A Phase 2 interventional study of carbidopa/levodopa and celecoxib and placebo1 and celecoxib in Chronic Back Pain, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Withdrawn at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-09.
Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Phase 2, Interventional, and Treatment
This is a 6-month double-blinded, randomized, placebo-controlled clinical trial of pharmacological treatment (carbidopa/levodopa and celecoxib) for acute/subacute back pain. All eligible patients will be randomly assigned to 3 different group and receive a 12-week treatment of "carbidopa/levodopa+celecoxib ", of "placebo+celecoxib", and of "placebo+placebo". In addition, all participants will be MRI-scanned twice and assessed daily with a mobile app for pan, mood, and behavior.
This is a 6-month double-blinded, randomized, placebo-controlled clinical trial of pharmacological treatment for acute/subacute back pain (carbidopa/levodopa and celecoxib).The dosage of carbidopa/levodopa is 25/100mg.After screening, all eligible patients will be randomly assigned to 3 different groups, with each receives a 12-week treatment of "carbidopa/levodopa+celecoxib (LDP+CLX)", of "placebo+celecoxib (PLC+CLX)", and of "placebo+placebo (PLC+PLC)". For each group, a subsequent 12-week follow-up efficacy evaluation will be conducted by telephone .At the end of the 24-week study, we will understand the durability of the treatment. During the drug treatment period for pain, all participants should return to the clinical follow-up center on week 0, 2, 6 and 12 to assess pain condition, properness of treatment and side effects .In the 24-week study of drug treatment and after treatment follow-up, pain and safety assessments will be conducted by telephone, at week 9, 16, and 20.In addition, all participants will be assessed daily with a mobile app for pain, mood and behavior.Participants will be scanned for brain structure images (T1), resting functional images (RS-fMRI) and diffusion tensor images (DTI) at the second follow-up visit (week 0) and at the end of study (week 24).
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
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Exclusion Criteria:
carbidopa/levodopa+celecoxib treatments will be effective.
Drug: carbidopa/levodopa and celecoxib
A placebo comparator for carbidopa/levodopa+celecoxib .
Drug: placebo1 and celecoxib
A placebo comparator for carbidopa/levodopa+celecoxib and placebo1+celecoxib.
Drug: placebo1 and placebo2
Every patient of this arm will get one bottle of carbidopa/levodopa and one bottle of celecoxib. At treatment initiation, Carbidopa/Levodopa will be taken once daily for 3 days, then twice daily for 3 days, and then thrice daily over one week and then continue on that dose for the duration of the treatment period (12 weeks total). At the last treatment visit (end of the treatment period), patients will begin tapering off the medication as follows. S/he will start with carbidopa/levodopa twice daily for 3 days and then once daily for 3 days before discontinuing it completely.Celecoxib will remain constant once daily for patients of this arm throughout the treatment period, but it will not be given during the tapering down at the end of the treatment period(12 weeks total).
Every patient of this arm will get one bottle of placebo1 and one bottle of celecoxib. At treatment initiation, placebo1 will be taken once daily for 3 days, then twice daily for 3 days, and then thrice daily over one week and then continue on that dose for the duration of the treatment period (12 weeks total). At the last treatment visit (end of the treatment period), patients will begin tapering off the medication as follows. S/he will start with placebo1 twice daily for 3 days and then once daily for 3 days before discontinuing it completely. Celecoxib will remain constant once daily for patients of this arm throughout the treatment period, but it will not be given during the tapering down at the end of the treatment period(12 weeks total).
Every patient of this arm will get one bottle of placebo1 and one bottle of placebo2. At treatment initiation, placebo1 will be taken once daily for 3 days, then twice daily for 3 days, and then thrice daily over one week and then continue on that dose for the duration of the treatment period (12 weeks total). At the last treatment visit (end of the treatment period), patients will begin tapering off the medication as follows. S/he will start with placebo1 twice daily for 3 days and then once daily for 3 days before discontinuing it completely. placebo2 will remain constant once daily for patients of this arm throughout the treatment period, but it will not be given during the tapering down at the end of the treatment period(12 weeks total).
Pain intensity of subjects
Numeric Rating Scale is an 11-point numerical rating scale used to measure pain intensity, the minimum score is 0 and maximum score is 10,the number 0 presents no pain, and number 10 presents the worst imaginable pain.The higher value represent a worse outcome.
Time frame: Baseline, 12th week, 24th week
Brain regional gray matter density of subjects
All the subjects will be scanned by MRI for contrasting anatomical brain image, and the brain regional gray matter density will be calculated from the contrasting anatomical image.
Time frame: Baseline, 24th week
Brain functional connectivity strength
All the subjects will be scanned by MRI for functional brain images, and the brain functional connectivity strengths will be calculated from the functional brain images, with number 1 presents the maximum positive connectivity between two different brain regions, number -1 presents maximum negative connectivity, and number 0 presents 0 connectivity.
Time frame: Baseline, 24th week
Sensory and affective components of pain of subjects
The scores of The McGill Pain Questionnaire is a well-validated pain measure with sensory and affective components of pain. The McGill Pain Questionnaire descriptors fall into two major groups: Sensory; Affective. The lowest possible score for each question is 0, the highest possible score for each question is 3, the higher value represent a worse outcome. Sensory (sections 1-11): The scores can range from 0 to 33. Affective (sections 12-15): The scores can range from 0 to 12.
Time frame: Baseline, 12th week, 24th week
Positive and negative mood affect of subjects
The Positive and Negative Affect Schedule has two mood scales, one measuring positive affect and the other measuring negative affect .The lowest possible score for each question is 1, the highest possible score for each question is 5. Positive Affect Schedule(sections 1,3,5,9,10,12,14,16,17,19): Scores can range from 10 to 50, with higher scores representing higher levels of positive affect. Negative Affect Score(sections 2,4,6,7,8,11,13,15,18,20): Scores can range from 10 to 50, with lower scores representing lower levels of negative affect.
Time frame: Baseline, 12th week, 24th week
The severity of depression of subjects
Beck's Depression Index add up the score for each of the 21 questions . The lowest possible score for each question is 0, the highest possible score for each question is 3. The possible total scores can range from 0 to 63, the higher value represent a worse depression.
Time frame: Baseline, 12th week, 24th week
Individual pain sensitivity of subjects
Pain Sensitivity Questionnaire (PSQ)is a 11-point, 17-item instrument used to assess individual pain sensitivity. PSQ-minor and PSQ-moderate were two subscales corresponding to mildly painful and moderately painful situation respectively. PSQ-minor(sections 3,6,7,10-12,14): the lowest possible score for each question is 0 the highest possible score for each question is 10. Scores can range from 0 to 70. PSQ-moderate(sections 1,2,4,8,15-17): the lowest possible score for each question is 0 the highest possible score for each question is 10. Scores can range from 0 to 70. The higher value represent more sensitive.
Time frame: Baseline, 12th week, 24th week
Thoughts or feelings on past pain experience of subjects
The Pain Catastrophizing Scale is a 5-point instrument to assess 13 thoughts or feelings on past pain experience. The Pain Catastrophizing Scale yields three sub-scale scores assessing rumination, magnification , and helplessness. The lowest possible score for each question is 0 the highest possible score for each question is 4. The higher value represent a worse outcome. Rumination(sections 8-11): The total score of the four items can range from 0 to 16. Magnification(sections 6,7,13):The total score of the three items can range from 0 to 12. Helplessness(sections 1-5,12): The total score of the six items can range from 0 to 24.
Time frame: Baseline, 12th week, 24th week
Fear and anxiety responses specific to pain of subjects
Pain Anxiety Symptom Scale measures fear and anxiety responses specific to pain. It has 13 questions consisted of four aspects of pain-related anxiety. Cognitive suffering(sections 1-5): the lowest possible score for each question is 0 the highest possible score for each question is 5. Scores can range from 0 to 25. Escape-avoidance behaviors(sections 6-10): the lowest possible score for each question is 0 the highest possible score for each question is 5. Scores can range from 0 to 25. Fear of pain(sections 11-15): the lowest possible score for each question is 0 the highest possible score for each question is 5. Scores can range from 0 to 25. Physiological symptoms of anxiety(sections 16-20): the lowest possible score for each question is 0 the highest possible score for each question is 5. Scores can range from 0 to 25. The higher value represent a worse anxiety.
Time frame: Baseline, 12th week, 24th week
Physical impairment in relation to pain of subjects
Pain Disability Index has 11-point, where 0 corresponds to no disability and 10 indicates worst disability.The lowest possible score for each question is 0(best), the highest possible score for each question is 10(worst). the total score of the seven items can range from 0 to 70, the higher value represent a worse disability.
Time frame: Baseline, 12th week, 24th week
This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital of Wenzhou Medical University