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N/A N=328 Randomized Double-blind Prevention

Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain

Recurrent Low Back Pain · Persistent Low Back Pain · Chronic Low Back Pain

Enrolled (actual)
328
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Number of Days With Bothersome Low Back Pain — 85.2; 98 Number of days with bothersome pain

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
maintenance care (Other); Treatment as needed (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Karolinska Institutet
Primary completion
Aug 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Days With Bothersome Low Back Pain
85.2; 98
SECONDARY
Cost-effectiveness

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01539863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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