Myofascial Techniques and Proprioceptive Neuromuscular Facilitation in Patients With Systemic Lupus Erythematosus.

NCT06383104 | Completed

• 1 other identifier: MyoLupus
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

System; Lupus Erythematosus

Keywords

Systemic lupus erythematosus; Physiotherapy; Joint pain; Range of motion; Functionality; Balance; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  Screening visit, within the first seven days after treatment and after four weeks follow-up visit

Study Arms (2)

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.

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.

Interventions

Intervention OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects over 18 years of age
• With a medical diagnosis of systemic lupus erythematosus
• Who sign the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Universidad Católica San Antonio, Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Arthralgia; Fatigue

Interventions

Methods

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 25, 2024
• Study Start: April 22, 2024
• Primary Completion: May 28, 2024
• Study Completion: June 26, 2024
• Last Updated: March 27, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)