PainReViEEWNCT05050526
Real-time Videoconference-based Exercise in Eldercare Workers
A study testing Real-time videoconference-based Exercise program in people with Pain and Mental Disorders, run by Ander Espin at 2 sites in Spain.
Trial summary
Formal caregiving of elderly dependent people is a both physically and psychologically demanding job, and both musculoskeletal and mental disorders with a negative impact in general health and quality of life are habitual among eldercare workers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Mental Disorders
- What is being tested?
- Real-time videoconference-based Exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Oct 2021to 30 Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Professional eldercare workers with ≥3 months of experience in the profession
- Employment contract at least until the anticipated date of study end
Who cannot join
- Pregnancy
- Contraindication to exercise according to the American College of Sports Medicine Guidelines
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Caser Residencial Betharram
Hondarribia, Gipuzkoa, 20280
Residencia Aspaldiko
Portugalete, Bizkaia, 48920
About this study
Official title: Effects of a Real-time Videoconference-based Exercise Program in Eldercare Workers: a Randomized Controlled Trial
Formal caregiving of elderly dependent people is a both physically and psychologically demanding job, and both musculoskeletal and mental disorders with a negative impact in general health and quality of life are habitual among eldercare workers. Previous research has shown that physical exercise programs can reduce and/or prevent those disorders, consequently improving well-being at work.
Online exercise interventions might be a cost-effective tool, as they can reach a large number of people at a relatively low cost. Moreover, they are compatible with situations in which interpersonal physical distancing is required, such as the current COVID-19 pandemic. However, real-time videoconference-based exercise interventions have not yet been studied in working populations.
Thus, the aim of this study is to assess the effects of a real-time videoconference-based exercise intervention in eldercare workers. The primary outcome will be low back pain. Pain in neck, shoulders and wrists/hands will also be recorded, as well as additional measures of physical fitness, psychoaffective state, health and work-related variables. All outcomes will be measured at baseline and at 12-week and 48-week follow-ups.
- Conditions
- Pain, Mental Disorders
- Being tested
- Real-time videoconference-based Exercise program
- Keywords
- Eldercare, Caregiver, Exercise, Tele-health, Musculoskeletal disorders, Mental disorders, Absenteeism, Work ability, Work performance
- Medical subject headings
- Pain, Mental Disorders, Motor Activity, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time videoconference-based Exercise programBehavioural
12-week exercise program consisting of two weekly 45 minute group-based sessions, remotely supervised by a professional via real-time videoconference. Each session will consist of a warm-up (5-10 min), general strengthening (30 min) and cool-down (5-10 min). Warm-up will include general joint mobility and exercises focused on increasing heart rate. General strengthening will include 4 series of 6 exercises (2 for lower limb, 2 for upper limb and 2 for the trunk) performed with minimal equipment, combining body-weight and elastic-band exercises. Three difficulty levels will be set for each of the exercises, and progression will be made at weeks 5 and 9. Participants will be asked to work in a given rate of perceived exertion (between 3 and 5 in Borg's CR10 scale) and not to reach failure in any of the exercises. Cool-down will include stretching and breathing/relaxing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Exercise program | Experimental | Participants in the experimental group will take part in a 12-week exercise program. Receives: Behavioral: Real-time videoconference-based Exercise program |
| Control | No intervention | Participants in the control group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline average pain intensity at 12 weeks
Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Measured: At baseline and at 12-week follow-up
Change from baseline average pain intensity at 48 weeks
Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Measured: At baseline and at 48-week follow-up
Change from baseline highest pain intensity at 12 weeks
Highest pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Measured: At baseline and at 12-week follow-up
Change from baseline highest pain intensity at 48 weeks
Highest pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Measured: At baseline and at 48-week follow-up
Change from baseline pain frequency at 12 weeks
Number of days in pain during the last 7 days (0-7). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Measured: At baseline and at 12-week follow-up
Change from baseline pain frequency at 48 weeks
Number of days in pain during the last 7 days (0-7). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Measured: At baseline and at 48-week follow-up
Change from baseline pain interference at 12 weeks
Number of days in which pain negatively interferes with work during the last 7 days of work (0-7). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Measured: At baseline and at 12-week follow-up
Change from baseline pain interference at 48 weeks
Number of days in which pain negatively interferes with work during the last 7 days of work (0-7). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Measured: At baseline and at 48-week follow-up
Secondary outcomes (14)
Analgesic medication consumption frequency
Number of days in which analgesic medication is taken during the last 7 days (0-7).
Measured: At baseline and at 12-week and 48-week follow-ups
5-repetition sit-to-stand test
It measures lower limb strength based on the time taken by the participant to get up from and sit down on a chair five times as quickly as possible.
Measured: At baseline and at 12-week and 48-week follow-ups
Kneeling push-up test
It measures upper limb strength based on the maximum number of "knee push-ups" the participant can perform until failure.
Measured: At baseline and at 12-week and 48-week follow-ups
Shirado-Ito trunk flexor endurance test
It measures trunk flexor endurance based on the maximum time the participant is able to maintain a defined body position, which mainly activates trunk flexor muscles.
Measured: At baseline and at 12-week and 48-week follow-ups
Subjective Happiness scale
It is comprised of 4 items, each of them answered with a score between 1 and 7. A single composite score is obtained by averaging the responses to the 4 items, and a higher score corresponds to a greater happiness.
Measured: At baseline and at 12-week and 48-week follow-ups
Goldberg Anxiety and Depression scale
The scale includes 9 items for anxiety symptoms and 9 items for depression symptoms. Each item is answered with a "Yes" or a "No". A higher number of positive answers corresponds to a higher risk of suffering a clinically relevant anxiety or depression disorder, respectively.
Measured: At baseline and at 12-week and 48-week follow-ups
Maslach Burnout Inventory
The Inventory is comprised of 22 items corresponding to three domains: personal accomplishment, emotional exhaustion and depersonalization. Each item is answered in a 0-6 Likert scale depending on the frequency with which the participant experiences the feelings described. One total score per domain is obtained.
Measured: At baseline and at 12-week and 48-week follow-ups
Single-Item Sleep Quality Scale
It evaluates overall sleep quality in the last 7 days with a numerical scale that ranges between 0 (terrible) and 10 (excellent).
Measured: At baseline and at 12-week and 48-week follow-ups
Hypnotic/anxiolytic medication consumption frequency
Number of days in which hypnotic/anxiolytic medication is taken during the last 7 days (0-7).
Measured: At baseline and at 12-week and 48-week follow-ups
EuroQol-5D 0-100 health state scale
It measures self-perceived current health state in a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: At baseline and at 12-week and 48-week follow-ups
Work Ability
Work ability will be assessed by the following item extracted from the Workability Index: "assuming that your work ability at its best has a value of 10 points, how many points would you rate your current work ability?". Participants are asked to give a score ranging from 0 (completely unable to work) to 10 (lifetime best work ability).
Measured: At baseline and at 12-week and 48-week follow-ups
Work Performance
Work performance will be assessed by the following item extracted from the World Health Organization Health and Work Performance Questionnaire: "On a scale from 0 to 10 where 0 is the worst job performance anyone could have at your job and 10 is the performance of a top worker, how would you rate your overall work performance on the days you worked during the last 12 weeks?" Participants are asked to give a score between 0 and 10.
Measured: At baseline and at 12-week and 48-week follow-ups
Borg's CR-10 scale for perceived physical exertion at work
It measures perceived physical exertion while doing physical work in a scale ranging from 0 (nothing at all) to 10 (extremely strong).
Measured: At baseline and at 12-week and 48-week follow-ups
Absenteeism
Days of absence from work during the last year will be collected from the official registry of the company and by self-reported questionnaire. Presence of absenteeism (yes/no), days of absence (n) and reason will be collected.
Measured: At baseline and at 12-week and 48-week follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start1 Oct 2021
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ander Espin
- Sponsor type
- University, hospital or other
- Collaborators
- Caser Residencial Betharram, Fundación Aspaldiko, Grupo Servicios Sociales Integrados, Igurco Residencias Sociosanitarias, Grupo Colisée
- Responsible party
- Sponsor-investigator, Ander Espin, University of the Basque Country (UPV/EHU)
- Investigators
- Ander Espin, PhD Student, Principal investigator, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050526
- Sponsor's protocol ID
- Eldercare2021
- Acronym
- ReViEEW
- Status last verified
- May 2024
- First submitted
- 9 Sep 2021
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Espin A, Irazusta J, Segovia Celaya I, Mosquera Lajas A, Gonzalez-Templado V, Rodriguez-Larrad A. Effects of a videoconference-based therapeutic exercise intervention on the musculoskeletal pain of eldercare workers: protocol for the ReViEEW randomized controlled trial. BMC Musculoskelet Disord. 2023 Jun 6;24(1):463. doi: 10.1186/s12891-023-06584-7.
PubMed 37280584Espin A, Irazusta J, Aiestaran M, Latorre Erezuma U, Garcia-Garcia J, Arrinda I, Acedo K, Rodriguez-Larrad A. Videoconference-Supervised Group Exercise Reduces Low Back Pain in Eldercare Workers: Results from the ReViEEW Randomised Controlled Trial. J Occup Rehabil. 2025 Mar;35(1):66-77. doi: 10.1007/s10926-024-10182-2. Epub 2024 Apr 17.
PubMed 38632115Teno SC, Rodriguez-Larrad A, Irazusta J, Echeverria I, Ugalde-Aranzabal N, Mosquera-Lajas A, Judice PB, Espin A. Predictors of Adherence to a videoconference-Based Therapeutic Exercise Intervention in Eldercare Workers: A Secondary Analysis of Participants in the ReViEEW Randomized Controlled Trial. J Occup Rehabil. 2026 Sep 7. doi: 10.1007/s10926-026-10449-w. Online ahead of print.
PubMed 42706473Espin A, Rodriguez-Larrad A, Ruiz-Fernandez A, Martin-Perez A, Fernandez-Gutierrez N, Andersen LL, Irazusta J. Predictors of response to physical exercise for low back pain: a secondary analysis of the ReViEEW trial. Musculoskelet Sci Pract. 2026 Feb;81:103465. doi: 10.1016/j.msksp.2025.103465. Epub 2025 Dec 3.
PubMed 41353795Espin A, Irazusta J, Urquiza M, Ruiz-Fernandez A, Latorre Erezuma U, Collado Torres L, Andersen LL, Rodriguez-Larrad A. Videoconference-Supervised Exercise for Low Back Pain in Eldercare Workers: One-Year Follow-up of the ReViEEW Randomized Controlled Trial. J Occup Environ Med. 2025 Oct 1;67(10):e720-e728. doi: 10.1097/JOM.0000000000003474. Epub 2025 Jun 2.
PubMed 40561221
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Real-time Videoconference-based Exercise Program in Eldercare Workers: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05050526
- Acronym / sponsor ID
- ReViEEW / Eldercare2021
- Conditions
- Pain, Mental Disorders
- Keywords
- Eldercare, Caregiver, Exercise, Tele-health, Musculoskeletal disorders, Mental disorders, Absenteeism, Work ability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ander EspinUniversity, hospital or other
- Collaborators
- Caser Residencial Betharram, Fundación Aspaldiko, Grupo Servicios Sociales Integrados, Igurco Residencias Sociosanitarias, Grupo Colisée
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 20 Sep 2021 (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.
Formal caregiving of elderly dependent people is a both physically and psychologically demanding job, and both musculoskeletal and mental disorders with a negative impact in general health and quality of life are habitual among eldercare workers. Previous research has shown that physical exercise programs can reduce and/or prevent those disorders, consequently improving well-being at work.
Online exercise interventions might be a cost-effective tool, as they can reach a large number of people at a relatively low cost. Moreover, they are compatible with situations in which interpersonal physical distancing is required, such as the current COVID-19 pandemic. However, real-time videoconference-based exercise interventions have not yet been studied in working populations.
Thus, the aim of this study is to assess the effects of a real-time videoconference-based exercise intervention in eldercare workers. The primary outcome will be low back pain. Pain in neck, shoulders and wrists/hands will also be recorded, as well as additional measures of physical fitness, psychoaffective state, health and work-related variables. All outcomes will be measured at baseline and at 12-week and 48-week follow-ups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise program | Experimental | Behavioral: Real-time videoconference-based Exercise programParticipants in the experimental group will take part in a 12-week exercise program. |
| Control | No intervention | –Participants in the control group will not receive any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Professional eldercare workers with ≥3 months of experience in the profession
- Employment contract at least until the anticipated date of study end
Key exclusion criteria (2 listed)
- Pregnancy
- Contraindication to exercise according to the American College of Sports Medicine Guidelines
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 |
|---|---|---|
| Real-time videoconference-based Exercise program12-week exercise program consisting of two weekly 45 minute group-based sessions, remotely supervised by a professional via real-time videoconference. Each session will consist of a warm-up (5-10 min), general strengthening (30 min) and cool-down (5-10 min). Warm-up will include general joint mobility and exercises focused on increasing heart rate. General strengthening will include 4 series of 6 exercises (2 for lower limb, 2 for upper limb and 2 for the trunk) performed with minimal equipment, combining body-weight and elastic-band exercises. Three difficulty levels will be set for each of the exercises, and progression will be made at weeks 5 and 9. Participants will be asked to work in a given rate of perceived exertion (between 3 and 5 in Borg's CR10 scale) and not to reach failure in any of the exercises. Cool-down will include stretching and breathing/relaxing exercises. | Behavioural | Exercise program |
Primary outcome
Change from baseline average pain intensity at 12 weeks
Time frame: At baseline and at 12-week follow-up
Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Change from baseline average pain intensity at 48 weeks
Time frame: At baseline and at 48-week follow-up
Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Change from baseline highest pain intensity at 12 weeks
Time frame: At baseline and at 12-week follow-up
Highest pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Change from baseline highest pain intensity at 48 weeks
Time frame: At baseline and at 48-week follow-up
Highest pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Change from baseline pain frequency at 12 weeks
Time frame: At baseline and at 12-week follow-up
Number of days in pain during the last 7 days (0-7). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Change from baseline pain frequency at 48 weeks
Time frame: At baseline and at 48-week follow-up
Number of days in pain during the last 7 days (0-7). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Change from baseline pain interference at 12 weeks
Time frame: At baseline and at 12-week follow-up
Number of days in which pain negatively interferes with work during the last 7 days of work (0-7). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
Change from baseline pain interference at 48 weeks
Time frame: At baseline and at 48-week follow-up
Number of days in which pain negatively interferes with work during the last 7 days of work (0-7). This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
14 secondary outcomes
Analgesic medication consumption frequency
Time frame: At baseline and at 12-week and 48-week follow-ups
5-repetition sit-to-stand test
Time frame: At baseline and at 12-week and 48-week follow-ups
Kneeling push-up test
Time frame: At baseline and at 12-week and 48-week follow-ups
Shirado-Ito trunk flexor endurance test
Time frame: At baseline and at 12-week and 48-week follow-ups
Subjective Happiness scale
Time frame: At baseline and at 12-week and 48-week follow-ups
Goldberg Anxiety and Depression scale
Time frame: At baseline and at 12-week and 48-week follow-ups
Maslach Burnout Inventory
Time frame: At baseline and at 12-week and 48-week follow-ups
Single-Item Sleep Quality Scale
Time frame: At baseline and at 12-week and 48-week follow-ups
Hypnotic/anxiolytic medication consumption frequency
Time frame: At baseline and at 12-week and 48-week follow-ups
EuroQol-5D 0-100 health state scale
Time frame: At baseline and at 12-week and 48-week follow-ups
Work Ability
Time frame: At baseline and at 12-week and 48-week follow-ups
Work Performance
Time frame: At baseline and at 12-week and 48-week follow-ups
Borg's CR-10 scale for perceived physical exertion at work
Time frame: At baseline and at 12-week and 48-week follow-ups
Absenteeism
Time frame: At baseline and at 12-week and 48-week follow-ups
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 24 May 2024.
- Background: PubMed 37280584Espin A, Irazusta J, Segovia Celaya I, Mosquera Lajas A, Gonzalez-Templado V, Rodriguez-Larrad A. Effects of a videoconference-based therapeutic exercise intervention on the musculoskeletal pain of eldercare workers: protocol for the ReViEEW randomized controlled trial. BMC Musculoskelet Disord. 2023 Jun 6;24(1):463. doi: 10.1186/s12891-023-06584-7.
- Results publication: PubMed 38632115Espin A, Irazusta J, Aiestaran M, Latorre Erezuma U, Garcia-Garcia J, Arrinda I, Acedo K, Rodriguez-Larrad A. Videoconference-Supervised Group Exercise Reduces Low Back Pain in Eldercare Workers: Results from the ReViEEW Randomised Controlled Trial. J Occup Rehabil. 2025 Mar;35(1):66-77. doi: 10.1007/s10926-024-10182-2. Epub 2024 Apr 17.
- Derived from this study: PubMed 42706473Teno SC, Rodriguez-Larrad A, Irazusta J, Echeverria I, Ugalde-Aranzabal N, Mosquera-Lajas A, Judice PB, Espin A. Predictors of Adherence to a videoconference-Based Therapeutic Exercise Intervention in Eldercare Workers: A Secondary Analysis of Participants in the ReViEEW Randomized Controlled Trial. J Occup Rehabil. 2026 Sep 7. doi: 10.1007/s10926-026-10449-w. Online ahead of print.
- Derived from this study: PubMed 41353795Espin A, Rodriguez-Larrad A, Ruiz-Fernandez A, Martin-Perez A, Fernandez-Gutierrez N, Andersen LL, Irazusta J. Predictors of response to physical exercise for low back pain: a secondary analysis of the ReViEEW trial. Musculoskelet Sci Pract. 2026 Feb;81:103465. doi: 10.1016/j.msksp.2025.103465. Epub 2025 Dec 3.
- Derived from this study: PubMed 40561221Espin A, Irazusta J, Urquiza M, Ruiz-Fernandez A, Latorre Erezuma U, Collado Torres L, Andersen LL, Rodriguez-Larrad A. Videoconference-Supervised Exercise for Low Back Pain in Eldercare Workers: One-Year Follow-up of the ReViEEW Randomized Controlled Trial. J Occup Environ Med. 2025 Oct 1;67(10):e720-e728. doi: 10.1097/JOM.0000000000003474. Epub 2025 Jun 2.
- Link to study protocol published in BMC Musculoskeletal DisordersLink provided by the sponsor.
- Link to study 12-week results in the Journal of Occupational RehabilitationLink provided by the sponsor.
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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.
Ander Espin, PhD Student principal investigator
University of the Basque Country (UPV/EHU)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time videoconference-based Exercise program in people with Pain and Mental Disorders, run by Ander Espin at 2 sites 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 2 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 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 average pain intensity at 12 weeks (time frame: At baseline and at 12-week follow-up). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05050526, which also lists 5 linked publications.
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 24 May 2024.