Acute Low Back PainALBPNCT02517762
Acute Low Back Pain: Causes, Mechanisms, Treatment and Followup
A study testing Physical activity in people with Acute Low Back Pain and Physical Activity, run by Göteborg University.
Trial summary
The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the cause of pain, evaluation of treatments and development. Employees from a large local manufacturing company are sent for a complete orthopedic and pain evaluation immediately after onset of acute low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Low Back Pain, Physical Activity
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Dec 2008
- 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
- Severe acute low back pain, duration within 24h after onset, pain exceeds 50mm on the visual analog scale (VAS)
Who cannot join
- Sick-leave because of low back pain or in spine in the last month
About this study
Official title: Labour Triggered Acute Low Back Pain: Origin, Mechanisms, Causes of Pain, Evaluation of Treatment and Followup
The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the cause of pain, evaluation of treatments and development. Employees from a large local manufacturing company are sent for a complete orthopedic and pain evaluation immediately after onset of acute low back pain. Thereafter, the included patients are allocated either to the advice to stay as active as possible in spite of the pain or to adjust their activity to the pain. Pain intensity and physical activity are followed prospectively over seven days using a diary and a pedometer.
Read the detailed description
The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the cause of pain, evaluation of treatments and development. Employees from a large local manufacturing company are sent for a complete orthopedic and pain evaluation immediately after onset of acute low back pain. The patients go through x-ray examinations, physical examinations, they complete a battery of questionnaires covering history of acute low back pain, lifestyle characteristics, work place factors, psychosocial factors, and indicate pain intensity and pain locations. Thereafter the patients are randomly allocated to one of two treatment advices: stay active as much as possible in spite of pain or adjust the activity to the pain. During seven days after the medical examination the patients wear a pedometer attached to the waist and annotate the number of steps and pain intensity, pain location and pain-related disability in a diary. A numeric graphic scale is used for pain intensity. Work absenteeism and sick leave due to the current acute back pain is collected from the company records. Immediate inclusion after pain onset is facilitated with continuous communication with the manufactory company. Physical activity and pain development over the seven days is investigated statistically using linear mixed models for repeated measures.
- Conditions
- Acute Low Back Pain, Physical Activity
- Being tested
- Physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Stay active | Experimental | Receive the advice by the physician to stay as active as possible in spite of the pain experienced Receives: Behavioral: Physical activity |
| Adjust activity | Experimental | Receive the advice by the physician to adjust the activity according to the pain, i.e. to avoid activities, movements or positions that cause or worsen the pain Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute low back pain
Pain intensity is assessed from a numerical graphic scale, ranging from 0 (no pain) to 10 (pain as bad as it can be); the patients complete the scale each day in a diary
Measured: 7 days
Physical activity
The patients wear a pedometer attached to the hip and annotate the number of daily steps each day in a diary
Measured: 7 days
Secondary outcomes (1)
Work absenteeism and sick leave
Work absenteeism and sick leave due to the current backpain is collected from the manufacturing company records up to one month after the onset of the acute low back pain
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startMar 2005
- Primary completionDec 2008
- Study completionDec 2008
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 Acute Low Back PainStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tommy Hansson, MD, PhD, Principal investigator, Department of Orthopedics, Sahlgrenska Academy at the University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517762
- Sponsor's protocol ID
- XC90-ALBP
- Acronym
- ALBP
- Status last verified
- Aug 2015
- First submitted
- 5 Aug 2015
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Olaya-Contreras P, Styf J, Arvidsson D, Frennered K, Hansson T. The effect of the stay active advice on physical activity and on the course of acute severe low back pain. BMC Sports Sci Med Rehabil. 2015 Aug 27;7:19. doi: 10.1186/s13102-015-0013-x. eCollection 2015.
PubMed 26322232
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labour Triggered Acute Low Back Pain: Origin, Mechanisms, Causes of Pain, Evaluation of Treatment and Followup
- ClinicalTrials.gov ID
- NCT02517762
- Acronym / sponsor ID
- ALBP / XC90-ALBP
- Conditions
- Acute Low Back Pain, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Aug 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.
The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the cause of pain, evaluation of treatments and development. Employees from a large local manufacturing company are sent for a complete orthopedic and pain evaluation immediately after onset of acute low back pain. Thereafter, the included patients are allocated either to the advice to stay as active as possible in spite of the pain or to adjust their activity to the pain. Pain intensity and physical activity are followed prospectively over seven days using a diary and a pedometer.
Detailed description
The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the cause of pain, evaluation of treatments and development. Employees from a large local manufacturing company are sent for a complete orthopedic and pain evaluation immediately after onset of acute low back pain. The patients go through x-ray examinations, physical examinations, they complete a battery of questionnaires covering history of acute low back pain, lifestyle characteristics, work place factors, psychosocial factors, and indicate pain intensity and pain locations. Thereafter the patients are randomly allocated to one of two treatment advices: stay active as much as possible in spite of pain or adjust the activity to the pain. During seven days after the medical examination the patients wear a pedometer attached to the waist and annotate the number of steps and pain intensity, pain location and pain-related disability in a diary. A numeric graphic scale is used for pain intensity. Work absenteeism and sick leave due to the current acute back pain is collected from the company records. Immediate inclusion after pain onset is facilitated with continuous communication with the manufactory company. Physical activity and pain development over the seven days is investigated statistically using linear mixed models for repeated measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stay active | Experimental | Behavioral: Physical activityReceive the advice by the physician to stay as active as possible in spite of the pain experienced |
| Adjust activity | Experimental | Behavioral: Physical activityReceive the advice by the physician to adjust the activity according to the pain, i.e. to avoid activities, movements or positions that cause or worsen the pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Severe acute low back pain, duration within 24h after onset, pain exceeds 50mm on the visual analog scale (VAS)
Key exclusion criteria (1 listed)
- Sick-leave because of low back pain or in spine in the last month
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 |
|---|---|---|
| Physical activity | Behavioural | Adjust activity, Stay active |
Primary outcome
Acute low back pain
Time frame: 7 days
Pain intensity is assessed from a numerical graphic scale, ranging from 0 (no pain) to 10 (pain as bad as it can be); the patients complete the scale each day in a diary
Physical activity
Time frame: 7 days
The patients wear a pedometer attached to the hip and annotate the number of daily steps each day in a diary
1 secondary outcome
Work absenteeism and sick leave
Time frame: 7 days
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 11 Aug 2015.
- Derived from this study: PubMed 26322232Olaya-Contreras P, Styf J, Arvidsson D, Frennered K, Hansson T. The effect of the stay active advice on physical activity and on the course of acute severe low back pain. BMC Sports Sci Med Rehabil. 2015 Aug 27;7:19. doi: 10.1186/s13102-015-0013-x. eCollection 2015.
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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.
Tommy Hansson, MD, PhD principal investigator
Department of Orthopedics, Sahlgrenska Academy at the University of Gothenburg
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Acute Low Back Pain and Physical Activity, run by Göteborg University.
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 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 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Acute low back pain (time frame: 7 days). 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?
On the ClinicalTrials.gov record for NCT02517762, 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 11 Aug 2015.