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Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy

Primary Purpose

Patellar Tendinopathy, Patellar Tendinitis, Patellar Tendon Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Treatment
Pain- Guided Activity Modification
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellar Tendinopathy focused on measuring Tendinopathy, Tendinitis, Tendinosis, Rehabilitation, Exercise Treatment, Activity Modification

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pain-guided Activity Modification

Pain-free Activity Modification

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Drop Out Rate
The percentage of participants that drop-out after study randomization.
Symptoms
Victorian Institute of Sport Assessment - Patella questionnaire (VISA-P)
Tendon Structure
Ultrasound imaging of tendon structure
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.
Muscle-tendon function
Functional test battery consisting of two jump tests, one muscle strength and activation test.

Secondary Outcome Measures

Adverse Events
The number and types of adverse events occurring in either group during study participation.
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.
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.
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.
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".
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.
Compliance with Activity Modification
Training log - Number of times pain exceeded pain threshold for either group

Full Information

First Posted
October 1, 2018
Last Updated
March 4, 2021
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT03694730
Brief Title
Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy
Official Title
Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 11, 2018 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
April 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinopathy, Patellar Tendinitis, Patellar Tendon Pain, Patellar Tendinosis, Jumper's Knee
Keywords
Tendinopathy, Tendinitis, Tendinosis, Rehabilitation, Exercise Treatment, Activity Modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two treatment groups receiving different activity modification instructions.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain-guided Activity Modification
Arm Type
Experimental
Arm Description
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.
Arm Title
Pain-free Activity Modification
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise Treatment
Other Intervention Name(s)
Rehabilitation exercise, Physical Therapy treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pain- Guided Activity Modification
Intervention Description
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.
Primary Outcome Measure Information:
Title
Willingness to Participate
Description
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
Time Frame
Percentage over initial year of study recruitment
Title
Drop Out Rate
Description
The percentage of participants that drop-out after study randomization.
Time Frame
Percentage over initial year of study recruitment
Title
Symptoms
Description
Victorian Institute of Sport Assessment - Patella questionnaire (VISA-P)
Time Frame
Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Title
Tendon Structure
Description
Ultrasound imaging of tendon structure
Time Frame
Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Title
Continuous Shear Wave Elastography (cSWE) to measure tendon mechanical properties
Description
Continuous shear wave elastography (cSWE) will be used to measure shear modulus, viscosity and dynamic shear modulus of the patellar tendon.
Time Frame
Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Title
Muscle-tendon function
Description
Functional test battery consisting of two jump tests, one muscle strength and activation test.
Time Frame
Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Secondary Outcome Measure Information:
Title
Adverse Events
Description
The number and types of adverse events occurring in either group during study participation.
Time Frame
Number over first year of study recruitment
Title
Knee Injury and Osteoarthritis Outcome Score - Quality of Life subscale (KOOS-QOL)
Description
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.
Time Frame
Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Title
Tampa Scale of Kinesiophobia (TSK)
Description
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.
Time Frame
Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Title
Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Title
Numeric Pain Rating Scale (NPRS)
Description
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".
Time Frame
Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Title
Depression, Anxiety and Stress Scale (DASS-21)
Description
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.
Time Frame
Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Title
Compliance with Activity Modification
Description
Training log - Number of times pain exceeded pain threshold for either group
Time Frame
Average compliance rate for each group over first year of study recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33632313
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.
Results Reference
result
Links:
URL
https://sites.udel.edu/pt/research/karin-gravare-silbernagel-pt-phd-atc/
Description
Delaware Tendon Research Group

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Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy

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