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The Acute Effect of Isometric Versus Isotonic Resistance Exercise in Patients With Patellar Tendinopathy

Primary Purpose

Patellar Tendinitis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Isotonic Exercise
Isometric exercise
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Patellar Tendinitis focused on measuring Patellar tendinopathy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women aged 18-40 years, with patellar tendinopathy will be included. Diagnosis of patellar tendinopathy, will be made by a physiotherapist (who has been trained by an experienced rheumatologist) as follows, similar to previously outlined criteria:

    • pain localised to the inferior pole of the patella during jumping and landing activities
    • pain during testing on the single-leg decline squat (SLDS)
    • The diagnosis will be confirmed by the presence of characteristic features on ultrasound imaging (eg, hypoechoic area and focal enlarged tendon).
    • Minimum pain of 3cm on a 10cm visual analogue scale (VAS)
    • Other concurrent diagnosable knee pathologies

Exclusion Criteria:

  • Previous surgery of the knee
  • Pregnancy
  • Corticosteroid injection within the previous 6 months

Sites / Locations

  • Research Unit for General Practice in Aalborg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Isometric exercise

Isotonic exercise

Arm Description

Participants will complete isometric quadriceps exercise

Participants will complete dynamic leg extension

Outcomes

Primary Outcome Measures

Change in pain during aggravating activity
The single leg decline squat (SLDS) will be used as the provocative activity, as this is an activity that usually induces pain in patients with patellar tendinopathy. Participants will be asked to stand on one limb, with their heel raised, so they are in approximately 25 degrees of plantar flexion. They will then be asked to perform a small squat, to about 60 degrees of knee flexion. This will be repeated three times. Participants will provide a numerical pain rating score for the decline squat on an 11-point numerical rating scale (NRS), anchored at left with '0, no pain' and at right with '10, worst possible pain'. If participants have bilateral patellar tendinopathy, data from the 'most painful' limb (indicated by participants) will be used for the primary outcome.

Secondary Outcome Measures

change in pain during aggravating activity
The single leg decline squat (SLDS) will be conducted as above.
change in pressure pain threshold (kPa)
Pain sensitivity is examined by the participants' pressure pain threshold (PPT). A hand-held algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe (covered by a disposable latex sheath) will be used to record the PPT. The probe is placed perpendicular to the skin and pressure is increased gradually at a rate of 30 kPa/s. Participants will be instructed to indicate when the sensation first changes from a sensation of pressure, to a sensation of pressure pain. The patient is fitted with a hand-held switch and is instructed to press the switch as soon as the pressure triggers pain, stopping the pressure algometer. To determine local pain sensitivity, PPTs will be done, at the most painful site point on the tendon as per previously methods in patellar tendionopathy which have demonstrated reliability. PPTs will also be taken at a distal site (on the muscle of tibialis anterior) to reflect segmental hypoalgesia and remotely at the elbow.
Change in patellar tendon thickness (mm)
Patellar tendon thickness will be measured by ultrasonography

Full Information

First Posted
December 5, 2017
Last Updated
October 10, 2018
Sponsor
Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03528746
Brief Title
The Acute Effect of Isometric Versus Isotonic Resistance Exercise in Patients With Patellar Tendinopathy
Official Title
The Acute Effect of Isometric Versus Isotonic Resistance Exercise in Patients With Patellar Tendinopathy: a Randomized, Participant Blinded, Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
October 3, 2018 (Actual)
Study Completion Date
October 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University

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
The purpose of this study is to compare the acute effects of two different types of resistance exercise (isometric versus isotonic) on exercise induced hypoalgesia during an aggravating activity, in participants with patellar tendinopathy.
Detailed Description
Exercise is a commonly prescribed treatment for patients with musculoskeletal pain, and is effective in treating tendon pain. It is well documented, that an acute bout of aerobic or resistance type exercise reduces sensitivity to pain in healthy individuals. Therefore the efficacy of exercise as an intervention may be partially due to the analgesic effect of exercise, also termed exercise-induced hypoalgesia (EIH). For tendinopathies, high load resistance exercise is frequently used during rehabilitation. However, the optimal mode and dosages required for reducing pain in patients with tendinopathies is unknown. Understanding the effect of different forms of exercise on pain may help optimize the prescription of exercise for pain management. A recent study by Rio and colleagues documented the acute effect of two different forms of resistance exercise in patients with patellar tendinopathy. The study compared, isometric resistance exercise (static muscular contractions), in comparison to isotonic resistance exercise (dynamic contractions) and found that isometric exercise induced greater participantive pain relief in response to an aggravating task. This study was the first to compare the analgesic effect of different forms of resistance exercise in patients with tendinopathy. Although the results appear promising, a limitation of the study was that it did not quantify the effect of the different exercises on measures of pain sensitivity as in previous studies examining EIH. Purpose The purpose of this study is to compare the acute effects of two different types of resistance exercise (isometric versus isotonic) on exercise induced hypoalgesia during an aggravating activity, in participants with patellar tendinopathy. Hypothesis The primary hypothesis is that isometric exercise will induce greater pain relief/reduction during an aggravating activity in comparison to isotonic exercises. Study Design and Methods The proposed study is a participant blinded, randomised crossover superiority trial, to examine acute effect of isometric versus isotonic resistance exercise on pain in patients with patellar tendinopathy. The trial will be pre-registered on clinicaltrials.gov before inclusion of participants commences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinitis
Keywords
Patellar tendinopathy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The proposed study is a participant blinded, randomised crossover superiority trial, to examine acute effect of isometric versus isotonic resistance exercise on pain in patients with patellar tendinopathy.
Masking
Participant
Masking Description
Participants will be blinded to the study hypothesis
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isometric exercise
Arm Type
Experimental
Arm Description
Participants will complete isometric quadriceps exercise
Arm Title
Isotonic exercise
Arm Type
Active Comparator
Arm Description
Participants will complete dynamic leg extension
Intervention Type
Other
Intervention Name(s)
Isotonic Exercise
Other Intervention Name(s)
resistance exercise
Intervention Description
Participants will complete dynamic leg extension in a leg extension machine with a range of motion from approximately 90 degrees flexion to full extension. Each repetition will be completed with a 3s concentric contraction, 0s isometric and 4s eccentric contraction.This will be repeated for 8 repetitions and for 5 sets with 2 minutes rest between each set, as per Rio and colleagues. The load used during the isotonic exercise will be equivalent to participants 8 repetition maximum, which will be determined by an experienced tester in a standardised manner according to NSCA guidelines.
Intervention Type
Other
Intervention Name(s)
Isometric exercise
Intervention Description
Participants will complete isometric quadriceps exercise, where they must hold a load statically for 45s with their knee in 60° flexion. This will be repeated for 5 sets with 2 minutes rest between each set. A load of 70% of the maximal voluntary isometric contraction (MVIC) will be used. MVIC will be assessed in an isokinetic dynamometer as per Rio and colleagues. Participants will be seated in a stable position in the dynamometer with the knee at 60° of knee flexion. First they will be familiarised with the procedure. Standardised instructions will be issued for participants to perform a maximal effort knee extension against the dynamometer for 3seconds. After a short break, the test will be repeated three times and the MVIC will be peak torque recorded during these three efforts.
Primary Outcome Measure Information:
Title
Change in pain during aggravating activity
Description
The single leg decline squat (SLDS) will be used as the provocative activity, as this is an activity that usually induces pain in patients with patellar tendinopathy. Participants will be asked to stand on one limb, with their heel raised, so they are in approximately 25 degrees of plantar flexion. They will then be asked to perform a small squat, to about 60 degrees of knee flexion. This will be repeated three times. Participants will provide a numerical pain rating score for the decline squat on an 11-point numerical rating scale (NRS), anchored at left with '0, no pain' and at right with '10, worst possible pain'. If participants have bilateral patellar tendinopathy, data from the 'most painful' limb (indicated by participants) will be used for the primary outcome.
Time Frame
baseline; immedietely after exercise
Secondary Outcome Measure Information:
Title
change in pain during aggravating activity
Description
The single leg decline squat (SLDS) will be conducted as above.
Time Frame
baseline; 45 minutes post exercise
Title
change in pressure pain threshold (kPa)
Description
Pain sensitivity is examined by the participants' pressure pain threshold (PPT). A hand-held algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe (covered by a disposable latex sheath) will be used to record the PPT. The probe is placed perpendicular to the skin and pressure is increased gradually at a rate of 30 kPa/s. Participants will be instructed to indicate when the sensation first changes from a sensation of pressure, to a sensation of pressure pain. The patient is fitted with a hand-held switch and is instructed to press the switch as soon as the pressure triggers pain, stopping the pressure algometer. To determine local pain sensitivity, PPTs will be done, at the most painful site point on the tendon as per previously methods in patellar tendionopathy which have demonstrated reliability. PPTs will also be taken at a distal site (on the muscle of tibialis anterior) to reflect segmental hypoalgesia and remotely at the elbow.
Time Frame
Baseline; Immediately after exercise; 45 min post exercise
Title
Change in patellar tendon thickness (mm)
Description
Patellar tendon thickness will be measured by ultrasonography
Time Frame
Baseline; Immedietly after exercise
Other Pre-specified Outcome Measures:
Title
Pain (during exercise)
Description
Participants will provide a numerical pain rating score on an 11-point numerical rating scale (NRS), anchored at left with '0, no pain' and at right with '10, worst possible pain'.
Time Frame
Immediately after exercise set

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women aged 18-40 years, with patellar tendinopathy will be included. Diagnosis of patellar tendinopathy, will be made by a physiotherapist (who has been trained by an experienced rheumatologist) as follows, similar to previously outlined criteria: pain localised to the inferior pole of the patella during jumping and landing activities pain during testing on the single-leg decline squat (SLDS) The diagnosis will be confirmed by the presence of characteristic features on ultrasound imaging (eg, hypoechoic area and focal enlarged tendon). Minimum pain of 3cm on a 10cm visual analogue scale (VAS) Other concurrent diagnosable knee pathologies Exclusion Criteria: Previous surgery of the knee Pregnancy Corticosteroid injection within the previous 6 months
Facility Information:
Facility Name
Research Unit for General Practice in Aalborg
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD will be available from the PI upon reasonable request.
Citations:
PubMed Identifier
25979840
Citation
Rio E, Kidgell D, Purdam C, Gaida J, Moseley GL, Pearce AJ, Cook J. Isometric exercise induces analgesia and reduces inhibition in patellar tendinopathy. Br J Sports Med. 2015 Oct;49(19):1277-83. doi: 10.1136/bjsports-2014-094386. Epub 2015 May 15.
Results Reference
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The Acute Effect of Isometric Versus Isotonic Resistance Exercise in Patients With Patellar Tendinopathy

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