Clinical trial NCT06226298: Benefits of the Xiaxi Postural Hammock and a Xiaxi Exercise Program
Official title: Benefits of the Xiaxi Postural Hammock and a Xiaxi Exercise Program: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Low Back Pain
Exercise
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic low back pain is one of the main causes of pain, dysfunction and disability worldwide. In Spain, 93% of the population has had back pain in the last year, and it is estimated that 50% of sick leave is due to this cause. This entails a great socioeconomic burden, since it is the main cause of absenteeism from work and the excessive use of therapeutic services.

Musculoskeletal disorders are related and associated with psychologically stressful jobs, that is, with psychosocial factors at work and related work stressors, such as time pressure, low job control, poor social or supervisor support, effort-reward imbalance or work-life conflict. Clinical management of both situations encompasses a variety of approaches, including medication and early physical exercise, which have shown promise in reducing pain and improving function.

A novel approach to address these problems is the use of Xiaxi, a patented postural hammock with multiple angles of inclination that promotes relaxation and elongation of the posterior chain, thereby improving overall well-being. Combining the use of Xiaxi with a comprehensive program of strengthening, stretching and relaxation exercises could offer benefits in the prevention and reduction of back pain.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years.
* Presence of back pain.

Exclusion Criteria:

* Have undergone surgery of the spine, ischiosural muscles, psoas-iliac, pectoral and rotator cuff.

  * to have any structured spinal spine alteration diagnosed by health personnel.
  * have had a rupture of the ischiosural, psoas-iliac, pectoral and rotator cuff muscles in the last year or during the intervention.
  * have any type of injury that prevents you from performing the initial assessment in the first week of the procedure.
  * to have practiced vigorous physical exercise on the day of the investigation or 24 hours before the initial or final assessment.
  * having eaten large meals on the days of the investigation
  * less than two hours had elapsed since any prolonged recumbent rest at the start of the assessment.

Primary outcomes:
measure: Visual Analog Scale (VAS) for pain
timeFrame: 1 minute
Secondary outcomes:
measure: International Physical Activity Questionnaire (IPAQ) for Physical Activity
timeFrame: 5 minutes
measure: General health status, the "SF-36", for quality of life
timeFrame: 5 minutes
measure: Satisfaction With Life Scale (SWLS) questionnaire, for quality of life
timeFrame: 5 minutes
measure: Perceived Stress Scale (PSS), for stress
timeFrame: 5 minutes
measure: The Hospital Anxiety and Depression Scale (HADS), for Anxiety and Depression
timeFrame: 5 minutes
measure: Oswestry Low Back Pain Disability Scale, for disability
timeFrame: 5 minutes
measure: Pressure pain threshold (PPT), for pain
timeFrame: 5 minutes
measure: Angular and a linear test for the assessment of hamstring extensibility for flexibility
timeFrame: 2 minutes
measure: Modified-Modified Schober Test, for flexibility
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
References: