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Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy

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ClinicalTrials.gov Identifier: NCT03694730
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
University of Delaware

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.

Condition or disease Intervention/treatment Phase
Patellar Tendinopathy Patellar Tendinitis Patellar Tendon Pain Patellar Tendinosis Jumper's Knee Other: Exercise Treatment Other: Pain- Guided Activity Modification Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two treatment groups receiving different activity modification instructions.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy
Actual Study Start Date : March 11, 2018
Actual Primary Completion Date : April 15, 2020
Actual Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pain-guided Activity Modification
Participants in the Pain guided Activity Modification group will receive an exercise program consisting of progressive patellar tendon loading exercises Outside of physical therapy treatment, these participants will modify activity based on the Pain-Monitoring Model.
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.
Other Names:
  • Rehabilitation exercise
  • Physical Therapy treatment

Other: 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.

Active Comparator: Pain-free Activity Modification
Participants in the Pain-free Activity Modification group will receive an identical exercise program to the Pain-guided Activity Modification group. However, participants will not be allowed to participate in activities that cause patellar tendon pain or excessively load the patellar tendon (e.g. jumping) outside of physical therapy treatment.
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.
Other Names:
  • Rehabilitation exercise
  • Physical Therapy treatment




Primary Outcome Measures :
  1. Willingness to Participate [ Time Frame: Percentage over initial year of study recruitment ]
    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

  2. Drop Out Rate [ Time Frame: Percentage over initial year of study recruitment ]
    The percentage of participants that drop-out after study randomization.

  3. Symptoms [ Time Frame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks ]
    Victorian Institute of Sport Assessment - Patella questionnaire (VISA-P)

  4. Tendon Structure [ Time Frame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks ]
    Ultrasound imaging of tendon structure

  5. Continuous Shear Wave Elastography (cSWE) to measure tendon mechanical properties [ Time Frame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks ]
    Continuous shear wave elastography (cSWE) will be used to measure shear modulus, viscosity and dynamic shear modulus of the patellar tendon.

  6. Muscle-tendon function [ Time Frame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks ]
    Functional test battery consisting of two jump tests, one muscle strength and activation test.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Number over first year of study recruitment ]
    The number and types of adverse events occurring in either group during study participation.

  2. Knee Injury and Osteoarthritis Outcome Score - Quality of Life subscale (KOOS-QOL) [ Time Frame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks ]
    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.

  3. Tampa Scale of Kinesiophobia (TSK) [ Time Frame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks ]
    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.

  4. Pain Catastrophizing Scale (PCS) [ Time Frame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks ]
    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.

  5. Numeric Pain Rating Scale (NPRS) [ Time Frame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks ]
    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".

  6. Depression, Anxiety and Stress Scale (DASS-21) [ Time Frame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks ]
    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.

  7. Compliance with Activity Modification [ Time Frame: Average compliance rate for each group over first year of study recruitment ]
    Training log - Number of times pain exceeded pain threshold for either group



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694730


Locations
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United States, Delaware
University of Delaware
Newark, Delaware, United States, 19713
Sponsors and Collaborators
University of Delaware
Additional Information:
Publications of Results:
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Responsible Party: University of Delaware
ClinicalTrials.gov Identifier: NCT03694730    
Other Study ID Numbers: 1217479
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Delaware:
Tendinopathy
Tendinitis
Tendinosis
Rehabilitation
Exercise Treatment
Activity Modification
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries