Benefits of the Xiaxi Postural Hammock and a Xiaxi Exercise Program

NCT06226298 | Completed DMC

• 1 other identifier: HAM_23
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Low Back Pain; Exercise

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) for pain

  The VAS will be used to assess the level of pain intensity. The VAS scale allows measuring the intensity of pain described by the patient with maximum reproducibility between observers. It consists of a horizontal line of 10 centimeters, at the ends of which are the extreme expressions of a symptom. On the left side is located the absence or lower intensity and on the right side the higher intensity. The patient is asked to mark on the line the point indicating the intensity and it is measured with a millimeter ruler. The intensity is expressed in centimeters or millimeters. It is a common, simple, well constructed, validated and reliable method.

  1 minute

Secondary Outcomes (9)

• International Physical Activity Questionnaire (IPAQ) for Physical Activity

  5 minutes

• General health status, the "SF-36", for quality of life

  5 minutes

• Satisfaction With Life Scale (SWLS) questionnaire, for quality of life

  5 minutes

• Perceived Stress Scale (PSS), for stress

  5 minutes

• The Hospital Anxiety and Depression Scale (HADS), for Anxiety and Depression

  5 minutes

Study Arms (2)

Xiaxi

EXPERIMENTAL

The experimental group will lie in the Xiaxi postural hammock for 10 minutes for 5 days.

Device: Xiaxi postural hammock

Control

ACTIVE COMPARATOR

The control group will lie on a mat on the floor for 10 minutes, 5 days of intervention.

Behavioral: Yoga mat

Interventions

Xiaxi postural hammock DEVICE

Lie in the Xiaxi postural hammock for 10 minutes for 5 days.

Xiaxi

Yoga mat BEHAVIORAL

Lie in the Yoga mat for 10 minutes for 5 days.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Chronic Pain; Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: January 26, 2024
• Study Start: November 13, 2023
• Primary Completion: November 20, 2023
• Study Completion: December 1, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)