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

NCT05375448 | Unknown

• 1 other identifier: CEU-025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (4)

• Numerical Rating Scale

  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

  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

  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

  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

Secondary Outcomes (2)

• Pain modulation

  12 months

• Temporal variation of pain

  12 months

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Other: Neural mobilisation

Interventions

Neural mobilisation OTHER

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.

Intervention

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CEU San Pablo University: lead

Study Sites (2)

Juan-Carlos Zuil-Escobar

Alcorcón, 28925, Spain

RECRUITING

CEU-San Pablo Universtiy

Madrid, 28922, Spain

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Juan-Carlos Zuil-Escobar

CONTACT

+34616442143; jczuil@ceu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 16, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 16, 2022

Record last verified: 2022-05

Locations

ES (2)