A Phase 4 interventional study of Mediclore and Normal Saline in Lumbar Disc Disease, Epidural Fibrosis and Failed Back Surgery Syndrome, sponsored by King Chulalongkorn Memorial Hospital. Not yet recruiting at 1 site in Thailand. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by King Chulalongkorn Memorial Hospital · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to compare efficacy and safety of Mediclore as anti-adhesion agent in patient who undergo endoscopic lumbar discectomy. The main question[s] it aims to answer are:
Researchers will compare to see if experimental group have better patient-reported outcomes (PROs) after surgery with no different in complications rate.
This study is a randomized clinical trial arrange in King Chulalongkorn Memorial Hospital. Participant will be randomly assigned into 2 groups by computer-generated sequence. Patients based-line characteristic data, patient-reported outcomes (VAS back/leg, ODI and EQ-5D) and a results of straight leg raising test will be collected. Participant will undergo a endoscopic lumbar discectomy by a singer spine surgeon. In experimental group, 1.5 CC. of Mediclore (poloxamer-based thermosensitive anti-adhesive agent) will be applied in after finish the operation. In control group normal saline 1.5 CC. will be applied instead.
Participants will proceed to regular follow-up protocol which include 1, 3 and 6 months visit at out-patient department. All of the PROs and a result of a straight leg raising test will be collected at each visit. MRI will be performed at 3 month after the surgery. The amount of epidural fibrosis will be evaluated according to Ross's method.
98 studies on the registry are indexed under Failed Back Surgery Syndrome; 16 are open to participants now.
This study's planned enrollment of 78 is above the median of 40 across 71 interventional studies indexed under Failed Back Surgery Syndrome.
Browse Failed Back Surgery Syndrome studies →King Chulalongkorn Memorial Hospital is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After finish the operation, Mediclore group will be applied 1.5 CC of Mediclore at the surgical site. Mediclore is a Poloxamer-based thermosensitive anti-adhesive agent which is in a liquid solution and transform to a gel-state after being in a body temperature.
Drug: Mediclore
After finish the operation, Control group will be applied 1.5 CC of normal saline at the surgical site.
Drug: Normal Saline
After finish the operation, Mediclore group will be applied 1.5 CC of Mediclore at the surgical site. Mediclore is a Poloxamer-based thermosensitive anti-adhesive agent which is in a liquid solution and transform to a gel-state after being in a body temperature.
After finish the operation, Control group will be applied 1.5 CC of normal saline at the surgical site.
Also known as: Control
Visual Analogue Score for Leg pain (VAS Leg)
The VAS Leg consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('the worst pain in a lifetime'). The patient was asked to rate their current pain level by pointing the mark on the line.
Time frame: 3 month after surgery
Visual Analogue Score for Leg and Back pain (VAS Leg, Back)
The VAS Leg and Back consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('the worst pain in a lifetime'). The patient was asked to rate their current pain level by pointing the mark on the line.
Time frame: 1, 3 and 6 month after surgery (for VAS Back) and 1 and 6 month after surgery (for VAS Leg)
Oswestry Disability Index (ODI)
The ODI consists of 10 questions to assess the function in daily activities living, in which the responses are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).
Time frame: 1, 3 and 6 month after surgery
EQ-5D-5L
The EQ-5D-5L has 2 parts. In the first part, consist of 5 questions to assess the function in daily activities living, in which the responses are presented as 5 level (1 means no problems to 5 means extreme problems). The digits for the five questions can be combined into a 5-digit number that describes the patient's health state. The results will interpreted with the country specific utility score (Thailand) and reported as three decimal digit range from 0 (the worst health you can imagine) to 1 (the best health you can imagine).
Time frame: 1, 3 and 6 month after surgery
Epidural Fibrosis
Evaluation of epidural fibrosis by method proposed by Ross et al (1999) by MRI. From MRI axial cut, A surgical intervertebral level will be marked as level 3, 2 adjacent cephalic image will be marked as level 1 and 2. 2 adjacent caudad level will be marked as level 4 and 5. Then each image will be separated into 4 quadrant. Fibrosis will be graded on a scale of 0-4 for each quadrant at each imaging slice encompassing the operative level: 0 = no/trace scar; 1 = \> 0-25% of quadrant filled with scar; 2 = 25-50% of quadrant filled with scar; 3 = 50-75% of quadrant filled with scar; 4 = \> 75% of quadrant filled with scar. The highest grade of epidural fibrosis from any image will represent the degree of epidural ficrosis.
Time frame: 3 month after surgery
Complication rate
Time frame: peri-operation, 1, 3 and 6 month after surgery
Straight leg raising test
Straight leg raising test will be performed at each visit. Results will be recorded as negative or positive. If positive, the degree that make a test positive will be also recorded.
Time frame: 1, 3 and 6 month after surgery
Plan to share: No
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
King Chulalongkorn Memorial Hospital