System; Lupus ErythematosusNCT06383104
Myofascial Techniques and Proprioceptive Neuromuscular Facilitation in Patients With Systemic Lupus Erythematosus.
A study testing Intervention in people with System; Lupus Erythematosus, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Introduction. Systemic lupus erythematosus is an autoimmune disease. The musculoskeletal system is affected in 90% of patients. The most common manifestations are myalgias, arthralgias and arthritis. Objective. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- System; Lupus Erythematosus
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSpain
- Study dates
- 22 Apr 2024to 26 Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects over 18 years of age
- With a medical diagnosis of systemic lupus erythematosus
- Who sign the informed consent form.
Who cannot join
- Patients with fever or acute phlebitis.
- Patients with recent lower limb fractures
- Amputees and people with neurological or cognitive impairments that prevent them from correctly understanding the questionnaires and performing the guided techniques.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Myofascial Techniques and Proprioceptive Neuromuscular Facilitation in the Clinical and Functional Improvement of Patients With Systemic Lupus Erythematosus. Randomised Clinical Study
Introduction. Systemic lupus erythematosus is an autoimmune disease. The musculoskeletal system is affected in 90% of patients. The most common manifestations are myalgias, arthralgias and arthritis.
Objective. To analyse the efficacy of an intervention using myofascial techniques and proprioceptive neuromuscular facilitation in patients with systemic lupus erythematosus.
Read more
Methods. Randomised clinical study with 20 patients with systemic lupus erythematosus, randomised to an experimental and control group. The intervention will last 4 weeks, with a periodicity of 2 weekly sessions of 50 minutes each. The intervention of the experimental group will consist of a protocol using myofascial and proprioceptive neuromuscular facilitation techniques.
Expected results. Improvement of knee and ankle pain intensity, functional capacity, basic mobility skills, strength, balance, agility and fatigue.
- Conditions
- System; Lupus Erythematosus
- Being tested
- Intervention
- Keywords
- Systemic lupus erythematosus, Physiotherapy, Joint pain, Range of motion, Functionality, Balance, Fatigue
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthralgia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Three myofascial release techniques will be performed with low load and long duration stretching to the myofascial complex to restore optimal length, decrease pain and improve function. In the development of the deep myofascial techniques, respiratory synchronisation with the patient will be performed. Proprioceptive neuromuscular facilitation techniques will be performed by executing diagonal spiral movements against resistance, several times, through a full range of motion. Three sets of three repetitions with 6-second contractions and a 30-second rest between sets shall be performed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The intervention period will last 4 weeks, with a periodicity of 2 weekly sessions of 50 minutes each. The intervention of the experimental group will consist of a protocol using myofascial and proprioceptive neuromuscular facilitation techniques. Receives: Other: Intervention |
| Control group | No intervention | Patients included in the control group will not receive any intervention, maintaining their activities of daily living in the same way as before the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline joint pain after treatment and at 4 weeks
The intensity of knee and ankle pain shall be measured with the visual analogue scale. This instrument has an excellent test-retest reliability. This measurement scale consists of an unnumbered 10 cm line, where the patient is asked to indicate the perception of pain in the knee and ankle joints in the last week. The scale ranges from 0 to 10, where 0 indicates no pain at all and 10 indicates maximum perceived pain.
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Secondary outcomes (3)
Change from baseline functional capacity after treatment and at 4 weeks
Functionality of the lower limbs will be measured with the 2-Minute Walking Test. Functional capacity to exercise will be assessed by this modified version of the 6-minute version. This instrument has shown excellent test-retest reliability. This test will be performed in a closed corridor, with a length of 30 m delimited between cones. Subsequently, they shall be instructed to walk around the circuit around the cones as fast as possible, but without running, for 2 minutes. The distance covered at the end of the 2 minutes, in metres, shall be recorded by the assessor.
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline functionality after treatment and at 4 weeks
The Timed Up and Go Functionality Test will assess basic mobility skills, strength, balance and agility. This instrument can help predict an individual's risk of falls and other adverse outcomes. This test has shown excellent intra-rater reliability. This test measures the time it takes a patient to get up from an armchair (without using the arms to get up), walk to a line on the floor 3 m away, turn around, and return to the chair and sit down. The unit of measurement is seconds
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline joint pain after treatment and at 4 weeks
Fatigue will be assessed using the Fatigue Assessment Scale. This scale provides information on physical and psychological aspects of fatigue. The reliability of this scale is high. This instrument is a self-report questionnaire consisting of 10 items with a 5-point Likert response scale ranging from "1=never to "5=Always". Five items reflect the physical component and five reflect the psychological component. The score range of the scale is 10-50, where the higher the score, the greater the degree of fatigue.
Measured: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start22 Apr 2024
- Primary completion28 May 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for System; Lupus ErythematosusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383104
- Sponsor's protocol ID
- MyoLupus
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Myofascial Techniques and Proprioceptive Neuromuscular Facilitation in the Clinical and Functional Improvement of Patients With Systemic Lupus Erythematosus. Randomised Clinical Study
- ClinicalTrials.gov ID
- NCT06383104
- Acronym / sponsor ID
- MyoLupus
- Conditions
- System; Lupus Erythematosus
- Keywords
- Systemic lupus erythematosus, Physiotherapy, Joint pain, Range of motion, Functionality, Balance, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 25 Apr 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.
Introduction. Systemic lupus erythematosus is an autoimmune disease. The musculoskeletal system is affected in 90% of patients. The most common manifestations are myalgias, arthralgias and arthritis.
Objective. To analyse the efficacy of an intervention using myofascial techniques and proprioceptive neuromuscular facilitation in patients with systemic lupus erythematosus.
Methods. Randomised clinical study with 20 patients with systemic lupus erythematosus, randomised to an experimental and control group. The intervention will last 4 weeks, with a periodicity of 2 weekly sessions of 50 minutes each. The intervention of the experimental group will consist of a protocol using myofascial and proprioceptive neuromuscular facilitation techniques.
Expected results. Improvement of knee and ankle pain intensity, functional capacity, basic mobility skills, strength, balance, agility and fatigue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: InterventionThe intervention period will last 4 weeks, with a periodicity of 2 weekly sessions of 50 minutes each. The intervention of the experimental group will consist of a protocol using myofascial and proprioceptive neuromuscular facilitation techniques. |
| Control group | No intervention | –Patients included in the control group will not receive any intervention, maintaining their activities of daily living in the same way as before the study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects over 18 years of age
- With a medical diagnosis of systemic lupus erythematosus
- Who sign the informed consent form.
Key exclusion criteria (3 listed)
- Patients with fever or acute phlebitis.
- Patients with recent lower limb fractures
- Amputees and people with neurological or cognitive impairments that prevent them from correctly understanding the questionnaires and performing the guided 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 |
|---|---|---|
| InterventionThree myofascial release techniques will be performed with low load and long duration stretching to the myofascial complex to restore optimal length, decrease pain and improve function. In the development of the deep myofascial techniques, respiratory synchronisation with the patient will be performed. Proprioceptive neuromuscular facilitation techniques will be performed by executing diagonal spiral movements against resistance, several times, through a full range of motion. Three sets of three repetitions with 6-second contractions and a 30-second rest between sets shall be performed. | Other | Experimental group |
Primary outcome
Change from baseline joint pain after treatment and at 4 weeks
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
The intensity of knee and ankle pain shall be measured with the visual analogue scale. This instrument has an excellent test-retest reliability. This measurement scale consists of an unnumbered 10 cm line, where the patient is asked to indicate the perception of pain in the knee and ankle joints in the last week. The scale ranges from 0 to 10, where 0 indicates no pain at all and 10 indicates maximum perceived pain.
3 secondary outcomes
Change from baseline functional capacity after treatment and at 4 weeks
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline functionality after treatment and at 4 weeks
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Change from baseline joint pain after treatment and at 4 weeks
Time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with System; Lupus Erythematosus, run by Universidad Católica San Antonio de Murcia at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline joint pain after treatment and at 4 weeks (time frame: Screening visit, within the first seven days after treatment and after four weeks follow-up visit). 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 27 Mar 2025.