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

Prolapse Clinical Trial

Official title:

Rehabilitation After Lumbar Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779544
• Other study ID #: 2012/1861
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: November 2016

Study information

• Verified date: February 2017
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Prolapse

Intervention

Other:
• Brief intervention, an educational model
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
Patients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these

Locations

Country	Name	City	State
Norway	Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik	Bergen	Hordaland

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery		Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Secondary	Disability and beliefs about the condition		Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Secondary	Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery		Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Secondary	Change from baseline in Tampa scale of Kinesiophobia (TSK-13) at 6-8 weeks and 1 year postsurgery		Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Secondary	Change from baseline in Fear-Avoidance Beliefs Questionnaire (physical activity) at 6-8 weeks and 1 year postsurgery		Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Secondary	Change from baseline in anticipation to return to work at 6-8 weeks postsurgery		Baseline and 6-8 weeks postsurgery postsurgery
Secondary	Change from baseline in health condition at 6-8 weeks and 1 year postsurgery		Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Secondary	Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery		Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Secondary	Recidive prolapse		1 year postsurgery