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Supervised Physical Therapy Versus Unsupervised Home Exercise After Surgery for Lumbar Disc Herniation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03505918
Recruitment Status : Active, not recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Karen Hoejmark Hansen, Sygehus Lillebaelt

Brief Summary:

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial with two parallel groups
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Oswestry disability index [ Time Frame: 6 month postoperative. ]
    Functional status questionaire


Secondary Outcome Measures :
  1. EuroQOL -5D [ Time Frame: 12 month postoperative ]
    Life quality questionaire.

  2. SF-6D [ Time Frame: 12 month postoperative ]
    Life quality questionaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Clinical symptoms and concordant MRI findings of a lumbar disc herniation from L1 to S1 with indications for discectomy surgery, assessed by an experienced spinal surgeon
  • Age 18-65 years

Exclusion Criteria:

  • History of previous spine surgery or disease (eg. spinal fracture, scoliosis or stenosis)
  • General contra-indication for spine surgery
  • Diagnosis of psychiatric disorder
  • Current malignant disease
  • Hematologic disease
  • Major surgical procedures within 12 months (eg. collum femoris fracture)
  • Chronic, generalized connective tissue disorders or chronic, non-specific pain disorders (fibromyalgia, whiplash, etc.)

Information from the National Library of Medicine

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


Locations
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Denmark
Spine Center of Southern Denmark
Middelfart, Denmark, 5500
Sponsors and Collaborators
Sygehus Lillebaelt
Investigators
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Principal Investigator: Rune Paulsen, M.D Sygehus Lillebælt

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Responsible Party: Karen Hoejmark Hansen, Research nurse, Sygehus Lillebaelt
ClinicalTrials.gov Identifier: NCT03505918     History of Changes
Other Study ID Numbers: S-20150051
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical