Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06051149 |
| Other study ID # |
AUN1615 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2024 |
| Est. completion date |
January 2026 |
Study information
| Verified date |
September 2023 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The approach toward FBSS involves conservative management that consists of physical therapy
and medication which aims to optimize gait and posture and can improve muscle strength and
physical function
Description:
The international association for the study of pain has defined failed back syndrome as
persistent pain despite spine surgery in the same topographical area.
Several causes have been introduced for FBSS including pressure on the nerve root due to disc
re-herniation or retained disc fragment, epidural fibrosis, acquired stenosis, and segmental
instability.
Thus, FBSS is a syndrome with diverse etiologies and noticeable heterogeneity among patients.
However, about 20% to 36% of FBSS occur due to epidural fibrosis, which is a progressive
disease.
The approach toward FBSS involves conservative management that consists of physical therapy
and medication which aims to optimize gait and posture and can improve muscle strength and
physical function. Oral pharmacological treatment of FBSS is multimodal and increasingly
controversial. Treatments include antiepileptics, non-steroidal anti-inflammatory drugs, oral
steroids, antidepressants, and opioids including injections, and finally surgical options as
a last line therapy. Other modalities including minimally invasive procedures like epidural
injections, Epidural steroid injections (ESIs) are the most commonly performed procedure in
pain clinics around the world. These can be administered primarily by three approaches:
transforaminal, interlaminar, or caudally, and are indicated for symptoms of radiculopathy.
Also radiofrequency ablation of nerves are often used to provide sustained relief that a
diagnostic block or therapeutic injection cannot provide. Successfully targeting the intended
nerve is achieved, maximizing the size of the lesion. Spinal cord stimulation (SCS) is a
nother treatment modality that has shown tremendous potential in the management of FBSS.
Adhesions can theoretically be lysed, thereby improving baseline pain scores and drug
delivery of the ESI. Lysis of adhesions typically occurs by delivering hyaluronidase with
hypertonic saline into the epidural space. The use of hyaluronidase with steroid may be more
effective and have longer duration of effect than either one alone. Finally, surgical
revision for FBSS is associated with a high morbidity with corresponding low rates of
success.
Percutaneous adhesiolysis (PA), is a minimally invasive technique, that might be useful in
the treatment of chronic pain refractory to conservative treatments. The basic idea behind PA
is inserting a catheter in the ventral epidural space could directly break up
perineural/epidural adhesions, that act as physical barriers to the perineurally deposited
drugs but also cause neural irritation predisposing to neural inflammation.
