Supervised Physical Therapy Versus Unsupervised Home Exercise After Surgery for Lumbar Disc Herniation
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|ClinicalTrials.gov Identifier: NCT03505918|
Recruitment Status : Completed
First Posted : April 23, 2018
Last Update Posted : September 24, 2019
This is a randomized controlled trial evaluation effect of postoperative rehabilitation after surgery for lumbar disc herniation.
The primary aim of this study is to evaluate the effect of unsupervised home exercises compared to supervised physical rehabilitation.
Secondary aims of this study are to determine if there is a difference in cost-effectiveness in patients undergoing supervised physical rehabilitation in patients after surgery for lumbar disc herniation compared to unsupervised home exercises.
|Condition or disease||Intervention/treatment||Phase|
|Disk Herniated Lumbar Physiotherapy Surgery||Other: No referral for rehabilitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised controlled trial with two parallel groups|
|Official Title:||Randomized Clinical Trial of Supervised Physical Therapy Versus Unsupervised Home Exercise in Patients Recovering After Surgery for Lumbar Disc Herniation|
|Actual Study Start Date :||October 1, 2015|
|Actual Primary Completion Date :||February 1, 2019|
|Actual Study Completion Date :||September 1, 2019|
No Intervention: Standard municipal rehabilitation
Standard care with postoperative rehabilitation at the municipal facility.
Experimental: No referral for rehabilitation
No referral for supervised postoperative rehabilitation. Only standard information booklet and advice during hospitalization.
Other: No referral for rehabilitation
Intervention is that some patients will not be refered for postoperative physiotherapy.
- Oswestry disability index [ Time Frame: 6 month postoperative. ]Functional status questionaire
- EuroQOL -5D [ Time Frame: 12 month postoperative ]Life quality questionaire.
- SF-6D [ Time Frame: 12 month postoperative ]Life quality questionaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505918
|Spine Center of Southern Denmark|
|Middelfart, Denmark, 5500|
|Principal Investigator:||Rune Paulsen, M.D||Sygehus Lillebælt|