Lower Back PainNCT05359640
Invasive Treatment of Lower Back Pain
An observational study of Lower Back Pain, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Lower back pain, especially chronic, is a very complex condition that has different causes. There is no single pathophysiological mechanism that could explain the causes of low back pain. It is defined as non-specific and results in only symptomatic treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- quality of pain
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 Apr 2022to 15 Apr 2022
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with low back pain, scheduled for invasive approach
Who may be able to join
- low back pain
Who cannot join
- under or overage
- pragnancy
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison on Lower Back Pain Treatment: Trigger Bloc vs. Faset Joint Block
Lower back pain, especially chronic, is a very complex condition that has different causes. There is no single pathophysiological mechanism that could explain the causes of low back pain. It is defined as non-specific and results in only symptomatic treatment. The mechanisms of pain overlap and combine with genetic, epigenetic, individual factors and lifestyle. On the other hand, when low back pain has a defined cause, the treatment can be causal.
At the beginning of the treatment of patients with non-specific low back pain, identification of those that would probably need more complex treatment is tried. More complex patients, are also referred to physiotherapy, and those who are more likely to develop chronic back pain, should be also referred to a psychologist.
An important place, to interrupt the back pain cycle has spine blockades, either local, trigger points blockades, or x-ray-guided blockades of facet joints or nerve roots.
Read the detailed description
Lower back pain is one of the most common conditions that lead a person to a doctor. It is defined as pain limited upwards by the lower part of the rib arch and down by the lower gluteal crease. It can spread in the lower limb, but not necessarily. About 7.5% of the world's population suffers from back pain. Most people experience an episode of low back pain at least once in their lives. A survey carried out in 2019 on the incidence of chronic pain in Slovenia ranked lower back pain first, with 63% of respondents describing it.
The prevalence of low back pain is between 21% and 75%. In 60% of these individuals it can lead to a reduction in the quality of life due to functional disability. Since 1990, lower back pain has been the leading cause of disability. Causes may be fractures of the osteoporotic vertebrae, spondyloarthritis, malignancy, infections. In 2019, the group of patients aged 50 to 54 were the most affected. Episodes of acute low back pain are usually transient and short-lived, but pain can persists occasionally in more than half of these patients. In most patients with lumbar back pain, the condition improves significantly within six weeks, 33% patients recover within the first three months and in 65% pain remains present also after 12 months. In 33% of patients, the pain recurs within a year after recovery from the previous episode.
Acute and initial chronic (> 6 months) back pain often occurs in the working active population. In 10 percent of patients, acute back pain, lasting more than 6 months, progresses into chronic. After an initial episode, lower back pain often repeates within 12 months after recovery. Treatment should be bio psycho social from the start. The prevalence of back pain is higher in women compared to men (ratio 1.27). This difference is greater when women reach postmenopausal period. It is gender-related (e.g. hormones, differences in the endogenous opioid system). Socio-economic status (level of education) is associated with recurrence of pain and disability, especially in men. The reasons could be behavioural and environmental risks, the professional status, the accessibility to the health system. The socio-economic situation in childhood is a risk factor for the occurrence of back pain in adulthood.
Lower back pain, especially chronic, is a very complex condition that has different causes. There is no single pathophysiological mechanism that could explain the causes of low back pain. Therefore, despite its frequency, we often do not find an exact cause. In 85 - 95% it is defined as non-specific and results in only symptomatic treatment. The mechanisms ob pain overlap and combine with genetic, epigenetic, individual factors and lifestyle. On the other hand, when low back pain have a defined cause, the treatment can be causal. Specific causes of back pain may be fractures, infection, autoimmune diseases, nerve cramping.
Inflammation, hypersensitivity and altered spine innervation are present. Even if nerve tightness due to hernia disci is not present, changes in peripheral nervous system may occur, which may contribute to the development of back pain. The cause could be inflammation in musculoskeletal structures. Compression and degeneration of intervertebral discs are associated with an increase in inflammatory mediators, increased sensory innervation of the disc and plastic changes in peripheral and spinal sensory neuron. These changes indicate a biological mechanism of pain origin. These patients have altered and increased pain sensitivity. This may be due to peripheral or central sensitisation. Hyperalgesia fluctuates with pain intensity and normalises with pain reduction.
According to the latest classification, low back pain is nociceptive, neuropathic or neuroplastic.
In the first case, the pain is caused by irritation of pain-sensing receptors, and in the second by disease or damage of the somatosensory nervous system. In neuroplastic pain perception to stimuli is changed, the patient describes pain, although no clear cause of it is found. When the neuropathic component is also present, pain is more resistant to treatment, the quality of life is even lower and the cost of treatment is higher.
Treatment should be causal when the cause of pain is known. If the neuropathic component is also present then treatment should follow guidelines for neuropathic pain management.
At the beginning of the treatment of patients with non-specific low back pain, identification of those that would probably need more complex treatment was tried. In simple cases education and low doses of simple analgesics are needed. More complex patients are also referred to physiotherapy, and those who are more likely to develop chronic back pain, should be also referred to a psychologist.
An important place to terminate the back pain cycle has spine blockades, either local, trigger points blockades, or x-ray-guided blockades of facet joints or nerve roots.
The research will be conducted in the Department for Chronic Pain, Clinical Department of Anaesthesiology and Intensive Therapy. Patients with chronic low back pain and/or spinal nerve root impairment, scheduled for invasive treatment, will be included in the study. Trigger points blockade were compared to x-ray-guided blockade of small joints of the spine or nerve roots.
Experts from different medical fields are involved in the treatment of chronic low back pain, as the outcome of treatment depends very much on a multidisciplinary approach. Beside the biological component, pain is also affected by the psychological and social components.
In the present research determination after 1, 3 and 6 months after procedure the difference between the groups in pain intensity and in pain quality was tried. The impact of other factors on chronic pain treatment was also determined.
PROTOCOL
In the control group, local anaesthetic and long-acting corticosteroid will be used for trigger blockade. In the study group, a blockade of the small joints of the spine and/or roots of the spinal nerves under x-ray control will also be performed by a combination of local anaesthetic and a long-acting corticosteroid. In each group, 30 patients, will be randomised. The pain will be recorded by using a short pain questionnaire and a McGill pain questionnaire. The consumption of analgesics, VAS score and improvement of quality of life will be monitored.
DATA GHADERING
Following values will be monitored:
- scoring of a Short pain questionnaire and the McGill Pain Questionnaire T
- Analgesic consumption
- Conditions
- Lower Back Pain
- Being tested
- quality of pain
- 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.
quality of painOther
We will recorded the pain by using a short pain questionnaire and a McGill pain questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| quality of pain | We will recorded the pain by using a short pain questionnaire and a McGill pain questionnaire. Receives: Other: quality of pain | |
| consumption of analgesics | The consumption of analgetics, VAS score and improvement of quality of life will be monitored. Receives: Other: quality of pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
VAS score will be used
Measured: 1 year
Secondary outcomes (2)
improvment of quality of life
McGill pain questionnaire will be used
Measured: 1 year
Pain quality
Short pain questionnaire will be used
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start15 Apr 2022
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasmina Markovic Bozic, University Medical Centre Ljubljana
- Investigators
- Alenka Spindler - Vesel, Principal investigator, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359640
- Sponsor's protocol ID
- 0120-457/2021/7
- Status last verified
- Apr 2023
- First submitted
- 15 Apr 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. de Souza IMB, Sakaguchi TF, Yuan SLK, et al. Prevalence of low back pain in the elderly population: a systematic review. Clinics (Sao Paulo). 2019;74:e789. Published 2019 Oct 28. doi:10.6061/clinics/2019/e789 2. Makris UE, Abrams RC, Gurland B, Reid MC. Management of persistent pain in the older patient: a clinical review. JAMA. 2014;312(8):825-836. doi:10.1001/jama.2014.9405 3. Hartvigsen J, Hancock MJ, Kongsted A, et al. Series Low back pain 1 What low back pain is and why we need to pay attention. Lancet. 2018;391:2356-2367. doi:10.1016/S0140-6736(18)30480-X 4. Itz CJ, Geurts JW, Van Kleef M, Nelemans P. Clinical course of non-specific low back pain: A systematic review of prospective cohort studies set in primary care. Eur J Pain. 2013;17(1):5-15. doi:10.1002/j.1532-2149.2012.00170.x 5. da C Menezes Costa L, Maher C, Hancock M, McAuley J, Herbert R, Costa L. The prognosis of acute and persistent low-back pain: a meta-analysis. CMAJ. 2012;184(11):1229-1230. doi:10.1503/cmaj.120627 6. Da Silva T, Mills K, Brown BT, Herbert RD, Maher CG, Hancock MJ. Risk of recurrence of low back pain: A systematic review. J Orthop Sports Phys Ther. 2017;47(5):305-313. doi:10.2519/jospt.2017.7415 7. Ferguson SA, Merryweather A, Thiese MS, Hegmann KT, Lu ML, Kapellusch JM, Marras WS. Prevalence of low back pain, seeking medical care, and lost time due to low back pain among manual material handling workers in the United States. BMC Musculoskeletal Disorders. 2019;20:243. 8. Hayden JA, Dunn KM, van der Windt DA, Shaw WS. What is the prognosis of back pain? Best Prac Res Clin Rheumatol. 2010;24:167-179. 9. Da Silva T, Mils K, Brown BT, Pocovi N, de Campos T, Maher C, Hancock MJ. Recurrence of low back pain is common: a prospective inception cohort study. J Physiother. 2019;65(3):159-165. 10. Marin TJ, Van Eerd D, Irvin E, Couban R, Koes BW, Malmivaara A, van Tulder MW, Kamper SJ. Multidisciplinary biopsychosocial rehabilitation for subacute low back pain. Cochrane Database Syst Rev. 2017 Jun 28;6(6):CD002193. 11. Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJEM, Ostelo RWJG, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis. BMJ. [7] Dorlin E. L'historicité du sexe. Sexe, genre et sexualités: Presses universitaires de France, 2008. pp. 33-54. 12. Fillingim RB, King CD, Ribeiro-Dasilva MC, Rahim-Williams B, Riley JL, 3rd. Sex, gender, and pain: a review of recent clinical and experimental findings. J Pain 2009;10(5):447-485. 13. Grossschadl F, Stolz E, Mayerl H, Rasky E, Freidl W, Stronegger W. Educational inequality as a predictor of rising back pain prevalence in Austria-sex differences. Eur J Public Health 2016;26(2):248-253. 14. Karran EL, Grant AR, Moseley GL. Low back pain and the social determinants of health: a systematic review and narrative synthesis. Pain 2020;161(11):2476-2493. 15. Lallukka T, Viikari-Juntura E, Raitakari OT, Kahonen M, Lehtimaki T, Viikari J, Solovieva S. Childhood and adult socioeconomic position and social mobility as determinants of low back pain outcomes. Eur J Pain 2014;18(1):128-138. 16. Leresche L. Defining gender disparities in pain management. Clin Orthop Relat Res 2011;469(7):1871-1877. 17. Muthuri SG, Kuh D, Cooper R. Longitudinal profiles of back pain across adulthood and their relationship with childhood factors: evidence from the 1946 British birth cohort. Pain 2018;159(4):764-774. 18. Wang YX, Wang JQ, Kaplar Z. Increased low back pain prevalence in females than in males after menopause age: evidences based on synthetic literature review. Quant Imaging Med Surg 2016;6(2):199-206. 2015;350:h444 19. Wu A, March L, Zheng X, Huang J, Wang X, Zhao J, Blyth FM, Smith E, Buchbinder R, Hoy D. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Ann Trans Med 2020; 8(6): 299-313. 20. Finucane LM, Downie A, Mercer C, Greenhalgh SM, Boissonnault WG, Pool-Goudzwaard AL, Beneciuk JM, Leech RL, Selfe J. International framework for red flags for potential serious spinal pathologies. J Orth Sports Phys Ther 2020; 50(7): 350-372. 21. Global Health Group Data Exchange http://ghdx.healthdata.org/gbd-results-tool accessed Nov 15, 2020).
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison on Lower Back Pain Treatment: Trigger Bloc vs. Faset Joint Block
- ClinicalTrials.gov ID
- NCT05359640
- Acronym / sponsor ID
- 0120-457/2021/7
- Conditions
- Lower Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 4 May 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.
Lower back pain, especially chronic, is a very complex condition that has different causes. There is no single pathophysiological mechanism that could explain the causes of low back pain. It is defined as non-specific and results in only symptomatic treatment. The mechanisms of pain overlap and combine with genetic, epigenetic, individual factors and lifestyle. On the other hand, when low back pain has a defined cause, the treatment can be causal.
At the beginning of the treatment of patients with non-specific low back pain, identification of those that would probably need more complex treatment is tried. More complex patients, are also referred to physiotherapy, and those who are more likely to develop chronic back pain, should be also referred to a psychologist.
An important place, to interrupt the back pain cycle has spine blockades, either local, trigger points blockades, or x-ray-guided blockades of facet joints or nerve roots.
Detailed description
Lower back pain is one of the most common conditions that lead a person to a doctor. It is defined as pain limited upwards by the lower part of the rib arch and down by the lower gluteal crease. It can spread in the lower limb, but not necessarily. About 7.5% of the world's population suffers from back pain. Most people experience an episode of low back pain at least once in their lives. A survey carried out in 2019 on the incidence of chronic pain in Slovenia ranked lower back pain first, with 63% of respondents describing it.
The prevalence of low back pain is between 21% and 75%. In 60% of these individuals it can lead to a reduction in the quality of life due to functional disability. Since 1990, lower back pain has been the leading cause of disability. Causes may be fractures of the osteoporotic vertebrae, spondyloarthritis, malignancy, infections. In 2019, the group of patients aged 50 to 54 were the most affected. Episodes of acute low back pain are usually transient and short-lived, but pain can persists occasionally in more than half of these patients. In most patients with lumbar back pain, the condition improves significantly within six weeks, 33% patients recover within the first three months and in 65% pain remains present also after 12 months. In 33% of patients, the pain recurs within a year after recovery from the previous episode.
Acute and initial chronic (> 6 months) back pain often occurs in the working active population. In 10 percent of patients, acute back pain, lasting more than 6 months, progresses into chronic. After an initial episode, lower back pain often repeates within 12 months after recovery. Treatment should be bio psycho social from the start. The prevalence of back pain is higher in women compared to men (ratio 1.27). This difference is greater when women reach postmenopausal period. It is gender-related (e.g. hormones, differences in the endogenous opioid system). Socio-economic status (level of education) is associated with recurrence of pain and disability, especially in men. The reasons could be behavioural and environmental risks, the professional status, the accessibility to the health system. The socio-economic situation in childhood is a risk factor for the occurrence of back pain in adulthood.
Lower back pain, especially chronic, is a very complex condition that has different causes. There is no single pathophysiological mechanism that could explain the causes of low back pain. Therefore, despite its frequency, we often do not find an exact cause. In 85 - 95% it is defined as non-specific and results in only symptomatic treatment. The mechanisms ob pain overlap and combine with genetic, epigenetic, individual factors and lifestyle. On the other hand, when low back pain have a defined cause, the treatment can be causal. Specific causes of back pain may be fractures, infection, autoimmune diseases, nerve cramping.
Inflammation, hypersensitivity and altered spine innervation are present. Even if nerve tightness due to hernia disci is not present, changes in peripheral nervous system may occur, which may contribute to the development of back pain. The cause could be inflammation in musculoskeletal structures. Compression and degeneration of intervertebral discs are associated with an increase in inflammatory mediators, increased sensory innervation of the disc and plastic changes in peripheral and spinal sensory neuron. These changes indicate a biological mechanism of pain origin. These patients have altered and increased pain sensitivity. This may be due to peripheral or central sensitisation. Hyperalgesia fluctuates with pain intensity and normalises with pain reduction.
According to the latest classification, low back pain is nociceptive, neuropathic or neuroplastic.
In the first case, the pain is caused by irritation of pain-sensing receptors, and in the second by disease or damage of the somatosensory nervous system. In neuroplastic pain perception to stimuli is changed, the patient describes pain, although no clear cause of it is found. When the neuropathic component is also present, pain is more resistant to treatment, the quality of life is even lower and the cost of treatment is higher.
Treatment should be causal when the cause of pain is known. If the neuropathic component is also present then treatment should follow guidelines for neuropathic pain management.
At the beginning of the treatment of patients with non-specific low back pain, identification of those that would probably need more complex treatment was tried. In simple cases education and low doses of simple analgesics are needed. More complex patients are also referred to physiotherapy, and those who are more likely to develop chronic back pain, should be also referred to a psychologist.
An important place to terminate the back pain cycle has spine blockades, either local, trigger points blockades, or x-ray-guided blockades of facet joints or nerve roots.
The research will be conducted in the Department for Chronic Pain, Clinical Department of Anaesthesiology and Intensive Therapy. Patients with chronic low back pain and/or spinal nerve root impairment, scheduled for invasive treatment, will be included in the study. Trigger points blockade were compared to x-ray-guided blockade of small joints of the spine or nerve roots.
Experts from different medical fields are involved in the treatment of chronic low back pain, as the outcome of treatment depends very much on a multidisciplinary approach. Beside the biological component, pain is also affected by the psychological and social components.
In the present research determination after 1, 3 and 6 months after procedure the difference between the groups in pain intensity and in pain quality was tried. The impact of other factors on chronic pain treatment was also determined.
PROTOCOL
In the control group, local anaesthetic and long-acting corticosteroid will be used for trigger blockade. In the study group, a blockade of the small joints of the spine and/or roots of the spinal nerves under x-ray control will also be performed by a combination of local anaesthetic and a long-acting corticosteroid. In each group, 30 patients, will be randomised. The pain will be recorded by using a short pain questionnaire and a McGill pain questionnaire. The consumption of analgesics, VAS score and improvement of quality of life will be monitored.
DATA GHADERING
Following values will be monitored:
- scoring of a Short pain questionnaire and the McGill Pain Questionnaire T
- Analgesic consumption
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| quality of pain | – | Other: quality of painWe will recorded the pain by using a short pain questionnaire and a McGill pain questionnaire. |
| consumption of analgesics | – | Other: quality of painThe consumption of analgetics, VAS score and improvement of quality of life will be monitored. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with low back pain, scheduled for invasive approach
Key inclusion criteria (1 listed)
- low back pain
Key exclusion criteria (3 listed)
- under or overage
- pragnancy
- patient refusal
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 |
|---|---|---|
| quality of painWe will recorded the pain by using a short pain questionnaire and a McGill pain questionnaire. | Other | consumption of analgesics, quality of pain |
Primary outcome
Pain intensity
Time frame: 1 year
VAS score will be used
2 secondary outcomes
improvment of quality of life
Time frame: 1 year
Pain quality
Time frame: 1 year
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 18 Apr 2023.
- Background1. de Souza IMB, Sakaguchi TF, Yuan SLK, et al. Prevalence of low back pain in the elderly population: a systematic review. Clinics (Sao Paulo). 2019;74:e789. Published 2019 Oct 28. doi:10.6061/clinics/2019/e789 2. Makris UE, Abrams RC, Gurland B, Reid MC. Management of persistent pain in the older patient: a clinical review. JAMA. 2014;312(8):825-836. doi:10.1001/jama.2014.9405 3. Hartvigsen J, Hancock MJ, Kongsted A, et al. Series Low back pain 1 What low back pain is and why we need to pay attention. Lancet. 2018;391:2356-2367. doi:10.1016/S0140-6736(18)30480-X 4. Itz CJ, Geurts JW, Van Kleef M, Nelemans P. Clinical course of non-specific low back pain: A systematic review of prospective cohort studies set in primary care. Eur J Pain. 2013;17(1):5-15. doi:10.1002/j.1532-2149.2012.00170.x 5. da C Menezes Costa L, Maher C, Hancock M, McAuley J, Herbert R, Costa L. The prognosis of acute and persistent low-back pain: a meta-analysis. CMAJ. 2012;184(11):1229-1230. doi:10.1503/cmaj.120627 6. Da Silva T, Mills K, Brown BT, Herbert RD, Maher CG, Hancock MJ. Risk of recurrence of low back pain: A systematic review. J Orthop Sports Phys Ther. 2017;47(5):305-313. doi:10.2519/jospt.2017.7415 7. Ferguson SA, Merryweather A, Thiese MS, Hegmann KT, Lu ML, Kapellusch JM, Marras WS. Prevalence of low back pain, seeking medical care, and lost time due to low back pain among manual material handling workers in the United States. BMC Musculoskeletal Disorders. 2019;20:243. 8. Hayden JA, Dunn KM, van der Windt DA, Shaw WS. What is the prognosis of back pain? Best Prac Res Clin Rheumatol. 2010;24:167-179. 9. Da Silva T, Mils K, Brown BT, Pocovi N, de Campos T, Maher C, Hancock MJ. Recurrence of low back pain is common: a prospective inception cohort study. J Physiother. 2019;65(3):159-165. 10. Marin TJ, Van Eerd D, Irvin E, Couban R, Koes BW, Malmivaara A, van Tulder MW, Kamper SJ. Multidisciplinary biopsychosocial rehabilitation for subacute low back pain. Cochrane Database Syst Rev. 2017 Jun 28;6(6):CD002193. 11. Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJEM, Ostelo RWJG, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis. BMJ. [7] Dorlin E. L'historicité du sexe. Sexe, genre et sexualités: Presses universitaires de France, 2008. pp. 33-54. 12. Fillingim RB, King CD, Ribeiro-Dasilva MC, Rahim-Williams B, Riley JL, 3rd. Sex, gender, and pain: a review of recent clinical and experimental findings. J Pain 2009;10(5):447-485. 13. Grossschadl F, Stolz E, Mayerl H, Rasky E, Freidl W, Stronegger W. Educational inequality as a predictor of rising back pain prevalence in Austria-sex differences. Eur J Public Health 2016;26(2):248-253. 14. Karran EL, Grant AR, Moseley GL. Low back pain and the social determinants of health: a systematic review and narrative synthesis. Pain 2020;161(11):2476-2493. 15. Lallukka T, Viikari-Juntura E, Raitakari OT, Kahonen M, Lehtimaki T, Viikari J, Solovieva S. Childhood and adult socioeconomic position and social mobility as determinants of low back pain outcomes. Eur J Pain 2014;18(1):128-138. 16. Leresche L. Defining gender disparities in pain management. Clin Orthop Relat Res 2011;469(7):1871-1877. 17. Muthuri SG, Kuh D, Cooper R. Longitudinal profiles of back pain across adulthood and their relationship with childhood factors: evidence from the 1946 British birth cohort. Pain 2018;159(4):764-774. 18. Wang YX, Wang JQ, Kaplar Z. Increased low back pain prevalence in females than in males after menopause age: evidences based on synthetic literature review. Quant Imaging Med Surg 2016;6(2):199-206. 2015;350:h444 19. Wu A, March L, Zheng X, Huang J, Wang X, Zhao J, Blyth FM, Smith E, Buchbinder R, Hoy D. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Ann Trans Med 2020; 8(6): 299-313. 20. Finucane LM, Downie A, Mercer C, Greenhalgh SM, Boissonnault WG, Pool-Goudzwaard AL, Beneciuk JM, Leech RL, Selfe J. International framework for red flags for potential serious spinal pathologies. J Orth Sports Phys Ther 2020; 50(7): 350-372. 21. Global Health Group Data Exchange http://ghdx.healthdata.org/gbd-results-tool accessed Nov 15, 2020).
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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.
Alenka Spindler - Vesel principal investigator
UMC Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Back Pain, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 1 inclusion and 3 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 18 Apr 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 Slovenia. 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?
Pain intensity (time frame: 1 year). 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 NCT05359640, which also lists 1 linked publication.
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 18 Apr 2023.