NCT06569433

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

August 20, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

August 11, 2024

Last Update Submit

August 23, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

    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.

    6 weeks

Study Arms (2)

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,

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.

Procedure: THERAPEUTIC EXERCISE AND MOBILISATION OF THE FEMORAL NERVE

Interventions

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.

Femoral nerve movilizationTherapeutic exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Patients aged 18 to 40 years old
  • Patients with chronic or acute knee tendinosis
  • Who have pain or functional limitation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigador principal

Study Record Dates

First Submitted

August 11, 2024

First Posted

August 26, 2024

Study Start

August 20, 2024

Primary Completion

September 20, 2024

Study Completion

December 20, 2024

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share