Patellar TendinitisNCT03528746
The Acute Effect of Isometric Versus Isotonic Resistance Exercise in Patients With Patellar Tendinopathy
A study testing Isotonic Exercise and Isometric exercise in people with Patellar Tendinitis, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Patellar Tendinitis
- What is being tested?
- Isotonic Exercise and Isometric exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Jul 2018to 3 Oct 2018
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Previous surgery of the knee
- Pregnancy
- Corticosteroid injection within the previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effect of Isometric Versus Isotonic Resistance Exercise in Patients With Patellar Tendinopathy: a Randomized, Participant Blinded, Crossover Trial
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.
Read the 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.
- Conditions
- Patellar Tendinitis
- Being tested
- Isotonic Exercise, Isometric exercise
- Keywords
- Patellar tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotonic ExerciseOther
Also called resistance exercise
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.
Isometric exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Isometric exercise | Experimental | Participants will complete isometric quadriceps exercise Receives: Other: Isometric exercise |
| Isotonic exercise | Active comparator | Participants will complete dynamic leg extension Receives: Other: Isotonic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline; immedietely after exercise
Secondary outcomes (3)
change in pain during aggravating activity
The single leg decline squat (SLDS) will be conducted as above.
Measured: baseline; 45 minutes post exercise
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.
Measured: Baseline; Immediately after exercise; 45 min post exercise
Change in patellar tendon thickness (mm)
Patellar tendon thickness will be measured by ultrasonography
Measured: Baseline; Immedietly after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start12 Jul 2018
- Primary completion3 Oct 2018
- Study completion3 Oct 2018
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 TendinitisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinead Holden, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528746
- Sponsor's protocol ID
- N-20160084
- Status last verified
- Oct 2018
- First submitted
- 5 Dec 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be available from the PI upon reasonable request.
Publications
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.
PubMed 25979840
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Isometric Versus Isotonic Resistance Exercise in Patients With Patellar Tendinopathy: a Randomized, Participant Blinded, Crossover Trial
- ClinicalTrials.gov ID
- NCT03528746
- Acronym / sponsor ID
- N-20160084
- Conditions
- Patellar Tendinitis
- Keywords
- Patellar tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 18 May 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Isometric exercise | Experimental | Other: Isometric exerciseParticipants will complete isometric quadriceps exercise |
| Isotonic exercise | Active comparator | Other: Isotonic ExerciseParticipants will complete dynamic leg extension |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (3 listed)
- Previous surgery of the knee
- Pregnancy
- Corticosteroid injection within the previous 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 |
|---|---|---|
| Isotonic ExerciseAlso: resistance exerciseParticipants 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. | Other | Isotonic exercise |
| Isometric exerciseParticipants 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. | Other | Isometric exercise |
Primary outcome
Change in pain during aggravating activity
Time frame: baseline; immedietely after exercise
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.
3 secondary outcomes
change in pain during aggravating activity
Time frame: baseline; 45 minutes post exercise
change in pressure pain threshold (kPa)
Time frame: Baseline; Immediately after exercise; 45 min post exercise
Change in patellar tendon thickness (mm)
Time frame: Baseline; Immedietly after exercise
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 11 Oct 2018.
- Background: PubMed 25979840Rio 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.
- Individual participant dataSharing planned: Undecided. IPD will be available from the PI upon reasonable request.
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Patellar Tendinitis, Jumper's Knee
Recruiting
Clinical Eficacy of Extracorporeal Shock Wave Therapy on Patellar Tendinitis
Shock Wave Threapy for Patellar Tendinitis
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 Isotonic Exercise and Isometric exercise in people with Patellar Tendinitis, run by Aalborg University at 1 site in Denmark.
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 6 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 11 Oct 2018. 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 Denmark. 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?
Change in pain during aggravating activity (time frame: baseline; immedietely after exercise). 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 NCT03528746, 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 11 Oct 2018.