Stratified Primary Care for Low Back Pain

NCT04046874 | Completed

• 1 other identifier: SAICT-POL/23439
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

The SPLIT project evaluates the implementation of a stratified model of care for people with low back pain patients who consulted primary care.This involves evaluating the process of implementation as well as patient level outcomes. The project consists of two phases: First, a before-after study comprising two sequential but independent cohort studies will be conducted to compare the outcomes and cost-effectiveness of current practice with the SPLIT stratified model of care. Second, an implementation strategy will be developed based on the results of a survey regarding determinants of current practice, and two focus groups concerning the barriers and facilitators for the implementation of the SPLIT stratified model of care.

Conditions

Low Back Pain

Keywords

Low Back Pain; Risk-stratification; STarT Back; Patient outcomes; Cost-effectiveness;; Barriers and Facilitators

Outcome Measures

Primary Outcomes (1)

• Low back Pain Disability will be assessed through the Roland Morris Disability Questionnaire (RMDQ)

  The RMDQ consists of 24 items that measures the functional status over the past 24 hours in patients with LBP. Each answer can be scored "0" or "1", thus leaving a range of scores from 0 to 24, with higher scores indicating higher disability. The RMDQ has shown good validity and test-retest reliability with reported intraclass correlation coefficients (ICC) of 0.8 or more.

  Change on disability from baseline to 2 and 6 months

Secondary Outcomes (6)

• Pain intensity will be assessed through the Numeric Pain Rating Scale (NPRS)

  Change on pain intensity from baseline to 2 and 6 months

• Health related Quality of life (HRQoL) will be assessed by the EuroQuol 5 dimensions, 3 levels (EQ-5D-3L) questionnaire.

  Change on HRQoL from baseline to 2 and 6 months

• Patients perception of global change will be assessed by the questionnaire Global Perceived Effect Scale

  Global perception of change related with low back condition at 2 and 6 months follow-ups

• Number of medical appointments for a low back pain complaint

  The number of medical appointments concerning of each participant will be collected during the 6 months period after patient's enrollment

• The rate of imaging tests prescribed related with a low back pain complaint

  The number of imaging tests prescribed will be collected during the 6 months period after patient's enrollment

Study Arms (2)

Usual Care

OTHER

All patients were referred for the study by their General Practitioner (GP). GPs were encouraged to assess and treat their patients as usual and make all the referrals they think are appropriate for their patients.

Drug: Usual Care

Stratified Model of Care

OTHER

A subgrouping tool helps guide clinical decision-making about treatment and onward referral (Start Back Screening Tool). Patients in each subgroup (low, medium or high risk of chronicity) are then managed according to a targeted treatment system of increasing complexity.

Other: SPLIT Stratified Model of Care

Interventions

Usual Care DRUG

Pain Medication, imaging, referrals to other health services, other health care appointments

Also known as: Pain Medication

Usual Care

SPLIT Stratified Model of Care OTHER

Physiotherapy targeted treatment system of increasing complexity for each subgroup (low, medium or high) of risk of chronicity. Includes patient education, manual therapy and exercise

Also known as: Physiotherapy

Stratified Model of Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Low back Pain of any duration;
• Age between 18 and 65 years;
• Able to read and speak the Portuguese language.

You may not qualify if:

• Clinical signs of infection;
• Clinical signs of tumor;
• Clinical signs of osteoporosis;
• Clinical signs of fracture;
• Clinical signs of structural deformity;
• Clinical signs of inflammatory disorder;
• Clinical signs of radicular syndrome;
• Clinical signs of cauda equine syndrome;
• Clinical signs of severe depression or other psychiatric condition;
• Pregnant women;
• Patients that undergone a back surgery in the prior 6 months;
• Patients that received any type of conservative treatment in the prior 3 months.

Sponsors & Collaborators

• Instituto Politécnico de Setúbal: lead
• Universidade Nova de Lisboa: collaborator

Study Sites (1)

Instituto Politécnico de Setúbal

Setúbal, 2910-761, Portugal

Location

Related Publications (1)

• Cruz EB, Canhao H, Fernandes R, Caeiro C, Branco JC, Rodrigues AM, Pimentel-Santos F, Gomes LA, Paiva S, Pinto I, Moniz R, Nunes C. Prognostic indicators for poor outcomes in low back pain patients consulted in primary care. PLoS One. 2020 Mar 27;15(3):e0229265. doi: 10.1371/journal.pone.0229265. eCollection 2020.

  PMID: 32218561 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Acetaminophen; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Therapeutics; Rehabilitation

Study Officials

• Helena Canhão, PhD

  Epidoc Unit- Nova Medical School. Universidade Nova de Lisboa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Eduardo José Brazete Carvalho Cruz

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: March 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: February 24, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will became available after publication which is anticipated for no earlier than 30 of June 2020. From this date, data will remain available for a period of 3 years.
• Access Criteria: The data will be available on request.

Locations

PT (1)