Low Back PainNCT02448888
Prevention and Treatment of Chronic Low Back Pain Through an Adapted Exercise Program
A study testing Adapted exercise and General exercise recommendations in people with Low Back Pain, run by Universidad San Jorge at 2 sites in Spain.
Trial summary
Objective: The purpose of this study is to investigate the effects of a adapted exercise program and general exercise recommendations compared with only general exercise recommendations for the management of chronic back pain among the workers of BSH (Bosch Siemens Hausgeräte), a manufacturing company. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Adapted exercise and General exercise recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2015to May 2016
- 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
- BSH industry workers.
- Spine pain diagnosed by a doctor, that has caused a previously sick-leave. The pain does not incapacitate to the patient to perform his job.
- In possession of a next-generation mobile.
Who cannot join
- Lumbar injury that does not let the patient performs his work or an exercise program.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
San Jorge University
Villanueva de Gállego, Zaragoza, 50830
BSH electrodomesticos España S.A
Zaragoza, Zaragoza, 50059
About this study
Official title: Prevention and Treatment of Chronic Low Back Pain Through an Adapted Exercise Program and General Exercise Recommendations Tailored to the Job on an Assembly Line Training Versus General Exercise Recommendations: Randomized Clinical Trial
Objective: The purpose of this study is to investigate the effects of a adapted exercise program and general exercise recommendations compared with only general exercise recommendations for the management of chronic back pain among the workers of BSH (Bosch Siemens Hausgeräte), a manufacturing company.
Read the detailed description
Design: Randomized controlled trial. Participants: Subjects (N_40 volunteers) experimental group (n_20) control group (n_20). All of the participants needs to be diagnosed with chronic back pain by a physician. Participants are going to be randomly assigned to two groups: a control group (CG), and experimental group (EG).
Intervention: The experimental group is going to follow a home-exercise program designed specifically to compensate the overloads and strength necessities of the workplace, the patient enter the description of the workplace in a mobile application (APP) and the APP shows specific exercises that the patient needs to practice. The exercise program includes muscle strengthening, flexibility, and endurance training, during 2 months, 3 times/week and generla recommendations. The control group is going to receive only general recommendation (ACSM recommendations) with the same kind of mobile application to control the amount of exercise that each patient performs during the week.
Data on pain intensity (BPI short form, Brief Pain Inventory), disability (Oswestry Low Back Pain Disability Questionnaire), functional assessment of the lumbar spine (EMG Flexion-relaxation test), amount of weekly physical activity (IPAQ), and number of sick leaves are going to be measured immediately before and after intervention and 3 months after the end of the intervention period.
- Conditions
- Low Back Pain
- Being tested
- Adapted exercise, General exercise recommendations
- 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.
Adapted exerciseOther
2 months, 3 times/week
General exercise recommendationsOther
2 months, 3 times/week
| Study group | Role | What they receive |
|---|---|---|
| Adapted exercise | Experimental | The experimental group is going to follow a home-exercise program designed specifically to compensate the overloads and strength necessities of the workplace, the patient enter the description of the workplace in a mobile application and the APP shows the specific exercise that the patient needs to practice and general exercise recommendations. Receives: Other: Adapted exercise |
| General exercise recommendations | Experimental | The control group is going to receive general exercise recommendations (ACSM recommendations) with the same kind of APP to control the amount of exercise that each patient performs during the week. Receives: Other: General exercise recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lumbar pain intensity
The assessment is performed with Brief Pain Index short form Self-administered questionnaire with 9 questions.
Measured: Baseline, at the end of the two weeks training period and three months after the end of the training period.
Change in disability caused by lumbar pain
The assessment is performed with Oswestry Low Back Pain Disability Questionnaire,
Measured: Baseline, at the end of the two weeks training period and three months after the end of the training period.
Change in the functional assessment of the lumbar spine
Functional assessment of the lumbar spine with EMG Flexion-relaxation test:
Measured: Baseline, at the end of the two weeks training period and three months after the end of the train
Secondary outcomes (2)
Change in weekly physical activity amount
Weekly physical activity performed by the patient assessed by the IPAQ
Measured: Baseline, at the end of the two weeks training period and three months after the end of the training period.
Incidence of sick-leave caused by lumbar pain
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 posted20 May 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Collaborators
- Mutua MAZ, BSH electrodomésticos España S.A.
- Responsible party
- Sponsor
- Investigators
- Vanessa Bataller, Study director, San Jorge UniversityCristina Cimarras, Principal investigator, San Jorge University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448888
- Sponsor's protocol ID
- PTDLEF1
- Status last verified
- Nov 2016
- First submitted
- 20 Mar 2015
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment of Chronic Low Back Pain Through an Adapted Exercise Program and General Exercise Recommendations Tailored to the Job on an Assembly Line Training Versus General Exercise Recommendations: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02448888
- Acronym / sponsor ID
- PTDLEF1
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Collaborators
- Mutua MAZ, BSH electrodomésticos España S.A.
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 May 2015 (estimated)
- 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.
Objective: The purpose of this study is to investigate the effects of a adapted exercise program and general exercise recommendations compared with only general exercise recommendations for the management of chronic back pain among the workers of BSH (Bosch Siemens Hausgeräte), a manufacturing company.
Detailed description
Design: Randomized controlled trial. Participants: Subjects (N_40 volunteers) experimental group (n_20) control group (n_20). All of the participants needs to be diagnosed with chronic back pain by a physician. Participants are going to be randomly assigned to two groups: a control group (CG), and experimental group (EG).
Intervention: The experimental group is going to follow a home-exercise program designed specifically to compensate the overloads and strength necessities of the workplace, the patient enter the description of the workplace in a mobile application (APP) and the APP shows specific exercises that the patient needs to practice. The exercise program includes muscle strengthening, flexibility, and endurance training, during 2 months, 3 times/week and generla recommendations. The control group is going to receive only general recommendation (ACSM recommendations) with the same kind of mobile application to control the amount of exercise that each patient performs during the week.
Data on pain intensity (BPI short form, Brief Pain Inventory), disability (Oswestry Low Back Pain Disability Questionnaire), functional assessment of the lumbar spine (EMG Flexion-relaxation test), amount of weekly physical activity (IPAQ), and number of sick leaves are going to be measured immediately before and after intervention and 3 months after the end of the intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted exercise | Experimental | Other: Adapted exerciseThe experimental group is going to follow a home-exercise program designed specifically to compensate the overloads and strength necessities of the workplace, the patient enter the description of the workplace in a mobile application and the APP shows the specific exercise that the patient needs to practice and general exercise recommendations. |
| General exercise recommendations | Experimental | Other: General exercise recommendationsThe control group is going to receive general exercise recommendations (ACSM recommendations) with the same kind of APP to control the amount of exercise that each patient performs during the week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BSH industry workers.
- Spine pain diagnosed by a doctor, that has caused a previously sick-leave. The pain does not incapacitate to the patient to perform his job.
- In possession of a next-generation mobile.
Key exclusion criteria (1 listed)
- Lumbar injury that does not let the patient performs his work or an exercise program.
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 |
|---|---|---|
| Adapted exercise2 months, 3 times/week | Other | Adapted exercise |
| General exercise recommendations2 months, 3 times/week | Other | General exercise recommendations |
Primary outcome
Change in lumbar pain intensity
Time frame: Baseline, at the end of the two weeks training period and three months after the end of the training period.
The assessment is performed with Brief Pain Index short form Self-administered questionnaire with 9 questions.
Change in disability caused by lumbar pain
Time frame: Baseline, at the end of the two weeks training period and three months after the end of the training period.
The assessment is performed with Oswestry Low Back Pain Disability Questionnaire,
Change in the functional assessment of the lumbar spine
Time frame: Baseline, at the end of the two weeks training period and three months after the end of the train
Functional assessment of the lumbar spine with EMG Flexion-relaxation test:
2 secondary outcomes
Change in weekly physical activity amount
Time frame: Baseline, at the end of the two weeks training period and three months after the end of the training period.
Incidence of sick-leave caused by lumbar pain
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 9 Nov 2016.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Vanessa Bataller study director
San Jorge University
Cristina Cimarras principal investigator
San Jorge University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted exercise and General exercise recommendations in people with Low Back Pain, run by Universidad San Jorge at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 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 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 lumbar pain intensity (time frame: Baseline, at the end of the two weeks training period and three months after the end of the training period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2016.