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

Low Back Pain Clinical Trial

— MyBack  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05841732
• Other study ID #: PTDC/SAU-SER/7406/2020
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Instituto Politécnico de Setúbal
• Contact: Eduardo Cruz, PhD
• Phone: +365 265 709 300
• Email: eduardo.cruz[@]ess.ips.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Recurrence

Intervention

Other:
• Usual Care
Education; Pain Medication, imaging, referrals to other health services, other health care appointments
• MyBack Program
A tailored exercise and behavioural change program

Locations

Country	Name	City	State
Portugal	Instituto Politécnico de Setúbal	Setúbal

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Politécnico de Setúbal	Universidade Nova de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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