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MOS
Sponsor study identifier
observational
70
1 country
1
Study Start
December 1, 2018
Actual (reported)Primary Completion
December 15, 2020
Actual (reported)Study Completion
December 15, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 3, 2016
Actual (reported)April 11, 2017
Actual (reported)December 1, 2018
Actual (reported)December 15, 2020
Actual (reported)December 15, 2021
Actual (reported)Pain level
Self-assessed pain for the last 24 hours on NRS Numeric Rating Scale (0-10) . A successful outcome will be defines as \>2 measured on NRS. This cut off was previously used in a smaller study of prognosis following an exercise intervention
Change from baseline to 6 months and to 12 months
Disability
Disability will be measured using Oswestry Disability Questionnaire (0-100). A successful outcome will be defines as \>20 measured on ODI. This cut off was previously used in a smaller study of prognosis following an exercise intervention
Change from baseline to 6 months and to 12 months
Generic health-related quality of life
Change from baseline to 6 months and to 12 months
Fear Avoidance Behavior
Change from baseline to 6 months and to 12 months
Self-efficacy in relation to activity
Change from baseline to 6 months and to 12 months
Expectation with treatment
Measured at baseline
Satisfaction with treatment and with outcome
Measured at 8 weeks and at 12 months
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients seeking primary health care (physiotherapy), for a primary complaint of LBP with/without leg-pain will be included. This recruitment strategy is used to ensure a broad representation of patients. Participants may be referred by general practitioner or specialist physicians or else self-referred. Participants are included regardless of symptom duration, as this will typify the clinical primary health care setting. LBP is for the present trial defined as dominant symptoms between the lower thoracic (T12) and the gluteal fold region, and/or dominant symptoms in the lower extremity due to LBP as defined using Glassman score.
Rehabtjänst
Stockholm, 11228, Sweden
Eva Rasmussen Barr, PhD
Karolinska Instiutet
70 participants (actual enrollment reported by the registry).
First Submitted
August 3, 2016
First Posted
April 11, 2017
Study Start
December 1, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 15, 2020
Actual (reported)Study Completion
December 15, 2021
Actual (reported)Last Updated
March 15, 2022
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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