Failed Back Surgery Syndrome
Conditions
Brief summary
In the past decade, spine surgery rates have dramatically increased in parallel to those of other procedural interventions. Persistent pain is a common occurrence after spine surgery, with the most commonly quoted prevalence rates ranging from 10% to 40%. This pain can be classified into failure to alleviate baseline pain, pain resulting from complications (e.g., arachnoiditis and epidural adhesions), and pain that ensues several years later as a sequele to alterations in spinal architecture and biomechanics (e.g., adjacent segment discogenic or facetogenic pain) which is called failed back surgery syndrome ( FBSS )
Detailed description
By observing adhesions directly, the lysis of scar tissue can be carried out mechanically using some percutaneous techniques as insertion of catheters as Rac'z catheter (thin in calibre) which will be inserted through the skin under fluoroscopy guidance or using NAVI catheter (large in calibre) either fluoroscopy guided or using thin epiduroscopy. Adhesions can be disintegrated and their evaluation scores may improve.
Interventions
PROCEDURERacz adhesolysis
adhesiolysis in failed back surgery
DEVICENAVI adhesolysis
adhesiolysis in failed back surgery
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with history of lumbar surgery of at least 6 months duration in the past. * Patients over the 18 years of age. * History of persistent function-limiting lower extremity pain aggravated by dural tug (observed when the patient, sitting on the exam table with legs stretched out, bends forward, bringing on the back pain) with or without low back pain of at least 6 months duration after failure of conventional conservative management in most patients including NSAIDS, muscle relaxants (tizanidine, magnesium sulphate) and pregabalin. * Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements.
Exclusion criteria
* Unstable or heavy opioid use. * Uncontrolled psychiatric disorders. * Uncontrolled medical illness. * Any conditions that could interfere with the interpretation of the outcome assessments. * Pregnant or lactating women. * Patients with a history or potential for adverse reaction(s) to local anaesthetics or steroid.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| numerical rating scale | 12 months | The VAS score was used that has 0-10 points. The 0 point represents the painless state and a score from 1 to 3 points represents mild pain, from 4 to 6 points represents moderate pain and from 7 to 10 points represents severe pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pregabalin consumption | 12 month | amount of pregabalin consumed by the patient per day |
| Oswestry Disability Index (ODI) | 12 month | 0 - 100% disability; minimal disability = 0% to either bed-bound or exaggerating symptoms = 100%) |
Countries
Egypt
Outcome results
None listed