Musculoskeletal PainIRMA20NCT03172962
Effect of Strength Training for Chronic Low Back Pain Patients (IRMA20)
A study testing Strength training in people with Musculoskeletal Pain and Low Back Pain, run by National Research Centre for the Working Environment, Denmark at 1 site in Spain.
Trial summary
Low back pain (LBP) is common in the population and has great socioeconomic consequences for societies across Europe and the United States. About a third of working-age adults have frequent LBP, and for about 10% the pain becomes chronic with consequences for work and leisure activities. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Low Back Pain
- What is being tested?
- Strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2017to 1 Nov 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-specific Chronic low back pain patient (more than 3 months) at the hospital Arnau de Vilanova
Who cannot join
- Spine surgery
- neurologic or psyquiatric disorders
- Low back traumastism
- Recent participation in a similar training program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Strength Training for Chronic Low Back Pain Patients: Randomized Clinical Trial
Low back pain (LBP) is common in the population and has great socioeconomic consequences for societies across Europe and the United States. About a third of working-age adults have frequent LBP, and for about 10% the pain becomes chronic with consequences for work and leisure activities. A Cochrane review from April 2017 concluded that physical exercise is an intervention with few adverse events and positive outcomes on pain and function in adults with chronic pain. However, when scrutinizing the specific studies of the review there are large differences in adherence to the exercise interventions and consequently in the results obtained. Thus, there is a need for simple exercises that the patients can easily adhere to.
- Conditions
- Musculoskeletal Pain, Low Back Pain
- Being tested
- Strength training, Usual care (control)
- Medical subject headings
- Musculoskeletal Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingBehavioural
Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks
Usual care (control)Behavioural
Will receive the usual care at the hospital
| Study group | Role | What they receive |
|---|---|---|
| Strength training | Experimental | Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks Receives: Behavioral: Strength training; Behavioral: Usual care (control) |
| Usual care (control) | Active comparator | Will receive the usual care at the hospital Receives: Behavioral: Usual care (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain intensity
Low back pain intensity (VAS 0-10)
Measured: change from baseline to 8-week follow-up
Back pain recurrence
number of episodes with back pain recurrence after termination of the intervention
Measured: 1 to 100 days, beginning from the last day of termination of the 8-week intervention
Secondary outcomes (5)
Roland-Morris disability
The Roland-Morris disability questionnaire
Measured: change from baseline to 8-week follow-up
Muscle endurance
The Biering-Sørensen test
Measured: change from baseline to 8-week follow-up
Use of analgesics
Number of days using analgesic within the last week
Measured: change from baseline to 8-week follow-up
Handgrip strength
Maximal force (kg) in handgrip
Measured: change from baseline to 8-week follow-up
Pain sites
Number of pain sites
Measured: change from baseline to 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start1 Jul 2017
- Primary completion1 Oct 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- Collaborators
- University of Valencia
- Responsible party
- Sponsor
- Investigators
- Joaquin Calatayud, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172962
- Sponsor's protocol ID
- IRMA20
- Acronym
- IRMA20
- Status last verified
- Nov 2018
- First submitted
- 30 May 2017
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strength Training for Chronic Low Back Pain Patients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03172962
- Acronym / sponsor ID
- IRMA20 / IRMA20
- Conditions
- Musculoskeletal Pain, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Collaborators
- University of Valencia
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low back pain (LBP) is common in the population and has great socioeconomic consequences for societies across Europe and the United States. About a third of working-age adults have frequent LBP, and for about 10% the pain becomes chronic with consequences for work and leisure activities. A Cochrane review from April 2017 concluded that physical exercise is an intervention with few adverse events and positive outcomes on pain and function in adults with chronic pain. However, when scrutinizing the specific studies of the review there are large differences in adherence to the exercise interventions and consequently in the results obtained. Thus, there is a need for simple exercises that the patients can easily adhere to.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength training | Experimental | Behavioral: Strength training, Behavioral: Usual care (control)Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks |
| Usual care (control) | Active comparator | Behavioral: Usual care (control)Will receive the usual care at the hospital |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-specific Chronic low back pain patient (more than 3 months) at the hospital Arnau de Vilanova
Key exclusion criteria (4 listed)
- Spine surgery
- neurologic or psyquiatric disorders
- Low back traumastism
- Recent participation in a similar training 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 |
|---|---|---|
| Strength trainingSpecific strength training exercises for the lumbar and abdominal muscles for 8 weeks | Behavioural | Strength training |
| Usual care (control)Will receive the usual care at the hospital | Behavioural | Strength training, Usual care (control) |
Primary outcome
Low back pain intensity
Time frame: change from baseline to 8-week follow-up
Low back pain intensity (VAS 0-10)
Back pain recurrence
Time frame: 1 to 100 days, beginning from the last day of termination of the 8-week intervention
number of episodes with back pain recurrence after termination of the intervention
5 secondary outcomes
Roland-Morris disability
Time frame: change from baseline to 8-week follow-up
Muscle endurance
Time frame: change from baseline to 8-week follow-up
Use of analgesics
Time frame: change from baseline to 8-week follow-up
Handgrip strength
Time frame: change from baseline to 8-week follow-up
Pain sites
Time frame: change from baseline to 8-week follow-up
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 30 Nov 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Musculoskeletal Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
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.
Joaquin Calatayud, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training in people with Musculoskeletal Pain and Low Back Pain, run by National Research Centre for the Working Environment, Denmark 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 1 inclusion and 4 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 30 Nov 2018. 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?
Low back pain intensity (time frame: change from baseline to 8-week follow-up). The study lists 2 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 30 Nov 2018.