Chronic Patellar TendinopathyNCT06569433
Efficacy of Therapeutic Exercise Compared to Femoral Nerve Mobilisation in Knee Tendinosis
A study testing THERAPEUTIC EXERCISE AND MOBILISATION OF THE FEMORAL NERVE in people with Chronic Patellar Tendinopathy, run by University of Alcala.
Trial summary
Tendons, located between muscle and bone, transmit force from the former to the latter, allowing joint movement. They are composed mainly of collagen, elastin and water, and are divided into three zones: osteotendinous junction (tendon-bone), myotendinous junction (muscle-tendon) and the tendon body. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Patellar Tendinopathy
- What is being tested?
- THERAPEUTIC EXERCISE AND MOBILISATION OF THE FEMORAL NERVE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2024to 20 Dec 2024
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Patients aged 18 to 40 years old
- Patients with chronic or acute knee tendinosis
- Who have pain or functional limitation
Who cannot join
- Patients with a contraindication to treatment
- Patients with a history of recent knee surgery or serious injury
- Who present neurological pathologies
- Who are using other physiotherapy techniques
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Therapeutic Exercise Compared to Femoral Nerve Mobilisation in Knee Tendinosis: Randomised Clinical Trial
Tendons, located between muscle and bone, transmit force from the former to the latter, allowing joint movement. They are composed mainly of collagen, elastin and water, and are divided into three zones: osteotendinous junction (tendon-bone), myotendinous junction (muscle-tendon) and the tendon body.
Knee tendinosis is a pathology that affects the tendons of this joint due to the breakdown of collagen in the tendon body, characterised by pain during and after exercise, inflammation and loss of function. It is common in athletes, especially in jumping sports such as basketball and volleyball, due to repetitive strain, injury or ageing. Factors such as weight, leg length and muscle strength can influence its development. Radiologically, patellar tendon thickening, and abnormalities are seen.
Read more
Treatment includes eccentric exercises, shock wave therapy, ultrasound-guided sclerosis, anti-inflammatory drugs, plasma injections and aprotinin. Neurodynamic theory suggests that altered mechanosensitivity of the femoral nerve may contribute to knee pain, and neurodynamic techniques can improve nerve mobility and reduce symptoms.
A strength exercise with isometric contractions can decrease pain for up to 45 minutes, being a therapeutic option for patellar tendinopathy without affecting muscle strength.
The research project presented in the master's thesis aims to compare the effectiveness of femoral nerve mobilisation and therapeutic exercise in the treatment of knee tendinosis.
Read the detailed description
Nowadays, tendon injuries affect a large part of the population, especially people who practice sports and the working population in industrial sectors, although they have also been observed in sedentary people. In terms of occupational diseases, these injuries account for more than 35% in the most industrialised countries of the European Union.
The indirect costs of tendinopathies can be significant in terms of lost productivity and workers' compensation.
Despite the lack of specific data on the economic impact of knee tendinosis on society, given the high prevalence of this condition, it is crucial to study its treatment to reduce recovery time and associated costs. Both therapeutic exercise and femoral nerve mobilisation are supported by scientific evidence suggesting their efficacy in the treatment of knee tendinitis. However, it is important to specifically investigate and compare how these interventions affect symptoms and function in patients with this condition.
Therapeutic exercise prevents injury and aids in the regeneration of the knee extensor system. The goal is to restore adequate strength, flexibility and endurance, as well as to correct joint limitations.
It has been studied that the success of treatment of tendinopathies may be determined by the adaptation of the exercise loads to the capacity of the tendons.
- Conditions
- Chronic Patellar Tendinopathy
- Being tested
- THERAPEUTIC EXERCISE AND MOBILISATION OF THE FEMORAL NERVE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERAPEUTIC EXERCISE AND MOBILISATION OF THE FEMORAL NERVEProcedure or surgery
the control group that will perform only therapeutic exercise will perform a specific exercise programme for knee tendinitis under the supervision of a physiotherapist, while the intervention group that will perform therapeutic exercise plus femoral nerve mobilisation will receive therapeutic exercise sessions and femoral nerve mobilisations performed by a trained physiotherapist.
The intervention will last for 6 weeks, during which 60-minute sessions will be held at the centre, measurements will be taken during the six weeks, using standardised questionnaires to evaluate the variables (set out below) and always measuring the range of movement and femoral nerve mobility with the Slump Test on the same day of the week and at the same time of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic exercise | Active comparator | In the interventions, the control group performing therapeutic exercise only, will perform a specific exercise programme for knee tendinitis under the supervision of a physiotherapist, Receives: Procedure: THERAPEUTIC EXERCISE AND MOBILISATION OF THE FEMORAL NERVE |
| Femoral nerve movilization | Active comparator | will receive therapeutic exercise sessions and femoral nerve mobilisations performed by a trained physiotherapist. Receives: Procedure: THERAPEUTIC EXERCISE AND MOBILISATION OF THE FEMORAL NERVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 'pain' variable
The variable 'pain' is subjective and qualitative and is measured quantitatively to facilitate its analysis. In this case the Visual Analogue Scale (VAS) will be used, which facilitates the subjective evaluation of the intensity of the pain that the patient experiences, through a score based on their perception of pain, It ranges from 0 (being the lowest score therefore there is no pain) to 10 (being the highest score therefore it is at its maximum pain level)
Measured: 6 weeks
functionality (VISA-P questionnaire)
the VISA-P questionnaire which allows us to classify tendinopathy according to the severity of the symptoms and the functional capacity of the patients.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start20 Aug 2024 (estimated)
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- The following criteria for inclusion and exclusion of participants have been established: Inclusion criteria: * Patients aged between 18 and 40 years. * Patients with chronic or acute knee tendinosis. * Patients with pain or functional limitation Exclusion criteria: * Patients with any contraindication to treatment. * Patients with a history of recent knee surgery or serious injury * Who present neurological pathologies * Who are using other physiotherapy techniques Prior to registration each participant must undergo a physical assessment, including a medical history check and provide information on neurological and trauma pathologies. Those who meet the criteria will be assigned to one of the two study groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Martinez, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569433
- Sponsor's protocol ID
- Silvia M
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Therapeutic Exercise Compared to Femoral Nerve Mobilisation in Knee Tendinosis: Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06569433
- Acronym / sponsor ID
- Silvia M
- Conditions
- Chronic Patellar Tendinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 20 Aug 2024 (estimated)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 26 Aug 2024 (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.
Tendons, located between muscle and bone, transmit force from the former to the latter, allowing joint movement. They are composed mainly of collagen, elastin and water, and are divided into three zones: osteotendinous junction (tendon-bone), myotendinous junction (muscle-tendon) and the tendon body.
Knee tendinosis is a pathology that affects the tendons of this joint due to the breakdown of collagen in the tendon body, characterised by pain during and after exercise, inflammation and loss of function. It is common in athletes, especially in jumping sports such as basketball and volleyball, due to repetitive strain, injury or ageing. Factors such as weight, leg length and muscle strength can influence its development. Radiologically, patellar tendon thickening, and abnormalities are seen.
Treatment includes eccentric exercises, shock wave therapy, ultrasound-guided sclerosis, anti-inflammatory drugs, plasma injections and aprotinin. Neurodynamic theory suggests that altered mechanosensitivity of the femoral nerve may contribute to knee pain, and neurodynamic techniques can improve nerve mobility and reduce symptoms.
A strength exercise with isometric contractions can decrease pain for up to 45 minutes, being a therapeutic option for patellar tendinopathy without affecting muscle strength.
The research project presented in the master's thesis aims to compare the effectiveness of femoral nerve mobilisation and therapeutic exercise in the treatment of knee tendinosis.
Detailed description
Nowadays, tendon injuries affect a large part of the population, especially people who practice sports and the working population in industrial sectors, although they have also been observed in sedentary people. In terms of occupational diseases, these injuries account for more than 35% in the most industrialised countries of the European Union.
The indirect costs of tendinopathies can be significant in terms of lost productivity and workers' compensation.
Despite the lack of specific data on the economic impact of knee tendinosis on society, given the high prevalence of this condition, it is crucial to study its treatment to reduce recovery time and associated costs. Both therapeutic exercise and femoral nerve mobilisation are supported by scientific evidence suggesting their efficacy in the treatment of knee tendinitis. However, it is important to specifically investigate and compare how these interventions affect symptoms and function in patients with this condition.
Therapeutic exercise prevents injury and aids in the regeneration of the knee extensor system. The goal is to restore adequate strength, flexibility and endurance, as well as to correct joint limitations.
It has been studied that the success of treatment of tendinopathies may be determined by the adaptation of the exercise loads to the capacity of the tendons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The following criteria for inclusion and exclusion of participants have been established: Inclusion criteria: * Patients aged between 18 and 40 years. * Patients with chronic or acute knee tendinosis. * Patients with pain or functional limitation Exclusion criteria: * Patients with any contraindication to treatment. * Patients with a history of recent knee surgery or serious injury * Who present neurological pathologies * Who are using other physiotherapy techniques Prior to registration each participant must undergo a physical assessment, including a medical history check and provide information on neurological and trauma pathologies. Those who meet the criteria will be assigned to one of the two study groups.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise | Active comparator | Procedure: THERAPEUTIC EXERCISE AND MOBILISATION OF THE FEMORAL NERVEIn the interventions, the control group performing therapeutic exercise only, will perform a specific exercise programme for knee tendinitis under the supervision of a physiotherapist, |
| Femoral nerve movilization | Active comparator | Procedure: THERAPEUTIC EXERCISE AND MOBILISATION OF THE FEMORAL NERVEwill receive therapeutic exercise sessions and femoral nerve mobilisations performed by a trained physiotherapist. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- - Patients aged 18 to 40 years old
- Patients with chronic or acute knee tendinosis
- Who have pain or functional limitation
Key exclusion criteria (4 listed)
- Patients with a contraindication to treatment
- Patients with a history of recent knee surgery or serious injury
- Who present neurological pathologies
- Who are using other physiotherapy techniques
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 |
|---|---|---|
| THERAPEUTIC EXERCISE AND MOBILISATION OF THE FEMORAL NERVEthe control group that will perform only therapeutic exercise will perform a specific exercise programme for knee tendinitis under the supervision of a physiotherapist, while the intervention group that will perform therapeutic exercise plus femoral nerve mobilisation will receive therapeutic exercise sessions and femoral nerve mobilisations performed by a trained physiotherapist. The intervention will last for 6 weeks, during which 60-minute sessions will be held at the centre, measurements will be taken during the six weeks, using standardised questionnaires to evaluate the variables (set out below) and always measuring the range of movement and femoral nerve mobility with the Slump Test on the same day of the week and at the same time of treatment. | Procedure or surgery | Femoral nerve movilization, Therapeutic exercise |
Primary outcome
The 'pain' variable
Time frame: 6 weeks
The variable 'pain' is subjective and qualitative and is measured quantitatively to facilitate its analysis. In this case the Visual Analogue Scale (VAS) will be used, which facilitates the subjective evaluation of the intensity of the pain that the patient experiences, through a score based on their perception of pain, It ranges from 0 (being the lowest score therefore there is no pain) to 10 (being the highest score therefore it is at its maximum pain level)
functionality (VISA-P questionnaire)
Time frame: 6 weeks
the VISA-P questionnaire which allows us to classify tendinopathy according to the severity of the symptoms and the functional capacity of the patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing THERAPEUTIC EXERCISE AND MOBILISATION OF THE FEMORAL NERVE in people with Chronic Patellar Tendinopathy, run by University of Alcala.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Martinez (626705563, silvia.martinezv@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 'pain' variable (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2024.