Chronic PainXHEPNCT06226298
Benefits of the Xiaxi Postural Hammock and a Xiaxi Exercise Program
A study testing Xiaxi postural hammock and Yoga mat in people with Chronic Pain and Low Back Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Low Back Pain, Exercise
- What is being tested?
- Xiaxi postural hammock and Yoga mat
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 13 Nov 2023to 1 Dec 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Presence of back pain.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of the Xiaxi Postural Hammock and a Xiaxi Exercise Program: A Randomized Controlled Trial
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
- Being tested
- Xiaxi postural hammock, Yoga mat
- Medical subject headings
- Chronic Pain, Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiaxi postural hammockDevice
Lie in the Xiaxi postural hammock for 10 minutes for 5 days.
Yoga matBehavioural
Lie in the Yoga mat for 10 minutes for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Xiaxi | Experimental | The experimental group will lie in the Xiaxi postural hammock for 10 minutes for 5 days. Receives: 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. Receives: Behavioral: Yoga mat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 minute
Secondary outcomes (9)
International Physical Activity Questionnaire (IPAQ) for Physical Activity
The IPAQ is a questionnaire with internationally accepted validity and reliability, which allows measuring the degree of activity in different populations between 15 and 69 years of age. This questionnaire asks about physical activity related to work, transportation, home activity, leisure time and determines the degree of physical activity according to the metabolic equivalents consumed during such activity.
Measured: 5 minutes
General health status, the "SF-36", for quality of life
For the assessment of general health status, the "SF-36" health status questionnaire will be used. The SF-36 health questionnaire is a widely used outcome instrument to assess health-related quality of life. It is a generic multidimensional instrument validated for several pathologies. The physical component summary of the SF36 assesses functional capacity, physical aspects, pain and general health, while its mental component summary assesses vitality, social functioning, emotional aspects and mental health.
Measured: 5 minutes
Satisfaction With Life Scale (SWLS) questionnaire, for quality of life
The SWLS is a useful instrument for academic research in social, medical and other disciplines, as it has demonstrated a high degree of reliability in several studies, appropriate internal consistency among items, correlations between items and adequate validity. The instrument consists of a brief 5-question questionnaire designed to evaluate people's general satisfaction with their lives. It requires approximately one to five minutes of the respondent's time to complete. Responses are recorded on a 7-point Likert rating scale, where 1 represents "strongly disagree" and 7 means "strongly agree". Scores obtained can range from 5 to 35, with higher scores indicating that the person perceives that important areas of his or her life are going well, while lower scores indicate the opposite.
Measured: 5 minutes
Perceived Stress Scale (PSS), for stress
The PSS is a scale designed to measure the degree to which individuals rate situations in their lives as stressful. The items assess the degree to which people consider life to be unpredictable, uncontrollable, or overloaded, central components of stress. The scale includes questions designed to assess the current level of stress experienced by the subject. It is a brief scale, consisting of only 14 items, takes only a few minutes to administer, and is easily scored.
Measured: 5 minutes
The Hospital Anxiety and Depression Scale (HADS), for Anxiety and Depression
The HADS will be used to assess anxiety and depression symptoms. The HADS is a brief two-dimensional self-completed questionnaire designed to assess anxiety and depression symptoms in individuals with physical health problems. It consists of 14 items, 7 of which focus on anxiety symptoms and the other 7 on depressive symptoms. The HADS is considered a valuable tool for screening for these psychological problems in medical settings because of its brevity, ease of administration, and good psychometric properties.
Measured: 5 minutes
Oswestry Low Back Pain Disability Scale, for disability
The Oswestry Low Back Pain Disability Scale will be used to assess the level of disability due to pain. This scale is the most widely used, together with the Roland-Morris scale, in the evaluation of the patient with low back pain to measure its functional repercussion on activities of daily living. It is made up of ten items related to activities of daily living. For each item there are 6 possible answers ranging from no disability [0] to total disability [5]. The Spanish version, which has been translated and culturally adapted, was used.
Measured: 5 minutes
Pressure pain threshold (PPT), for pain
A digital algometer (Model FXD 10, Wagner Instruments, Greewich, CT, USA) that measures pressure in kg/cm2 will be used to assess the PPT. The UDP is defined as the minimum pressure necessary for the pressure sensation to begin to be perceived as painful. To assess it, increasing pressure is applied to the upper portion of the trapezius muscle on the right side at a rate of one kilogram per second until the subject indicates that the sensation begins to be painful. The study subject was in a seated position. To improve accuracy, the investigator in charge of taking this measurement precisely marked the area where the measurement would be taken with a marker. Each measurement would be taken three times and the arithmetic mean was taken to establish the final value collected. Subsequently, it was evaluated in the left upper trapezius muscle, in the right quadratus lumborum muscle and in the left quadratus lumborum muscle, following the procedure previously described.
Measured: 5 minutes
Angular and a linear test for the assessment of hamstring extensibility for flexibility
For the assessment of hamstring extensibility, angular tests and a linear test will be performed. As a reference angular test, the straight leg raising test will be performed, assessing both legs passively (EPRPassive) and actively (EPRActive). The measurement will be performed with an inclinometer (Baseline, model Bubble ® inclinometer, White Plains, NY 10602 (USA). The sit-and-reach test will also be performed, assessing both the pelvic tilt (with the inclinometer) and the distance reached in the test (linear measurement). The tests will be performed in a randomized order and by the same investigator for each test.
Measured: 2 minutes
Modified-Modified Schober Test, for flexibility
For the assessment of lumbar spine flexibility, the Modified-Modified Schober Test will be performed. The examiner places the thumbs on the lower margin of the subject's upper posterior spines. An ink mark is drawn along the midline of the lumbar spine horizontal to the spines. While the examiner holds the tape measure firmly against the subject's skin, he or she marks a second line 15 cm above the original (upper mark). The subject is then asked to perform active anterior trunk flexion without increasing pain. The new distance between the lower and upper marks is measured. The subject returns to the neutral position. The difference in the initial distance between the marks in the neutral position and the new measurements taken in the flexion position is used to indicate the amount of lumbar flexion. After each measurement, the skin marks are removed with alcohol.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start13 Nov 2023
- Primary completion20 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226298
- Sponsor's protocol ID
- HAM_23
- Acronym
- XHEP
- Status last verified
- Jan 2024
- First submitted
- 7 Nov 2023
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of the Xiaxi Postural Hammock and a Xiaxi Exercise Program: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06226298
- Acronym / sponsor ID
- XHEP / HAM_23
- Conditions
- Chronic Pain, Low Back Pain, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 26 Jan 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xiaxi | Experimental | Device: Xiaxi postural hammockThe experimental group will lie in the Xiaxi postural hammock for 10 minutes for 5 days. |
| Control | Active comparator | Behavioral: Yoga matThe control group will lie on a mat on the floor for 10 minutes, 5 days of intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years.
- Presence of back pain.
Key exclusion criteria (7 listed)
- Have undergone surgery of the spine, ischiosural muscles, psoas-iliac, pectoral and rotator cuff.
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 |
|---|---|---|
| Xiaxi postural hammockLie in the Xiaxi postural hammock for 10 minutes for 5 days. | Device | Xiaxi |
| Yoga matLie in the Yoga mat for 10 minutes for 5 days. | Behavioural | Control |
Primary outcome
Visual Analog Scale (VAS) for pain
Time frame: 1 minute
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.
9 secondary outcomes
International Physical Activity Questionnaire (IPAQ) for Physical Activity
Time frame: 5 minutes
General health status, the "SF-36", for quality of life
Time frame: 5 minutes
Satisfaction With Life Scale (SWLS) questionnaire, for quality of life
Time frame: 5 minutes
Perceived Stress Scale (PSS), for stress
Time frame: 5 minutes
The Hospital Anxiety and Depression Scale (HADS), for Anxiety and Depression
Time frame: 5 minutes
Oswestry Low Back Pain Disability Scale, for disability
Time frame: 5 minutes
Pressure pain threshold (PPT), for pain
Time frame: 5 minutes
Angular and a linear test for the assessment of hamstring extensibility for flexibility
Time frame: 2 minutes
Modified-Modified Schober Test, for flexibility
Time frame: 2 minutes
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 26 Jan 2024.
- Individual participant dataSharing planned: Yes
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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 Xiaxi postural hammock and Yoga mat in people with Chronic Pain and Low Back Pain, run by Universidad Rey Juan Carlos 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 2 inclusion and 7 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 26 Jan 2024. 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?
Visual Analog Scale (VAS) for pain (time frame: 1 minute). 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 26 Jan 2024.