Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy

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Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 15, 2018

Estimated Primary Completion Date

October 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Drop Out Rate[ Time Frame: Percentage over initial year of study recruitment ]

The percentage of participants that drop-out after study randomization.

Symptoms[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ]

Victorian Institute of Sport Assessment - Patella questionnaire (VISA-P)

Tendon Structure[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ]

Ultrasound imaging of tendon structure

Continuous Shear Wave Elastography (cSWE) to measure tendon mechanical properties[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ]

Continuous shear wave elastography (cSWE) will be used to measure shear modulus, viscosity and dynamic shear modulus of the patellar tendon.

Muscle-tendon function[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ]

Functional test battery consisting of two jump tests, one muscle strength and activation test.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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.
Knee Injury and Osteoarthritis Outcome Score - Quality of Life subscale (KOOS-QOL)[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ]
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)[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ]
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)[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ]
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.
Physical Activity Scale (PAS)[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ]
Physical activity level will be measured using the Physical Activity Scale (PAS). Scores on the PAS range from 1 to 6 with 1 indicating "Hardly any physical activity" and 6 indicating "Hard or very hard exercise regularly and several times a week".
Numeric Pain Rating Scale (NPRS)[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ]
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".
Mechanical Pain Threshold[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ]
Pain Pressure Threshold
Depression, Anxiety and Stress Scale (DASS-21)[ Time Frame: Change over time with evaluations at baseline, 6-weeks, 12-weeks, 6-months and 1-year ]
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[ 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

Descriptive Information

Brief Title ^ICMJE

Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy

Official Title ^ICMJE

Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two treatment groups receiving different activity modification instructions.
Masking: Interventional
Masking Description:The study staff responsible for collecting primary and secondary outcomes will be blinded to group allocation.
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

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: 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.

Study Arms

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.
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 outside of physical therapy treatment.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 15, 2020

Estimated Primary Completion Date

October 15, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - 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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

16 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

，

Study Sponsor ^ICMJE

University of Delaware

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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