NCT02695576

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable low-back-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

9.8 years

First QC Date

February 2, 2016

Last Update Submit

April 24, 2017

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (4)

  • Low back pain assessed with Visual Analog Scale

    Visual Analog Scale for Pain

    One year

  • Low back pain assessed with Balanced Inventory for Spinal Disorders (BIS)

    Balanced Inventory for Spinal Disorders (BIS)

    One year

  • Low back pain assessed with Oswestry Disability Index (ODI)

    Oswestry Disability Index (ODI)

    One year

  • Low back pain assessed with Short-Form-36 (SF-36)

    Short-Form-36 (SF-36)

    One year

Secondary Outcomes (4)

  • Pain related functions assessed with Roland-Morris questionnaire

    One year

  • Pain related functions assessed with European Quality-of-Life Scale (EQ-5D)

    One year

  • Pain related functions assessed with Balanced Inventory for Spinal Disorders questionnaire (BIS)

    One year

  • Pain related functions assessed with Short-Form-36 questionnaire (SF-36)

    One year

Study Arms (2)

Surgery

EXPERIMENTAL

Lumbar fusion surgery Physiotherapy Cognitive behavioral therapy

Procedure: Lumbar Fusion SurgeryOther: PhysiotherapyOther: Cognitive behavioral therapy

Non-surgery

ACTIVE COMPARATOR

Physiotherapy Cognitive behavioral therapy

Other: PhysiotherapyOther: Cognitive behavioral therapy

Interventions

Lumbar Fusion SurgeryPROCEDURE

Interbody fusion with fixation

Surgery
PhysiotherapyOTHER

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.

Non-surgerySurgery
Cognitive behavioral therapyOTHER

Individual and group lessons performed by psychologists.

Non-surgerySurgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low back pain
  • Clinical diagnosis
  • No radiological correlates

You may not qualify if:

  • No previous fusion operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy ModalitiesCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 2, 2016

First Posted

March 1, 2016

Study Start

July 1, 2007

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share