ProlapseNCT01779544
Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention
A study testing Brief intervention, an educational model and Exercise therapy in people with Prolapse, run by Haukeland University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Prolapse
- What is being tested?
- Brief intervention, an educational model and Exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2013to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with lumbar disc prolapse with radicular pain
- Age between 18 and 60
Who cannot join
- Previous lumbar disc surgery (prolapse)
- Spondyloarthritis
- Arthritis
- Systematic disease
- Heart disease
- Does not understand Norwegian language, spoken or in writing
Trial locations and contacts
1 site in 1 country.
Norway1 site
Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik
Bergen, Hordaland
About this study
Official title: 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.
Read more
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.
- Conditions
- Prolapse
- Being tested
- Brief intervention, an educational model, Exercise therapy
- Keywords
- rehabilitation,surgery,brief intervention, exercises
- Medical subject headings
- Prolapse, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief intervention, an educational modelOther
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 therapyOther
Patients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these
| Study group | Role | What they receive |
|---|---|---|
| Brief intervention only | Active comparator | Brief intervention, an educational model, consists of information Receives: Other: Brief intervention, an educational model |
| Exercise group | Active comparator | Brief educational intervention combined with exercise therapy Receives: Other: Brief intervention, an educational model; Other: Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery
Measured: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Secondary outcomes (8)
Disability and beliefs about the condition
Measured: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery
Measured: 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
Measured: 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
Measured: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Change from baseline in anticipation to return to work at 6-8 weeks postsurgery
Measured: Baseline and 6-8 weeks postsurgery postsurgery
Change from baseline in health condition at 6-8 weeks and 1 year postsurgery
Measured: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery
Measured: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Recidive prolapse
Measured: 1 year postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProlapseStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kari Indrekvam, phd, MD, Study director, Helse Bergen HF, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779544
- Sponsor's protocol ID
- 2012/1861
- Status last verified
- Feb 2017
- First submitted
- 24 Jan 2013
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation After Lumbar Surgery
- ClinicalTrials.gov ID
- NCT01779544
- Acronym / sponsor ID
- 2012/1861
- Conditions
- Prolapse
- Keywords
- rehabilitation,surgery,brief intervention, exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief intervention only | Active comparator | Other: Brief intervention, an educational modelBrief intervention, an educational model, consists of information |
| Exercise group | Active comparator | Other: Brief intervention, an educational model, Other: Exercise therapyBrief educational intervention combined with exercise therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with lumbar disc prolapse with radicular pain
- Age between 18 and 60
Key exclusion criteria (6 listed)
- Previous lumbar disc surgery (prolapse)
- Spondyloarthritis
- Arthritis
- Systematic disease
- Heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief intervention, an educational modelThe 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 | Brief intervention only, Exercise group |
| Exercise therapyPatients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these | Other | Exercise group |
Primary outcome
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
8 secondary outcomes
Disability and beliefs about the condition
Time frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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
Change from baseline in Tampa scale of Kinesiophobia (TSK-13) at 6-8 weeks and 1 year postsurgery
Time frame: 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
Time frame: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
Change from baseline in anticipation to return to work at 6-8 weeks postsurgery
Time frame: Baseline and 6-8 weeks postsurgery postsurgery
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
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
Recidive prolapse
Time frame: 1 year postsurgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari Indrekvam, phd, MD study director
Helse Bergen HF, Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief intervention, an educational model and Exercise therapy in people with Prolapse, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.