Low Back PainNCT03141541
Pain Management for Patients With Low Back Pain and Psychosocial Risk Factors in a Hospital Setting.
A study testing Group based pain management intervention in people with Low Back Pain, run by Central Jutland Regional Hospital at 1 site in Denmark.
Trial summary
Patients with low back pain and coexisting psychosocial risk factors have a poorer prognosis in terms of quality of life, disability, sick leave and health care use. Despite existing literature showing that low back pain patients benefit from cognitive therapy interventions, this has not been investigated in subgroups… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Group based pain management intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2017to 1 May 2020
- Phase
- Interventional
- 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
Who may be able to join
- Non-specifick low back pain lasting ≥ 3 months
- Psychosocial risk profile defined as a fear avoidance score >24 (Örebro Musculoskeletal Pain Questionnaire) and/or a bodily distress score >15 (Common Mental Disorder Questionnaire) and/or health anxiety score >9 (Common Mental Disorder Questionnaire)
- Speaks and understands Danish
- Age ≥ 18 years
Who cannot join
- Inflammatory or malignant disease
- Spine surgery within the last year
- Untreated or severe depression
- Psychiatric course of treatment within the last year
- Abuse of drugs or alcohol
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Patient Education Focused on Pain Management Improve Disability, Pain Coping and Quality of Life in Patients With Low Back Pain and Psychosocial Risk Factors?
Patients with low back pain and coexisting psychosocial risk factors have a poorer prognosis in terms of quality of life, disability, sick leave and health care use. Despite existing literature showing that low back pain patients benefit from cognitive therapy interventions, this has not been investigated in subgroups of low back pain patients with psychosocial risk factors.
The purpose of the study is to investigate whether patients referred to secondary care with low back pain and coexisting psychosocial risk factors will have a better treatment outcome when participating in a pain management course in addition to usual care.
Read more
This will be investigated in a randomised study design, where 130 patients with chronic low back pain and psychosocial risk factors will be randomly allocated to either usual care or a cognitive-therapy based pain management intervention in addition to usual care.
The patients will be followed for one year after inclusion, and patientreported outcomes on disability, pain, sick leave, quality of life and pain coping will be collected by the use of questionnaires at baseline, 6 months and 12 months.
- Conditions
- Low Back Pain
- Being tested
- Group based pain management intervention
- Keywords
- low back pain, cognitive behavioural therapy, randomised controlled trial
- 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.
Group based pain management interventionBehavioural
The intervention is delivered as six separate sessions of each two hours duration over a four month period. The sessions are managed by a multidisciplinary team from the Spine Center, led by a psychologist. Before the first session, each patient in the intervention group participates in an individual consultation with the psychologist or nurse, with the aim of matching expectations for the group intervention, and hereby ensure the patients compliance throughout the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | All patients receive a thorough physical examination by a rheumatologist or a chiropractor with a subsequent examination by a physiotherapist.The patients receive general information about the nature back pain, adjustment of analgesic treatment and clarification of any need of further diagnosing or assessment by a surgeon. The physiotherapist furthermore makes an assessment of the patients' physical capacity and function and provides guidelines for any exercise programme. Based on the physiotherapist's judgement, the patient may be referred to rehabilitation in the local community |
| Group based pain management intervention | Experimental | In addition to usual care as described for the control group, the patients in the intervention group will participate in a cognitive group-based pain management intervention. The aim of the intervention is to improve the patients' understanding of their back pain problem, and that they learn different pain coping strategies. The intervention is based on cognitive behavioural therapy including elements of acceptance and commitment therapy, and furthermore uses different relaxation and breathing exercises. Receives: Behavioral: Group based pain management intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland Morris Disability Questionnaire
The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability).
Measured: Change from baseline to 12 months after baseline
Secondary outcomes (5)
Low Back Pain Rating Scale - Back pain
In the present study only the pain index of the LBPRS is used. The LBPRS pain index consists of two subscales, which measure back pain and leg pain, respectively. On each subscale the intensity of back pain and leg pain are reported on a 0-10 scale (best-worst) using the following three questions: the pain intensity at the time of examination, the average pain intensity within the past two weeks and the worst pain experienced within the past two weeks. The score of each subscale are reported separately (0-10 scale).
Measured: Change from baseline to 12 months after baseline
Low Back Pain Rating Scale - Leg pain
In the present study only the pain index of the LBPRS is used. The LBPRS pain index consists of two subscales, which measure back pain and leg pain, respectively. On each subscale the intensity of back pain and leg pain are reported on a 0-10 scale (best-worst) using the following three questions: the pain intensity at the time of examination, the average pain intensity within the past two weeks and the worst pain experienced within the past two weeks. The score of each subscale are reported separately (0-10 scale).
Measured: Change from baseline to 12 months after baseline
EuroQol 5 Dimensions
The EQ-5D is a measure of generic quality of life. It comprises five dimensions, which are mobility, selfcare, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels (no problem, some problems, extreme problems) resulting in a total of 245 potential health states. The scores fall on a scale of -0.624 to 1.000 (perfect health) including the scores of -0.293 for "unconscious" and 0.000 for "dead".
Measured: Change from baseline to 12 months after baseline
Pain Catastrophizing Scale
The PCS measures an individual's pain experience through 13 questions asking about how one feels and what he/she thinks about when in pain. The PCS evaluates pain catastrophizing as a single construct with three components: rumination, magnification, and helplessness. Each question is answered on a 0-4 scale (best worst), adding up to a total score of 0-52 (best-worst).
Measured: Change from baseline to 12 months after baseline
Sick leave
The patients report their average weekly sick leave during the past 4 weeks in the three categories 0 days per week, 1-4 days per week, 5-7 days per week, all the time.
Measured: Change from baseline to 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 Apr 2017
- Primary completion1 Mar 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group randomised controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nanna Rolving, PhD, Principal investigator, Diagnostic Centre, Silkeborg Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141541
- Sponsor's protocol ID
- 6300005
- Status last verified
- Aug 2019
- First submitted
- 3 Mar 2017
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available to other researchers when the study results have been published (anticipated 2020). The data will be available on request from the authors.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Patient Education Focused on Pain Management Improve Disability, Pain Coping and Quality of Life in Patients With Low Back Pain and Psychosocial Risk Factors?
- ClinicalTrials.gov ID
- NCT03141541
- Acronym / sponsor ID
- 6300005
- Conditions
- Low Back Pain
- Keywords
- low back pain, cognitive behavioural therapy, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 5 May 2017 (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.
Patients with low back pain and coexisting psychosocial risk factors have a poorer prognosis in terms of quality of life, disability, sick leave and health care use. Despite existing literature showing that low back pain patients benefit from cognitive therapy interventions, this has not been investigated in subgroups of low back pain patients with psychosocial risk factors.
The purpose of the study is to investigate whether patients referred to secondary care with low back pain and coexisting psychosocial risk factors will have a better treatment outcome when participating in a pain management course in addition to usual care.
This will be investigated in a randomised study design, where 130 patients with chronic low back pain and psychosocial risk factors will be randomly allocated to either usual care or a cognitive-therapy based pain management intervention in addition to usual care.
The patients will be followed for one year after inclusion, and patientreported outcomes on disability, pain, sick leave, quality of life and pain coping will be collected by the use of questionnaires at baseline, 6 months and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel group randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –All patients receive a thorough physical examination by a rheumatologist or a chiropractor with a subsequent examination by a physiotherapist.The patients receive general information about the nature back pain, adjustment of analgesic treatment and clarification of any need of further diagnosing or assessment by a surgeon. The physiotherapist furthermore makes an assessment of the patients' physical capacity and function and provides guidelines for any exercise programme. Based on the physiotherapist's judgement, the patient may be referred to rehabilitation in the local community |
| Group based pain management intervention | Experimental | Behavioral: Group based pain management interventionIn addition to usual care as described for the control group, the patients in the intervention group will participate in a cognitive group-based pain management intervention. The aim of the intervention is to improve the patients' understanding of their back pain problem, and that they learn different pain coping strategies. The intervention is based on cognitive behavioural therapy including elements of acceptance and commitment therapy, and furthermore uses different relaxation and breathing exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-specifick low back pain lasting ≥ 3 months
- Psychosocial risk profile defined as a fear avoidance score >24 (Örebro Musculoskeletal Pain Questionnaire) and/or a bodily distress score >15 (Common Mental Disorder Questionnaire) and/or health anxiety score >9 (Common Mental Disorder Questionnaire)
- Speaks and understands Danish
- Age ≥ 18 years
Key exclusion criteria (6 listed)
- Inflammatory or malignant disease
- Spine surgery within the last year
- Untreated or severe depression
- Psychiatric course of treatment within the last year
- Abuse of drugs or alcohol
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 |
|---|---|---|
| Group based pain management interventionThe intervention is delivered as six separate sessions of each two hours duration over a four month period. The sessions are managed by a multidisciplinary team from the Spine Center, led by a psychologist. Before the first session, each patient in the intervention group participates in an individual consultation with the psychologist or nurse, with the aim of matching expectations for the group intervention, and hereby ensure the patients compliance throughout the intervention. | Behavioural | Group based pain management intervention |
Primary outcome
Roland Morris Disability Questionnaire
Time frame: Change from baseline to 12 months after baseline
The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability).
5 secondary outcomes
Low Back Pain Rating Scale - Back pain
Time frame: Change from baseline to 12 months after baseline
Low Back Pain Rating Scale - Leg pain
Time frame: Change from baseline to 12 months after baseline
EuroQol 5 Dimensions
Time frame: Change from baseline to 12 months after baseline
Pain Catastrophizing Scale
Time frame: Change from baseline to 12 months after baseline
Sick leave
Time frame: Change from baseline to 12 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Individual participant dataSharing planned: Yes. The data will be available to other researchers when the study results have been published (anticipated 2020). The data will be available on request from the authors.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Nanna Rolving, PhD principal investigator
Diagnostic Centre, Silkeborg Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group based pain management intervention in people with Low Back Pain, run by Central Jutland Regional Hospital 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 29 Oct 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland Morris Disability Questionnaire (time frame: Change from baseline to 12 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2020.