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

NCT02695576 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2017-04-25

No results posted yet for this study

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: [email protected]

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).

Conditions

  • Low Back Pain

Interventions

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.

Sponsors & Collaborators

  • Spinal Surgery Clinic, Strängnäs

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2017-04-30
Completion
2017-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02695576 on ClinicalTrials.gov