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

NCT ID: NCT01779544

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-11-30

Brief 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.

Conditions

Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brief intervention only

Brief intervention, an educational model, consists of information

Group Type: ACTIVE_COMPARATOR

Brief intervention, an educational model

Intervention Type: 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 group

Brief educational intervention combined with exercise therapy

Group Type: ACTIVE_COMPARATOR

Brief intervention, an educational model

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Exercise therapy

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kari Indrekvam, phd, MD

Role: STUDY_DIRECTOR

Helse Bergen HF, Haukeland University Hospital

Locations

Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik

Bergen, Hordaland, Norway

Countries

Norway

Other Identifiers

2012/1861

Identifier Type: -

Identifier Source: org_study_id