Chronic Low-back Pain Clinical Trial
— LIFEHABOfficial title:
The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial
NCT number | NCT06169488 |
Other study ID # | 506009 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 15, 2024 |
Est. completion date | December 2030 |
The goal of this randomized controlled trial is to compare lumbar interbody fusion surgery with multidisciplinary rehabilitation in participants aged 20-65 years with persisting (≥ one year) low back pain. The main question it aims to answer is: • Is lumbar fusion surgery superior to multidisciplinary rehabilitation in alleviating persisting low back pain? Participants will be randomized to either lumbar interbody fusion surgery or a multidisciplinary rehabilitation program. If randomized to lumbar fusion interbody surgery, the participants will: - undergo radiologic examinations, including X-ray, MRI, and MRI spectroscopy - provide blood samples at four intervals including postoperatively - complete PROMs at five intervals - have their activity monitored through the ActivePAL accelerometer - undergo lumbar fusion surgery If randomized to multidisciplinary rehabilitation, the participants will: - undergo radiologic examinations, including X-ray, MRI, and MRI spectroscopy - provide blood samples at three intervals - complete PROMs at five intervals - have their activity monitored through the ActivePAL accelerometer - undergo multidisciplinary rehabilitation
Status | Recruiting |
Enrollment | 202 |
Est. completion date | December 2030 |
Est. primary completion date | October 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Male and non-pregnant female patients between 20 and 65 years of age with persistent low back pain of at least one year's duration at inclusion 2. Received non-operative treatment in line with national [50] and international [49] guidelines, including at least self-management, exercise, and physical therapy, without satisfactory effect before study enrolment 3. Back-related disability: ODI 30 - 60 points at baseline 4. Back pain > leg pain 5. One- or two-level disc degeneration between L2 and sacrum with any of the following: - High-intensity zone (HiZ) - Modic changes - Severe disc height reduction exceeding 50% of the cranial disc Exclusion Criteria: 1. Multilevel disc degeneration requiring intervention beyond two levels 2. Spondylolysis or lytic spondylolisthesis 3. History of previous spondylodiscitis 4. Previous lumbar fusion surgery 5. Scoliosis >20 degrees 6. Signs of a vertebral fracture at the planned level of fusion or its adjacent levels 7. Active smokers 8. Unlikely to adhere to treatment or complete follow-up (e.g., ongoing serious psychiatric disease, drug abuse, plans to move outside the catchment areas of the trial centers) 9. Significant nerve root compression assessed by MRI and clinical examination 10. BMI > 40 11. Not understanding the Norwegian language. 12. Generalized myalgia, including history or signs of fibromyalgia and myalgic encephalitis 13. Contraindications to MRI (e.g., cardiac pacemaker electrodes, metal implants in the eye or brain, claustrophobia). 14. Active cancer 15. Disabling chronic neurological disease (e.g., Parkinson's disease, ALS, MS) 16. Disabling osteoarthritis of the hip or knee (Kellgren & Lawrence grade III or higher) 17. Daily use of morphine equivalents = 60mg or regular use of morphine-containing pain patches 18. Decline specific treatment arm |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital | Hagavik | |
Norway | Akershus University Hospital | Lørenskog | |
Norway | Oslo University Hospital | Oslo | |
Norway | St. Olavs Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Haukeland University Hospital, St. Olavs Hospital, Unicare, University Hospital, Akershus, Vestre Viken Hospital Trust |
Norway,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oswestry Disability Index (ODI): Change in percent | Improvement in the ODI score of a minimum of 30% from baseline. The ODI questionnaire examines the level of disability based on 10 everyday activities of daily living. Each item consists of 6 statements which are scored from 0 to 5, with 0 indicating the least disability and 5 the highest level of disability. The total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability. | At one-year follow-up | |
Secondary | Oswestry Disability Index (ODI): Dichotomized | ODI dichotomized as a Positive response: PASS (ODI=22), i.e., participant reaches a Patient Acceptable Symptom State or a Negative response (ODI >22). | At one-year follow-up | |
Secondary | Oswestry Disability Index (ODI): Continuous | Change in ODI from baseline (continuous variable) | At one-year follow-up | |
Secondary | Numeric Rating Scale back pain (NRS back pain) | Change in NRS back pain from baseline (continuous variable). The NRS is a 11-point numeric scale ranging from '0' (e.g. "no pain") to '10' (e.g. "worst possible pain"). | At one-year follow-up | |
Secondary | Numeric Rating Scale leg pain (NRS leg pain) | Change in NRS leg pain from baseline (continuous variable). The NRS is a 11-point numeric scale ranging from '0' (e.g. "no pain") to '10' (e.g. "worst possible pain"). | At one-year follow-up | |
Secondary | Global perceived effect (GPE) | The GPE scale asks the participant to rate, on a 7 point Likert scale, how much their condition has improved or deteriorated. GPE 1-2 defined as success (completely recovered (1), much better (2)), GPE 3-5 defined as no change (somewhat better (3), no change (4), somewhat worse (5)), GPE 6-7 defined as worsening (much worse (6), worse than ever (7)) | At one-year follow-up | |
Secondary | EuroQol-5 dimensions-5 levels (EQ-5D-5L) | Change in EQ-5D-5L from baseline (continuous variable). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each EQ-5D-5L dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Index scores range from -0.59 to 1, where1 is the best possible health state. | At one-year follow-up | |
Secondary | Fear Avoidance Beliefs Questionnaire (FABQ) | Change in FABQ from baseline (continuous variable). The questionnaire consists of 16 items in which a participant rates their agreement with each statement on a 7-point Likert scale, where 0 = completely disagree, 6 = completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. | At one-year follow-up | |
Secondary | Hopkins Symptom Check List (HSCL-25) | Change in HSCL-25 from baseline (continuous variable). The HSCL-25 consists of 25 items: Part I of the HSCL-25 has 10 items for anxiety symptoms; Part II has 15 items for depression symptoms. The scale for each question includes four categories of response ("Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively). Two scores are calculated: the total score is the average of all 25 items, while the depression score is the average of the 15 depression items. | At one-year follow-up | |
Secondary | Pain Catastrophizing Scale (PCS) | Change in PCS from baseline (continuous variable). The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization. | At one-year follow-up | |
Secondary | Adverse Events of special interest (AESI) and Serious Adverse Events (SAEs) | Incidence of AESI and SAEs | During study period (two years) | |
Secondary | Occupational status and return to work | To evaluate the effect of LIF versus MRE on ability to work, the participants will be asked about their occupational status and return to work | At one-year follow-up | |
Secondary | ActivePAL accelerometer and sleep diary | To evaluate the effect of LIF versus MRE on physical activity, sleep disturbances, and circadian rhythm | At one-year follow-up | |
Secondary | MRI spectroscopy biomarkers: Change in ODI from baseline (continuous variable) | To evaluate whether baseline MRS biomarkers are associated with treatment response after lumbar interbody fusion or multidisciplinary rehabilitation measured by change in ODI from baseline (continuous variable). MRI spectroscopy biomarkers 1: Trichotomized disc-specific NOCISCORE® for disc acidity (NOCI-, NOCImild, NOCI+). 2. Total disc-specific NOCISCORE® (continuous 0-10) 3. Normalized disc-specific NOCISCORE® (continuous 0-1) The trichotomized NOCISCORE® is based on the total vs the normalized NOCISCORES® and is calculated as previously published by standardized custom post-processing (NOCISCAN-LS®; Aclarion Inc.) of spectral feature disc data on acidic pain markers (alanine, lactic acid, propionic acid) in relation to structural integrity markers (carbohydrate/collagen and proteoglycan) Biomarker 1 will be used as the primary MRI spectroscopy biomarker for assessing the association between baseline disc acidity and treatment response. |
At one-year follow-up | |
Secondary | MRI spectroscopy biomarkers: Change in NRS back pain from baseline (continuous variable) | To evaluate whether baseline MRS biomarkers are associated with treatment response after lumbar interbody fusion or multidisciplinary rehabilitation measured by change in NRS back pain from baseline (continuous variable). MRI spectroscopy biomarkers 1: Trichotomized disc-specific NOCISCORE® for disc acidity (NOCI-, NOCImild, NOCI+). 2. Total disc-specific NOCISCORE® (continuous 0-10) 3. Normalized disc-specific NOCISCORE® (continuous 0-1) The trichotomized NOCISCORE® is based on the total vs the normalized NOCISCORES® and is calculated as previously published by standardized custom post-processing (NOCISCAN-LS®; Aclarion Inc.) of spectral feature disc data on acidic pain markers (alanine, lactic acid, propionic acid) in relation to structural integrity markers (carbohydrate/collagen and proteoglycan) Biomarker 1 will be used as the primary MRI spectroscopy biomarker for assessing the association between baseline disc acidity and treatment response. |
At one-year follow-up | |
Secondary | MRI spectroscopy biomarkers: Change in NRS leg pain from baseline (continuous variable) | To evaluate whether baseline MRS biomarkers are associated with treatment response after lumbar interbody fusion or multidisciplinary rehabilitation measured by change in NRS leg pain from baseline (continuous variable). MRI spectroscopy biomarkers 1: Trichotomized disc-specific NOCISCORE® for disc acidity (NOCI-, NOCImild, NOCI+). 2. Total disc-specific NOCISCORE® (continuous 0-10) 3. Normalized disc-specific NOCISCORE® (continuous 0-1) The trichotomized NOCISCORE® is based on the total vs the normalized NOCISCORES® and is calculated as previously published by standardized custom post-processing (NOCISCAN-LS®; Aclarion Inc.) of spectral feature disc data on acidic pain markers (alanine, lactic acid, propionic acid) in relation to structural integrity markers (carbohydrate/collagen and proteoglycan) Biomarker 1 will be used as the primary MRI spectroscopy biomarker for assessing the association between baseline disc acidity and treatment response. |
At one-year follow-up | |
Secondary | MRI spectroscopy biomarkers: Improvement in the ODI score of a minimum 30% from baseline | To evaluate whether baseline MRS biomarkers are associated with treatment response after lumbar interbody fusion or multidisciplinary rehabilitation measured by improvement in the ODI score of a minimum 30% from baseline. MRI spectroscopy biomarkers 1: Trichotomized disc-specific NOCISCORE® for disc acidity (NOCI-, NOCImild, NOCI+). 2. Total disc-specific NOCISCORE® (continuous 0-10) 3. Normalized disc-specific NOCISCORE® (continuous 0-1) The trichotomized NOCISCORE® is based on the total vs the normalized NOCISCORES® and is calculated as previously published by standardized custom post-processing (NOCISCAN-LS®; Aclarion Inc.) of spectral feature disc data on acidic pain markers (alanine, lactic acid, propionic acid) in relation to structural integrity markers (carbohydrate/collagen and proteoglycan) Biomarker 1 will be used as the primary MRI spectroscopy biomarker for assessing the association between baseline disc acidity and treatment response. |
At one-year follow-up | |
Secondary | MRI spectroscopy biomarkers and molecular biomarkers | To evaluate the association between MRI spectroscopy and molecular biomarkers. See outcomes 14-17 for MRI spectroscopy description and outcomes 19-22 for cytokine description. | At baseline, 6-, and 12 months follow-up | |
Secondary | Molecular biomarkers: Change in ODI from baseline (continuous variable) | To evaluate whether serum inflammatory cytokines are associated with treatment response after lumbar interbody fusion or multidisciplinary rehabilitation on change in ODI from baseline (continuous variable). The unit of measure of cytokines is concentration. | At one-year follow-up | |
Secondary | Molecular biomarkers: Change in NRS back pain from baseline (continuous variable) | To evaluate whether serum inflammatory cytokines are associated with treatment response after lumbar interbody fusion or multidisciplinary rehabilitation on change in NRS back pain from baseline (continuous variable). The unit of measure of cytokines is concentration. | At one-year follow-up | |
Secondary | Molecular biomarkers: Change in NRS leg pain from baseline (continuous variable) | To evaluate whether serum inflammatory cytokines are associated with treatment response after lumbar interbody fusion or multidisciplinary rehabilitation on change in NRS leg pain from baseline (continuous variable). The unit of measure of cytokines is concentration. | At one-year follow-up | |
Secondary | Molecular biomarkers: Improvement in the ODI score of a minimum 30% from baseline | To evaluate whether serum inflammatory cytokines are associated with treatment response after lumbar interbody fusion or multidisciplinary rehabilitation on improvement in the ODI score of a minimum 30% from baseline. The unit of measure of cytokines is concentration. | At one-year follow-up | |
Secondary | Cost-effectiveness: EQ-5D-5L | To evaluate the cost-effectiveness of lumbar interbody fusion versus multidisciplinary rehabilitation on change in EQ-5D-5L from baseline (continuous variable). | At one-year follow-up | |
Secondary | Cost-effectiveness: Hospital costs | To evaluate the cost-effectiveness of lumbar interbody fusion versus multidisciplinary rehabilitation on hospital costs. | At one-year follow-up | |
Secondary | Cost-effectiveness: Community costs including sick leave | To evaluate the cost-effectiveness of lumbar interbody fusion versus multidisciplinary rehabilitation on community costs including sick leave | At one-year follow-up | |
Secondary | Cost-effectiveness: Co-interventions (pharmacological and non-pharmacological) | To evaluate the cost-effectiveness of lumbar interbody fusion versus multidisciplinary rehabilitation on co-interventions (pharmacological and non-pharmacological) | At one-year follow-up |
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