GLA:D® Back: Patient Education and Exercises for Self-management of Back Pain

Back Pain, Low Clinical Trial

Official title:

GLA:D® Back: Implementation of Group-based Patient Education and Exercises to Support Self-management of Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03570463
• Other study ID #: DPA 2015-57-0008 SDU 17/30591
• Status: Recruiting
• Start date: April 11, 2018
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: University of Southern Denmark
• Contact: Alice Kongsted, PhD
• Phone: +4565504531
• Email: akongsted[@]health.sdu.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The GLA:D Back project evaluates the implementation of standardised patient education and exercise therapy for people with persistent or recurrent low back pain (LBP) in a hybrid implementation-effectiveness design. This involves evaluating the process of implementation as well as clinician level outcomes and patient level outcomes.

GLA:D (Good Life with OsteoArthritis in Denmark) is a non-profit initiative and registered trademark from the University of Southern Denmark. It educates clinicians in delivering evidence-based care for musculoskeletal health conditions and registers outcomes in a clinical registry. GLA:D Back uses only the acronym.

The main activity of the implementation strategy is a two-days course for physiotherapists and chiropractors in delivering patient education and exercise therapy that is aimed at supporting patient self-management of LBP. This comes with ready-to-use patient education materials and exercise programs. The course is targeted at chiropractors and physiotherapists, but any health care provider authorised to treat patients with back pain in Denmark can participate, i.e. medical doctors, physiotherapists and chiropractors.

The clinical intervention is a group-based program consisting of two sessions of patient education and 8 weeks of supervised exercises. The program uses a cognitive-behavioural approach and the aim of the exercise component is to restore the patient's ability and confidence to move freely. Clinicians decide which patients are offered the program.

The implementation process is evaluated in a dynamic process monitoring the penetration, adoption and fidelity of the clinical intervention.

The education of clinicians is evaluated via clinician-level outcomes concerning attitudes towards back pain and confidence in managing people with LBP.

The clinical intervention and potential effect mechanisms are evaluated at the patient-level in an observational design. Patients who are participating in the GLA:D Back program are followed using measures of knowledge, skills, beliefs, performance, self-efficacy and success in self-management.

Effects at a national level will be investigated via data from national registries of health care utilisation and sick-leave. Patient- and clinician reported data are collected in a registry.

Description:

The clinician training courses are open to all interested authorised back pain clinicians practicing in Denmark. The study evaluates courses conducted in 2018 which involves one or two courses for clinicians in each of five Danish regions.

The adoption of GLA:D Back is investigated by measuring the extent to which clinicians who have participated in the GLA:D Back course conduct the program in their clinics. Reach of the patient target group is determined by asking clinicians about the degree to which patients offered the treatment accept this. Fidelity with the program is investigated quantitatively by asking about treatment content and recall of key messages via patient questionnaires, and by ensuring that patients' individual goals are registered. The quality of care in terms of delivering the key elements of the intervention will be further explored qualitatively.

The profile of patients enrolled in the GLA:D Back programme will be compared between clinics and administrative regions.

Clinician level effects are investigated in an observational longitudinal design with clinician reported data collected before the clinician training course, immediately after the course and 4 months later, and with patient-reported information on delivery collected at their three-months follow up. Indicators of implementation are registration of patients in the GLA:D Back registry and that patients report receiving the educational components of care and supervised exercises. Orientation towards treatment of LBP and confidence in managing patients with LBP are evaluated by clinicians' answers to standardised questionnaires.

Patient level outcomes are aimed at investigating changes in knowledge, beliefs and skills related to the LBP condition which is hypothesized to lead to improved self-efficacy. The initial measures are related to knowledge skills, beliefs and performance, the next line of outcomes to self-efficacy, then daily activities and quality of life and last health care utilisation and work ability.

The compliance with the program is evaluated by patient report of the number of patient education sessions and exercise sessions attended.

The registry is delivered by Odense Patient data Explorative Network (OPEN) at University of Southern Denmark and uses REDCap (Vanderbilt University) as the platform for data collection. Clinicians are registered when signing up for the GLA:D Back course and agreeing to participate in research. Patients are registered by the clinician and have links to patient questionnaires sent to their email before beginning the GLA:D Back program and after 3, 6 and 12 months if consenting to their data being used for research.

Rather than testing effects on one primary outcome, the study evaluates the implementation process and a number of outcomes based on a logical model of change.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

The decision to invite a patient to participate in the GLA:D Back program is at the discretion of the clinician. Clinicians are taught that the program was developed for people with persistent or recurrent low back pain and a need for improved self-management

Exclusion Criteria:

Back pain related to specific spinal or systemic pathology, signs of acute nerve root involvement

Related Conditions & MeSH terms

• Back Pain
• Back Pain, Low
• Low Back Pain

Intervention

Behavioral:
• GLA:D Back
The intervention aims at improving the participant's ability to self-manage low back pain (LBP). The content is based on a cognitive behavioural approach aimed at supporting pain self-efficacy. An individual session at the beginning and the end of the group sessions involve goal-setting and physical tests. Key messages of the patient education include that pain is not a sign of danger and back pain is explained using a behavioural model of (im)balance between demands and capacity rather than emphasising tissue damage. The exercises aim at restoring natural variation in movement and provides guidance for patients in exploring movement rather than teaching exercises in only one correct manner.

Locations

Country	Name	City	State
Denmark	University of Southern Denmark (central unit)	Odense

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (8)

Joern L, Kongsted A, Thomassen L, Hartvigsen J, Ravn S. Pain cognitions and impact of low back pain after participation in a self-management program: a qualitative study. Chiropr Man Therap. 2022 Feb 21;30(1):8. doi: 10.1186/s12998-022-00416-6. — View Citation

Kjaer P, Kongsted A, Ris I, Abbott A, Rasmussen CDN, Roos EM, Skou ST, Andersen TE, Hartvigsen J. GLA:D(R) Back group-based patient education integrated with exercises to support self-management of back pain - development, theories and scientific evidence. BMC Musculoskelet Disord. 2018 Nov 29;19(1):418. doi: 10.1186/s12891-018-2334-x. — View Citation

Kongsted A, Hartvigsen J, Boyle E, Ris I, Kjaer P, Thomassen L, Vach W. GLA:D(R) Back: group-based patient education integrated with exercises to support self-management of persistent back pain - feasibility of implementing standardised care by a course for clinicians. Pilot Feasibility Stud. 2019 May 9;5:65. doi: 10.1186/s40814-019-0448-z. eCollection 2019. — View Citation

Kongsted A, Ris I, Kjaer P, Vach W, Morso L, Hartvigsen J. GLA:D(R) Back: implementation of group-based patient education integrated with exercises to support self-management of back pain - protocol for a hybrid effectiveness-implementation study. BMC Musculoskelet Disord. 2019 Feb 18;20(1):85. doi: 10.1186/s12891-019-2443-1. — View Citation

Morso L, Bogh SB, Ris I, Kongsted A. Mind the gap - Evaluation of the promotion initiatives for implementation of the GLA:D(R) back clinician courses. Musculoskelet Sci Pract. 2021 Jun;53:102373. doi: 10.1016/j.msksp.2021.102373. Epub 2021 Mar 27. — View Citation

Nim CG, Kongsted A, Downie A, Vach W. Temporal stability of self-reported visual back pain trajectories. Pain. 2022 Nov 1;163(11):e1104-e1114. doi: 10.1097/j.pain.0000000000002661. Epub 2022 Apr 25. — View Citation

Ris I, Boyle E, Myburgh C, Hartvigsen J, Thomassen L, Kongsted A. Factors influencing implementation of the GLA:D Back, an educational/exercise intervention for low back pain: a mixed-methods study. JBI Evid Implement. 2021 May 10;19(4):394-408. doi: 10.1097/XEB.0000000000000284. — View Citation

Ris I, Broholm D, Hartvigsen J, Andersen TE, Kongsted A. Adherence and characteristics of participants enrolled in a standardised programme of patient education and exercises for low back pain, GLA:D(R) Back - a prospective observational study. BMC Musculoskelet Disord. 2021 May 22;22(1):473. doi: 10.1186/s12891-021-04329-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT)	Clinician reported 19-item scale. Two subscales: biomedical orientation and behavioural orientation are scored	Change from before course participation to 4 months
Other	Practitioner Confidence Scale (PCS)	Clinician reported 4-item scale plus two items added to capture confidence about using a behavioral pain model	Change from before course participation to 4 months
Other	The Determinants of Implementation Behavior Questionnaire (DIBQ)	Clinician level measure of the implementation process. Thirty-one items from the domains of knowledge, skills, beliefs about capability, beliefs about consequences, innovation, patients, intentions, organisation, social influences, social context, behavioural regulation, and innovation strategy	Immediately after curse participation and 4 months
Other	Adoption	Proportion of clinicians participating in a GLA:D Back course that delivers the program	Within 6 months
Other	Patients participation	Clinician reported proportion of invited patients who decide to participate	4 months
Other	Patient compliance	Proportion of patients enrolled in GLA:D Back that complete the program	3 months
Primary	Brief Illness Perceptions Questionnaire (B-IPQ)	Nine items covering the constructs of consequences, timeline (expectations of prognosis), personal control, treatment control, identity (extent of symptoms), coherence (understanding of symptoms), emotional representation, concerns, and cause. Each of the items 1 to 8 are scored 0 - 10. If internal consistency allows so a sum score is calculated (0-80). Cause is registered as text.	Change from baseline to 3 months
Primary	Fear Avoidance Beliefs Questionnaire (FABQ)	FABQ physical activity subscale (0 = no fear avoidance beliefs; 24 = highest possible fear avoidance)	Change from baseline to 3 months
Primary	The Arthritis Self-efficacy (ASES)	ASES subscales of pain and other symptoms. Each item is scored on a 0 - 10 scale (0 = very uncertain; 10 = very certain)	Change from baseline to 6 months
Primary	Quality of Life (General health)	The 36-Item Short Form Health Survey (SF-36 item1); 5-point likert scale	Proportions in response categories baseline to 12 months
Primary	Quality of Life (Social functioning)	The 36-Item Short Form Health Survey (SF-36) subdomain social functioning, transformed score 0-100	Change from baseline to 12 months
Primary	Quality of Life (Mental functioning)	The 36-Item Short Form Health Survey (SF-36) subdomain mental functioning, transformed score 0-100	Change from baseline to 12 months
Primary	General Health	Health thermometer from Eq-5D, score 0= worst imaginable to 100= best imaginable	Change from baseline to 12 months
Primary	Health care visits primary care	Number of primary care visits from national registries	During 12 months after participation
Primary	Health care visits hospital	Number of hospital visits due to LBP from national registries	During 12 months after participation
Primary	Imaging	x-rays, MRI and CT-scans of lower back from national registries	During 12 months after participation
Primary	Pain medication	Prescriptions of pain medication from national registries	During 12 months after participation
Secondary	Confidence with exercises	How confident are you in performing exercises in a beneficial way?' (0-10 scale from 'not confident at all' to 'absolutely confident')	Change from baseline to 3 months
Secondary	Self-assessed physical capacity	Self-assessed physical fitness visual analogue scales on perceived strength, endurance, flexibility, balance, and moving unhindered as compared with that of other people of the same age and sex. Each item is scored on a 9-point scale (1 = poor; 5 = average; 9 = super). Each item is treated as one subscale	Change from baseline to 3 months
Secondary	Satisfaction with care	Overall satisfaction with care (5-point Likert scale; 0 = Not at all satisfied, 5 = Extremely satisfied)	3 months
Secondary	Patient reported harms or side effects	Text description of any side effects or problems experienced in relation to the participation in GLA:D Back.	3 months
Secondary	Oswestry Disability Index	Ten items, sum score 0 - 50 recalculated to 0-100 (0 = No disability; 100 = Maximum disability)	Change from baseline to 3, 6, 12 months
Secondary	Pain Intensity	Numeric Rating Scale 0-10 for typical back pain last week (0 = no pain; 10 = worst imaginable pain)	Change from baseline to 3, 6, 12 months
Secondary	Work ability	Number of days off work after 1 month of absenteeism available from the 'DREAM' registry from the Danish Ministry of Employment	During 12 months after participation
Secondary	Brief Illness Perceptions Questionnaire (B-IPQ)	Nine items covering the constructs of consequences, timeline (expectations of prognosis), personal control, treatment control, identity (extent of symptoms), coherence (understanding of symptoms), emotional representation, concerns, and cause. Each of the items 1 to 8 are scored 0 - 10. If internal consistency allows so a sum score is calculated (0-80). Cause is registered as text.	Change from baseline to 6, 12 months
Secondary	Fear Avoidance Beliefs Questionnaire (FABQ)	FABQ physical activity subscale (0 = no fear avoidance beliefs; 24 = highest possible fear avoidance)	Change from baseline to 6, 12 months
Secondary	The Arthritis Self-efficacy (ASES)	ASES subscales of pain and other symptoms. Each item is scored on a 0 - 10 scale (0 = very uncertain; 10 = very certain)	Change from baseline to 3, 12 months
Secondary	Quality of Life (General Health)	The 36-Item Short Form Health Survey (SF-36 item 1),5-point Likert scale	Proportions in response categories baseline to 3, 6 months
Secondary	Quality of Life (Social functioning)	The 36-Item Short Form Health Survey (SF-36) subdomains social functioning, transformed score 0-100	Change from baseline to 3, 6 months
Secondary	Quality of Life /Mental functioning)	The 36-Item Short Form Health Survey (SF-36) subdomains of mental functioning, transformed score 0-100	Change from baseline to 3, 6 months

External Links

•   Data management plan
•   Odense Patient data Explorative Network
•   Project website