Chronic Pain
Conditions
Brief summary
in this trial, we will test the analgesic efficacy of sacral neuromodulation for patients with pelvic cancer, complaining of chronic pelvic pain in comparison to medical treatment.
Interventions
DEVICEsacral neuromodulation
Sacral neuromodulation group, N=22 will be treated with Stimulation of the sacral nerve roots by placement of a lead and generator, typically using an implanted InterStim® device that provides constant electrical stimulation to the S 2, 3 and 4 nerve roots, for 2-week trial stimulation
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age, 18-70 * Pain localized to the pelvic and perineal region * The pain is due to pelvic cancer or chronic pelvic pain after pelvic surgery for cancer * The intensity of pain assessed by VAS (visual analogue pain scale) \> 7 * Importantly, the included participants should gain \> 50% reduction of their pain in response to sacral roots block, S2,3 and 4 with bupivacaine 0.5%, 2 ml for each root
Exclusion criteria
* Coagulopathy * Infection at site of maneuver * Abnormal Psychological behavior that interfere with integrity of obtained data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of intensity of pain | The outcome will be measured at day 15 postoperatively. | The intensity of pain measured by VAS pain score (visual analogue pain scale) where 0= no pain and 10=the maximum tolerated pain |
Outcome results
None listed