Subacute Low Back PainJustinaNCT00923429
Trial on Subacute Low Back Pain
A study testing Stay-active care, Stay-active care+stretching and Stay-active+stretching+manual therapy in people with Subacute Low Back Pain, run by Uppsala University at 1 site in Sweden.
Trial summary
A randomized controlled trial over a 10-week period with a two-year follow-up. The objectives were to compare effects of manual therapy in addition to the stay-active concept versus the stay-active concept only in low back pain patients recruited from primary health care. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Subacute Low Back Pain
- What is being tested?
- Stay-active care, Stay-active care+stretching and Stay-active+stretching+manual therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSweden
- Study dates
- Jan 1994to Dec 2000
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- acute or subacute perceived low back pain with or without pain radiating to one or both legs
- symptom duration of three months or less preceded by at least two months of relative freedom from symptoms
- consent to treatment and follow up for ten weeks
- agreement not to consult therapists other than those participating in the study during the treatment period
Who cannot join
- other conditions or circumstances that might jeopardize completion of treatment and follow up, such as pregnancy, malignant tumors, etcetera
- need for acute surgical or rheumatologic care
- previous treatment of current complaints with specific mobilisation or manipulation
- previous participation in the present study
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Public Health and Caring Sciences, Family Medicin and Clinical Epidemiology Section
Uppsala, SE-75185
About this study
Official title: A Randomized Controlled Clinical Trial of Stay-Active Care and Manual Therapy Versus Stay-Active Care Only in Subacute Low Back Pain in a Primary Health Care Setting. The Gotland Low Back Pain Study
A randomized controlled trial over a 10-week period with a two-year follow-up. The objectives were to compare effects of manual therapy in addition to the stay-active concept versus the stay-active concept only in low back pain patients recruited from primary health care. 160 outpatients with acute or subacute low back pain with or without pain radiation into the legs (70 women, 90 men, ages 20-55 years) were recruited from a geographically defined area and randomly allocated to stay-active care with or without muscle stretching, or to manual therapy with or without specific corticosteroid injections in addition to the stay-active concept. Pain, disability rating index, and sickness absence measures were used as outcome at 10-week follow-up and sickness absence was measured at two-year follow-up.
Read the detailed description
The study is a randomized, controlled, clinical trial in the Swedish province of Gotland, with primary data collection from 1994 to 1998. The recruitment population consisted of the 19000 employed persons born in Sweden, 20-55 years of age. Additional inclusion criteria were:
Acute or subacute perceived low back pain with or without pain radiating to one or both legs, not requiring acute surgical or rheumatological care, low back pain was required to be the dominating symptom, symptom duration of 3 months or less, preceded by at least 2 months of relative freedom from symptoms, consent to treatment and follow-up for 10 weeks, agreement not to consult other therapists during the treatment period, absence of conditions or circumstances that might jeopardize completion of treatment and follow-up, no previous treatment of current complaints with specific mobilization or manipulation, and no previous participation in the present study.
In Sweden, the National Social Insurance Offices (a government agency running the mandatory national social insurance scheme applicable to all Swedish residents) handle sick leave with a duration of two weeks or more. They as well as general practitioners (GP) and other physicians referred patients. The recruiting physician examined all patients, performed a physical examination, and made the final assessment whether they fulfilled the inclusion criteria. Of the 316 patients who were referred to the study, 111 did not meet the inclusion criteria and 45 declined participation. The 160 patients that gave informed consent were entered in the study. After baseline evaluation they were randomized by the study monitor, using sealed pre-prepared envelopes with group assignment derived from a random number table. The envelopes were inaccessible to anyone but the monitor. A design with four treatment groups was used: two experimental and two reference groups with treatment items added successively. The two-group comparison (reference vs experimental treatment) was the primary planned analysis, and pain, disability rating and sickness absence were the main outcome measures. A weighted randomization procedure was used, with 45% of the patients to reference and 55% to the experimental therapies. The Research Ethics Committee at Uppsala University approved the study.
The stay active concept was the basic management strategy in all study groups. Treatment was individual, in groups or both. Treatment modalities were chosen from a group-specific 'toolbox' after clinical assessment of the patients and according to need. Two orthopedic surgeons at Visby Hospital and eight physiotherapists treated the reference patients. In accordance with the study design, muscle stretching was a treatment option in 51% of the reference group, 41% actually received muscle stretching. Two GPs and nine physiotherapists treated the experimental patients. They received the full reference treatment, plus specific mobilization, spinal manipulation, and auto-traction when indicated. Steroid injections were a treatment option in 52% of the experimental group, 36% actually received injections.
The study population was followed over ten weeks with measurements of outcome and progression variables. Outcome measures were self-reported back pain, disability rating, return to work as assessed from sick leave records, quality of life measures, and pain drawings. Moreover, sick leave data during two years of follow up from baseline were obtained.
- Conditions
- Subacute Low Back Pain
- Being tested
- Stay-active care, Stay-active care+stretching, Stay-active+stretching+manual therapy, Stay-active+stretching+manual therapy+steroid injections
- Keywords
- Manual therapy, Low back pain, Pain, Return to work
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stay-active careProcedure or surgery
No other treatment than the stay-active care
Stay-active care+stretchingProcedure or surgery
Stay-active care and muscle stretching at home and during physiotherapist appointments
Stay-active+stretching+manual therapyProcedure or surgery
Manual therapy in addition to stay-active care and stretching given during GP or physiotherapist appointments and matching home exercises
Stay-active+stretching+manual therapy+steroid injectionsProcedure or surgery
Manual therapy including steroid injection when indicated in addition to stay-active care and stretching during GP appointments (injections) and during GP or physiotherapist appointments (remaining treatment modalities)
| Study group | Role | What they receive |
|---|---|---|
| S-A | Active comparator | Not described Receives: Procedure: Stay-active care |
| S-A+stretch | Active comparator | Not described Receives: Procedure: Stay-active care+stretching |
| S-A+stretch+manther | Experimental | Not described Receives: Procedure: Stay-active+stretching+manual therapy |
| S-A+stretch+manther+sterinject | Experimental | Not described Receives: Procedure: Stay-active+stretching+manual therapy+steroid injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sick leave
Measured: 2 years
Secondary outcomes (2)
Disability
Measured: 10 weeks
Pain
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startJan 1994
- Primary completionDec 1998
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Subacute 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, National Social Insurance Board, Sweden, Uppsala County Council, Sweden, Länsförsäkringar Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923429
- Sponsor's protocol ID
- Justina
- Acronym
- Justina
- Status last verified
- Jun 2009
- First submitted
- 17 Jun 2009
- Last updated
- 18 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Grunnesjo MI, Bogefeldt JP, Svardsudd KF, Blomberg SI. A randomized controlled clinical trial of stay-active care versus manual therapy in addition to stay-active care: functional variables and pain. J Manipulative Physiol Ther. 2004 Sep;27(7):431-41. doi: 10.1016/j.jmpt.2004.06.001.
PubMed 15389174Grunnesjo M, Bogefeldt J, Blomberg S, Delaney H, Svardsudd K. The course of pain drawings during a 10-week treatment period in patients with acute and sub-acute low back pain. BMC Musculoskelet Disord. 2006 Aug 11;7:65. doi: 10.1186/1471-2474-7-65.
PubMed 16901354Bogefeldt J, Grunnesjo M, Svardsudd K, Blomberg S. Diagnostic differences between general practitioners and orthopaedic surgeons in low back pain patients. Ups J Med Sci. 2007;112(2):199-212. doi: 10.3109/2000-1967-194.
PubMed 17578820Bogefeldt J, Grunnesjo MI, Svardsudd K, Blomberg S. Sick leave reductions from a comprehensive manual therapy programme for low back pain: the Gotland Low Back Pain Study. Clin Rehabil. 2008 Jun;22(6):529-41. doi: 10.1177/0269215507087294.
PubMed 18511533Grunnesjo MI, Bogefeldt JP, Blomberg SI, Strender LE, Svardsudd KF. A randomized controlled trial of the effects of muscle stretching, manual therapy and steroid injections in addition to 'stay active' care on health-related quality of life in acute or subacute low back pain. Clin Rehabil. 2011 Nov;25(11):999-1010. doi: 10.1177/0269215511403512. Epub 2011 Aug 10.
PubMed 21831926
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Stay-Active Care and Manual Therapy Versus Stay-Active Care Only in Subacute Low Back Pain in a Primary Health Care Setting. The Gotland Low Back Pain Study
- ClinicalTrials.gov ID
- NCT00923429
- Acronym / sponsor ID
- Justina / Justina
- Conditions
- Subacute Low Back Pain
- Keywords
- Manual therapy, Low back pain, Pain, Return to work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Region Stockholm, National Social Insurance Board, Sweden, Uppsala County Council, Sweden, Länsförsäkringar Research Foundation
- Study start
- Jan 1994
- Primary completion
- Dec 1998 (actual)
- Study completion
- Dec 2000 (actual)
- First posted
- 18 Jun 2009 (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.
A randomized controlled trial over a 10-week period with a two-year follow-up. The objectives were to compare effects of manual therapy in addition to the stay-active concept versus the stay-active concept only in low back pain patients recruited from primary health care. 160 outpatients with acute or subacute low back pain with or without pain radiation into the legs (70 women, 90 men, ages 20-55 years) were recruited from a geographically defined area and randomly allocated to stay-active care with or without muscle stretching, or to manual therapy with or without specific corticosteroid injections in addition to the stay-active concept. Pain, disability rating index, and sickness absence measures were used as outcome at 10-week follow-up and sickness absence was measured at two-year follow-up.
Detailed description
The study is a randomized, controlled, clinical trial in the Swedish province of Gotland, with primary data collection from 1994 to 1998. The recruitment population consisted of the 19000 employed persons born in Sweden, 20-55 years of age. Additional inclusion criteria were:
Acute or subacute perceived low back pain with or without pain radiating to one or both legs, not requiring acute surgical or rheumatological care, low back pain was required to be the dominating symptom, symptom duration of 3 months or less, preceded by at least 2 months of relative freedom from symptoms, consent to treatment and follow-up for 10 weeks, agreement not to consult other therapists during the treatment period, absence of conditions or circumstances that might jeopardize completion of treatment and follow-up, no previous treatment of current complaints with specific mobilization or manipulation, and no previous participation in the present study.
In Sweden, the National Social Insurance Offices (a government agency running the mandatory national social insurance scheme applicable to all Swedish residents) handle sick leave with a duration of two weeks or more. They as well as general practitioners (GP) and other physicians referred patients. The recruiting physician examined all patients, performed a physical examination, and made the final assessment whether they fulfilled the inclusion criteria. Of the 316 patients who were referred to the study, 111 did not meet the inclusion criteria and 45 declined participation. The 160 patients that gave informed consent were entered in the study. After baseline evaluation they were randomized by the study monitor, using sealed pre-prepared envelopes with group assignment derived from a random number table. The envelopes were inaccessible to anyone but the monitor. A design with four treatment groups was used: two experimental and two reference groups with treatment items added successively. The two-group comparison (reference vs experimental treatment) was the primary planned analysis, and pain, disability rating and sickness absence were the main outcome measures. A weighted randomization procedure was used, with 45% of the patients to reference and 55% to the experimental therapies. The Research Ethics Committee at Uppsala University approved the study.
The stay active concept was the basic management strategy in all study groups. Treatment was individual, in groups or both. Treatment modalities were chosen from a group-specific 'toolbox' after clinical assessment of the patients and according to need. Two orthopedic surgeons at Visby Hospital and eight physiotherapists treated the reference patients. In accordance with the study design, muscle stretching was a treatment option in 51% of the reference group, 41% actually received muscle stretching. Two GPs and nine physiotherapists treated the experimental patients. They received the full reference treatment, plus specific mobilization, spinal manipulation, and auto-traction when indicated. Steroid injections were a treatment option in 52% of the experimental group, 36% actually received injections.
The study population was followed over ten weeks with measurements of outcome and progression variables. Outcome measures were self-reported back pain, disability rating, return to work as assessed from sick leave records, quality of life measures, and pain drawings. Moreover, sick leave data during two years of follow up from baseline were obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| S-A | Active comparator | Procedure: Stay-active care |
| S-A+stretch | Active comparator | Procedure: Stay-active care+stretching |
| S-A+stretch+manther | Experimental | Procedure: Stay-active+stretching+manual therapy |
| S-A+stretch+manther+sterinject | Experimental | Procedure: Stay-active+stretching+manual therapy+steroid injections |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- acute or subacute perceived low back pain with or without pain radiating to one or both legs
- symptom duration of three months or less preceded by at least two months of relative freedom from symptoms
- consent to treatment and follow up for ten weeks
- agreement not to consult therapists other than those participating in the study during the treatment period
Key exclusion criteria (4 listed)
- other conditions or circumstances that might jeopardize completion of treatment and follow up, such as pregnancy, malignant tumors, etcetera
- need for acute surgical or rheumatologic care
- previous treatment of current complaints with specific mobilisation or manipulation
- previous participation in the present study
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 |
|---|---|---|
| Stay-active careNo other treatment than the stay-active care | Procedure or surgery | S-A |
| Stay-active care+stretchingStay-active care and muscle stretching at home and during physiotherapist appointments | Procedure or surgery | S-A+stretch |
| Stay-active+stretching+manual therapyManual therapy in addition to stay-active care and stretching given during GP or physiotherapist appointments and matching home exercises | Procedure or surgery | S-A+stretch+manther |
| Stay-active+stretching+manual therapy+steroid injectionsManual therapy including steroid injection when indicated in addition to stay-active care and stretching during GP appointments (injections) and during GP or physiotherapist appointments (remaining treatment modalities) | Procedure or surgery | S-A+stretch+manther+sterinject |
Primary outcome
Sick leave
Time frame: 2 years
2 secondary outcomes
Disability
Time frame: 10 weeks
Pain
Time frame: 10 weeks
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 18 Jun 2009.
- Results publication: PubMed 15389174Grunnesjo MI, Bogefeldt JP, Svardsudd KF, Blomberg SI. A randomized controlled clinical trial of stay-active care versus manual therapy in addition to stay-active care: functional variables and pain. J Manipulative Physiol Ther. 2004 Sep;27(7):431-41. doi: 10.1016/j.jmpt.2004.06.001.
- Results publication: PubMed 16901354Grunnesjo M, Bogefeldt J, Blomberg S, Delaney H, Svardsudd K. The course of pain drawings during a 10-week treatment period in patients with acute and sub-acute low back pain. BMC Musculoskelet Disord. 2006 Aug 11;7:65. doi: 10.1186/1471-2474-7-65.
- Results publication: PubMed 17578820Bogefeldt J, Grunnesjo M, Svardsudd K, Blomberg S. Diagnostic differences between general practitioners and orthopaedic surgeons in low back pain patients. Ups J Med Sci. 2007;112(2):199-212. doi: 10.3109/2000-1967-194.
- Results publication: PubMed 18511533Bogefeldt J, Grunnesjo MI, Svardsudd K, Blomberg S. Sick leave reductions from a comprehensive manual therapy programme for low back pain: the Gotland Low Back Pain Study. Clin Rehabil. 2008 Jun;22(6):529-41. doi: 10.1177/0269215507087294.
- Derived from this study: PubMed 21831926Grunnesjo MI, Bogefeldt JP, Blomberg SI, Strender LE, Svardsudd KF. A randomized controlled trial of the effects of muscle stretching, manual therapy and steroid injections in addition to 'stay active' care on health-related quality of life in acute or subacute low back pain. Clin Rehabil. 2011 Nov;25(11):999-1010. doi: 10.1177/0269215511403512. Epub 2011 Aug 10.
- Department of Public Health and Caring SciencesLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stay-active care, Stay-active care+stretching and Stay-active+stretching+manual therapy in people with Subacute Low Back Pain, run by Uppsala University at 1 site in Sweden.
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 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 18 Jun 2009. 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 Sweden. 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?
Sick leave (time frame: 2 years). 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 NCT00923429, which also lists 5 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 18 Jun 2009.