Neuralgia, Sciatic Clinical Trial
Official title:
An Effect and Safety Investigation on Percutaneous Endoscopic Lumbar Discectomy Technique to Remove Extraforaminal Disc Herniation at L5/S1 Segment Through 5th Transverse Process-facet Joint-sacrum Space
NCT number | NCT03511456 |
Other study ID # | NFEC-2018-022 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 5, 2016 |
Est. completion date | March 5, 2022 |
43% or so of far lateral lumbar disc herniation (FLLDH) occurred at L5/S1, however, the surgical treatment is still quite challenging. We conducted a modified PELD technique that enable us to remove the extraforaminal herniated disc at L5/S1, through the anatomical space surrounded by transverse process, facet joint and sacrum (TFS space). This study is to this technique's effect and safety in a one year follow-up.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | March 5, 2022 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients suffered with extraforaminal lumbar disc herniation at L5/S1 - Patients received percutaneous endoscopic lumbar discectomy Exclusion Criteria: - The diagnosis is not comply with the FLLDH - patients not choose PELD operation - patients unwilling to accept regular followup |
Country | Name | City | State |
---|---|---|---|
China | Nanfang Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital of Southern Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Physical functional ability | The life quality specially associated with LDP is evaluated by the Oswestry Disability Index (ODI), an index derived from the Oswestry Low Back Pain Questionnaire.The self-completed questionnaire contains ten topics including intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Patients choose 6 statements describing different potential scenarios in each topic. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. | The change of physical functional ability before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation). | |
Primary | Pain score | Pain evaluated by Visual Analogue Scale system. Using a scale ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" and the "agonizing pain" according to the patient's mark, providing a range of scores from 0-10. A higher score means intensifier pain. The effects of operation is based on the different VAS scores evaluated by pre- or post- surgical patients who described their pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-1), mild pain(2-5), moderate pain (6-8 mm), and severe pain (9-10). | The change of leg/waist pain before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation). | |
Secondary | Life quality | SF-36(The Short Form (36) Health Survey), a 36-item, patient-reported survey of patient health will be used for life quality evaluation. it consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health). The lower the score the more disability. The higher the score the less disability. The scores are compared pre- and post-operation. | The change of life quality before (1 day before operation) and post operation (2 days, 1 month and 3 months after operation). |