Low Back PainNCT04685837
New Technologies in the Management of Lumbopelvic Pain
A study testing therapeutic exercise in people with Low Back Pain and Rehabilitation, run by Alexander Achalandabaso at 1 site in Spain.
Trial summary
Lumbopelvic pain represents one of the leading causes of disability and pain in the world population. It is estimated that 84% of the world's population will suffer from lumbar pelvic pain in their lifetime. This high prevalence causes it to be classified as a public health problem. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Rehabilitation, Exercise
- What is being tested?
- therapeutic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 21 Dec 2020to 15 Jun 2021
- 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
- Age between 18-65 years.
- Non-specific low back pain less than 12 weeks of evolution.
- Knowledge of new information and communication technologies.
- Internet access.
Who cannot join
- Inflammatory pathologies of the locomotor system.
- Infectious processes.
- Oncological processes.
- Neurodegenerative diseases.
- Pain with neuropathic characteristics.
- Fractures.
- Lack of fluency in Spanish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tele-rehabilitation Versus Face-to-face in the Approach to Non-specific Subacute Low Back Pain
Lumbopelvic pain represents one of the leading causes of disability and pain in the world population. It is estimated that 84% of the world's population will suffer from lumbar pelvic pain in their lifetime. This high prevalence causes it to be classified as a public health problem.
Traditional primary care measures have failed to reduce the prevalence, recurrences and costs of this pathology. In the search for treatments focused on reducing public spending, the concept of tele-rehabilitation appears. It is a tool, via telematics, that provides knowledge on rehabilitation and education in neurobiology of pain, demonstrated in cardiovascular and respiratory diseases. It has been suggested that the use of this instrument could help improve the patient's quality of life at the biopsychosocial level.
- Conditions
- Low Back Pain, Rehabilitation, Exercise
- Being tested
- therapeutic exercise
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic exerciseOther
As soon as the study investigators have obtained a significant sample of patients with non-specific sub-acute low back pain, the intervention will begin.
The principal investigator will perform an individual assessment of the patients. At the end of the assessment, he will randomly distribute them into two groups. Tele-rehabilitation group and face-to-face group.
On the one hand, the main researcher will explain the application works to the tele-rehabilitation group. For 8 weeks, they have to perform 2 therapy exercise training sessions following the instructions on the application.
On the other hand, the researcher will explain the protocol to be followed by the group face to face. In addition, he will provide a schedule to follow a correct development of the protocol. Like the tele-rehabilitation group, they will carry out 16 sessions over 8 weeks.
At the end of the protocol, the principal investigator will perform an individualized assessment of each of the study participants.
| Study group | Role | What they receive |
|---|---|---|
| Tele-rehabilitation group | Experimental | The participants randomly assigned to the tele-rehabilitation group will use a computer application to know and execute the exercise protocol. Before starting the protocol, each participant will be assessed by the principal investigator. He will explain how the application works. They will perform 2 sessions of therapeutic exercise for 8 weeks. At the end of the protocol, they will be re-evaluated by the principal investigator. Receives: Other: therapeutic exercise |
| Face to face group | Experimental | Participants randomly assigned to the face-to-face group will use the physical therapy clinic to do the exercises controlled by the principal investigator. Before starting the protocol, each participant will be assessed by the principal investigator. He will explain how the protocol works. They will perform 2 sessions of therapeutic exercise for 8 weeks. At the end of the protocol, they will be re-evaluated by the principal investigator. Receives: Other: therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life
Using the SF-12 Questionnaire
Measured: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Secondary outcomes (12)
Change in Pain perception
Using the Visual Analog Scale (VAS) from 0 to 10
Measured: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Disability
Using the Oswestry Disability Questionnaire
Measured: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Physical Activity
Using the Baecke Physical Activity Questionnaire
Measured: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Kinesiophobia
Using the Tampa Kinesiophobia Scale (TSK-11) form 11 to 44
Measured: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Sleep Quality
Using the Pittsburgh Sleep Quality Index
Measured: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Catastrophism
Using the Pain catastrophizing scale from 0 to 56
Measured: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Lumbar motor control
Using the Rocking backward test.
Measured: Baseline, 2 months (primary timepoint).
Change in Lumbar motor control
Using the knee extended test.
Measured: Baseline, 2 months (primary timepoint).
Change in Intramuscular contraction capacity erector muscles
Using the Double straight-leg raise test.
Measured: Baseline, 2 months (primary timepoint).
Change in Intramuscular contraction capacity erector muscles
Using the Ito test.
Measured: Baseline, 2 months (primary timepoint).
Change in Intramuscular contraction capacity hip flexor muscles
Using the Hip flexion test supine position and sitting position
Measured: Baseline, 2 months (primary timepoint).
Change in Intramuscular contraction capacity extensor flexor muscles
Using the Hip extension test prone position
Measured: Baseline, 2 months (primary timepoint).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start21 Dec 2020
- Primary completion15 Apr 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexander Achalandabaso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexander Achalandabaso, University of Jaén
- Investigators
- Francisco Villatoro, Principal investigator, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685837
- Sponsor's protocol ID
- CEID/HU/2020/48
- Status last verified
- Jul 2021
- First submitted
- 17 Dec 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waddell G, Burton AK. Concepts of rehabilitation for the management of low back pain. Best Pract Res Clin Rheumatol. 2005 Aug;19(4):655-70. doi: 10.1016/j.berh.2005.03.008.
PubMed 15949782Macedo LG, Maher CG, Hancock MJ, Kamper SJ, McAuley JH, Stanton TR, Stafford R, Hodges PW. Predicting response to motor control exercises and graded activity for patients with low back pain: preplanned secondary analysis of a randomized controlled trial. Phys Ther. 2014 Nov;94(11):1543-54. doi: 10.2522/ptj.20140014. Epub 2014 Jul 10.
PubMed 25013000Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.
PubMed 16034851Truter P, Russell T, Fary R. The validity of physical therapy assessment of low back pain via telerehabilitation in a clinical setting. Telemed J E Health. 2014 Feb;20(2):161-7. doi: 10.1089/tmj.2013.0088. Epub 2013 Nov 27.
PubMed 24283249Dario AB, Moreti Cabral A, Almeida L, Ferreira ML, Refshauge K, Simic M, Pappas E, Ferreira PH. Effectiveness of telehealth-based interventions in the management of non-specific low back pain: a systematic review with meta-analysis. Spine J. 2017 Sep;17(9):1342-1351. doi: 10.1016/j.spinee.2017.04.008. Epub 2017 Apr 13.
PubMed 28412562Palacin-Marin F, Esteban-Moreno B, Olea N, Herrera-Viedma E, Arroyo-Morales M. Agreement between telerehabilitation and face-to-face clinical outcome assessments for low back pain in primary care. Spine (Phila Pa 1976). 2013 May 15;38(11):947-52. doi: 10.1097/BRS.0b013e318281a36c.
PubMed 23238489Mbada CE, Olaoye MI, Dada OO, Ayanniyi O, Johnson OE, Odole AC, Ishaya GP, Omole OJ, Makinde MO. Comparative Efficacy of Clinic-Based and Telerehabilitation Application of Mckenzie Therapy in Chronic Low-Back Pain. Int J Telerehabil. 2019 Jun 12;11(1):41-58. doi: 10.5195/ijt.2019.6260. eCollection 2019 Spring.
PubMed 31341546del Pozo-Cruz B, Gusi N, del Pozo-Cruz J, Adsuar JC, Hernandez-Mocholi M, Parraca JA. Clinical effects of a nine-month web-based intervention in subacute non-specific low back pain patients: a randomized controlled trial. Clin Rehabil. 2013 Jan;27(1):28-39. doi: 10.1177/0269215512444632. Epub 2012 May 31.
PubMed 22653374Peterson S, Kuntz C, Roush J. Use of a modified treatment-based classification system for subgrouping patients with low back pain: Agreement between telerehabilitation and face-to-face assessments. Physiother Theory Pract. 2019 Nov;35(11):1078-1086. doi: 10.1080/09593985.2018.1470210. Epub 2018 May 3.
PubMed 29723124Vilagut G, Valderas JM, Ferrer M, Garin O, Lopez-Garcia E, Alonso J. [Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components]. Med Clin (Barc). 2008 May 24;130(19):726-35. doi: 10.1157/13121076. Spanish.
PubMed 18570798Cuesta Vargas AI, Rodríguez Moya A. Frecuencia de uso de escalas de dolor, incapacidad fisica y calidad de vida en el estudio de lumbalgia con intervenciones fisioterápicas. Fisioterapia 2008; 30(4), 204-208.
Flórez García MT, García Pérez MA, García Pérez F, et al. Adaptación transcultural a la población española de la escala de incapacidad por dolor lumbar de Oswestry. Rehab (Madr). 1995; 29:138-45.
Gomez-Perez L, Lopez-Martinez AE, Ruiz-Parraga GT. Psychometric Properties of the Spanish Version of the Tampa Scale for Kinesiophobia (TSK). J Pain. 2011 Apr;12(4):425-35. doi: 10.1016/j.jpain.2010.08.004.
PubMed 20926355Hita-Contreras F, Martinez-Lopez E, Latorre-Roman PA, Garrido F, Santos MA, Martinez-Amat A. Reliability and validity of the Spanish version of the Pittsburgh Sleep Quality Index (PSQI) in patients with fibromyalgia. Rheumatol Int. 2014 Jul;34(7):929-36. doi: 10.1007/s00296-014-2960-z. Epub 2014 Feb 8.
PubMed 24509897
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-rehabilitation Versus Face-to-face in the Approach to Non-specific Subacute Low Back Pain
- ClinicalTrials.gov ID
- NCT04685837
- Acronym / sponsor ID
- CEID/HU/2020/48
- Conditions
- Low Back Pain, Rehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Alexander AchalandabasoUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 28 Dec 2020 (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.
Lumbopelvic pain represents one of the leading causes of disability and pain in the world population. It is estimated that 84% of the world's population will suffer from lumbar pelvic pain in their lifetime. This high prevalence causes it to be classified as a public health problem.
Traditional primary care measures have failed to reduce the prevalence, recurrences and costs of this pathology. In the search for treatments focused on reducing public spending, the concept of tele-rehabilitation appears. It is a tool, via telematics, that provides knowledge on rehabilitation and education in neurobiology of pain, demonstrated in cardiovascular and respiratory diseases. It has been suggested that the use of this instrument could help improve the patient's quality of life at the biopsychosocial level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-rehabilitation group | Experimental | Other: therapeutic exerciseThe participants randomly assigned to the tele-rehabilitation group will use a computer application to know and execute the exercise protocol. Before starting the protocol, each participant will be assessed by the principal investigator. He will explain how the application works. They will perform 2 sessions of therapeutic exercise for 8 weeks. At the end of the protocol, they will be re-evaluated by the principal investigator. |
| Face to face group | Experimental | Other: therapeutic exerciseParticipants randomly assigned to the face-to-face group will use the physical therapy clinic to do the exercises controlled by the principal investigator. Before starting the protocol, each participant will be assessed by the principal investigator. He will explain how the protocol works. They will perform 2 sessions of therapeutic exercise for 8 weeks. At the end of the protocol, they will be re-evaluated by the principal investigator. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18-65 years.
- Non-specific low back pain less than 12 weeks of evolution.
- Knowledge of new information and communication technologies.
- Internet access.
Key exclusion criteria (7 listed)
- Inflammatory pathologies of the locomotor system.
- Infectious processes.
- Oncological processes.
- Neurodegenerative diseases.
- Pain with neuropathic characteristics.
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 exerciseAs soon as the study investigators have obtained a significant sample of patients with non-specific sub-acute low back pain, the intervention will begin. The principal investigator will perform an individual assessment of the patients. At the end of the assessment, he will randomly distribute them into two groups. Tele-rehabilitation group and face-to-face group. On the one hand, the main researcher will explain the application works to the tele-rehabilitation group. For 8 weeks, they have to perform 2 therapy exercise training sessions following the instructions on the application. On the other hand, the researcher will explain the protocol to be followed by the group face to face. In addition, he will provide a schedule to follow a correct development of the protocol. Like the tele-rehabilitation group, they will carry out 16 sessions over 8 weeks. At the end of the protocol, the principal investigator will perform an individualized assessment of each of the study participants. | Other | Face to face group, Tele-rehabilitation group |
Primary outcome
Change in Quality of Life
Time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Using the SF-12 Questionnaire
12 secondary outcomes
Change in Pain perception
Time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Disability
Time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Physical Activity
Time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Kinesiophobia
Time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Sleep Quality
Time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Catastrophism
Time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.
Change in Lumbar motor control
Time frame: Baseline, 2 months (primary timepoint).
Change in Lumbar motor control
Time frame: Baseline, 2 months (primary timepoint).
Change in Intramuscular contraction capacity erector muscles
Time frame: Baseline, 2 months (primary timepoint).
Change in Intramuscular contraction capacity erector muscles
Time frame: Baseline, 2 months (primary timepoint).
Change in Intramuscular contraction capacity hip flexor muscles
Time frame: Baseline, 2 months (primary timepoint).
Change in Intramuscular contraction capacity extensor flexor muscles
Time frame: Baseline, 2 months (primary timepoint).
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 21 Jul 2021.
- Background: PubMed 15949782Waddell G, Burton AK. Concepts of rehabilitation for the management of low back pain. Best Pract Res Clin Rheumatol. 2005 Aug;19(4):655-70. doi: 10.1016/j.berh.2005.03.008.
- Background: PubMed 25013000Macedo LG, Maher CG, Hancock MJ, Kamper SJ, McAuley JH, Stanton TR, Stafford R, Hodges PW. Predicting response to motor control exercises and graded activity for patients with low back pain: preplanned secondary analysis of a randomized controlled trial. Phys Ther. 2014 Nov;94(11):1543-54. doi: 10.2522/ptj.20140014. Epub 2014 Jul 10.
- Background: PubMed 16034851Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD000335. doi: 10.1002/14651858.CD000335.pub2.
- Background: PubMed 24283249Truter P, Russell T, Fary R. The validity of physical therapy assessment of low back pain via telerehabilitation in a clinical setting. Telemed J E Health. 2014 Feb;20(2):161-7. doi: 10.1089/tmj.2013.0088. Epub 2013 Nov 27.
- Background: PubMed 28412562Dario AB, Moreti Cabral A, Almeida L, Ferreira ML, Refshauge K, Simic M, Pappas E, Ferreira PH. Effectiveness of telehealth-based interventions in the management of non-specific low back pain: a systematic review with meta-analysis. Spine J. 2017 Sep;17(9):1342-1351. doi: 10.1016/j.spinee.2017.04.008. Epub 2017 Apr 13.
- Background: PubMed 23238489Palacin-Marin F, Esteban-Moreno B, Olea N, Herrera-Viedma E, Arroyo-Morales M. Agreement between telerehabilitation and face-to-face clinical outcome assessments for low back pain in primary care. Spine (Phila Pa 1976). 2013 May 15;38(11):947-52. doi: 10.1097/BRS.0b013e318281a36c.
- Background: PubMed 31341546Mbada CE, Olaoye MI, Dada OO, Ayanniyi O, Johnson OE, Odole AC, Ishaya GP, Omole OJ, Makinde MO. Comparative Efficacy of Clinic-Based and Telerehabilitation Application of Mckenzie Therapy in Chronic Low-Back Pain. Int J Telerehabil. 2019 Jun 12;11(1):41-58. doi: 10.5195/ijt.2019.6260. eCollection 2019 Spring.
- Background: PubMed 22653374del Pozo-Cruz B, Gusi N, del Pozo-Cruz J, Adsuar JC, Hernandez-Mocholi M, Parraca JA. Clinical effects of a nine-month web-based intervention in subacute non-specific low back pain patients: a randomized controlled trial. Clin Rehabil. 2013 Jan;27(1):28-39. doi: 10.1177/0269215512444632. Epub 2012 May 31.
- Background: PubMed 29723124Peterson S, Kuntz C, Roush J. Use of a modified treatment-based classification system for subgrouping patients with low back pain: Agreement between telerehabilitation and face-to-face assessments. Physiother Theory Pract. 2019 Nov;35(11):1078-1086. doi: 10.1080/09593985.2018.1470210. Epub 2018 May 3.
- Background: PubMed 18570798Vilagut G, Valderas JM, Ferrer M, Garin O, Lopez-Garcia E, Alonso J. [Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components]. Med Clin (Barc). 2008 May 24;130(19):726-35. doi: 10.1157/13121076. Spanish.
- BackgroundCuesta Vargas AI, Rodríguez Moya A. Frecuencia de uso de escalas de dolor, incapacidad fisica y calidad de vida en el estudio de lumbalgia con intervenciones fisioterápicas. Fisioterapia 2008; 30(4), 204-208.
- BackgroundFlórez García MT, García Pérez MA, García Pérez F, et al. Adaptación transcultural a la población española de la escala de incapacidad por dolor lumbar de Oswestry. Rehab (Madr). 1995; 29:138-45.
- 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.
Francisco Villatoro principal investigator
University of Jaén
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 in people with Low Back Pain and Rehabilitation, run by Alexander Achalandabaso 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 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. 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?
Change in Quality of Life (time frame: Baseline, 2 months (primary timepoint), 3 months after intervention commencement.). 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 NCT04685837, which also lists 14 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 21 Jul 2021.