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Lumbar Fusion or Non-operative Care for Treatment of Presumed Discogenic Pain

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: NCT02695576
Recruitment Status : Completed
First Posted : March 1, 2016
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Bo Nyström, Spinal Surgery Clinic, Strängnäs

Brief Summary:

Title and abstract

1 a. Title: Lumbar fusion or non-operative care for treatment of presumed discogenic pain.

A randomized study.

1 b. Structured summary:

Authors: B. Nyström, B. Schillberg, E. Svensson, T. Stiles.

Corresponding author: Bo Nyström, Clinic of Spinal Surgery, Strängnäs, Sweden. e-mail address: pgbo.nystrom@gmail.com

Background: At present there is no clear evidence that surgical treatment by fusion operation is more advisable than non-surgical treatment in patients suffering from unspecific chronic low back pain (CLBP). By personal experience a subgroup among the CLBP patients is selected, possibly representing patients with pain from a motion segment/disc, thus making patient selection more specified. Furthermore, selection of level to fuse based on radiological findings has not been found reliable. Therefore a mechanical provocation test has been developed at the clinic. The aim of this randomized study was to compare the outcomes in pain and pain related functions perceived by this specific subgroup of CLBP patients following fusion surgery with those following non-surgical treatment.

Methods: Patients with a specified symptomatology and specified clinical signs at examination were recruited and randomized to either type of treatment, non-surgical (NS) including cognitive-behavioral therapy and physiotherapy (37 pat.) or surgical (S), including the same cognitive-behavioral therapy and physiotherapy as in the NS group plus fusion surgery (37 pat.). All patients were thoroughly investigated before start of the study and at follow-up one year after treatment. The outcomes perceived by the patients were assessed on the validated questionnaires Oswestry Disability Index (ODI), Roland-Morris, Balanced Inventory for Spinal Disorders (BIS), Short-Form-36 (SF-36) and Euro-Quol (EQ-5D).


Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: Lumbar Fusion Surgery Other: Physiotherapy Other: Cognitive behavioral therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lumbar Fusion or Non-operative Care for Treatment of Presumed Discogenic Pain: A Randomized Study
Actual Study Start Date : July 2007
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Surgery
Lumbar fusion surgery Physiotherapy Cognitive behavioral therapy
Procedure: Lumbar Fusion Surgery
Interbody fusion with fixation

Other: Physiotherapy
Examination by physiotherapist, motivation of the patient, training in body awareness, physical activity/Qigong, training in water, outdoor pole work, circle training, stabilization training, massage, stretching, lessons and practice in ergonomics.

Other: Cognitive behavioral therapy
Individual and group lessons performed by psychologists.

Active Comparator: Non-surgery
Physiotherapy Cognitive behavioral therapy
Other: Physiotherapy
Examination by physiotherapist, motivation of the patient, training in body awareness, physical activity/Qigong, training in water, outdoor pole work, circle training, stabilization training, massage, stretching, lessons and practice in ergonomics.

Other: Cognitive behavioral therapy
Individual and group lessons performed by psychologists.




Primary Outcome Measures :
  1. Low back pain assessed with Visual Analog Scale [ Time Frame: One year ]
    Visual Analog Scale for Pain

  2. Low back pain assessed with Balanced Inventory for Spinal Disorders (BIS) [ Time Frame: One year ]
    Balanced Inventory for Spinal Disorders (BIS)

  3. Low back pain assessed with Oswestry Disability Index (ODI) [ Time Frame: One year ]
    Oswestry Disability Index (ODI)

  4. Low back pain assessed with Short-Form-36 (SF-36) [ Time Frame: One year ]
    Short-Form-36 (SF-36)


Secondary Outcome Measures :
  1. Pain related functions assessed with Roland-Morris questionnaire [ Time Frame: One year ]
    Roland-Morris questionnaire

  2. Pain related functions assessed with European Quality-of-Life Scale (EQ-5D) [ Time Frame: One year ]
    European Quality-of-Life Scale (EQ-5D)

  3. Pain related functions assessed with Balanced Inventory for Spinal Disorders questionnaire (BIS) [ Time Frame: One year ]
    Balanced Inventory for Spinal Disorders questionnaire (BIS)

  4. Pain related functions assessed with Short-Form-36 questionnaire (SF-36) [ Time Frame: One year ]
    Short-Form-36 questionnaire (SF-36)



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Low back pain
  • Clinical diagnosis
  • No radiological correlates

Exclusion Criteria:

  • No previous fusion operation.
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Responsible Party: Bo Nyström, MD, PhD, Spinal Surgery Clinic, Strängnäs
ClinicalTrials.gov Identifier: NCT02695576    
Other Study ID Numbers: SpinalSC
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Pain
Neurologic Manifestations