Back Pain, LowNCT03570463
GLA:D® Back: Patient Education and Exercises for Self-management of Back Pain
An observational study of Back Pain, Low, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain, Low
- What is being tested?
- GLA:D Back
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Apr 2018to Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Back pain related to specific spinal or systemic pathology, signs of acute nerve root involvement
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University of Southern Denmark (central unit)
Odense, 5230
Alice R Kongsted, PhD, +4565504531, akongsted@health.sdu.dk
Anne Marie Rosager, gladryg@sdu.dk
About this study
Official title: GLA:D® Back: Implementation of Group-based Patient Education and Exercises to Support Self-management of Back Pain
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.
Read more
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.
Read the detailed 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.
- Conditions
- Back Pain, Low
- Being tested
- GLA:D Back
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLA:D BackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| GLA:D Back | Two 1-hour group sessions of patient education 8 weeks of twice-weekly 1-hour supervised group exercise sessions Receives: Behavioral: GLA:D Back |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline to 12 months
General Health
Health thermometer from Eq-5D, score 0= worst imaginable to 100= best imaginable
Measured: Change from baseline to 12 months
Health care visits primary care
Number of primary care visits from national registries
Measured: During 12 months after participation
Health care visits hospital
Number of hospital visits due to LBP from national registries
Measured: During 12 months after participation
Imaging
x-rays, MRI and CT-scans of lower back from national registries
Measured: During 12 months after participation
Pain medication
Prescriptions of pain medication from national registries
Measured: During 12 months after participation
Secondary outcomes (13)
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')
Measured: Change from baseline to 3 months
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
Measured: Change from baseline to 3 months
Satisfaction with care
Overall satisfaction with care (5-point Likert scale; 0 = Not at all satisfied, 5 = Extremely satisfied)
Measured: 3 months
Patient reported harms or side effects
Text description of any side effects or problems experienced in relation to the participation in GLA:D Back.
Measured: 3 months
Oswestry Disability Index
Ten items, sum score 0 - 50 recalculated to 0-100 (0 = No disability; 100 = Maximum disability)
Measured: Change from baseline to 3, 6, 12 months
Pain Intensity
Numeric Rating Scale 0-10 for typical back pain last week (0 = no pain; 10 = worst imaginable pain)
Measured: Change from baseline to 3, 6, 12 months
Work ability
Number of days off work after 1 month of absenteeism available from the 'DREAM' registry from the Danish Ministry of Employment
Measured: During 12 months after participation
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.
Measured: Change from baseline to 6, 12 months
Fear Avoidance Beliefs Questionnaire (FABQ)
FABQ physical activity subscale (0 = no fear avoidance beliefs; 24 = highest possible fear avoidance)
Measured: Change from baseline to 6, 12 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)
Measured: Change from baseline to 3, 12 months
Quality of Life (General Health)
The 36-Item Short Form Health Survey (SF-36 item 1),5-point Likert scale
Measured: Proportions in response categories baseline to 3, 6 months
Quality of Life (Social functioning)
The 36-Item Short Form Health Survey (SF-36) subdomains social functioning, transformed score 0-100
Measured: Change from baseline to 3, 6 months
Quality of Life /Mental functioning)
The 36-Item Short Form Health Survey (SF-36) subdomains of mental functioning, transformed score 0-100
Measured: Change from baseline to 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start11 Apr 2018
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Back Pain, LowStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Kongsted, University of Southern Denmark
- Investigators
- Alice Kongsted, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570463
- Sponsor's protocol ID
- DPA 2015-57-0008 SDU 17/30591
- Status last verified
- Nov 2023
- First submitted
- 31 May 2018
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30497440Kongsted 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.
PubMed 31086676Kongsted 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.
PubMed 30777049Ris 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.
PubMed 33965996Morso 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.
PubMed 33823485Ris 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.
PubMed 34022826Joern 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.
PubMed 35189908Nim 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.
PubMed 35467586
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLA:D® Back: Implementation of Group-based Patient Education and Exercises to Support Self-management of Back Pain
- ClinicalTrials.gov ID
- NCT03570463
- Acronym / sponsor ID
- DPA 2015-57-0008 SDU 17/30591
- Conditions
- Back Pain, Low
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLA:D Back | – | Behavioral: GLA:D BackTwo 1-hour group sessions of patient education 8 weeks of twice-weekly 1-hour supervised group exercise sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Back pain related to specific spinal or systemic pathology, signs of acute nerve root involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLA:D BackThe 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. | Behavioural | GLA:D Back |
Primary outcome
Brief Illness Perceptions Questionnaire (B-IPQ)
Time frame: Change from baseline to 3 months
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.
Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: Change from baseline to 3 months
FABQ physical activity subscale (0 = no fear avoidance beliefs; 24 = highest possible fear avoidance)
The Arthritis Self-efficacy (ASES)
Time frame: Change from baseline to 6 months
ASES subscales of pain and other symptoms. Each item is scored on a 0 - 10 scale (0 = very uncertain; 10 = very certain)
Quality of Life (General health)
Time frame: Proportions in response categories baseline to 12 months
The 36-Item Short Form Health Survey (SF-36 item1); 5-point likert scale
Quality of Life (Social functioning)
Time frame: Change from baseline to 12 months
The 36-Item Short Form Health Survey (SF-36) subdomain social functioning, transformed score 0-100
Quality of Life (Mental functioning)
Time frame: Change from baseline to 12 months
The 36-Item Short Form Health Survey (SF-36) subdomain mental functioning, transformed score 0-100
General Health
Time frame: Change from baseline to 12 months
Health thermometer from Eq-5D, score 0= worst imaginable to 100= best imaginable
Health care visits primary care
Time frame: During 12 months after participation
Number of primary care visits from national registries
Health care visits hospital
Time frame: During 12 months after participation
Number of hospital visits due to LBP from national registries
Imaging
Time frame: During 12 months after participation
x-rays, MRI and CT-scans of lower back from national registries
Pain medication
Time frame: During 12 months after participation
Prescriptions of pain medication from national registries
13 secondary outcomes
Confidence with exercises
Time frame: Change from baseline to 3 months
Self-assessed physical capacity
Time frame: Change from baseline to 3 months
Satisfaction with care
Time frame: 3 months
Patient reported harms or side effects
Time frame: 3 months
Oswestry Disability Index
Time frame: Change from baseline to 3, 6, 12 months
Pain Intensity
Time frame: Change from baseline to 3, 6, 12 months
Work ability
Time frame: During 12 months after participation
Brief Illness Perceptions Questionnaire (B-IPQ)
Time frame: Change from baseline to 6, 12 months
Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: Change from baseline to 6, 12 months
The Arthritis Self-efficacy (ASES)
Time frame: Change from baseline to 3, 12 months
Quality of Life (General Health)
Time frame: Proportions in response categories baseline to 3, 6 months
Quality of Life (Social functioning)
Time frame: Change from baseline to 3, 6 months
Quality of Life /Mental functioning)
Time frame: Change from baseline to 3, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 30497440Kjaer 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.
- Background: PubMed 31086676Kongsted 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.
- Background: PubMed 30777049Kongsted 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.
- Background: PubMed 33965996Ris 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.
- Background: PubMed 33823485Morso 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.
- Background: PubMed 34022826Ris 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.
- Background: PubMed 35189908Joern 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.
- Background: PubMed 35467586Nim 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.
- Project websiteLink provided by the sponsor.
- Data management planLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Kongsted, PhD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain, Low, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alice Kongsted, PhD (+4565504531, akongsted@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Illness Perceptions Questionnaire (B-IPQ) (time frame: Change from baseline to 3 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03570463, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.