Chronic Low Back Pain, Persistent Low Back Pain, Recurrent Low Back Pain
Conditions
Brief summary
As low back pain is often a recurrent and sometime persistent problem, research into prevention is important. Chiropractors have traditionally treated patients with maintenance care, which means that patients are seen on a regular basis to prevent recurrences or to stop a persistent problem getting worse. However, it is not known if this has the expected effect. This study will test the effectiveness of the maintenance care approach. Patients with recurrent or persistent low back pain will be treated in accordance with two different models. The first model is the maintenance care model, meaning that chiropractors will see the patient on a regular basis, regardless symptoms. The other model means that patients should be treated patients only when they themselves experience symptoms bad enough to seek care. After one year, it will be possible to see if there has been any difference between the groups in terms of pain, disability, quality of life and total number of treatments over the study period and to investigate if there is any difference in the cost-effectiveness between the two treatment models.Thus, the study hypothesis is that there is no difference between the two models regarding the number of days with pain. This study will be a multi-centre trial, and as part of the study, it will be necessary to formalize a network of research clinics all over Sweden in which participating chiropractors accept to perform complex data collection. This network will then have the expertise and potential to perform future clinical studies together with networks in other countries, allowing large clinical trials across countries.
Interventions
OTHERmaintenance care
Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor
OTHERTreatment as needed
Participants may never receive treatment, there is no upper limit
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* non-specific low back pain \> 30 days previous year * non-specific low back pain with previous episodes * age 18-65 * access to a mobile phone * knowledge of how to text message * proficiency in the Swedish language * must rate themselves as definitely improved by the 4th visit
Exclusion criteria
* pregnancy * contraindication to spinal manipulative therapy * liability issues
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days With Bothersome Low Back Pain | 12 months | Participants will report their number of days with bothersome low back pain via text message (SMS) on a weekly basis for 52 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness | 12 months | Cost-effectiveness will be based on Quality Adjusted Life Years calculated through the use of the Euroqol-5 instrument, these results are not yet published |
Countries
Sweden
Participant flow
Recruitment details
Patients with persistent or recurrent LBP were screened for eligibility in a stepwise manner (at Baseline 1, Baseline 2 and inclusion visit). The study started at the inclusion visit, when the initial treatment plan was completed when the clinician perceived that the patient's next visit could be scheduled with an interval of 1 month or longer, at which patients were randomly allocated to one of the treatment arms. Recruitment lasted from 2012 to 2016, in 40 Swedish chiropractic clinics.
Pre-assignment details
Some individuals were lost in the inclusion process: At the 4th visit (baseline 2) a total of 616 subjects were screened for definite improvement, where 176 subjects were excluded from the trial. At the inclusion visit, 328 subjects were randomized into the trial, thus another 112 subjects were lost for unknown reasons.
Participants by arm
| Arm | Count |
|---|---|
| Treatment at Regular Intervals Participants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management
maintenance care: Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor | 164 |
| Treatment as Needed Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration
Treatment as needed: Participants may never receive treatment, there is no upper limit | 160 |
| Total | 324 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 |
Baseline characteristics
| Characteristic | Treatment as Needed | Total | Treatment at Regular Intervals |
|---|---|---|---|
| Age, Continuous | 43.0 years STANDARD_DEVIATION 13.1 | 43.3 years STANDARD_DEVIATION 12.4 | 43.4 years STANDARD_DEVIATION 11.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Sweden | 160 participants | 324 participants | 164 participants |
| Sex: Female, Male Female | 85 Participants | 181 Participants | 96 Participants |
| Sex: Female, Male Male | 56 Participants | 110 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 164 | 0 / 160 |
| other Total, other adverse events | 43 / 164 | 40 / 160 |
| serious Total, serious adverse events | 0 / 164 | 0 / 160 |
Outcome results
Primary
Number of Days With Bothersome Low Back Pain
Participants will report their number of days with bothersome low back pain via text message (SMS) on a weekly basis for 52 weeks.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment at Regular Intervals | Number of Days With Bothersome Low Back Pain | 85.2 Number of days with bothersome pain |
| Treatment as Needed | Number of Days With Bothersome Low Back Pain | 98 Number of days with bothersome pain |
Secondary
Cost-effectiveness
Cost-effectiveness will be based on Quality Adjusted Life Years calculated through the use of the Euroqol-5 instrument, these results are not yet published
Time frame: 12 months