Back PainNCT05571124
Workplace Exercise Intervention in Administrative Personnel to Reduce Spinal Pain
A study testing Therapeutic Exercise Intervention in people with Back Pain and Sedentary Behavior, run by Universitat de Lleida at 1 site in Spain.
Trial summary
The goal of this Clinical trial is to compare treatments in sedentary administrative personnel with back pain. The main question it aims to answer: The benefits of a workplace intervention with therapeutic exercise and pain education compared with only therapeutic exercise intervention Participants will perform active… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain, Sedentary Behavior
- What is being tested?
- Therapeutic Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2023to 31 Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 80% of the working day is in a seated position.
- Workers who have a computer or mobile device with an internet connection.
- Workers with more than three months of pain in the back area due to a non-specific cause.
Who cannot join
- Part-time workers.
- Pathologies that cause chronic pain.
- Radiculopathies or symptomatic disc herniations/protrusions.
- Inability to perform low-moderate intensity exercise.
- People who are active in their daily lives outside of work willing to report that they meet the minimum stipulated by the WHO (a minimum of 10,000 steps per day and 75-150 minutes of vigorous-moderate physical activity per week).
- Undergoing physiotherapy treatment through public health or a private company.
- Workers on sick leave or during pregnancy.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat de Lleida
Lleida, Catalonia, 25008
Francesc Rubí, PhD, 973 702 446, dif.secretaria@udl.cat
About this study
Official title: The Implementation of a Web-based Workplace Exercise Intervention in the Reduction of Spinal Pain in Sedentary Administrative Personnel: Protocol of a Mixed Methodology Study.
The goal of this Clinical trial is to compare treatments in sedentary administrative personnel with back pain. The main question it aims to answer:
The benefits of a workplace intervention with therapeutic exercise and pain education compared with only therapeutic exercise intervention
Read more
Participants will perform active pauses in their workplace with a web-based program that consists of videos or images of exercises and pain education information.
Researchers will compare a group Therapeutic exercise and pain education intervention with a group therapeutic exercise only to see if pain education plus exercise is a more beneficial intervention in reducing back pain in symptomatic administrative personnel.
Read the detailed description
Introduction: Musculoskeletal pathologies are one of the leading causes of disability for the population worldwide, with office workers being one of the most affected groups. This study aims to design and implement a programme of therapeutic exercise and pain education in the workplace to reduce musculoskeletal pathology. The use of therapeutic exercise interventions at work is an economical and feasible option in which it is essential to consider biopsychosocial aspects when designing a successful treatment.
Methods: Mixed methodology study. Phase 1: A qualitative study with a phenomenological approach using semi-structured interviews to determine factors related to office workers' expectations about pain, maintaining static postures at work and implementing active breaks. Phase 2: Implementation of a Randomised Controlled Trial considering current scientific evidence and the results of the first phase with two intervention groups. A group in which therapeutic exercise will be performed at work with pain education, compared to a group implementing only exercise at the workplace.
Discussion: This study is a comprehensive and pragmatic intervention to implement therapeutic exercise in the workplace, considering workers' expectations regarding their pain and the implementation of active breaks. The use of digitalisation in the implementation of therapeutic exercise and pain education in office workers is a feasible and low-cost option. It can improve office workers' quality of life by increasing motivation and adherence to such interventions.
- Conditions
- Back Pain, Sedentary Behavior
- Being tested
- Therapeutic Exercise Intervention
- Keywords
- Back Pain, Health Education, Therapeutic Exercise, Sedentary Behavior
- Medical subject headings
- Back Pain, Sedentary Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Exercise InterventionBehavioural
Also called Workplace exercise intervention, Active Breaks
Participants will perform stretching and mobility exercises in short bouts of time.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic exercise | Experimental | It consists of implementing active breaks at the workstation through the use of the open source Learning Management System Sakai [33], It will be easy to use by the participants due to the platform is used by them in their daily work. Also, an administrative worker from the university will be involved in creating the modules where the content will be allocated to ensure that the navigation in the platform is user-friendly for them.musculoskeletal pathologies with sedentary lifestyles and maintained postures. The type of online application will depend on the results obtained in the qualitative phase, as we will adapt to the workers' preferences to facilitate accessibility to the content and make the experience as satisfactory as possible for them. Receives: Behavioral: Therapeutic Exercise Intervention |
| No intervention | No intervention | Participants of the control group will be on a waiting list, encouraging them to maintain the same as usual in their daily activities and working hours. Once the intervention is finished, they will have access to the platform with the same content as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Back Pain
The primary outcome to be analysed is back pain using the Visual Analogue Scale, a subjective assessment scale of intensity from 0 to 10, with 0 being "no pain" and 10 being "the worst possible pain".
Measured: Change from baseline back pain at six weeks
Secondary outcomes (4)
Back pain dysfunction
Will be analysed using the Spanish version of the Spine Functional Index, a self-administered questionnaire in which the patient reports the state of his or her back concerning disability and dysfunction in daily activities.
Measured: Change from baseline back pain dysfunction at six weeks
Health related quality of life
Will be analysed using the Spanish version of the EQ-5D-5L quality of life questionnaire which consists of 5 dimensions: mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression.
Measured: Change from baseline quality of life at six weeks
Motivation of performing therapeutic exercise
Motivation when performing the therapeutic exercise intervention will be analysed using the Spanish version of the questionnaire: Behavioural Regulation in Exercise Questionnaire-2.
Measured: Change from baseline motivation of performing therapeutic exercise at six weeks
Adherence to therapeutic exercise
The percentage of open sessions and total video played of the participant will be analysed by the web analytics.
Measured: Through study completion, an average of six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Oct 2023
- Primary completion30 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Back 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Tersa Miralles, Universitat de Lleida
- Investigators
- Esther Rubinat Arnaldo, PhD, Study director, Universitat de LleidaFrancesc Rubi Carnacea, PhD, Study director, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571124
- Sponsor's protocol ID
- WEI
- Status last verified
- Nov 2023
- First submitted
- 30 Sep 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
PubMed 28919117Sohrabi MS, Babamiri M. Effectiveness of an ergonomics training program on musculoskeletal disorders, job stress, quality of work-life and productivity in office workers: a quasi-randomized control trial study. Int J Occup Saf Ergon. 2022 Sep;28(3):1664-1671. doi: 10.1080/10803548.2021.1918930. Epub 2021 May 15.
PubMed 33870873Bevan S. Economic impact of musculoskeletal disorders (MSDs) on work in Europe. Best Pract Res Clin Rheumatol. 2015 Jun;29(3):356-73. doi: 10.1016/j.berh.2015.08.002. Epub 2015 Oct 24.
PubMed 26612235Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006 Jun 17;332(7555):1430-4. doi: 10.1136/bmj.332.7555.1430. No abstract available.
PubMed 16777886Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
PubMed 21982256Janwantanakul P, Sihawong R, Sitthipornvorakul E, Paksaichol A. A Path Analysis of the Effects of Biopsychosocial Factors on the Onset of Nonspecific Low Back Pain in Office Workers. J Manipulative Physiol Ther. 2018 Jun;41(5):405-412. doi: 10.1016/j.jmpt.2017.10.012. Epub 2018 Jul 12.
PubMed 30007743Amiri S, Behnezhad S. Is job strain a risk factor for musculoskeletal pain? A systematic review and meta-analysis of 21 longitudinal studies. Public Health. 2020 Apr;181:158-167. doi: 10.1016/j.puhe.2019.11.023. Epub 2020 Feb 28.
PubMed 32059156Hoe VC, Urquhart DM, Kelsall HL, Zamri EN, Sim MR. Ergonomic interventions for preventing work-related musculoskeletal disorders of the upper limb and neck among office workers. Cochrane Database Syst Rev. 2018 Oct 23;10(10):CD008570. doi: 10.1002/14651858.CD008570.pub3.
PubMed 30350850Tersa-Miralles C, Bravo C, Bellon F, Pastells-Peiro R, Rubinat Arnaldo E, Rubi-Carnacea F. Effectiveness of workplace exercise interventions in the treatment of musculoskeletal disorders in office workers: a systematic review. BMJ Open. 2022 Jan 31;12(1):e054288. doi: 10.1136/bmjopen-2021-054288.
PubMed 35105632Luque-Suarez A, Martinez-Calderon J, Falla D. Role of kinesiophobia on pain, disability and quality of life in people suffering from chronic musculoskeletal pain: a systematic review. Br J Sports Med. 2019 May;53(9):554-559. doi: 10.1136/bjsports-2017-098673. Epub 2018 Apr 17.
PubMed 29666064Coggon D, Ntani G, Palmer KT, Felli VE, Harari R, Barrero LH, Felknor SA, Gimeno D, Cattrell A, Serra C, Bonzini M, Solidaki E, Merisalu E, Habib RR, Sadeghian F, Masood Kadir M, Warnakulasuriya SS, Matsudaira K, Nyantumbu B, Sim MR, Harcombe H, Cox K, Marziale MH, Sarquis LM, Harari F, Freire R, Harari N, Monroy MV, Quintana LA, Rojas M, Salazar Vega EJ, Harris EC, Vargas-Prada S, Martinez JM, Delclos G, Benavides FG, Carugno M, Ferrario MM, Pesatori AC, Chatzi L, Bitsios P, Kogevinas M, Oha K, Sirk T, Sadeghian A, Peiris-John RJ, Sathiakumar N, Wickremasinghe AR, Yoshimura N, Kelsall HL, Hoe VC, Urquhart DM, Derrett S, McBride D, Herbison P, Gray A. Disabling musculoskeletal pain in working populations: is it the job, the person, or the culture? Pain. 2013 Jun;154(6):856-63. doi: 10.1016/j.pain.2013.02.008.
PubMed 23688828Miles CL, Pincus T, Carnes D, Homer KE, Taylor SJ, Bremner SA, Rahman A, Underwood M. Can we identify how programmes aimed at promoting self-management in musculoskeletal pain work and who benefits? A systematic review of sub-group analysis within RCTs. Eur J Pain. 2011 Sep;15(8):775.e1-11. doi: 10.1016/j.ejpain.2011.01.016. Epub 2011 Feb 26.
PubMed 21354838Smith J, Faux SG, Gardner T, Hobbs MJ, James MA, Joubert AE, Kladnitski N, Newby JM, Schultz R, Shiner CT, Andrews G. Reboot Online: A Randomized Controlled Trial Comparing an Online Multidisciplinary Pain Management Program with Usual Care for Chronic Pain. Pain Med. 2019 Dec 1;20(12):2385-2396. doi: 10.1093/pm/pnz208.
PubMed 31498393Toelle TR, Utpadel-Fischler DA, Haas KK, Priebe JA. App-based multidisciplinary back pain treatment versus combined physiotherapy plus online education: a randomized controlled trial. NPJ Digit Med. 2019 May 3;2:34. doi: 10.1038/s41746-019-0109-x. eCollection 2019.
PubMed 31304380Palsson TS, Boudreau S, Hogh M, Herrero P, Bellosta-Lopez P, Domenech-Garcia V, Langella F, Gagni N, Christensen SW, Villumsen M. Education as a strategy for managing occupational-related musculoskeletal pain: a scoping review. BMJ Open. 2020 Feb 12;10(2):e032668. doi: 10.1136/bmjopen-2019-032668.
PubMed 32051307
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation of a Web-based Workplace Exercise Intervention in the Reduction of Spinal Pain in Sedentary Administrative Personnel: Protocol of a Mixed Methodology Study.
- ClinicalTrials.gov ID
- NCT05571124
- Acronym / sponsor ID
- WEI
- Conditions
- Back Pain, Sedentary Behavior
- Keywords
- Back Pain, Health Education, Therapeutic Exercise, Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Oct 2022 (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.
The goal of this Clinical trial is to compare treatments in sedentary administrative personnel with back pain. The main question it aims to answer:
The benefits of a workplace intervention with therapeutic exercise and pain education compared with only therapeutic exercise intervention
Participants will perform active pauses in their workplace with a web-based program that consists of videos or images of exercises and pain education information.
Researchers will compare a group Therapeutic exercise and pain education intervention with a group therapeutic exercise only to see if pain education plus exercise is a more beneficial intervention in reducing back pain in symptomatic administrative personnel.
Detailed description
Introduction: Musculoskeletal pathologies are one of the leading causes of disability for the population worldwide, with office workers being one of the most affected groups. This study aims to design and implement a programme of therapeutic exercise and pain education in the workplace to reduce musculoskeletal pathology. The use of therapeutic exercise interventions at work is an economical and feasible option in which it is essential to consider biopsychosocial aspects when designing a successful treatment.
Methods: Mixed methodology study. Phase 1: A qualitative study with a phenomenological approach using semi-structured interviews to determine factors related to office workers' expectations about pain, maintaining static postures at work and implementing active breaks. Phase 2: Implementation of a Randomised Controlled Trial considering current scientific evidence and the results of the first phase with two intervention groups. A group in which therapeutic exercise will be performed at work with pain education, compared to a group implementing only exercise at the workplace.
Discussion: This study is a comprehensive and pragmatic intervention to implement therapeutic exercise in the workplace, considering workers' expectations regarding their pain and the implementation of active breaks. The use of digitalisation in the implementation of therapeutic exercise and pain education in office workers is a feasible and low-cost option. It can improve office workers' quality of life by increasing motivation and adherence to such interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise | Experimental | Behavioral: Therapeutic Exercise InterventionIt consists of implementing active breaks at the workstation through the use of the open source Learning Management System Sakai [33], It will be easy to use by the participants due to the platform is used by them in their daily work. Also, an administrative worker from the university will be involved in creating the modules where the content will be allocated to ensure that the navigation in the platform is user-friendly for them.musculoskeletal pathologies with sedentary lifestyles and maintained postures. The type of online application will depend on the results obtained in the qualitative phase, as we will adapt to the workers' preferences to facilitate accessibility to the content and make the experience as satisfactory as possible for them. |
| No intervention | No intervention | –Participants of the control group will be on a waiting list, encouraging them to maintain the same as usual in their daily activities and working hours. Once the intervention is finished, they will have access to the platform with the same content as the intervention group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- More than 80% of the working day is in a seated position.
- Workers who have a computer or mobile device with an internet connection.
- Workers with more than three months of pain in the back area due to a non-specific cause.
Key exclusion criteria (7 listed)
- Part-time workers.
- Pathologies that cause chronic pain.
- Radiculopathies or symptomatic disc herniations/protrusions.
- Inability to perform low-moderate intensity exercise.
- People who are active in their daily lives outside of work willing to report that they meet the minimum stipulated by the WHO (a minimum of 10,000 steps per day and 75-150 minutes of vigorous-moderate physical activity per week).
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 |
|---|---|---|
| Therapeutic Exercise InterventionAlso: Workplace exercise intervention, Active BreaksParticipants will perform stretching and mobility exercises in short bouts of time. | Behavioural | Therapeutic exercise |
Primary outcome
Reduction of Back Pain
Time frame: Change from baseline back pain at six weeks
The primary outcome to be analysed is back pain using the Visual Analogue Scale, a subjective assessment scale of intensity from 0 to 10, with 0 being "no pain" and 10 being "the worst possible pain".
4 secondary outcomes
Back pain dysfunction
Time frame: Change from baseline back pain dysfunction at six weeks
Health related quality of life
Time frame: Change from baseline quality of life at six weeks
Motivation of performing therapeutic exercise
Time frame: Change from baseline motivation of performing therapeutic exercise at six weeks
Adherence to therapeutic exercise
Time frame: Through study completion, an average of six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 28919117GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
- Background: PubMed 33870873Sohrabi MS, Babamiri M. Effectiveness of an ergonomics training program on musculoskeletal disorders, job stress, quality of work-life and productivity in office workers: a quasi-randomized control trial study. Int J Occup Saf Ergon. 2022 Sep;28(3):1664-1671. doi: 10.1080/10803548.2021.1918930. Epub 2021 May 15.
- Background: PubMed 26612235Bevan S. Economic impact of musculoskeletal disorders (MSDs) on work in Europe. Best Pract Res Clin Rheumatol. 2015 Jun;29(3):356-73. doi: 10.1016/j.berh.2015.08.002. Epub 2015 Oct 24.
- Background: PubMed 16777886Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006 Jun 17;332(7555):1430-4. doi: 10.1136/bmj.332.7555.1430. No abstract available.
- Background: PubMed 21982256Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
- Background: PubMed 30007743Janwantanakul P, Sihawong R, Sitthipornvorakul E, Paksaichol A. A Path Analysis of the Effects of Biopsychosocial Factors on the Onset of Nonspecific Low Back Pain in Office Workers. J Manipulative Physiol Ther. 2018 Jun;41(5):405-412. doi: 10.1016/j.jmpt.2017.10.012. Epub 2018 Jul 12.
- Background: PubMed 32059156Amiri S, Behnezhad S. Is job strain a risk factor for musculoskeletal pain? A systematic review and meta-analysis of 21 longitudinal studies. Public Health. 2020 Apr;181:158-167. doi: 10.1016/j.puhe.2019.11.023. Epub 2020 Feb 28.
- Background: PubMed 30350850Hoe VC, Urquhart DM, Kelsall HL, Zamri EN, Sim MR. Ergonomic interventions for preventing work-related musculoskeletal disorders of the upper limb and neck among office workers. Cochrane Database Syst Rev. 2018 Oct 23;10(10):CD008570. doi: 10.1002/14651858.CD008570.pub3.
- Background: PubMed 35105632Tersa-Miralles C, Bravo C, Bellon F, Pastells-Peiro R, Rubinat Arnaldo E, Rubi-Carnacea F. Effectiveness of workplace exercise interventions in the treatment of musculoskeletal disorders in office workers: a systematic review. BMJ Open. 2022 Jan 31;12(1):e054288. doi: 10.1136/bmjopen-2021-054288.
- Background: PubMed 29666064Luque-Suarez A, Martinez-Calderon J, Falla D. Role of kinesiophobia on pain, disability and quality of life in people suffering from chronic musculoskeletal pain: a systematic review. Br J Sports Med. 2019 May;53(9):554-559. doi: 10.1136/bjsports-2017-098673. Epub 2018 Apr 17.
- Background: PubMed 23688828Coggon D, Ntani G, Palmer KT, Felli VE, Harari R, Barrero LH, Felknor SA, Gimeno D, Cattrell A, Serra C, Bonzini M, Solidaki E, Merisalu E, Habib RR, Sadeghian F, Masood Kadir M, Warnakulasuriya SS, Matsudaira K, Nyantumbu B, Sim MR, Harcombe H, Cox K, Marziale MH, Sarquis LM, Harari F, Freire R, Harari N, Monroy MV, Quintana LA, Rojas M, Salazar Vega EJ, Harris EC, Vargas-Prada S, Martinez JM, Delclos G, Benavides FG, Carugno M, Ferrario MM, Pesatori AC, Chatzi L, Bitsios P, Kogevinas M, Oha K, Sirk T, Sadeghian A, Peiris-John RJ, Sathiakumar N, Wickremasinghe AR, Yoshimura N, Kelsall HL, Hoe VC, Urquhart DM, Derrett S, McBride D, Herbison P, Gray A. Disabling musculoskeletal pain in working populations: is it the job, the person, or the culture? Pain. 2013 Jun;154(6):856-63. doi: 10.1016/j.pain.2013.02.008.
- Background: PubMed 21354838Miles CL, Pincus T, Carnes D, Homer KE, Taylor SJ, Bremner SA, Rahman A, Underwood M. Can we identify how programmes aimed at promoting self-management in musculoskeletal pain work and who benefits? A systematic review of sub-group analysis within RCTs. Eur J Pain. 2011 Sep;15(8):775.e1-11. doi: 10.1016/j.ejpain.2011.01.016. Epub 2011 Feb 26.
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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.
Esther Rubinat Arnaldo, PhD study director
Universitat de Lleida
Francesc Rubi Carnacea, PhD study director
Universitat de Lleida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Exercise Intervention in people with Back Pain and Sedentary Behavior, run by Universitat de Lleida 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 3 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: status not confirmed, as of the sponsor's last update on 5 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Tersa Miralles, PhD student (676201743, carles.tersa@udl.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Back Pain (time frame: Change from baseline back pain at six weeks). 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 NCT05571124, which also lists 43 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 5 Dec 2023.