Clinical trial NCT03694730: Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy
Official title: Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellar Tendinopathy
Patellar Tendinitis
Patellar Tendon Pain
Patellar Tendinosis
Jumper's Knee
Keywords: Tendinopathy
Tendinitis
Tendinosis
Rehabilitation
Exercise Treatment
Activity Modification
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two treatment groups receiving different activity modification instructions.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Willingness to Participate
timeFrame: Percentage over initial year of study recruitment
measure: Drop Out Rate
timeFrame: Percentage over initial year of study recruitment
measure: Symptoms
timeFrame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
measure: Tendon Structure
timeFrame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
measure: Continuous Shear Wave Elastography (cSWE) to measure tendon mechanical properties
timeFrame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
measure: Muscle-tendon function
timeFrame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: Number over first year of study recruitment
measure: Knee Injury and Osteoarthritis Outcome Score - Quality of Life subscale (KOOS-QOL)
timeFrame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
measure: Depression, Anxiety and Stress Scale (DASS-21)
timeFrame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
measure: Compliance with Activity Modification
timeFrame: Average compliance rate for each group over first year of study recruitment
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
References:
citation: Sprague AL, Couppe 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/s40814-021-00792-5.