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Effects of Neurodynamics of Pain and Function in Patients With Knee Osteoarthrosis

11 maggio 2022 aggiornato da: CEU San Pablo University

Osteoarthritis is defined as a degenerative joint disease characterised by a decrease in joint space due to cartilage loss and the presence of subchondral sclerosis and osteophytes. It is the most common joint disease and is expected to become the fourth leading cause of disability worldwide by 2020. The knee is the joint most affected by osteoarthritis.

The prevalence of osteoarthritis of the knee has been increasing in recent years. The main risk factors are female sex, although in recent years there has been a greater relative increase in men, comorbidity, age, mechanical stress and obesity, the latter being of great importance in the progression and development of osteoarthritis.

There are two types of osteoarthritis of the knee, primary (idiopathic) and secondary (previous causal alteration). This disease causes pain and disability, so that these patients have difficulty walking, standing, sitting, climbing and descending stairs, resulting in decreased function and negatively impacting the performance of activities of daily living.

The Kellgren and Lawrence scale, which marks the degree of involvement of osteoarthritis by the level of joint destruction based on radiography, is a validated method that gives us IV degrees of the disease, with grade I being the mildest and IV the most severe.

Pain in this syndrome is a multifactorial phenomenon involving neurophysiological, structural and psychosocial factors (10). In relation to neurophysiological factors, it has been shown that inflammatory mediators in somatic structures alter afferent sensory inputs and induce plastic changes in the nervous system, which can lead to central sensitisation (CS).

Sensitisation is defined as an increased response to a painful stimulus by increasing the signal in the central nervous system, either by decreasing the activation of descending inhibitory pain systems or by increasing the pain signal.

MRI studies have also shown that patients with osteoarthritis of the knee have a lower degree of disengagement and increased pain vigilance, associated with abnormal activity in different areas of the brain such as the cingulate cortex, insula, amygdala, prefrontal areas and nucleus accubens.

Currently, conservative treatment of osteoarthritis of the knee is aimed at reducing pain, increasing function and reducing joint damage by means of pharmacological and non-pharmacological therapies. Pharmacological treatment is based primarily on paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs), but these drugs are associated with adverse effects, especially at older ages. As for non-pharmacological therapy, we mainly find exercise-based treatment and manual therapy-based treatment, both showing improvements in pain and function of patients and showing better results in combination.

Neural mobilisation consists of sliding the nerves, seeking to restore the dynamic balance between the nerve and associated tissues, thus increasing vascularisation, decreasing neural pressure and eliminating harmful fluids. There are studies showing how this technique improves range of motion and knee pain, but more literature on this technique is needed.Our hypothesis is that femoral nerve mobilisation can have a positive effect on function and a decrease in pain in patients with grades I-II osteoarthritis of the knee, with neurodynamics being a possible treatment for these patients.

Aims:

To determine the effectiveness of treatment with femoral nerve neurodynamics in patients with osteoarthritis of the knee. Assessing the decrease in pain and increase in function by means of pain intensity, pressure pain thresholds, temporal assessment, pain modulation, KOOS, SF-12 and CSI questionnaires.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Anticipato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Juan-Carlos Zuil-Escobar
  • Numero di telefono: +34616442143
  • Email: jczuil@ceu.es

Luoghi di studio

      • Alcorcón, Spagna, 28925
        • Reclutamento
        • Juan-Carlos Zuil-Escobar
        • Contatto:
          • Juan-Carlos Zuil-Escobar
          • Numero di telefono: +34616442143
          • Email: jczuil@ceu.es
      • Madrid, Spagna, 28922
        • Reclutamento
        • CEU-San Pablo Universtiy

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 50 anni a 95 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Knee osteoarthritis, grade I and II, of the Kellgren Lawrence scale.
  • Knee pain diagnosed as osteoarthritis of the knee using the American College of Rheumatology criteria.

Exclusion Criteria:

  • Disorders, syndromes or diseases that may cause myofascial or neuropathic pain in the lower limbs, such as lumbar radiculopathy, meralgia paraesthetica or saphenous nerve entrapment.
  • Chronic diseases that may be considered perpetuating factors such as fibromyalgia
  • Corticosteroid or local anaesthetic injections during the year prior to the patient's participation in the study or during follow-up.
  • Consumption of oral analgesics on a constant basis and 24 h before the measurements.
  • Ingesting substances of abuse that may interfere during treatment such as alcohol and drugs.
  • Cognitive deficit manifested in the clinical history (Alzheimer, dementia) or measured by the Mini-Cognitive Examination

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention

Participants will perform an active femoral nerve mobilisation technique. The treatment will be performed at home.

Patients will receive a video model to perform the exercise during the 8 weeks of treatment. The treatment should be performed 10 repetitions twice a day, with one set recommended in the morning and one in the evening.

The treatment will be monitored by telephone and if there are any doubts, the session will be carried out together with the patient.

Participants will perform an active femoral nerve mobilisation technique. The treatment will be performed at home.

Patients will receive a video model to perform the exercise during the 8 weeks of treatment. The treatment should be performed 10 repetitions twice a day, with one set recommended in the morning and one in the evening.

The treatment will be monitored by telephone and if there are any doubts, the session will be carried out together with the patient.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Numerical Rating Scale
Lasso di tempo: 12 months
The Numerical Rating Scale (NRS) will be used with 11 intervals with a score of 0-10, where 0 would correspond to no pain and 10 to the worst pain imaginab
12 months
threshold pain
Lasso di tempo: 12 months
To measure pressure pain thresholds, we use an algometer with a surface area of 1 cm2 , applying it perpendicularly to the skin at a speed of 1 kg/cm2/s until the patient indicates that the first sensation of pain appears, at which point the pressure applied stops.
12 months
SF-12
Lasso di tempo: 12 months

It is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.

The SF-12 is a shortened version of the SF-36.

12 months
KOOS questionnaire
Lasso di tempo: 12 months
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. The KOOS meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome. KOOS is patient-administered, the format is user-friendly and it takes about 10 minutes to fill out
12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain modulation
Lasso di tempo: 12 months
We combine temporary assessment and a sphygmomanometer on the contralateral arm of the knee with osteoarthritis. It is inflated at a rate of 20 mm Hg/s until the first sensation of pain and held for 30 seconds. The sphygmomanometer shall be inflated or deflated until a pain intensity of 3/10 on the numerical pain rating scale is achieved. The temporary assessment shall then be repeated with inflation of the sphygmomanometer
12 months
Temporal variation of pain
Lasso di tempo: 12 months
pressure pain thresholds shall be measured. Subsequently, 10 consecutive pulses shall be made at the same locations to elicit the temporary assessment, increasing the pressure by 2 kg/s and maintained for 1 second (followed by 1 second of rest) at each pulse. The intensity of pain at the 1st, 5th and 10th pulse shall be assessed by means of a numerical pain scale (0 being no pain and 10 being the maximum pain imaginable).
12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 giugno 2022

Completamento primario (Anticipato)

1 giugno 2023

Completamento dello studio (Anticipato)

1 luglio 2023

Date di iscrizione allo studio

Primo inviato

11 maggio 2022

Primo inviato che soddisfa i criteri di controllo qualità

11 maggio 2022

Primo Inserito (Effettivo)

16 maggio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 maggio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 maggio 2022

Ultimo verificato

1 maggio 2022

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • CEU-025

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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