MyBack - A Behavior Change Informed Exercise Program to Prevent Low Back Pain Recurrences (MyBack)

MyBack - Effectiveness and Implementation of a Behavior Change Informed Exercise Program to Prevent Low Back Pain Recurrences: a Hybrid Effectiveness-implementation Randomized Controlled Study

Low Back Pain is a common heath condition with high rates of recurrence and huge associated costs. Research has focused its efforts on analysing the effects of interventions while knowledge about effective secondary prevention strategies is limited. MyBack study aims to analyse the effectiveness of a tailored exercise and behavioural change program (MyBack program) in the secondary prevention of low back pain, and evaluate acceptability, feasibility and determinants of implementation by the different stakeholders, as well as the implementation strategy of the MyBack program, through a hybrid type I, randomized, controlled and multicentre study of effectiveness and implementation in the context of primary health care.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Usual Care; Other: MyBack Program

• Study Type: Interventional
• Enrollment (Anticipated): 186
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eduardo Cruz, PhD; Phone Number: +365 265 709 300; Email: eduardo.cruz@ess.ips.pt

Study Locations

• Portugal
  • Setúbal, Portugal, 2914-503
    • Recruiting
    • Instituto Politécnico de Setúbal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Recovered (within the last 3 months) from an episode of non-specific LBP (with or without leg pain and of any duration)
• Recovery from an LBP episode is defined as having a pain score of "0" or "1" on a 11-point Numeric Pain Rating Scale for, at least, 30 consecutive days
• Age between 18 and 65 years;
• Read and speak the Portuguese language;
• Having a mobile phone capable of receiving and sending text messages;
• No medical contraindication to exercise.

Exclusion Criteria:

• Diagnosis, or symptoms consistent with, severe depression or other psychiatric condition,
• Pregnancy
• Spinal surgery in the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual Care; Participants allocated to the usual care group will be informed that they can access their GP in the usual way (GPs consultation, pain medication, referral for other treatments/ services) and that they should contact their GP if their condition worsens. In addition, they will receive a minimal educational intervention focused on symptom management and promotion of physical activity ("stay active").	Other: Usual Care; Education; Pain Medication, imaging, referrals to other health services, other health care appointments; Other Names: Minimal intervention
Experimental: MyBack; Patients in the MyBack group will participate in a patient-centred, tailored exercise programme informed by a behavioural change approach in addition to receiving usual care. The MyBack intervention programme will consist of 12 bi-weekly sessions (60 minutes each) over 6 weeks complemented by 12 exercise sessions to be carried out autonomously by the participants over the following 6 weeks	Other: Usual Care; Education; Pain Medication, imaging, referrals to other health services, other health care appointments; Other Names: Minimal intervention; Other: MyBack Program; A tailored exercise and behavioural change program; Other Names: Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of low back pain recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.	1 month after baseline
Risk of low back pain recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.	2 months after baseline
Risk of low back pain recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.	3 months after baseline
Risk of low back pain recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.	4 months after baseline
Risk of low back pain recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.	5 months after baseline
Risk of low back pain recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.	6 months after baseline
Risk of low back pain recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.	7 months after baseline
Risk of low back pain recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.	8 months after baseline
Risk of low back pain recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.	9 months after baseline
Risk of low back pain recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.	10 months after baseline
Risk of low back pain recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.	11 months after baseline
Risk of low back pain recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected.	12 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity will be measured with a 11-point Numeric Pain Rating Scale. Total scores range from 0 to 10, with higher scores indicating higher levels of pain.	Baseline, 3, 6 and 12 months after baseline
Functional Disability	Functional Disability will be measured through the Roland Morris Disability Questionnaire (RMDQ). Total scores range from 0 to 24, with higher scores indicating higher levels of functional disability.	Baseline, 3, 6 and 12 months after baseline
Musculoskeletal Health	Musculoskeletal Health will be measured through the Musculoskeletal Health Questionnaire (MSK-HQ). Total scores range from 0 to 56, with higher scores indicating higher levels of musculoskeletal health.	Baseline, 3, 6 and 12 months after baseline
Health-related quality of life	Health-related Quality of life (HRQoL) will be measured by the EuroQuol 5 dimensions, 5 levels questionnaire. Total scores range from 0 to 1, with higher scores indicating higher levels of health-related quality of life.	Baseline, 3, 6 and 12 months after baseline
Medical appointments for a low back pain recurrence	The number of primary care visits to the General Practitioner for a low back pain recurrence, for each participant, will be collected from the local medical records	3, 6, 9 and 12 months after baseline
Imaging tests prescribed related with a low back pain recurrence	The number of x-rays, MRI and CT-scans of lower back will be collected for each participant from the local medical records	3, 6, 9 and 12 months after baseline
Pain medication for low back pain recurrence	The number and name of the medication prescribed will be collected for each participant from the local medical records	3, 6, 9 and 12 months after baseline
Referral to other interventions and sickness certificates	Referral to other interventions or to other medical specialities or services or sickness certificates will be recorded will be collected for each participant from the local medical records.	3, 6, 9 and 12 months after baseline
Impact of LBP recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.	1 month after baseline
Impact of LBP recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.	2 months after baseline
Impact of LBP recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.	3 months after baseline
Impact of LBP recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.	4 months after baseline
Impact of LBP recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.	5 months after baseline
Impact of LBP recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.	6 months after baseline
Impact of LBP recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.	7 months after baseline
Impact of LBP recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.	8 months after baseline
Impact of LBP recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.	9 months after baseline
Impact of LBP recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.	10 months after baseline
Impact of LBP recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.	11 months after baseline
Impact of LBP recurrence	Participants will receive a text message with a yes/no question regarding low back pain recurrence. The number of participants with a recurrence of low back pain, defined as the return of LBP with a minimum duration of 24 hours, with a pain intensity ≥2 on an 11-point numerical scale, preceded by a minimum period of 30 days without pain, will be collected. In the presence of a LBP recurrence, pain intensity (11-point Numeric Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire), care seeking (number of primary care visits, imaging tests prescribed and pain medication) and work status (sick leave: yes/no) will be collected by telephone.	12 months after baseline

Collaborators and Investigators

• Sponsor: Instituto Politécnico de Setúbal
• Collaborators: Universidade Nova de Lisboa
• Investigators: Principal Investigator: Eduardo Cruz, PhD, Instituto Politécnico de Setúbal

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Low back pain; Primary health care; Behaviour change; Recurrences
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Back Pain; Low Back Pain; Recurrence
• Other Study ID Numbers: PTDC/SAU-SER/7406/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No