tendon Pain
• Tendinopathy

Intervention

Other:
• Exercise Treatment
Exercise treatment will consist of squatting and knee extension exercises, designed to progressively load the patellar tendon (Heavy-Slow Resistance protocol). A pain-monitoring model is used to guide exercise loads. As the protocol progresses, exercise load is increased while repetitions are decreased.
• Pain- Guided Activity Modification
Participants sports participation and physical activity will be guided by the Pain-Monitoring Model. Using the Pain-Monitoring Model, patients may participate in activities that cause patellar tendon pain, as long as pain does not exceed 5/10 on the numeric pain rating scale (NPRS) (0 = No pain, 10 = Worst pain imaginable) during or immediately after activity. Additionally, pain should return to pre-activity levels by the following morning and pain should not increase from week-to-week.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sprague AL, Couppé C, Pohlig RT, Snyder-Mackler L, Silbernagel KG. Pain-guided activity modification during treatment for patellar tendinopathy: a feasibility and pilot randomized clinical trial. Pilot Feasibility Stud. 2021 Feb 25;7(1):58. doi: 10.1186/s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Willingness to Participate	The percentage of potential participants that are willing to enroll and be randomized to one of the two groups after being informed of the study	Percentage over initial year of study recruitment
Primary	Drop Out Rate	The percentage of participants that drop-out after study randomization.	Percentage over initial year of study recruitment
Primary	Symptoms	Victorian Institute of Sport Assessment - Patella questionnaire (VISA-P)	Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Primary	Tendon Structure	Ultrasound imaging of tendon structure	Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Primary	Continuous Shear Wave Elastography (cSWE) to measure tendon mechanical properties	Continuous shear wave elastography (cSWE) will be used to measure shear modulus, viscosity and dynamic shear modulus of the patellar tendon.	Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Primary	Muscle-tendon function	Functional test battery consisting of two jump tests, one muscle strength and activation test.	Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Secondary	Adverse Events	The number and types of adverse events occurring in either group during study participation.	Number over first year of study recruitment
Secondary	Knee Injury and Osteoarthritis Outcome Score - Quality of Life subscale (KOOS-QOL)	The Knee Injury and Osteoarthritis Outcome Score - Quality of Life subscale (KOOS-QOL) will be used to assess the impact of knee injury on quality of life. The KOOS-QOL is a subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). Scores range from 0 to 100 with 0 indicating extreme detrimental effect on quality of life and 100 indicating no effect on quality of life.	Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Secondary	Tampa Scale of Kinesiophobia (TSK)	The Tampa Scale of Kinesiophobia (TSK) will be used to measure participants fear of movement and re-injury (kinesiophobia). Scores on the TSK range from 17 to 68 with 17 indicating minimal to no fear of movement and re-injury and 68 indicating very high fear of movement and re-injury.	Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Secondary	Pain Catastrophizing Scale (PCS)	The Pain Catastrophizing Scale (PCS) will be used to assess patients pain catastrophizing. Scores on the PCS range from 0 to 52 with 0 indicating no pain catastrophizing and 52 indicating high levels of pain catastrophizing.	Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Secondary	Numeric Pain Rating Scale (NPRS)	Patellar tendon pain will be assessed using the numeric pain rating scale. Participants are asked to verbally rate their pain on a scale of 0 to 10 with 0 indicating "No pain at all" and 10 indicating the "Worst pain imaginable".	Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Secondary	Depression, Anxiety and Stress Scale (DASS-21)	Participant's depression, anxiety and stress levels will be assessed using the Depression, Anxiety and Stress Scale (DASS-21). The DASS-21 consists of three subscales, (1) Depression, (2) Anxiety, and (3) Stress. Scores for each subscale range form 0 to 42, where 0 indicates normal levels of the measured trait (depression, anxiety or stress) and 42 indicates extremely severe levels of the measured trait.	Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Secondary	Compliance with Activity Modification	Training log - Number of times pain exceeded pain threshold for either group	Average compliance rate for each group over first year of study recruitment

External Links

•   Delaware Tendon Research Group