. 2021 Feb 25;7(1):58.

doi: 10.1186/s40814-021-00792-5.

Pain-guided activity modification during treatment for patellar tendinopathy: a feasibility and pilot randomized clinical trial

Andrew L Sprague^{1

2

3}, Christian Couppé^{4

5

6}, Ryan T Pohlig⁷, Lynn Snyder-Mackler^{8

9

10}, Karin Grävare Silbernagel^{8

9

10}

Affiliations

¹ Department of Physical Therapy, University of Delaware, Newark, DE, USA. asprague@udel.edu.
² Department of Biomechanics and Movement Science, University of Delaware, Newark, DE, USA. asprague@udel.edu.
³ Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA. asprague@udel.edu.
⁴ Department of Orthopaedic Surgery M, Faculty of Health and Medical Sciences, Institute of Sports Medicine Copenhagen, Bispebjerg Hospital and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.
⁵ Department of Physical and Occupational Therapy, Bispebjerg Hospital, Copenhagen, Denmark.
⁶ IOC Research Center Copenhagen Center for Injury Prevention and Protection of Athlete Health, Bispebjerg Hospital, Copenhagen, Denmark.
⁷ Biostatistic Core Facility, College of Health Sciences, University of Delaware, Newark, DE, USA.
⁸ Department of Physical Therapy, University of Delaware, Newark, DE, USA.
⁹ Department of Biomechanics and Movement Science, University of Delaware, Newark, DE, USA.
¹⁰ Department of Biomedical Engineering, University of Delaware, Newark, DE, USA.

PMID: 33632313
PMCID: PMC7905015
DOI: 10.1186/s40814-021-00792-5

Pain-guided activity modification during treatment for patellar tendinopathy: a feasibility and pilot randomized clinical trial

Andrew L Sprague et al. Pilot Feasibility Stud. 2021.

. 2021 Feb 25;7(1):58.

doi: 10.1186/s40814-021-00792-5.

Authors

Andrew L Sprague^{1

2

3}, Christian Couppé^{4

5

6}, Ryan T Pohlig⁷, Lynn Snyder-Mackler^{8

9

10}, Karin Grävare Silbernagel^{8

9

10}

Affiliations

¹ Department of Physical Therapy, University of Delaware, Newark, DE, USA. asprague@udel.edu.
² Department of Biomechanics and Movement Science, University of Delaware, Newark, DE, USA. asprague@udel.edu.
³ Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA. asprague@udel.edu.
⁴ Department of Orthopaedic Surgery M, Faculty of Health and Medical Sciences, Institute of Sports Medicine Copenhagen, Bispebjerg Hospital and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.
⁵ Department of Physical and Occupational Therapy, Bispebjerg Hospital, Copenhagen, Denmark.
⁶ IOC Research Center Copenhagen Center for Injury Prevention and Protection of Athlete Health, Bispebjerg Hospital, Copenhagen, Denmark.
⁷ Biostatistic Core Facility, College of Health Sciences, University of Delaware, Newark, DE, USA.
⁸ Department of Physical Therapy, University of Delaware, Newark, DE, USA.
⁹ Department of Biomechanics and Movement Science, University of Delaware, Newark, DE, USA.
¹⁰ Department of Biomedical Engineering, University of Delaware, Newark, DE, USA.

PMID: 33632313
PMCID: PMC7905015
DOI: 10.1186/s40814-021-00792-5

Abstract

Background: Activity modification is a key component of patellar tendinopathy treatment but there is a lack of evidence guiding activity modification prescription. Use of activity modification in treatment studies has varied widely and the impact of those recommendations has not been directly investigated or compared. The purpose of this study was to assess (1) the feasibility of using pain-guided activity modification during treatment for patellar tendinopathy and (2) if our outcome measures are responsive to changes in tendon health over the course of treatment.

Methods: This was an unblinded, randomized two-arm pilot and feasibility study randomized clinical trial with parallel assignment, conducted in Newark, DE. Individuals between the ages of 16 and 40 years old with patellar tendinopathy were included. Participants were randomly assigned to a pain-guided activity (PGA) or pain-free activity (PFA) group using a spreadsheet-based randomization scheme. All participants received standardized treatment using a modified version of the heavy-slow resistance protocol 3×/week for 12 weeks. For the first 6 weeks, the PGA group used the Pain-Monitoring Model to guide activity outside of treatment and the PFA group was restricted from running, jumping, or activities that provoked their patellar tendon pain. Feasibility outcomes included recruitment, enrollment, randomization, compliance, and retention percentages. Clinical evaluations were conducted at baseline, 6, and 12 weeks to assess symptom severity, psychological factors, tendon morphology and mechanical properties, lower extremity function, and quadriceps muscle performance.

Results: In a ~ 13-month period, 108 individuals were screened, 47/108 (43.5%) were eligible for participation, and 15/47 (32.0%) of those were enrolled (9 PGA, 6 PFA). The recruitment rate was 1.15 participants/month. The mean ± SD compliance with treatment was PGA: 86.1 ± 13.0% and PFA: 67.1 ± 30.7%. There was one missed evaluation session and two adverse events, which were not due to study interventions. Changes exceeding the smallest detectable change were observed for at least one outcome in each domain of tendon health.

Conclusions: Use of pain-guided activity modification during exercise therapy for patellar tendinopathy was found to be feasible, and the proposed outcome measures appropriate. Computer-based allocation concealment, blinding of evaluators, and greater recruitment of high-level athletes should be implemented in future trials.

Trial registration: ClinicalTrials.gov identifier: NCT03694730 . Registered 3^rd of October, 2018.

Keywords: Activity modification; Elastography; Exercise therapy; Jumper’s Knee; Patellar tendinopathy; Tendon loading; patellar tendinitis.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

**Fig. 2**
Heavy-slow resistance training parameters for the a squat, b knee extension, and c leg press

**Fig. 3**
CONSORT flowchart for recruitment and randomization

**Fig. 4**
Estimated marginal means for a VISA-P and b palpatory pain for the pooled samples and groups. Note: Statistical significance is for the pooled sample only and Y-axis is truncated

**Fig. 5**
Estimated marginal means for KOOS-QOL for the pooled sample and groups. Note: Statistical significance is for the pooled sample only and Y-axis is truncated

**Fig. 6**
Estimated marginal means for the a TSK-17 and b DASS-21 for the pooled sample and groups. Note: Statistical significance is for the pooled sample only and the Y-axis is truncated

**Fig. 7**
Estimated marginal means for a tendon thickness and b cross-sectional area for the pooled sample and groups. Note: Y-axis is truncated

**Fig. 8**
Estimated marginal means for a shear modulus and b viscosity for the pooled sample and groups. Note: Y-axis truncated

**Fig. 9**
Estimated marginal means for a CMJ and b drop CMJ height for the pooled sample and groups. Note: Statistical significance is for the pooled sample only and the Y-axis is truncated

**Fig. 10**
Estimated marginal means for a knee extension MVIC and b central activation ratio for the pooled sample and groups. Note: Y-axis is truncated

See this image and copyright information in PMC

References

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Pain-guided activity modification during treatment for patellar tendinopathy: a feasibility and pilot randomized clinical trial

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Pain-guided activity modification during treatment for patellar tendinopathy: a feasibility and pilot randomized clinical trial

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