Low Back PainNCT03469024
Effectiveness of a Home Rehabilitation Program vs an e-Health Program in Patients With Chronic Low Back Pain
A study testing Home Rehabilitation Program and e-Health program in people with Low Back Pain, run by Universidad de Almeria at 1 site in Spain.
Trial summary
The main objetive of this study is to analyze the effectiveness of a home rehabilitaton program vs a e-Health program. Therapeutic approach will be by electroanalgesia and exercise of patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 30 to 67 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Home Rehabilitation Program and e-Health program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2018to 15 Apr 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 30 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back pain ≥ 3 months.
- Age between 30 and 67 years old.
- Score ≥ 4 points on the Roland Morris Disability Questionnaire.
- Not being receiving physical therapy.
Who cannot join
- Presence of lumbar stenosis.
- Diagnosis of spondylolisthesis.
- Diagnosis of fibromyalgia.
- Treatment with corticosteroids or oral medication in recent weeks.
- History of spine surgery.
- Contraindication of analgesic electrical therapy.
Show all 9Show fewer
- Have previously received a treatment of electrical analgesia or exercise.
- Central or peripheral nervous system disease.
- Agoraphobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effectiveness of a Home Rehabilitation Program vs an e-Healt Program on Disability, Pain, Fear of Movement, Quality of Life and Spinal Mobility in Patients With Chronic Low Back Pain.
The main objetive of this study is to analyze the effectiveness of a home rehabilitaton program vs a e-Health program. Therapeutic approach will be by electroanalgesia and exercise of patients with chronic low back pain.
Read the detailed description
A double blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients will receive 3 weekly sessions of electroanalgesia and an exercise program for 8 weeks, for a total of 24 sessions. The aim is to analyze the effectiveness of a home rehabilitation program vs a web platform program on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility in flexion and muscular electrical activity.
- Conditions
- Low Back Pain
- Being tested
- Home Rehabilitation Program, e-Health program
- Keywords
- Low back pain, Electroanalgesia, Exercise program, Randomized clinical trial
- 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.
Home Rehabilitation ProgramOther
It consists in a home rehabilitation program performing electroanalgesia and an exercise program following the Mckenzie method. Patients will be instructed in the use of the TENS device using 5x9cm electrodes at the bilateral paravertebral level, the patients that present radicular pain, the electrodes will be placed in the path of the affected nerve. The realization of exercises will be through the application of an Mckezie protocol. The duration will be the same as that used to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal components periarticular of the spine.
e-Health programOther
It consists in an e-Health rehabilitation program through a web platform performing electroanalgesia and an exercise program following the Mckenzie method. Patients will be instructed in the use of the TENS device using 5x9cm electrodes at the bilateral paravertebral level, the patients that present radicular pain, the electrodes will be placed in the path of the affected nerve. The realization of exercises will be through the application of an Mckezie protocol. The duration will be the same as that used to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal components periarticular of the spine.
| Study group | Role | What they receive |
|---|---|---|
| Home rehabilitation program | Experimental | It consists in a home rehabilitation program. Patients will recieve electroanalgesia with TENS and an exercise program following the McKenzie method. At first and second sessions, patients will be instructed on how to use electroanalgesia and how to perform the exercises. Then, patients will perform the therapy at home. Patients will perform the treatment 3 times per week, for 4 weeks, with a total of 24 sessions Receives: Other: Home Rehabilitation Program |
| e-Health program | Active comparator | It consists in a support system for the treatment of chronic low back pain based on web technologies. The system can register a subject and provide a treatment of electroanalgesia and exercise through the Mckenzie method. Video applications of electroanalgesia and exercises will be shown to patients who use their computer or mobile device to access the platform through the Internet. The treatments will be recommended by the system based on the database that is configured to accommodate the application of electroanalgesia and McKenzie exercises based on the diagnosis according to the McKenzie method.patients will perform the treatment 3 times per week, for 4 weeks, with a total of 24 sessions Receives: Other: e-Health program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
Measured: At baseline, at 8 weeks and at 6 months
Secondary outcomes (8)
Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
It has 10 items associated to activities of daily living, each ítem has a puntuation fron 0 to 5 points.
Measured: At baseline, at 8 weeks and at 6 months.
Change from baseline in pain intensity. Visual analogue scale.
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain
Measured: At baseline, at 8 weeks and at 6 months
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
Is a 17-item questionnaire that measures the fear of movement and (re)injury.
Measured: At baseline, at 8 weeks and at 6 months
Change from baseline on Quality of Life. SF-36 Health questionnaire.
. SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
Measured: At baseline, at 8 weeks and at 6 months
Change from Mcquade Test.
It measures the isometric endurance of trunk flexion muscles.
Measured: At baseline, at 8 weeks and at 6 months
Change from baseline in lumbar mobility flexion.
For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil).
Measured: At baseline, at 8 weeks and at 6 months
Changes from baseline in Lumbar electromyography.
The degree of electromyographic activation of the lumbar paravertebral musculature will be carried out by using a set of electrodes of 3x7 dimensions that will be applied uniformly in the lumbar region from the spinal level from L2 to L5.
Measured: At baseline, at 8 weeks and at 6 months
Change from baselina in range of motion and lumbar segmental mobility
This variable is quantified using the SpinalMouse ® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagittal spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way.
Measured: At baseline, at 8 weeks and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 May 2018
- Primary completion15 Oct 2020
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Collaborators
- Junta de Andalucia
- Responsible party
- Principal investigator, Adelaida María Castro-Sánchez, Universidad de Almeria
- Investigators
- Adelaida María Castro-Sánchez, PhD, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469024
- Sponsor's protocol ID
- CFS/apg
- Status last verified
- Sep 2023
- First submitted
- 12 Mar 2018
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Von Korff M, Moore JC. Stepped care for back pain: activating approaches for primary care. Ann Intern Med. 2001 May 1;134(9 Pt 2):911-7. doi: 10.7326/0003-4819-134-9_part_2-200105011-00016.
PubMed 11346328Schaafsma FG, Whelan K, van der Beek AJ, van der Es-Lambeek LC, Ojajarvi A, Verbeek JH. Physical conditioning as part of a return to work strategy to reduce sickness absence for workers with back pain. Cochrane Database Syst Rev. 2013 Aug 30;2013(8):CD001822. doi: 10.1002/14651858.CD001822.pub3.
PubMed 23990391Becker A, Held H, Redaelli M, Strauch K, Chenot JF, Leonhardt C, Keller S, Baum E, Pfingsten M, Hildebrandt J, Basler HD, Kochen MM, Donner-Banzhoff N. Low back pain in primary care: costs of care and prediction of future health care utilization. Spine (Phila Pa 1976). 2010 Aug 15;35(18):1714-20. doi: 10.1097/brs.0b013e3181cd656f.
PubMed 21374895Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003.
PubMed 10872758Elfering A, Semmer N, Birkhofer D, Zanetti M, Hodler J, Boos N. Risk factors for lumbar disc degeneration: a 5-year prospective MRI study in asymptomatic individuals. Spine (Phila Pa 1976). 2002 Jan 15;27(2):125-34. doi: 10.1097/00007632-200201150-00002.
PubMed 11805656Haladay DE, Miller SJ, Challis J, Denegar CR. Quality of systematic reviews on specific spinal stabilization exercise for chronic low back pain. J Orthop Sports Phys Ther. 2013 Apr;43(4):242-50. doi: 10.2519/jospt.2013.4346. Epub 2013 Jan 14.
PubMed 23321935Palacin-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 23238489Descarreaux M, Normand MC, Laurencelle L, Dugas C. Evaluation of a specific home exercise program for low back pain. J Manipulative Physiol Ther. 2002 Oct;25(8):497-503. doi: 10.1067/mmt.2002.127078.
PubMed 12381971Petersen T, Kryger P, Ekdahl C, Olsen S, Jacobsen S. The effect of McKenzie therapy as compared with that of intensive strengthening training for the treatment of patients with subacute or chronic low back pain: A randomized controlled trial. Spine (Phila Pa 1976). 2002 Aug 15;27(16):1702-9. doi: 10.1097/00007632-200208150-00004.
PubMed 12195058Khadilkar A, Odebiyi DO, Brosseau L, Wells GA. Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003008. doi: 10.1002/14651858.CD003008.pub3.
PubMed 18843638
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of a Home Rehabilitation Program vs an e-Healt Program on Disability, Pain, Fear of Movement, Quality of Life and Spinal Mobility in Patients With Chronic Low Back Pain.
- ClinicalTrials.gov ID
- NCT03469024
- Acronym / sponsor ID
- CFS/apg
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Electroanalgesia, Exercise program, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Collaborators
- Junta de Andalucia
- Study start
- 1 May 2018 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 19 Mar 2018 (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 main objetive of this study is to analyze the effectiveness of a home rehabilitaton program vs a e-Health program. Therapeutic approach will be by electroanalgesia and exercise of patients with chronic low back pain.
Detailed description
A double blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients will receive 3 weekly sessions of electroanalgesia and an exercise program for 8 weeks, for a total of 24 sessions. The aim is to analyze the effectiveness of a home rehabilitation program vs a web platform program on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility in flexion and muscular electrical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home rehabilitation program | Experimental | Other: Home Rehabilitation ProgramIt consists in a home rehabilitation program. Patients will recieve electroanalgesia with TENS and an exercise program following the McKenzie method. At first and second sessions, patients will be instructed on how to use electroanalgesia and how to perform the exercises. Then, patients will perform the therapy at home. Patients will perform the treatment 3 times per week, for 4 weeks, with a total of 24 sessions |
| e-Health program | Active comparator | Other: e-Health programIt consists in a support system for the treatment of chronic low back pain based on web technologies. The system can register a subject and provide a treatment of electroanalgesia and exercise through the Mckenzie method. Video applications of electroanalgesia and exercises will be shown to patients who use their computer or mobile device to access the platform through the Internet. The treatments will be recommended by the system based on the database that is configured to accommodate the application of electroanalgesia and McKenzie exercises based on the diagnosis according to the McKenzie method.patients will perform the treatment 3 times per week, for 4 weeks, with a total of 24 sessions |
Who may qualify
- Ages
- 30 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Low back pain ≥ 3 months.
- Age between 30 and 67 years old.
- Score ≥ 4 points on the Roland Morris Disability Questionnaire.
- Not being receiving physical therapy.
Key exclusion criteria (9 listed)
- Presence of lumbar stenosis.
- Diagnosis of spondylolisthesis.
- Diagnosis of fibromyalgia.
- Treatment with corticosteroids or oral medication in recent weeks.
- History of spine surgery.
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 |
|---|---|---|
| Home Rehabilitation ProgramIt consists in a home rehabilitation program performing electroanalgesia and an exercise program following the Mckenzie method. Patients will be instructed in the use of the TENS device using 5x9cm electrodes at the bilateral paravertebral level, the patients that present radicular pain, the electrodes will be placed in the path of the affected nerve. The realization of exercises will be through the application of an Mckezie protocol. The duration will be the same as that used to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal components periarticular of the spine. | Other | Home rehabilitation program |
| e-Health programIt consists in an e-Health rehabilitation program through a web platform performing electroanalgesia and an exercise program following the Mckenzie method. Patients will be instructed in the use of the TENS device using 5x9cm electrodes at the bilateral paravertebral level, the patients that present radicular pain, the electrodes will be placed in the path of the affected nerve. The realization of exercises will be through the application of an Mckezie protocol. The duration will be the same as that used to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal components periarticular of the spine. | Other | e-Health program |
Primary outcome
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
Time frame: At baseline, at 8 weeks and at 6 months
This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
8 secondary outcomes
Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
Time frame: At baseline, at 8 weeks and at 6 months.
Change from baseline in pain intensity. Visual analogue scale.
Time frame: At baseline, at 8 weeks and at 6 months
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
Time frame: At baseline, at 8 weeks and at 6 months
Change from baseline on Quality of Life. SF-36 Health questionnaire.
Time frame: At baseline, at 8 weeks and at 6 months
Change from Mcquade Test.
Time frame: At baseline, at 8 weeks and at 6 months
Change from baseline in lumbar mobility flexion.
Time frame: At baseline, at 8 weeks and at 6 months
Changes from baseline in Lumbar electromyography.
Time frame: At baseline, at 8 weeks and at 6 months
Change from baselina in range of motion and lumbar segmental mobility
Time frame: At baseline, at 8 weeks and at 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 21 Sep 2023.
- Background: PubMed 11346328Von Korff M, Moore JC. Stepped care for back pain: activating approaches for primary care. Ann Intern Med. 2001 May 1;134(9 Pt 2):911-7. doi: 10.7326/0003-4819-134-9_part_2-200105011-00016.
- Background: PubMed 23990391Schaafsma FG, Whelan K, van der Beek AJ, van der Es-Lambeek LC, Ojajarvi A, Verbeek JH. Physical conditioning as part of a return to work strategy to reduce sickness absence for workers with back pain. Cochrane Database Syst Rev. 2013 Aug 30;2013(8):CD001822. doi: 10.1002/14651858.CD001822.pub3.
- Background: PubMed 21374895Becker A, Held H, Redaelli M, Strauch K, Chenot JF, Leonhardt C, Keller S, Baum E, Pfingsten M, Hildebrandt J, Basler HD, Kochen MM, Donner-Banzhoff N. Low back pain in primary care: costs of care and prediction of future health care utilization. Spine (Phila Pa 1976). 2010 Aug 15;35(18):1714-20. doi: 10.1097/brs.0b013e3181cd656f.
- Background: PubMed 10872758Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003.
- Background: PubMed 11805656Elfering A, Semmer N, Birkhofer D, Zanetti M, Hodler J, Boos N. Risk factors for lumbar disc degeneration: a 5-year prospective MRI study in asymptomatic individuals. Spine (Phila Pa 1976). 2002 Jan 15;27(2):125-34. doi: 10.1097/00007632-200201150-00002.
- Background: PubMed 23321935Haladay DE, Miller SJ, Challis J, Denegar CR. Quality of systematic reviews on specific spinal stabilization exercise for chronic low back pain. J Orthop Sports Phys Ther. 2013 Apr;43(4):242-50. doi: 10.2519/jospt.2013.4346. Epub 2013 Jan 14.
- 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 12381971Descarreaux M, Normand MC, Laurencelle L, Dugas C. Evaluation of a specific home exercise program for low back pain. J Manipulative Physiol Ther. 2002 Oct;25(8):497-503. doi: 10.1067/mmt.2002.127078.
- Background: PubMed 12195058Petersen T, Kryger P, Ekdahl C, Olsen S, Jacobsen S. The effect of McKenzie therapy as compared with that of intensive strengthening training for the treatment of patients with subacute or chronic low back pain: A randomized controlled trial. Spine (Phila Pa 1976). 2002 Aug 15;27(16):1702-9. doi: 10.1097/00007632-200208150-00004.
- Background: PubMed 18843638Khadilkar A, Odebiyi DO, Brosseau L, Wells GA. Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003008. doi: 10.1002/14651858.CD003008.pub3.
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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.
Adelaida María Castro-Sánchez, PhD principal investigator
Universidad de Almeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Rehabilitation Program and e-Health program in people with Low Back Pain, run by Universidad de Almeria 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 9 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 Sep 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?
Change from baseline in Roland Morris Disability Questionnaire (RMDQ). (time frame: At baseline, at 8 weeks and at 6 months). 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 NCT03469024, which also lists 10 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 Sep 2023.