Patellar TendinopathyNCT03694730
Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy
A study testing Exercise Treatment and Pain- Guided Activity Modification in people with Patellar Tendinopathy and Patellar Tendinitis, run by University of Delaware at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Patellar Tendinopathy, Patellar Tendinitis, Patellar Tendon Pain
- What is being tested?
- Exercise Treatment and Pain- Guided Activity Modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2018to 15 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Physically active individuals with a diagnosis of patellar tendinopathy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Patellar Tendinopathy, Patellar Tendinitis, Patellar Tendon Pain, Patellar Tendinosis, Jumper's Knee
- Being tested
- Exercise Treatment, Pain- Guided Activity Modification
- Keywords
- Tendinopathy, Tendinitis, Tendinosis, Rehabilitation, Exercise Treatment, Activity Modification
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TreatmentOther
Also called Rehabilitation exercise, Physical Therapy 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 ModificationOther
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 group | Role | What they receive |
|---|---|---|
| Pain-guided Activity Modification | Experimental | 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. Receives: Other: Exercise Treatment; Other: Pain- Guided Activity Modification |
| Pain-free Activity Modification | Active comparator | 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. Receives: Other: Exercise Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Percentage over initial year of study recruitment
Drop Out Rate
The percentage of participants that drop-out after study randomization.
Measured: Percentage over initial year of study recruitment
Symptoms
Victorian Institute of Sport Assessment - Patella questionnaire (VISA-P)
Measured: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Tendon Structure
Ultrasound imaging of tendon structure
Measured: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
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.
Measured: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Muscle-tendon function
Functional test battery consisting of two jump tests, one muscle strength and activation test.
Measured: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Secondary outcomes (7)
Adverse Events
The number and types of adverse events occurring in either group during study participation.
Measured: Number over first year of study recruitment
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.
Measured: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
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.
Measured: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
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.
Measured: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
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".
Measured: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
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.
Measured: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Compliance with Activity Modification
Training log - Number of times pain exceeded pain threshold for either group
Measured: Average compliance rate for each group over first year of study recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start11 Mar 2018
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellar TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two treatment groups receiving different activity modification instructions.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694730
- Sponsor's protocol ID
- 1217479
- Status last verified
- Mar 2021
- First submitted
- 1 Oct 2018
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33632313
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT03694730
- Acronym / sponsor ID
- 1217479
- Conditions
- Patellar Tendinopathy, Patellar Tendinitis, Patellar Tendon Pain, Patellar Tendinosis, Jumper's Knee
- Keywords
- Tendinopathy, Tendinitis, Tendinosis, Rehabilitation, Exercise Treatment, Activity Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 11 Mar 2018 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two treatment groups receiving different activity modification instructions.
| Arm | Type | Receives |
|---|---|---|
| Pain-guided Activity Modification | Experimental | Other: Exercise Treatment, Other: Pain- Guided Activity ModificationParticipants 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. |
| Pain-free Activity Modification | Active comparator | Other: Exercise TreatmentParticipants 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. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Physically active individuals with a diagnosis of patellar tendinopathy
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TreatmentAlso: Rehabilitation exercise, Physical Therapy treatmentExercise 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-free Activity Modification, Pain-guided Activity Modification |
| Pain- Guided Activity ModificationParticipants 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. | Other | Pain-guided Activity Modification |
Primary outcome
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, and 12-weeks
Victorian Institute of Sport Assessment - Patella questionnaire (VISA-P)
Tendon Structure
Time frame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
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, and 12-weeks
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, and 12-weeks
Functional test battery consisting of two jump tests, one muscle strength and activation test.
7 secondary outcomes
Adverse Events
Time frame: Number over first year of study recruitment
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
Tampa Scale of Kinesiophobia (TSK)
Time frame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Pain Catastrophizing Scale (PCS)
Time frame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Numeric Pain Rating Scale (NPRS)
Time frame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Depression, Anxiety and Stress Scale (DASS-21)
Time frame: Change over time with evaluations at baseline, 6-weeks, and 12-weeks
Compliance with Activity Modification
Time frame: Average compliance rate for each group over first year of study recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Results publication: PubMed 33632313Sprague 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.
- Delaware Tendon Research GroupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Treatment and Pain- Guided Activity Modification in people with Patellar Tendinopathy and Patellar Tendinitis, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness to Participate (time frame: Percentage over initial year of study recruitment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03694730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.