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

NCT03570463 | Unknown

• 1 other identifier: DPA 2015-57-0008 SDU 17/30591
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Back Pain, Low

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• General Health

  Health thermometer from Eq-5D, score 0= worst imaginable to 100= best imaginable

  Change from baseline to 12 months

• Health care visits primary care

  Number of primary care visits from national registries

  During 12 months after participation

• Health care visits hospital

  Number of hospital visits due to LBP from national registries

  During 12 months after participation

• Imaging

  x-rays, MRI and CT-scans of lower back from national registries

  During 12 months after participation

• Pain medication

  Prescriptions of pain medication from national registries

  During 12 months after participation

Secondary Outcomes (13)

• Confidence with exercises

  Change from baseline to 3 months

• Self-assessed physical capacity

  Change from baseline to 3 months

• Satisfaction with care

  3 months

• Patient reported harms or side effects

  3 months

• Oswestry Disability Index

  Change from baseline to 3, 6, 12 months

Other Outcomes (6)

• The Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT)

  Change from before course participation to 4 months

• Practitioner Confidence Scale (PCS)

  Change from before course participation to 4 months

• The Determinants of Implementation Behavior Questionnaire (DIBQ)

  Immediately after curse participation and 4 months

Study Arms (1)

GLA:D Back

Two 1-hour group sessions of patient education 8 weeks of twice-weekly 1-hour supervised group exercise sessions

Behavioral: GLA:D Back

Interventions

GLA:D Back BEHAVIORAL

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.

GLA:D Back

Eligibility Criteria

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

Study Population

Participants are people consulting a physiotherapist or chiropractor who are trained in the GLA:D Back program. The decision to enrol a patient in GLA:D Back is at the discretion of the clinician in a dialogue with the patient, when clinicians judge that the patient would benefit from improved self-management skills

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

University of Southern Denmark (central unit)

Odense, 5230, Denmark

RECRUITING

Related Publications (8)

• 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.

  PMID: 30497440 BACKGROUND

• 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.

  PMID: 31086676 BACKGROUND

• 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.

  PMID: 30777049 BACKGROUND

• 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.

  PMID: 33965996 BACKGROUND

• 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.

  PMID: 33823485 BACKGROUND

• 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.

  PMID: 34022826 BACKGROUND

• 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.

  PMID: 35189908 BACKGROUND

• 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.

  PMID: 35467586 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Alice Kongsted, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Kongsted, PhD

CONTACT

+4565504531; akongsted@health.sdu.dk

Jan Hartvigsen, PhD

CONTACT

+4565504522; jhartvigsen@health.sdu.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor wsr

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 27, 2018
• Study Start: April 11, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 5, 2023

Record last verified: 2023-11

Locations

DK (1)