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Completed

NCT Number: NCT01779544

Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention

Rehabilitation after lumbar disc surgery (prolapse) focuses on various elements such as endurance, strength, stretching and information. Evidence concludes that it is not harmful to return to activity after lumbar disc surgery, and restrictions to activities after these operations are today more or less nonexistent. Some studies have shown that high intensity programs might be more effective, but they are probably more expensive. In recent years cognitive interventions have received more attention in rehabilitation programs after lumbar disc surgery. The cognitive approach is focused on providing patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases. A goal of the rehabilitation is to get the patient to resume normal activities. Reviews ask for how much treatment are needed in a rehabilitation program after lumbar disc surgery.

The study will be a randomized clinical trial. The study will compare two different post-operative rehabilitation programs (general information or general information + exercise therapy). Both groups will begin treatment 1 day after surgery. Subjects in exercise therapy group are supposed to continue with exercises 3 months.

In this study the following hypothesis will be studied:

1. Brief intervention, an educational model, alone after lumbar disc surgery do have the same effect on pain in legs and low back as brief intervention, an educational model, combined with exercise therapy. 2. Exercises which are instructed after lumbar disc surgery in a rehabilitation program, are being done by the patients.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik

Bergen, Hordaland, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with lumbar disc prolapse with radicular pain
  • Age between 18 and 60

Exclusion criteria

  • Previous lumbar disc surgery (prolapse)
  • Spondyloarthritis
  • Arthritis
  • Systematic disease
  • Heart disease
  • Does not understand Norwegian language, spoken or in writing

Treatment and study plan

Brief intervention, an educational model

Other

The goal of the the brief intervention is to provide the patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases.

Exercise therapy

Other

Patients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these

Primary outcomes

  1. Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery

    Time frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery

Secondary outcomes

  1. Disability and beliefs about the condition

    Time frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery

  2. Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery

    Time frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery

  3. Change from baseline in Tampa scale of Kinesiophobia (TSK-13) at 6-8 weeks and 1 year postsurgery

    Time frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery

  4. Change from baseline in Fear-Avoidance Beliefs Questionnaire (physical activity) at 6-8 weeks and 1 year postsurgery

    Time frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery

  5. Change from baseline in anticipation to return to work at 6-8 weeks postsurgery

    Time frame: Baseline and 6-8 weeks postsurgery postsurgery

  6. Change from baseline in health condition at 6-8 weeks and 1 year postsurgery

    Time frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery

  7. Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery

    Time frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery

  8. Recidive prolapse

    Time frame: 1 year postsurgery

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

Rehabilitation After Lumbar Surgery

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 30, 2013
Registry last updated
Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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