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

NCT01779544 | Completed DMC

• 1 other identifier: 2012/1861
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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. 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. 2.Exercises which are instructed after lumbar disc surgery in a rehabilitation program, are being done by the patients.

Conditions

Prolapse

Keywords

rehabilitation,surgery,brief intervention, exercises

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

Brief intervention only

ACTIVE COMPARATOR

Brief intervention, an educational model, consists of information

Other: Brief intervention, an educational model

Exercise group

ACTIVE COMPARATOR

Brief educational intervention combined with exercise therapy

Other: Brief intervention, an educational model; Other: Exercise therapy

Interventions

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.

Brief intervention only; Exercise group

Exercise therapy OTHER

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

Exercise group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik

Bergen, Hordaland, Norway

Location

MeSH Terms

Conditions

Prolapse; Motor Activity

Interventions

Crisis Intervention; Exercise Therapy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Kari Indrekvam, phd, MD

  Helse Bergen HF, Haukeland University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 30, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 9, 2019

Record last verified: 2017-02

Locations

NO (1)