Osteoarthritis, KneeNCT05375448
Effects of Neurodynamics of Pain and Function in Patients With Knee Osteoarthrosis
A study testing Neural mobilisation in people with Osteoarthritis, Knee, run by CEU San Pablo University at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Neural mobilisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jun 2022to Jul 2023
- 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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Juan-Carlos Zuil-Escobar
Alcorcón, 28925
Juan-Carlos Zuil-Escobar, +34616442143, jczuil@ceu.es
- Recruiting
CEU-San Pablo Universtiy
Madrid, 28922
Juan Carlos Zuil-Escobar, PhD, 913724700, jczuil@ceu.es
About this study
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.
Read more
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
- Being tested
- Neural mobilisation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural mobilisationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neural mobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 months
Secondary outcomes (2)
Pain modulation
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
Measured: 12 months
Temporal variation of pain
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375448
- Sponsor's protocol ID
- CEU-025
- Status last verified
- May 2022
- First submitted
- 11 May 2022
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neurodynamics of Pain and Function in Patients With Knee Osteoarthrosis
- ClinicalTrials.gov ID
- NCT05375448
- Acronym / sponsor ID
- CEU-025
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 16 May 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Neural mobilisationParticipants 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. |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Neural mobilisationParticipants 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 | Intervention |
Primary outcome
Numerical Rating Scale
Time frame: 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
threshold pain
Time frame: 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.
SF-12
Time frame: 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.
KOOS questionnaire
Time frame: 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
2 secondary outcomes
Pain modulation
Time frame: 12 months
Temporal variation of pain
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural mobilisation in people with Osteoarthritis, Knee, run by CEU San Pablo University at 2 sites in Spain.
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 2 inclusion and 6 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 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan-Carlos Zuil-Escobar (+34616442143, jczuil@ceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (time frame: 12 months). The study lists 4 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 16 May 2022.