Transition From Acute to Chronic Back Pain : Effect of L-dopa,Gender,and Associated Brain Plasticity

NCT04082715 | Withdrawn Phase 2 DMC

• 1 other identifier: SAHoWMU-CR2019-05-105
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Back Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 12th week, 24th week

Secondary Outcomes (2)

• Brain regional gray matter density of subjects

  Baseline, 24th week

• Brain functional connectivity strength

  Baseline, 24th week

Other Outcomes (7)

• Sensory and affective components of pain of subjects

  Baseline, 12th week, 24th week

• Positive and negative mood affect of subjects

  Baseline, 12th week, 24th week

• The severity of depression of subjects

  Baseline, 12th week, 24th week

Study Arms (3)

carbidopa/levodopa+celecoxib

EXPERIMENTAL

carbidopa/levodopa+celecoxib treatments will be effective.

Drug: carbidopa/levodopa and celecoxib

placebo1+celecoxib

PLACEBO COMPARATOR

A placebo comparator for carbidopa/levodopa+celecoxib .

Drug: placebo1 and celecoxib

placebo1+placebo2

PLACEBO COMPARATOR

A placebo comparator for carbidopa/levodopa+celecoxib and placebo1+celecoxib.

Drug: placebo1 and placebo2

Interventions

carbidopa/levodopa and celecoxib DRUG

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).

carbidopa/levodopa+celecoxib

placebo1 and celecoxib DRUG

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).

placebo1+celecoxib

placebo1 and placebo2 DRUG

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).

placebo1+placebo2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• New onset subacute or acute back pain (\< 6 months' duration, no back pain for 3 months before the new onset)
• Signs and symptoms: positive straight leg raising test with dermatomal radiation and/or myotomal weakness and/or reflex asymmetry, pain must radiate into buttock or below
• Average reported pain intensity from App greater than 4/10 during the first week
• MUST be able to undergo MRI procedures (no pacemaker, any metal implants)

You may not qualify if:

• Previous (distinct) episodes of back pain onset (more than 3 distinct episodes of back pain lasting for a total of more than 4 weeks) in the previous year;
• Evidence of acute vertebral fracture;
• Low back pain associated with any systemic signs or symptoms, e.g., fever, chills;
• Symptoms of neuropathy due to diabetes Type I or Type II;
• Chronic neurologic conditions, including Parkinson's disease, Alzheimer's disease, and other conditions associated with dementia;
• Significant other medical diseases such as congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy;
• History of glaucoma or narrow angle glaucoma;
• Presence of undiagnosed skin lesions or history of melanoma;
• Presence of severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease;
• History of myocardial infarction with residual cardiac arrhythmia;
• History of gastrointestinal bleeding or peptic ulcer;
• Diagnosis of current depression (assessed via BDI, total \> 28 are excluded) or psychiatric disorder requiring treatment, or such a diagnosis in the previous 6 months;
• Use of therapeutic doses of antidepressant medications (i.e., tricyclic antidepressants, SSRIs, SNRIs; low doses used only in the evening for sleep will be allowed if dose is not changed;
• Current use of recreational drugs or recent history of alcohol abuse (pattern of drinking having social, financial or physical consequences) or drug abuse (urine screening);
• Current use of cannabinoids (4 participants tested positive; 3 completed the study, in these blood test at the end of the study confirmed cannabinoid use; excluding these subjects does not importantly alter results, see below);

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead
• Northwestern University: collaborator

Study Sites (1)

Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325035, China

Location

MeSH Terms

Conditions

Pain

Interventions

Carbidopa; Levodopa; Celecoxib

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyldopa; Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Hydrazines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Benzenesulfonamides; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• BinBin Wu, doctor

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: September 9, 2019
• Study Start: October 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

CN (1)