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

NCT03108339 | Completed

• 1 other identifier: EUROSPINE 2016_21
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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

Interventions

Guideline recommended physiotherapy care OTHER

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.

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Males and females above 16 years of age reporting pain of at least 2/10 on a Numeric Pain Rating Scale (NPRS) sufficient to cause them to modify their activities of daily living, and seeking care for LBP, ability to read and speak the Swedish language.

You may not qualify if:

• Participants are excluded if they have serious spinal pathology (i.e. fracture, metastatic disease), neurological disorders, severe spinal structural deformity, previous lower back surgery, pregnancy or other diagnoses that would require modification of the examination.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Rehabtjänst

Stockholm, 11228, Sweden

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eva Rasmussen Barr, PhD

  Karolinska Instiutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: April 11, 2017
• Study Start: December 1, 2018
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

SE (1)