Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention - Full Text View

Purpose

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:

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

Condition	Intervention
Prolapse	Other: Brief intervention, an educational model Other: Exercise therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Rehabilitation After Lumbar Surgery

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disability and beliefs about the condition [ Time Frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change from baseline in Tampa scale of Kinesophobia (TSK-13) at 6-8 weeks and 1 year postsurgery [ Time Frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change from baseline in anticipation to return to work at 6-8 weeks postsurgery [ Time Frame: Baseline and 6-8 weeks postsurgery postsurgery ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Recidive prolapse [ Time Frame: 1 year postsurgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2013
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779544

Contacts

Contact: Vegard Pihl Moen, MSc, PT	+4756565971	vegard.pihl.moen@helse-bergen.no
Contact: Eva Saltskår Jentoft, PT	+4756565910	eva.saltskar.jentoft@helse-bergen.no

Locations

Norway
Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik	Recruiting
Bergen, Hordaland, Norway
Contact: Vegard P moen, MSc, PT +4756565971 vegard.pihl.moen@helse-bergen.no
Contact: Eva S Jentoft, PT +4756565910 eva.saltskar.jentoft@helse-bergen.no
Principal Investigator: Kari Indrekvam, phd, MD

Sponsors and Collaborators

Haukeland University Hospital

Investigators

Study Director:

Kari Indrekvam, phd, MD

Helse Bergen HF, Haukeland University Hospital

More Information

No publications provided

Responsible Party:	Vegard Phil, Physical Therapist, Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT01779544 History of Changes
Other Study ID Numbers:	2012/1861
Study First Received:	January 24, 2013
Last Updated:	January 28, 2013
Health Authority:	Norway: Regional Ethics Commitee

Keywords provided by Haukeland University Hospital:

rehabilitation,surgery,brief intervention, exercises

Additional relevant MeSH terms:

Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 17, 2013