Chronic Low Back PainNCT03482856
Cognitive Behavioural Therapy for Insomnia in Chronic Spinal Pain
A study testing MNA plus CBT-I and MNA alone in people with Chronic Low Back Pain and Chronic Neck Pain, run by University Ghent at 2 sites in Belgium.
Trial summary
Chronic spinal pain (CSP) includes chronic low back and neck pain. CSP is a highly prevalent and severely debilitating disorder characterized by tremendous personal and socioeconomic impact, long-term sick leave, low quality of life and very high socioeconomical costs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain, Chronic Neck Pain, Insomnia Chronic
- What is being tested?
- MNA plus CBT-I and MNA alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 2 sitesBelgium
- Study dates
- 29 Mar 2018to 30 Jul 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nonspecific spinal pain for at least 3 months' duration, at least 3 days per week
- Seeking care because of neck pain or low back pain
- Native Dutch speaker
- Having insomnia: in the absence of other intrinsic sleep disorders and shift work, insomnia is defined as > 30 minutes of sleep latency and/or minutes awake after sleep onset for > 3 days / week for > 6 months
- Living or working within a radius of 50 km around the therapy location
- Not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain a steady state)
Show all 9Show fewer
- Refraining from analgesics, caffeine, alcohol or nicotine in the previous 48h of the assessments
- Nonspecific failed back surgery > 3 years are permitted
- Not undertaking exercise (> 3 metabolic Equivalents) 3 days before the assessments
Who cannot join
- Severe underlying sleep pathology (identified through baseline data of polysomnography)
- Neuropathic pain
- Chronic widespread pain
- Being pregnant or pregnancy (including given birth) in the preceding year
- History of specific spinal surgery
- Thoracic pain in absence of neck or low back pain
Show all 9Show fewer
- Shift workers
- Diagnosed depression
- Body Mass Index below 30
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Hospital Brussels
Brussels, Brussels Capital, 1090
University Hospital Ghent
Ghent, Oost-Vlaanderen, 9000
About this study
Official title: Cognitive Behavioural Therapy for Insomnia in Patients With Chronic Spinal Pain: a Multi-center Randomized Controlled Trial
Chronic spinal pain (CSP) includes chronic low back and neck pain. CSP is a highly prevalent and severely debilitating disorder characterized by tremendous personal and socioeconomic impact, long-term sick leave, low quality of life and very high socioeconomical costs. The current strategies for treating CSP are not yet optimal in reducing pain and related disability, urging the need for improvement. A possible problem is that the current approaches are often to limited and only address pain.
Current treatments for CSP do not address associated complaints like sleeping problems which are however important issues. If present, sleeping problems may contribute to CSP severity and related disability. If left untreated, they represent a barrier for effective CSP management. Up to now, however, sleeping problems are hardly addressed and if so, it is mostly limited to sleeping medication. This is a problem since the efficacy and safety of drug treatment has not been established.
Read more
Therefore, within the current innovative project we propose examining the added value of cognitive behavioral therapy for insomnia (CBT-I) to the current best physical therapy treatment for CSP. CBT-I includes changing negative thoughts about sleep, sleep hygiene, altering sleeping patterns, and teaching relaxation skills.
The objectives of the study are to examine if CBT-I combined with the modern physical therapy approach (education about pain followed by exercise therapy) is more effective than the modern physical therapy approach alone for reducing pain, improving sleep and functionality in CSP patients with sleeping problems.
Therefore 120 CSP patients with sleeping problems will be randomly divided over the 2 treatment programs (60 per group) and will be assessed before and after their 14-week therapy program consisting of 18 therapy sessions. Comparisons will be made for pain severity, sleep quality and functionality.
Read the detailed description
Modern pain neuroscience has advanced our understanding of chronic spinal pain (CSP). Despite the scientific progresses with regard to the treatment of chronic spinal pain (CSP), current treatments for CSP do not address pain comorbidities like insomnia, an important yet seldom addressed issue. Treatment of CSP mostly still relies on monotherapies or on biomedical models, as shown by expensive but ineffective treatments like lumbar fusion surgery, ignoring important comorbidities such as insomnia.
Within the current innovative project we propose examining the added value of cognitive behavioral therapy for insomnia (CBT-I) to the current best evidence treatment for CSP. The innovative nature of this approach to CSP goes well beyond the combination of 2 available and effective treatments: combining cognitive behavioral therapy for insomnia with the recently established modern neuroscience approach (pain neuroscience education followed by cognition-targeted exercise therapy) strengthens the content of both individual approaches and applies the current understanding regarding insomnia and pain neuroscience to clinical practice. This innovative combination will result in a synergistic effect of both treatments.
The primary scientific objective of the study is to examine if CBT-I combined with a modern neuroscience approach (pain neuroscience education followed by cognition-targeted exercise therapy) is more effective than the modern neuroscience approach alone for reducing pain in CSP patients with insomnia. Secondary objectives of the study are to examine if CBT-I combined with the modern neuroscience approach is more effective than the modern neuroscience approach alone for improving pain related outcomes, sleep related outcomes and physical activity/functionality in CSP patients with insomnia.
To comply with these scientific objectives, the 120 CSP patients with comorbid insomnia will be subjected to the baseline assessment of all outcome measures.
Follow-up assessments will be performed immediately after 14 weeks of therapy (all tests), and 3 months (questionnaires), 6 months (questionnaires) and 12 months (all tests, depending on a go/no go decision) after finishing the therapeutic intervention.
To investigate these objectives, a muli-center triple-blind randomized, controlled trial with 1 year follow up will be performed.
Appropriate statistical analyses will be performed to evaluate and compare treatment effects. Statistical, as well as clinical significant differences will be defined and the effect size will be determined.
- Conditions
- Chronic Low Back Pain, Chronic Neck Pain, Insomnia Chronic
- Being tested
- MNA plus CBT-I, MNA alone
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNA plus CBT-IBehavioural
MNA plus CBT-I includes 3 sessions (1 group, 1 online and 1 individual session) of therapeutic pain neuroscience education, 6 individual sessions of CBT-I and 9 individual sessions of time-contingent dynamic and functional cognition-targeted exercise therapy, combined with home exercises. CBT-I is the standard evidence-based care for treating chronic primary insomnia and typically includes changing negative thoughts about sleep, sleep hygiene, sleep restriction therapy, and teaching relaxation skills. The 18 sessions will be spread over a period of 14 weeks.
MNA aloneBehavioural
MNA alone includes 3 sessions (1 group, 1 online and 1 individual session) of therapeutic pain neuroscience education, and 15 individual sessions of time-contingent dynamic and functional cognition-targeted exercise therapy, combined with home exercises. The 18 sessions will be spread over a period of 14 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Modern Neuroscience Approach (MNA) plus CBT-I | Experimental | MNA (i.e. modern pain neuroscience approach) combined with CBT-I (i.e. cognitive-behavioural therapy for insomnia) Receives: Behavioral: MNA plus CBT-I |
| MNA alone | Active comparator | The MNA (i.e. modern pain neuroscience approach) alone Receives: Behavioral: MNA alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory (Numeric Rating Scale)
Change in self-reported pain: The question "please rate your pain by circling the one number that best describes your pain on the AVERAGE" is used as the primary outcome measure to evaluate pain intensity. Scale ranges from 0 to 10, with higher scores indicating more self-reported pain.
Measured: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Secondary outcomes (13)
Brief Pain Inventory
Change in self-reported impact of pain on functioning. Scale ranges from 0 to 10, with higher scores indicating more self-reported pain or higher interference of pain in daily life.
Measured: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Central Sensitization Inventory
Change in self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.
Measured: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Pressure Pain Thresholds
Change in Pressure Pain Thresholds at measured bilaterally with a digital pressure algometer (Wagner Instruments), both at symptomatic levels (trapezius muscle and 5 centimetres lateral to the spinous process of L3) and at remote sites (i.e. secondary hyperalgesia).
Measured: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, and T4 follow-up assessment 12 months after the end of therapy
Polysomnography (PSG)
Change in polysomnography. Participants will be monitored in the comfort of their own home by ambulatory PSG.
Measured: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, and T4 follow-up 12 months after the end of therapy. Polysomnography T4 assessment will be carried out based on a go/no go decision, if improvements are visible at the T1 assessment.
Pittsburg Sleep Quality Index
Change in self-reported perceived sleep quality. Score ranges from 0 to 21, 0 indicating no difficulty and 21 indicating severe sleep difficulties.
Measured: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Insomnia Severity Index
Change in self-reported insomnia severity. Score ranges from 0 to 28, with 0 indicating no clinically significant insomnia and 28 indicating severe clinical insomnia.
Measured: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
DBAS (i.e. Dysfunctional Beliefs and Attitudes about Sleep)
Change in self-reported dysfunctional beliefs and attitudes about sleep. Score ranges from 0 to 10. Scores above 4 indicate unrealistic expectations for sleep or unrealistic thoughts about sleep.
Measured: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Epworth Sleepiness Scale
Change in self-reported sleep propensity. Score ranges from 0 to 24, with 0 indicating normal daytime sleepiness and 24 indicating severe excessive daytime sleepiness.
Measured: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Brugmann Fatigue Scale
Change in self-reported fatigue severity. Score ranges from 0 to 24, with higher scores indicating higher subjective levels of fatigue.
Measured: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Hospital Anxiety and Depression rating scale
Change in self-reported affective symptoms. Score ranges from 0 to 21, with 0 indicating absence of depression or anxiety and 21 indicating the presence of depression or anxiety.
Measured: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Physical Activity using Actigraphy
Change in physical activity: Continuous assessment of physical activity and rest/activity cycles
Measured: 1 week at baseline, 1 week at T1 follow-up assessment after 14 weeks of therapy, 1 week at T4 follow-up assessment 12 months after the end of therapy
Short Form Health Survey - 36 items Mental Health
Change in self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better mental health.
Measured: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Short Form Health Survey - 36 items Physical Health
Change in self-reported functional status and well-being or quality of life. Score ranges from 0 to 400 with higher scores indicating better physical health.
Measured: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start29 Mar 2018
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial will randomize 120 patients with CSP and comorbid insomnia, aged between 18 and 65 years, to the experimental intervention (i.e. 18 sessions of the modern neuroscience approach combined with CBT-I, including 3 sessions of therapeutic pain neuroscience education, 6 sessions of CBT-I and 9 sessions of cognition-targeted exercise therapy, n=60) or the control intervention (i.e. 18 sessions of the modern neuroscience approach alone, including 3 sessions of therapeutic pain neuroscience education, and 15 sessions of cognition-targeted exercise therapy, n=60).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel, University Hospital, Ghent, Research Foundation Flanders
- Responsible party
- Sponsor
- Investigators
- Barbara Cagnie, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482856
- Sponsor's protocol ID
- EC/2018/0277
- Status last verified
- Nov 2022
- First submitted
- 19 Mar 2018
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nijs J, Meeus M, Cagnie B, Roussel NA, Dolphens M, Van Oosterwijck J, Danneels L. A modern neuroscience approach to chronic spinal pain: combining pain neuroscience education with cognition-targeted motor control training. Phys Ther. 2014 May;94(5):730-8. doi: 10.2522/ptj.20130258. Epub 2014 Jan 30.
PubMed 24481595Nijs J, Mairesse O, Neu D, Leysen L, Danneels L, Cagnie B, Meeus M, Moens M, Ickmans K, Goubert D. Sleep Disturbances in Chronic Pain: Neurobiology, Assessment, and Treatment in Physical Therapist Practice. Phys Ther. 2018 May 1;98(5):325-335. doi: 10.1093/ptj/pzy020.
PubMed 29425327Nijs J, Lluch Girbes E, Lundberg M, Malfliet A, Sterling M. Exercise therapy for chronic musculoskeletal pain: Innovation by altering pain memories. Man Ther. 2015 Feb;20(1):216-20. doi: 10.1016/j.math.2014.07.004. Epub 2014 Jul 18.
PubMed 25090974Malfliet A, Kregel J, Meeus M, Cagnie B, Roussel N, Dolphens M, Danneels L, Nijs J. Applying contemporary neuroscience in exercise interventions for chronic spinal pain: treatment protocol. Braz J Phys Ther. 2017 Sep-Oct;21(5):378-387. doi: 10.1016/j.bjpt.2017.06.019. Epub 2017 Jul 8.
PubMed 28736211Malfliet A, De Baets L, Bilterys T, Van Looveren E, Mairesse O, Cagnie B, Meeus M, Moens M, Goubert D, Munneke W, Daneels L, Ickmans K, Kamper S, Nijs J. Cognitive Behavioral Therapy for Insomnia in Pain Management for Nonspecific Chronic Spinal Pain: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2425856. doi: 10.1001/jamanetworkopen.2024.25856.
PubMed 39120902Malfliet A, Bilterys T, Van Looveren E, Meeus M, Danneels L, Ickmans K, Cagnie B, Mairesse O, Neu D, Moens M, Goubert D, Kamper SJ, Nijs J. The added value of cognitive behavioral therapy for insomnia to current best evidence physical therapy for chronic spinal pain: protocol of a randomized controlled clinical trial. Braz J Phys Ther. 2019 Jan-Feb;23(1):62-70. doi: 10.1016/j.bjpt.2018.10.007. Epub 2018 Oct 29.
PubMed 30389347
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy for Insomnia in Patients With Chronic Spinal Pain: a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03482856
- Acronym / sponsor ID
- EC/2018/0277
- Conditions
- Chronic Low Back Pain, Chronic Neck Pain, Insomnia Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel, University Hospital, Ghent, Research Foundation Flanders
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 29 Mar 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.
Chronic spinal pain (CSP) includes chronic low back and neck pain. CSP is a highly prevalent and severely debilitating disorder characterized by tremendous personal and socioeconomic impact, long-term sick leave, low quality of life and very high socioeconomical costs. The current strategies for treating CSP are not yet optimal in reducing pain and related disability, urging the need for improvement. A possible problem is that the current approaches are often to limited and only address pain.
Current treatments for CSP do not address associated complaints like sleeping problems which are however important issues. If present, sleeping problems may contribute to CSP severity and related disability. If left untreated, they represent a barrier for effective CSP management. Up to now, however, sleeping problems are hardly addressed and if so, it is mostly limited to sleeping medication. This is a problem since the efficacy and safety of drug treatment has not been established.
Therefore, within the current innovative project we propose examining the added value of cognitive behavioral therapy for insomnia (CBT-I) to the current best physical therapy treatment for CSP. CBT-I includes changing negative thoughts about sleep, sleep hygiene, altering sleeping patterns, and teaching relaxation skills.
The objectives of the study are to examine if CBT-I combined with the modern physical therapy approach (education about pain followed by exercise therapy) is more effective than the modern physical therapy approach alone for reducing pain, improving sleep and functionality in CSP patients with sleeping problems.
Therefore 120 CSP patients with sleeping problems will be randomly divided over the 2 treatment programs (60 per group) and will be assessed before and after their 14-week therapy program consisting of 18 therapy sessions. Comparisons will be made for pain severity, sleep quality and functionality.
Detailed description
Modern pain neuroscience has advanced our understanding of chronic spinal pain (CSP). Despite the scientific progresses with regard to the treatment of chronic spinal pain (CSP), current treatments for CSP do not address pain comorbidities like insomnia, an important yet seldom addressed issue. Treatment of CSP mostly still relies on monotherapies or on biomedical models, as shown by expensive but ineffective treatments like lumbar fusion surgery, ignoring important comorbidities such as insomnia.
Within the current innovative project we propose examining the added value of cognitive behavioral therapy for insomnia (CBT-I) to the current best evidence treatment for CSP. The innovative nature of this approach to CSP goes well beyond the combination of 2 available and effective treatments: combining cognitive behavioral therapy for insomnia with the recently established modern neuroscience approach (pain neuroscience education followed by cognition-targeted exercise therapy) strengthens the content of both individual approaches and applies the current understanding regarding insomnia and pain neuroscience to clinical practice. This innovative combination will result in a synergistic effect of both treatments.
The primary scientific objective of the study is to examine if CBT-I combined with a modern neuroscience approach (pain neuroscience education followed by cognition-targeted exercise therapy) is more effective than the modern neuroscience approach alone for reducing pain in CSP patients with insomnia. Secondary objectives of the study are to examine if CBT-I combined with the modern neuroscience approach is more effective than the modern neuroscience approach alone for improving pain related outcomes, sleep related outcomes and physical activity/functionality in CSP patients with insomnia.
To comply with these scientific objectives, the 120 CSP patients with comorbid insomnia will be subjected to the baseline assessment of all outcome measures.
Follow-up assessments will be performed immediately after 14 weeks of therapy (all tests), and 3 months (questionnaires), 6 months (questionnaires) and 12 months (all tests, depending on a go/no go decision) after finishing the therapeutic intervention.
To investigate these objectives, a muli-center triple-blind randomized, controlled trial with 1 year follow up will be performed.
Appropriate statistical analyses will be performed to evaluate and compare treatment effects. Statistical, as well as clinical significant differences will be defined and the effect size will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The trial will randomize 120 patients with CSP and comorbid insomnia, aged between 18 and 65 years, to the experimental intervention (i.e. 18 sessions of the modern neuroscience approach combined with CBT-I, including 3 sessions of therapeutic pain neuroscience education, 6 sessions of CBT-I and 9 sessions of cognition-targeted exercise therapy, n=60) or the control intervention (i.e. 18 sessions of the modern neuroscience approach alone, including 3 sessions of therapeutic pain neuroscience education, and 15 sessions of cognition-targeted exercise therapy, n=60).
| Arm | Type | Receives |
|---|---|---|
| Modern Neuroscience Approach (MNA) plus CBT-I | Experimental | Behavioral: MNA plus CBT-IMNA (i.e. modern pain neuroscience approach) combined with CBT-I (i.e. cognitive-behavioural therapy for insomnia) |
| MNA alone | Active comparator | Behavioral: MNA aloneThe MNA (i.e. modern pain neuroscience approach) alone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Nonspecific spinal pain for at least 3 months' duration, at least 3 days per week
- Seeking care because of neck pain or low back pain
- Native Dutch speaker
- Having insomnia: in the absence of other intrinsic sleep disorders and shift work, insomnia is defined as > 30 minutes of sleep latency and/or minutes awake after sleep onset for > 3 days / week for > 6 months
- Living or working within a radius of 50 km around the therapy location
Key exclusion criteria (9 listed)
- Severe underlying sleep pathology (identified through baseline data of polysomnography)
- Neuropathic pain
- Chronic widespread pain
- Being pregnant or pregnancy (including given birth) in the preceding year
- History of specific spinal surgery
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 |
|---|---|---|
| MNA plus CBT-IMNA plus CBT-I includes 3 sessions (1 group, 1 online and 1 individual session) of therapeutic pain neuroscience education, 6 individual sessions of CBT-I and 9 individual sessions of time-contingent dynamic and functional cognition-targeted exercise therapy, combined with home exercises. CBT-I is the standard evidence-based care for treating chronic primary insomnia and typically includes changing negative thoughts about sleep, sleep hygiene, sleep restriction therapy, and teaching relaxation skills. The 18 sessions will be spread over a period of 14 weeks. | Behavioural | Modern Neuroscience Approach (MNA) plus CBT-I |
| MNA aloneMNA alone includes 3 sessions (1 group, 1 online and 1 individual session) of therapeutic pain neuroscience education, and 15 individual sessions of time-contingent dynamic and functional cognition-targeted exercise therapy, combined with home exercises. The 18 sessions will be spread over a period of 14 weeks. | Behavioural | MNA alone |
Primary outcome
Brief Pain Inventory (Numeric Rating Scale)
Time frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Change in self-reported pain: The question "please rate your pain by circling the one number that best describes your pain on the AVERAGE" is used as the primary outcome measure to evaluate pain intensity. Scale ranges from 0 to 10, with higher scores indicating more self-reported pain.
13 secondary outcomes
Brief Pain Inventory
Time frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Central Sensitization Inventory
Time frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Pressure Pain Thresholds
Time frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, and T4 follow-up assessment 12 months after the end of therapy
Polysomnography (PSG)
Time frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, and T4 follow-up 12 months after the end of therapy. Polysomnography T4 assessment will be carried out based on a go/no go decision, if improvements are visible at the T1 assessment.
Pittsburg Sleep Quality Index
Time frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Insomnia Severity Index
Time frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
DBAS (i.e. Dysfunctional Beliefs and Attitudes about Sleep)
Time frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Epworth Sleepiness Scale
Time frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Brugmann Fatigue Scale
Time frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Hospital Anxiety and Depression rating scale
Time frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Physical Activity using Actigraphy
Time frame: 1 week at baseline, 1 week at T1 follow-up assessment after 14 weeks of therapy, 1 week at T4 follow-up assessment 12 months after the end of therapy
Short Form Health Survey - 36 items Mental Health
Time frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
Short Form Health Survey - 36 items Physical Health
Time frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy
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 1 Dec 2022.
- Background: PubMed 24481595Nijs J, Meeus M, Cagnie B, Roussel NA, Dolphens M, Van Oosterwijck J, Danneels L. A modern neuroscience approach to chronic spinal pain: combining pain neuroscience education with cognition-targeted motor control training. Phys Ther. 2014 May;94(5):730-8. doi: 10.2522/ptj.20130258. Epub 2014 Jan 30.
- Background: PubMed 29425327Nijs J, Mairesse O, Neu D, Leysen L, Danneels L, Cagnie B, Meeus M, Moens M, Ickmans K, Goubert D. Sleep Disturbances in Chronic Pain: Neurobiology, Assessment, and Treatment in Physical Therapist Practice. Phys Ther. 2018 May 1;98(5):325-335. doi: 10.1093/ptj/pzy020.
- Background: PubMed 25090974Nijs J, Lluch Girbes E, Lundberg M, Malfliet A, Sterling M. Exercise therapy for chronic musculoskeletal pain: Innovation by altering pain memories. Man Ther. 2015 Feb;20(1):216-20. doi: 10.1016/j.math.2014.07.004. Epub 2014 Jul 18.
- Background: PubMed 28736211Malfliet A, Kregel J, Meeus M, Cagnie B, Roussel N, Dolphens M, Danneels L, Nijs J. Applying contemporary neuroscience in exercise interventions for chronic spinal pain: treatment protocol. Braz J Phys Ther. 2017 Sep-Oct;21(5):378-387. doi: 10.1016/j.bjpt.2017.06.019. Epub 2017 Jul 8.
- Derived from this study: PubMed 39120902Malfliet A, De Baets L, Bilterys T, Van Looveren E, Mairesse O, Cagnie B, Meeus M, Moens M, Goubert D, Munneke W, Daneels L, Ickmans K, Kamper S, Nijs J. Cognitive Behavioral Therapy for Insomnia in Pain Management for Nonspecific Chronic Spinal Pain: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2425856. doi: 10.1001/jamanetworkopen.2024.25856.
- Derived from this study: PubMed 30389347Malfliet A, Bilterys T, Van Looveren E, Meeus M, Danneels L, Ickmans K, Cagnie B, Mairesse O, Neu D, Moens M, Goubert D, Kamper SJ, Nijs J. The added value of cognitive behavioral therapy for insomnia to current best evidence physical therapy for chronic spinal pain: protocol of a randomized controlled clinical trial. Braz J Phys Ther. 2019 Jan-Feb;23(1):62-70. doi: 10.1016/j.bjpt.2018.10.007. Epub 2018 Oct 29.
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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.
Barbara Cagnie, PhD principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MNA plus CBT-I and MNA alone in people with Chronic Low Back Pain and Chronic Neck Pain, run by University Ghent at 2 sites in Belgium.
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 9 inclusion and 9 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 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Brief Pain Inventory (Numeric Rating Scale) (time frame: Baseline assessment, T1 follow-up assessment after 14 weeks of therapy, T2 follow-up assessment 3 months after the end of therapy, T3 follow-up assessment 6 months after the end of therapy, and T4 follow-up assessment 12 months after the end of therapy). 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 NCT03482856, which also lists 6 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 1 Dec 2022.