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Markers of Outcome - a Cohort Study of LBP in Primary Health Care

NCT03108339 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2022-03-15

No results posted yet for this study

Summary

Low-back pain (LBP) is a complex and heterogeneous disorder commonly seen in primary health care. Despite a variety of treatment options available, it seems that few of these prevent recurrent LBP and chronicity. In addition, when comparing different treatment options, effect sizes are not impressive, indicating that we either lack effective treatment for LBP, diagnose poorly or that we measure the outcome of treatment incorrectly. Sub groups within the heterogeneous group suffering from LBP need to be identified and also markers influencing treatment efficacy. The project aims to conduct a cohort study with the objective to identify prognostic markers and sub groups for a successful or poor outcome of low-back pain and disability in short and long term. We aim to follow the trajectory of pain, to study interactions of markers and associations with days of pain and activity level. We will include people seeking physiotherapy care for a primary complaint of LBP to collect data on a core set of outcome measurements concerning pain, functional limitations, health and quality of life, self- efficacy and fear avoidance. The data will be collected at baseline, at 8 weeks and 6 and 12 months following an intervention of guideline recommended physiotherapeutic care comprising information to "stay active" and exercises enhancing core stability supervised by experienced physiotherapist. We aim to collect data on movement control of the lower back and general excessive mobility of the joints at base line. We will collect longitudinal data on days with troublesome pain and activity level through text-messages sent every 2 weeks. We will analyze the data with mixed model regression analyses and cluster analyses to be able to identify predictive factors and interactions to sub group the participants.

Conditions

  • Low-back Pain

Interventions

OTHER

Guideline recommended physiotherapy care

The intervention will follow current care i.e. guideline informed intervention used by physiotherapists in the treatment of LBP in primary health care. The intervention will use a pragmatic approach and follow a framework of: 1) information of return to activity and to stay active 2) instruction on posture in loaded and unloaded positions 3) information on work and leisure based positions in activity and sitting 4) information on good sleeping position 4) instruction of an individualized exercise program based on findings from the examination enhancing core control 5) a choice of exercises as a home training program. Manual methods may if necessary be used. Choice of treatment, choice of exercises (loaded, unloaded) and also number of treatments is logged and noted.

Sponsors & Collaborators

Principal Investigators

  • Eva Rasmussen Barr, PhD · Karolinska Instiutet

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2020-12-15
Completion
2021-12-15

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03108339 on ClinicalTrials.gov