PREPARE (PREhabilitation, Physical Activity and ExeRcisE) persons with severe low back pain for an optimal functional outcome after lumbar fusion surgery

PREPARE (PREhabilitation, Physical Activity and ExeRcisE) persons with severe low back pain for an optimal functional outcome after lumbar fusion surgery: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17115599

Enrollment

160

Registered

2015-05-18

Start date

2015-01-01

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Severe low back pain (disc degenerative disease) Musculoskeletal Diseases Other specified intervertebral disc degeneration

Interventions

1. Group A (n=55) will receive specific guidance from a physiotherapist on how to stay active despite pain based on cognitive behavioral therapy (CBT) principles. 2. Group B (n=55) will receive treat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Swedish speaking patients with persistent LBP scheduled for surgical intervention attached to the Orthopedic Department at Sahlgrenska University Hospital or Spine Center, Gothenburg

Exclusion criteria

Exclusion criteria: Patients with malignant pain, confirmed neurological disease or rheumatic disease, post traumatic changes, idiopathic scoliosis, isthmic spondylolisthesis, disc herniation, spinal stenosis or poor understanding of the Swedish language

Design outcomes

Primary

Measure	Time frame
Disability measured by Oswestry Disability Index (ODI).	—

Secondary

Measure	Time frame
1. Patient Specific Function Scale will be used to measure patients' own functioning goal. 2. Physical activity levels (sitting/lying and time spent upright) will be measured by the movement registration system Actigraph (uniaxial accelerometer). 3. The Pain Catastrophising Scale (PCS). 4. Zung Self-Rating Depression Scale (Zung). 5. Functional performance testing: five-minute walking, 50-ft (15 m) fast walking, sit to stand, 1-min stair-climbing. 6. The Swedish version of Tampa Scale of Kinesiophobia (TSK-SV) questionnaire. 7. Self-Efficacy for Exercise (SEE) self-report scale to measure self-efficacy for exercise in nine specific situations. 8. European Quality of Life 5 Dimensions Questionnaire (EuroQol/EQ-5D) (mobility, self-care, usual activity, pain/discomfort and anxiety/depression). 9. Patients’ self-report the effect of treatment (surgery) measured by Global Assessment. 10. The patients perceived harmfulness of daily activities will be measured by Photographs of Daily Activities (PHODA). 11. Cost-effectiveness will be measured by estimating quality of life before and after the treatment (EQ-5D), the number of quality adjusted-life-years (QALY) will be calculated. Days of sick-leave will be collected from the Social Security Office. The days of hospital stay as well as number of health-care consultation will be collected through the patients’ charts in addition to the patient’s own recording.	—

Measure

Time frame

1. Patient Specific Function Scale will be used to measure patients' own functioning goal. 2. Physical activity levels (sitting/lying and time spent upright) will be measured by the movement registration system Actigraph (uniaxial accelerometer). 3. The Pain Catastrophising Scale (PCS). 4. Zung Self-Rating Depression Scale (Zung). 5. Functional performance testing: five-minute walking, 50-ft (15 m) fast walking, sit to stand, 1-min stair-climbing. 6. The Swedish version of Tampa Scale of Kinesiophobia (TSK-SV) questionnaire. 7. Self-Efficacy for Exercise (SEE) self-report scale to measure self-efficacy for exercise in nine specific situations. 8. European Quality of Life 5 Dimensions Questionnaire (EuroQol/EQ-5D) (mobility, self-care, usual activity, pain/discomfort and anxiety/depression). 9. Patients’ self-report the effect of treatment (surgery) measured by Global Assessment. 10. The patients perceived harmfulness of daily activities will be measured by Photographs of Daily Activities (PHODA). 11. Cost-effectiveness will be measured by estimating quality of life before and after the treatment (EQ-5D), the number of quality adjusted-life-years (QALY) will be calculated. Days of sick-leave will be collected from the Social Security Office. The days of hospital stay as well as number of health-care consultation will be collected through the patients’ charts in addition to the patient’s own recording.

—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026