Low Back PainNCT05093543
Feasibility and Effect of a Multidisciplinary Telematics Approach for Chronic Non-specific Low Back Pain: a Randomized, Open-label, Controlled, Pilot Clinical Trial. Study Protocol
A study testing physical rehabilitation/physiotherapy and psychosocial group sessions in people with Low Back Pain, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
Low back pain is a challenging condition, with a lifetime prevalence of up to 84%. The estimated prevalence of chronic non-specific low back pain is of approximately 23%. Although pain is a sensory experience triggered by a peripheral stimulus, psychosocial factors influence on its perception and on the risk of… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- physical rehabilitation/physiotherapy and psychosocial group sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to 1 Apr 2022
- 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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 67 years of age (i.e., working age population).
- Both genders.
- Patients with chronic non-specific low back pain that does not improve with conservative treatment (including rehabilitation and Pain Clinic evaluation and follow-up).
- The predominant symptom must be low back pain (and not pain radiating to the extremities).
- Patients who sign the informed consent form
Who cannot join
- Patients who have previously undergone lumbar arthrodesis.
- Patients diagnosed with lumbar instability or non-degenerative pathologies (fractures, tumors, infections, etc.) that justify their chronic low back pain.
- Patients who cannot move independently.
- Patients who have a contraindication to perform light aerobic exercise or physical therapy exercises for the treatment of low back pain.
- Patients with a psychiatric history that interferes with their daily life
- Patients who are possible candidates for low back surgery, with a planned intervention during the study period.
Show all 10Show fewer
- Patients who have a programmed Pain Clinic intervention or extra rehabilitation sessions scheduled during the study period.
- Patients who lack motivation or show no commitment to the program.
- Patients who do not have access to a device with internet connection and/or to a webcam (smartphone, tablet, or computer).
- Note: Since this is a pilot clinical trial with a small sample size, patients who receive extra sessions of rehabilitation or interventions in Pain Clinic will be withdrawn from the study to minimize the impact on the results, although these treatments are also part of the SoC.
Trial locations and contacts
1 site in 1 country.
About this study
Low back pain is a challenging condition, with a lifetime prevalence of up to 84%. The estimated prevalence of chronic non-specific low back pain is of approximately 23%. Although pain is a sensory experience triggered by a peripheral stimulus, psychosocial factors influence on its perception and on the risk of chronification.
Chronic Low Back Pain imposes a substantial socioeconomic burden to patients, families, and healthcare systems worldwide. It is a multifactorial condition, characterized by a combination of physical, psychosocial and occupational factors. We have planned two working hypotheses: (1) coordinating several healthcare professionals is feasible to manage chronic non-specific low back pain through telematics multidisciplinary approach; (2) telematics multidisciplinary approach improves the quality of life of patients with chronic non-specific low back pain and in whom conservative treatment has failed. Hence, we aim to assess the feasibility and effect of telematics multidisciplinary approach in patients suffering from chronic non-specific low back pain and who have not improved with conservative treatment.
Read more
Patients will be randomized to the telematics multidisciplinary approach (Experimental Group) or to the Standard of Care (Control Group). Scheduled and periodic telematics multidisciplinary sessions will be performed. Each session will consist of an integrated program that combines rehabilitation (i.e., group-based exercise program), psychological treatment and social work sessions. Standard of Care, after conservative treatment failure, depends mainly on the physician in charge's discretion and on the patients' preferences. An exploratory analysis will be performed.
The results of this clinical trial will provide evidence that a scheduled telematics multidisciplinary approach will improve the quality of life of these patients and empower them to be more autonomous. Likewise, telematics multidisciplinary approach is feasible to manage chronic non-specific low back pain in patients unresponsive to conservative treatment. Consequently, these patients are less likely to wander through different medical specialties seeking for a solution to their condition, presumably avoiding ineffective back surgeries. The results will also highlight the importance of patients playing an active role in their own treatment to successfully manage chronic non-specific low back pain.
Read the detailed description
Objectives {#7}:
Hypothesis:
Two working hypothesis have been planned: i) the coordination of several health care professionals is feasible to manage CnsLBP (Chronic non-specific Low Back Pain) through telematics multidisciplinary approach; ii) telematics multidisciplinary approach improves the quality of life of patients who suffer from CnsLBP and in whom conservative treatment has failed
Primary Objective The primary aims are to assess the feasibility and effect of the telematics multidisciplinary approach in patients who suffer from non-specific CnsLBP and in whom conservative treatment has failed.
Secondary objectives
The secondary objectives are:
- to quantify the desertion rate
- to study the level of usual physical activity
- to quantify disability due to CnsLBP
- to study anxiety and depression
- to assess chronic pain coping strategies
- to study self-awareness and emotional self-regulation
- to evaluate perceived social support
- to estimate mental well-being
Trial Design {#8}:
This is an open-label, randomized, controlled, parallel-group, pilot clinical trial. Patients will be randomized to the telematic multidisciplinary biopsychosocial approach (Experimental Group) or to the Standard of Care (Control Group).
This pilot clinical trial will provide evidence on the feasibility of the coordination of several health care professionals to manage CnsLBP through telematics multidisciplinary approach; and it will provide the first evidence on the impact of the telematics multidisciplinary approach on the QoL of these patients.
The target population will be patients with CnsLBP who have already undergone rehabilitation and pain clinic therapy and are still in pain and seeking for a solution (i.e., patients on a waiting list to see a spine surgeon for surgical assessment, patients who might be candidates to lumbar surgery depending on their evolution, patients being followed up by a Pain Clinic specialist or by their assigned General Practitioner specialist). If during the trial it is decided to perform a lumbar surgical intervention on an included patient, he/she will be automatically excluded from the trial.
Methods: Participants, Interventions and Outcomes
Study Setting {#9}:
This trial will be carried out in the premises of the Bellvitge University Hospital (a tertiary hospital), the Viladecans Hospital (a secondary hospital) and primary care centers: Delta del Llobregat Primary Care Center, L'Hospitalet de Llobregat Mental Health Unit, Santa Eulalia Primary Care Center.
- Conditions
- Low Back Pain
- Being tested
- physical rehabilitation/physiotherapy and psychosocial group sessions
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical rehabilitation/physiotherapy and psychosocial group sessionsBehavioural
physical rehabilitation/physiotherapy and psychosocial group sessions
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The experimental group is based on a telematic multidisciplinary approach for CnsLBP. Scheduled and periodic telematic sessions will be performed. The multidisciplinary approach (to be carried out by telematic means) consists of a biopsychosocial rehabilitation program for patients with CnsLBP that includes physical rehabilitation/physiotherapy and psychosocial group sessions (performed by psychologists, social workers), which will be offered as part of the integrated program.
Patients assigned to the experimental group will receive a Google Meet® link by email, so that they may join the weekly 2-hour group sessions (every Tuesday at 9 a.m.). Google Meet® is a free real-time meeting app by Google that does not require download, has no session time limit, and neither limits the number of users per session. Patients assigned to the experimental group will receive a single-use link by email to access each online group session. Receives: Behavioral: physical rehabilitation/physiotherapy and psychosocial group sessions |
| Control | No intervention | Explanation for choice of comparators {6b} The telematics multidisciplinary approach (experimental group) will be compared to Standard of Care (SoC) (control group). SoC consists of a patient's follow up according to the usual clinical practice. In Bellvitge University Hospital's setting, the treatment protocol for CnsLBP indicates physical rehabilitation/physiotherapy as the first treatment step, and Pain Clinic evaluation as a second step for those who did not improve. For patients who did not improve with the previous steps and that still demand a solution for their CnsLBP, a third step would be to refer the patient for surgical evaluation - a spine surgeon would, then, evaluate, alongside with the patient, whether a surgical approach would be appropriate for his/her case. If the surgery is ruled out by the spine surgeon, the patient may be referred, once more, to physical rehabilitation/physiotherapy and/or to the Pain Clinic, at the surgeon's discretion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sessions performed out of the 8 sessions scheduled
number of telematics multidisciplinary sessions performed out of the 8 sessions scheduled acording the study protocol
Measured: 6 months
Number of scheduled visits attended
Number of visits attended by the patients out of the total of scheduled visits
Measured: 6 months
Number of questionnaires fulfilled
Number of questionnaires fulfilled by the patients out of the total scheduled questionnaires
Measured: 6 months
Number of telematics multidisciplinary sessions attended
Number of telematics multidisciplinary sessions attended by the patients out of the total scheduled sessions
Measured: 6 months
Number of withdrawals
Number of withdrawals out of the total patients enrolled in the study
Measured: 6 months
Secondary outcomes (1)
SF-36 (Short Form-36) total punctuation
Quality of Life will be assessed by the SF-36 questionnaire.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Low 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iago Garreta Catala, Hospital Universitari de Bellvitge
- Investigators
- Iago Garreta-Catala, MD, Principal investigator, Orthopaedics Attending physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093543
- Sponsor's protocol ID
- HUB-COT-ENFORMA-2021
- Status last verified
- Mar 2023
- First submitted
- 5 May 2021
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.
PubMed 29480409Latremoliere A, Woolf CJ. Central sensitization: a generator of pain hypersensitivity by central neural plasticity. J Pain. 2009 Sep;10(9):895-926. doi: 10.1016/j.jpain.2009.06.012.
PubMed 19712899Searle A, Spink M, Ho A, Chuter V. Exercise interventions for the treatment of chronic low back pain: a systematic review and meta-analysis of randomised controlled trials. Clin Rehabil. 2015 Dec;29(12):1155-67. doi: 10.1177/0269215515570379. Epub 2015 Feb 13.
PubMed 25681408Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
PubMed 16550448Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.
PubMed 26487293Balague 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 21982256Garreta-Catala I, Planas-Balague R, Abouzari R, Carnaval T, Nolla JM, Videla S, Agullo-Ferre JL; EN-FORMA study group. Feasibility of a multidisciplinary group videoconferencing approach for chronic low back pain: a randomized, open-label, controlled, pilot clinical trial (EN-FORMA). BMC Musculoskelet Disord. 2023 Aug 9;24(1):642. doi: 10.1186/s12891-023-06763-6.
PubMed 37558990
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effect of a Multidisciplinary Telematics Approach for Chronic Non-specific Low Back Pain: a Randomized, Open-label, Controlled, Pilot Clinical Trial. Study Protocol
- ClinicalTrials.gov ID
- NCT05093543
- Acronym / sponsor ID
- HUB-COT-ENFORMA-2021
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 26 Oct 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.
Low back pain is a challenging condition, with a lifetime prevalence of up to 84%. The estimated prevalence of chronic non-specific low back pain is of approximately 23%. Although pain is a sensory experience triggered by a peripheral stimulus, psychosocial factors influence on its perception and on the risk of chronification.
Chronic Low Back Pain imposes a substantial socioeconomic burden to patients, families, and healthcare systems worldwide. It is a multifactorial condition, characterized by a combination of physical, psychosocial and occupational factors. We have planned two working hypotheses: (1) coordinating several healthcare professionals is feasible to manage chronic non-specific low back pain through telematics multidisciplinary approach; (2) telematics multidisciplinary approach improves the quality of life of patients with chronic non-specific low back pain and in whom conservative treatment has failed. Hence, we aim to assess the feasibility and effect of telematics multidisciplinary approach in patients suffering from chronic non-specific low back pain and who have not improved with conservative treatment.
Patients will be randomized to the telematics multidisciplinary approach (Experimental Group) or to the Standard of Care (Control Group). Scheduled and periodic telematics multidisciplinary sessions will be performed. Each session will consist of an integrated program that combines rehabilitation (i.e., group-based exercise program), psychological treatment and social work sessions. Standard of Care, after conservative treatment failure, depends mainly on the physician in charge's discretion and on the patients' preferences. An exploratory analysis will be performed.
The results of this clinical trial will provide evidence that a scheduled telematics multidisciplinary approach will improve the quality of life of these patients and empower them to be more autonomous. Likewise, telematics multidisciplinary approach is feasible to manage chronic non-specific low back pain in patients unresponsive to conservative treatment. Consequently, these patients are less likely to wander through different medical specialties seeking for a solution to their condition, presumably avoiding ineffective back surgeries. The results will also highlight the importance of patients playing an active role in their own treatment to successfully manage chronic non-specific low back pain.
Detailed description
Objectives {#7}:
Hypothesis:
Two working hypothesis have been planned: i) the coordination of several health care professionals is feasible to manage CnsLBP (Chronic non-specific Low Back Pain) through telematics multidisciplinary approach; ii) telematics multidisciplinary approach improves the quality of life of patients who suffer from CnsLBP and in whom conservative treatment has failed
Primary Objective The primary aims are to assess the feasibility and effect of the telematics multidisciplinary approach in patients who suffer from non-specific CnsLBP and in whom conservative treatment has failed.
Secondary objectives
The secondary objectives are:
- to quantify the desertion rate
- to study the level of usual physical activity
- to quantify disability due to CnsLBP
- to study anxiety and depression
- to assess chronic pain coping strategies
- to study self-awareness and emotional self-regulation
- to evaluate perceived social support
- to estimate mental well-being
Trial Design {#8}:
This is an open-label, randomized, controlled, parallel-group, pilot clinical trial. Patients will be randomized to the telematic multidisciplinary biopsychosocial approach (Experimental Group) or to the Standard of Care (Control Group).
This pilot clinical trial will provide evidence on the feasibility of the coordination of several health care professionals to manage CnsLBP through telematics multidisciplinary approach; and it will provide the first evidence on the impact of the telematics multidisciplinary approach on the QoL of these patients.
The target population will be patients with CnsLBP who have already undergone rehabilitation and pain clinic therapy and are still in pain and seeking for a solution (i.e., patients on a waiting list to see a spine surgeon for surgical assessment, patients who might be candidates to lumbar surgery depending on their evolution, patients being followed up by a Pain Clinic specialist or by their assigned General Practitioner specialist). If during the trial it is decided to perform a lumbar surgical intervention on an included patient, he/she will be automatically excluded from the trial.
Methods: Participants, Interventions and Outcomes
Study Setting {#9}:
This trial will be carried out in the premises of the Bellvitge University Hospital (a tertiary hospital), the Viladecans Hospital (a secondary hospital) and primary care centers: Delta del Llobregat Primary Care Center, L'Hospitalet de Llobregat Mental Health Unit, Santa Eulalia Primary Care Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: physical rehabilitation/physiotherapy and psychosocial group sessionsThe experimental group is based on a telematic multidisciplinary approach for CnsLBP. Scheduled and periodic telematic sessions will be performed. The multidisciplinary approach (to be carried out by telematic means) consists of a biopsychosocial rehabilitation program for patients with CnsLBP that includes physical rehabilitation/physiotherapy and psychosocial group sessions (performed by psychologists, social workers), which will be offered as part of the integrated program. Patients assigned to the experimental group will receive a Google Meet® link by email, so that they may join the weekly 2-hour group sessions (every Tuesday at 9 a.m.). Google Meet® is a free real-time meeting app by Google that does not require download, has no session time limit, and neither limits the number of users per session. Patients assigned to the experimental group will receive a single-use link by email to access each online group session. |
| Control | No intervention | –Explanation for choice of comparators {6b} The telematics multidisciplinary approach (experimental group) will be compared to Standard of Care (SoC) (control group). SoC consists of a patient's follow up according to the usual clinical practice. In Bellvitge University Hospital's setting, the treatment protocol for CnsLBP indicates physical rehabilitation/physiotherapy as the first treatment step, and Pain Clinic evaluation as a second step for those who did not improve. For patients who did not improve with the previous steps and that still demand a solution for their CnsLBP, a third step would be to refer the patient for surgical evaluation - a spine surgeon would, then, evaluate, alongside with the patient, whether a surgical approach would be appropriate for his/her case. If the surgery is ruled out by the spine surgeon, the patient may be referred, once more, to physical rehabilitation/physiotherapy and/or to the Pain Clinic, at the surgeon's discretion. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients between 18 and 67 years of age (i.e., working age population).
- Both genders.
- Patients with chronic non-specific low back pain that does not improve with conservative treatment (including rehabilitation and Pain Clinic evaluation and follow-up).
- The predominant symptom must be low back pain (and not pain radiating to the extremities).
- Patients who sign the informed consent form
Key exclusion criteria (10 listed)
- Patients who have previously undergone lumbar arthrodesis.
- Patients diagnosed with lumbar instability or non-degenerative pathologies (fractures, tumors, infections, etc.) that justify their chronic low back pain.
- Patients who cannot move independently.
- Patients who have a contraindication to perform light aerobic exercise or physical therapy exercises for the treatment of low back pain.
- Patients with a psychiatric history that interferes with their daily life
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 |
|---|---|---|
| physical rehabilitation/physiotherapy and psychosocial group sessionsphysical rehabilitation/physiotherapy and psychosocial group sessions | Behavioural | Intervention |
Primary outcome
Number of sessions performed out of the 8 sessions scheduled
Time frame: 6 months
number of telematics multidisciplinary sessions performed out of the 8 sessions scheduled acording the study protocol
Number of scheduled visits attended
Time frame: 6 months
Number of visits attended by the patients out of the total of scheduled visits
Number of questionnaires fulfilled
Time frame: 6 months
Number of questionnaires fulfilled by the patients out of the total scheduled questionnaires
Number of telematics multidisciplinary sessions attended
Time frame: 6 months
Number of telematics multidisciplinary sessions attended by the patients out of the total scheduled sessions
Number of withdrawals
Time frame: 6 months
Number of withdrawals out of the total patients enrolled in the study
1 secondary outcome
SF-36 (Short Form-36) total punctuation
Time frame: 6 months
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 3 Mar 2023.
- Results publication: PubMed 29480409Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.
- Results publication: PubMed 19712899Latremoliere A, Woolf CJ. Central sensitization: a generator of pain hypersensitivity by central neural plasticity. J Pain. 2009 Sep;10(9):895-926. doi: 10.1016/j.jpain.2009.06.012.
- Results publication: PubMed 25681408Searle A, Spink M, Ho A, Chuter V. Exercise interventions for the treatment of chronic low back pain: a systematic review and meta-analysis of randomised controlled trials. Clin Rehabil. 2015 Dec;29(12):1155-67. doi: 10.1177/0269215515570379. Epub 2015 Feb 13.
- Results publication: PubMed 16550448Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
- Results publication: PubMed 26487293Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.
- Results publication: 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.
- Derived from this study: PubMed 37558990Garreta-Catala I, Planas-Balague R, Abouzari R, Carnaval T, Nolla JM, Videla S, Agullo-Ferre JL; EN-FORMA study group. Feasibility of a multidisciplinary group videoconferencing approach for chronic low back pain: a randomized, open-label, controlled, pilot clinical trial (EN-FORMA). BMC Musculoskelet Disord. 2023 Aug 9;24(1):642. doi: 10.1186/s12891-023-06763-6.
- Individual participant dataSharing planned: No
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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.
Iago Garreta-Catala, MD principal investigator
Orthopaedics Attending physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical rehabilitation/physiotherapy and psychosocial group sessions in people with Low Back Pain, run by Hospital Universitari de Bellvitge 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 5 inclusion and 10 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 3 Mar 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?
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?
Number of sessions performed out of the 8 sessions scheduled (time frame: 6 months). The study lists 5 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 NCT05093543, which also lists 7 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 3 Mar 2023.