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

Rehabilitation After Lumbar Surgery

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.

Study Overview

• Status: Completed
• Conditions: Prolapse
• Intervention / Treatment: Other: Brief intervention, an educational model; Other: Exercise therapy

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Hordaland
    • Bergen, Hordaland, Norway
      • Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Brief intervention only; Brief intervention, an educational model, consists of information	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.
Active Comparator: Exercise group; Brief educational intervention combined with exercise therapy	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.; Other: Exercise therapy; Patients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Disability and beliefs about the condition	Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery	Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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
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
Change from baseline in anticipation to return to work at 6-8 weeks postsurgery	Baseline and 6-8 weeks postsurgery postsurgery
Change from baseline in health condition at 6-8 weeks and 1 year postsurgery	Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery	Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Recidive prolapse	1 year postsurgery

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Study Director: Kari Indrekvam, phd, MD, Helse Bergen HF, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: January 24, 2013
• First Submitted That Met QC Criteria: January 28, 2013
• First Posted (Estimate): January 30, 2013

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: rehabilitation,surgery,brief intervention, exercises
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: 2012/1861