Can patient education focused on coping with pain facilitate return to work and everyday life following lumbar spinal fusion surgery?

Effect and cost-effectiveness of a multidisciplinary preoperative cognitive intervention for lumbar spinal fusion patients: a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42281022

Enrollment

Registered

2014-01-15

Start date

2011-10-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing lumbar spinal fusion surgery at a maximum of three levels due to chronic low back pain caused by degenerative diseases or spondylolisthesis grade 1-2. Musculoskeletal Diseases Low back pain

Interventions

Participants will be randomised to one of the following two groups: Control Treatment as usual, which includes surgery and the standard postoperative physical rehabilitation. Rehabilitation commences

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18-64 years 2. Scheduled for lumbar spinal fusion surgery due to degenerative disc disease or spondylolisthesis grade I to II 3. Ability to speak and understand Danish

Exclusion criteria

Exclusion criteria: 1. Psychiatric diseases 2. Co-morbidity such as infection, fractures or malignant disease

Design outcomes

Primary

Measure	Time frame
1. Disability: measured using the Oswestry Disability Index (0% = no disability, 100% = bed bound). Self reported at baseline, 1 month, 3 months, 6 months and 12 months. 2. Return to work/sick leave: data will be obtained from the DREAM Database, a national database administered by the Ministry of Employment at 12 months following surgery.	—

Secondary

Measure	Time frame
1. Pain: measured using the Low Back Pain Rating Scale (pain index). This is a self-report measure consisting of six scales (three for leg, three for back) questioning on pain right now, worst pain in the past 14 days, and average pain in the past 14 days. All scales are from 0 (no pain) to 10 (unbearable pain). Self reported at baseline, 1 month, 3 months, 6 months and 12 months. 2. Quality of life: measured using the Euroquol 5D (1 = full health, 0 = dead). Self reported at baseline, 1 month, 3 months, 6 months and 12 months. Self reported at baseline, 1 month, 3 months, 6 months and 12 months. 3. Coping strategies: measured using the Coping Strategies Questionnaire. The questionnaire is a 31-item (seven subscales) self-report inventory, where participants rate to what extent they use a given coping strategy on a seven-point Likert scale, ranging from 0 = ?never? to 6 = ?always?. Self reported at baseline, 1 month, 3 months, 6 months and 12 months. 4. Fear avoidance: measured using the fear avoidance beliefs questionnaire. The questionnaire consists of two subscales with several items each, a Physical Activity subscale (0-24 points) and a Work subscale (0-42 points). A higher score is indicative of a higher (worse) level of fear avoidance belief. Self reported at baseline, 1 month, 3 months, 6 months and 12 months. 5. Readmission to hospital and use of healthcare services: data are obtained from self-report diaries and Danish registries. Measured at 12 months.	—

Measure

Time frame

1. Pain: measured using the Low Back Pain Rating Scale (pain index). This is a self-report measure consisting of six scales (three for leg, three for back) questioning on pain right now, worst pain in the past 14 days, and average pain in the past 14 days. All scales are from 0 (no pain) to 10 (unbearable pain). Self reported at baseline, 1 month, 3 months, 6 months and 12 months. 2. Quality of life: measured using the Euroquol 5D (1 = full health, 0 = dead). Self reported at baseline, 1 month, 3 months, 6 months and 12 months. Self reported at baseline, 1 month, 3 months, 6 months and 12 months. 3. Coping strategies: measured using the Coping Strategies Questionnaire. The questionnaire is a 31-item (seven subscales) self-report inventory, where participants rate to what extent they use a given coping strategy on a seven-point Likert scale, ranging from 0 = ?never? to 6 = ?always?. Self reported at baseline, 1 month, 3 months, 6 months and 12 months. 4. Fear avoidance: measured using the fear avoidance beliefs questionnaire. The questionnaire consists of two subscales with several items each, a Physical Activity subscale (0-24 points) and a Work subscale (0-42 points). A higher score is indicative of a higher (worse) level of fear avoidance belief. Self reported at baseline, 1 month, 3 months, 6 months and 12 months. 5. Readmission to hospital and use of healthcare services: data are obtained from self-report diaries and Danish registries. Measured at 12 months.

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Countries

Denmark

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 21, 2026