Continued Activity During Rehabilitation in Patients With Patellar Tendinopathy

NCT03694730 | Completed

• 1 other identifier: 1217479
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellar Tendinopathy; Patellar Tendinitis; Patellar Tendon Pain; Patellar Tendinosis; Jumper's Knee

Keywords

Tendinopathy; Tendinitis; Tendinosis; Rehabilitation; Exercise Treatment; Activity Modification

Outcome Measures

Primary Outcomes (6)

• 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

  Percentage over initial year of study recruitment

• Drop Out Rate

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

  Percentage over initial year of study recruitment

• Symptoms

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

  Change over time with evaluations at baseline, 6-weeks, and 12-weeks

• Tendon Structure

  Ultrasound imaging of tendon structure

  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.

  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.

  Change over time with evaluations at baseline, 6-weeks, and 12-weeks

Secondary Outcomes (7)

• Adverse Events

  Number over first year of study recruitment

• Knee Injury and Osteoarthritis Outcome Score - Quality of Life subscale (KOOS-QOL)

  Change over time with evaluations at baseline, 6-weeks, and 12-weeks

• Tampa Scale of Kinesiophobia (TSK)

  Change over time with evaluations at baseline, 6-weeks, and 12-weeks

• Pain Catastrophizing Scale (PCS)

  Change over time with evaluations at baseline, 6-weeks, and 12-weeks

• Numeric Pain Rating Scale (NPRS)

  Change over time with evaluations at baseline, 6-weeks, and 12-weeks

Study Arms (2)

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.

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.

Other: Exercise Treatment

Interventions

Exercise Treatment OTHER

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.

Also known as: Rehabilitation exercise, Physical Therapy treatment

Pain-free Activity Modification; Pain-guided Activity Modification

Pain- Guided Activity Modification OTHER

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.

Pain-guided Activity Modification

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Physically active individuals with a diagnosis of patellar tendinopathy

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

Related Publications (1)

• 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.

  PMID: 33632313 RESULT

Related Links

• Delaware Tendon Research Group

MeSH Terms

Conditions

Tendinopathy

Interventions

Exercise Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two treatment groups receiving different activity modification instructions.

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: March 11, 2018
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)