Short summary

Spinal pain is the leading worldwide cause of patient years lived with chronic pain and disability. One of the most prescribed treatment forms are medical analgesics. Opioids are frequently used and are well documented as an effective short-term painrelieving medication. However, more than a few weeks of treatment often results in a diminishing effect and the development of addictive behaviour. Additionally, the Long-Term Opioid Therapy may also result in somatic and psychological side effects and isassociated with a poor prognosis regarding working status and participation in social activities.

The aim of this prospective cohort study has been to collate relevant individual patient data over a decade in order to illuminate both the overall group data developments as well as developments relating to individual usage of opioids during this period and to correlate these findings with the individual patient's physical, psychological, and social data over a ten-year period. 

---

Rationale

One of the most prescribed treatment forms are medical analgesics. Opioids are frequently used and are well documented as an effective short-term painrelieving medication. However, more than a few weeks of treatment often results in a diminishing effect and the development of addictive behaviour. Additionally, the Long-Term Opioid Therapy (L-TOT) may also result in a long series of somatic and psychological side effects. 

Spinal pain has been conceptualized to the biopsychosocial model and several systematic reviews have disclosed strong relationships between a number of psychological factors - eg. depression, anxiety and catastrophizing behavior - and the risk of developing chronic pain. Also, long term usage of opioids is associated with a poor prognosis regarding working status and participation in social activities.

Despite the increasing time dependence risk of change in behavior and associated treatment complications most back pain cohorts do not include follow up data beyond a 1-year period. At the same time, data from our own studies indicate that the premorbid individual psychological status may impact the individual prognostic course following the first spinal pain episode.

The aim of this prospective cohort study has been to collate relevant individual patient data over a decade in order to illuminate both the overall group data developments as well as developments relating to individual usage of opioids during this period and to correlate these findings with the individual patient's physical, psychological, and social data over a ten-year period. 

---

Description of the cohort

Patients aged between 18and 65 years (included) and who have had their first outpatient visit at The Spine Centre between November 1. 2012 and December 31. 2013 with spinal pain were enrolled in the cohort: Spinal Pain Opioid Cohort (SPOC).

The main complaint was defined by the patient's response when asked to indicate the area for which they were seeking care on the touch screen body chart.  The patient could visualise the area of pain on the screen and choose between neck pain, mid-back pain and lower back pain. The patient's initial choice of which area of the spine was giving them the most trouble determined which subgroup in SPOC they were enrolled in.

In order to be included in the study, patients had to have completed the registry questionnaires with no missing data related to pain intensity. For patients who were  referred  to  the  Spine Centre for more than one episode of LBP during the  study period (<1% of the cohort) only data relating to the first episode has been included in SPOC.

Domains and items

According to the biopsychosocial model of health, informa¬tion was collected in SpineData across the broad health domains of pain, activity limitation, work participation, psychological factors, physical impairment, and contextual factors. Wherever possible, the choice of questions and questionnaires was based on evidence of their role in the diagnosis, prognosis, or treat¬ment of spinal pain. At the inclusion consultation, the patient completed a battery of baseline questionnaires. The questions vary across the three spinal regions of principal complaint: neck pain, mid-back pain, and low back pain. 

Pain domain

Patient-reported questions: main pain chart (current pain) and other pain chart (any additional areas of pain during the previous 2 weeks), onset date of pain, any previous low back pain or radiating episodes, pain intensity (current, typical, and worst in last 14 days), extremity pain intensity (current, typical, and worst in last 14 days), numbers of days per week with pain, cause of or reason for onset, morn¬ing stiffness, diurnal variation, movement-related pain, activity-related pain, effect of physical rest on pain and pain easily aggravated by movement.

Activity limitation domain

Patient-reported questions: the 23-item Roland-Morris Disability Questionnairefor low back pain. Neck Disability index (NDI) if midback- or neck pain

Participation domain

Patient-reported questions: type of employment, whether on sick leave due to back pain any time in the last 3 months and for how long, on reduced work hours due to back pain, expectation of being able to sit or stand long enough for normal work in 6 weeks time, expecta¬tion of working in 6 months, physically strenuous work, monotonous work, and work satisfaction.

Psychological domain

Patient-reported questions: anxiety, depression, pain catastrophization and fear of movement......Noget om trauma(oplevelse) ved 5 årsskemaet. ReferencerTonny.

Contextual factors domain

Patient-reported questions: height, weight, previous back surgery, prolonged corticosteroid use, exposure to prolonged mechanical vibration, handedness, level of recreational physical activity, allergies, cigarette use, alcohol consumption, serious lung disease, heart disease or cancer. Age and sex were generated from central person registration number. 

Data and biological material

According to the biopsychosocial model of health, informa¬tion was collected in SpineData across the broad health domains of pain, activity limitation, work participation, psychological factors, physical impairment, and contextual factors. Wherever possible, the choice of questions and questionnaires was based on evidence of their role in the diagnosis, prognosis, or treat¬ment of spinal pain. At the inclusion consultation, the patient completed a battery of baseline questionnaires. The questions vary across the three spinal regions of principal complaint: neck pain, mid-back pain, and low back pain. From Danish National Patient register we obtained information on the patient's comorbidities from 2007 to 2017 using the diagnostic codes, the disease-specific international classification of Disease, version 10, (ICD-10). The Danish National Prescription Registry all dispensed prescribed medications classified according to the Anatomical Therapeutic Chemical classification system (ATC). From the Danish National Prescription Registry we obtained data on dispensed prescribed medication from 2007- June 30th 2018. From Denmark Statistics we obtained information on education based on highest attained level and socio-economic position. 

Collaborating researchers and departments

Spine Centre of Southern Denmark, Sygehus Lillebaelt Middelfart Sygehus, Middelfart, and University of Southern Denmark, Odense Denmark

• Claus Manniche, MD, DMSc
• Berit Schiøttz-Christensen, MD, PhD

Department of Occupational and Environmental Medicine, Odense University Hospital, and Institute of Clinical Research, University of Southern Denmark, Odense, Denmark

• Søren Glud Skousgaard, MD, PhD
• Lars Brandt, MD, PhD
• Tonny Elmose Andersen, MSc Psychology, PhD

Department of Psychology, University of Southern Denmark, Odense Denmark

• Tonny Elmose Andersen, MSc Psychology, PhD

OPEN – Open Patient Data Explorative Network, Department of Clinical Research, University of Southern Denmark, and Odense University Hospital, Odense, Denmark

• Lonny Stokholm, MScPH, PhD
• Katrine Hass Rubin, MHS, PhD

Publications associated with the project

Manniche C, Stokholm L, Ravn SL, Andersen TA, Brandt L, Rubin KH, Schiøttz-Christensen B, Andersen LL, Skousgaard SG. Prevalence of long-term opioid therapy in spine center outpatients the spinal pain opioid cohort (SPOC). Eur Spine J. 2021 Oct;30(10):2989-2998. doi: 10.1007/s00586-021-06849-6. Epub 2021 Apr 24. PMID: 33893870.