Placebo In Chronic Back Pain (Phase 2)

NCT02986334 | Completed Phase 4 Results DMC

• 2 other identifiers: STU00080585 (Phase 2)5R01AT007987-03
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to examine brain properties for placebo response in chronic back pain patients. The investigators have preliminary data indicating that, in blinded clinical trial studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can be subdivided into placebo responders and non-responders, and these differences are PREDICTABLE a priori, by brain activity. The results imply that CBP placebo may have clinical utility and that its properties can be studied by human brain imaging techniques. In Phase I of the study, the investigators seek to identify brain imaging parameters that predict the propensity for the placebo response in an independent CBP cohort. In Phase II, the investigators will evaluate the interaction between placebo response and medication treatment in individuals stratified as placebo responders versus non-responders. This research is designed to critically assess the neurobiology of placebo analgesia for chronic pain in a partially-blind clinical trial.

Conditions

Chronic Low Back Pain

Keywords

chronic; low back; back; pain; brain; MRI

Outcome Measures

Primary Outcomes (1)

• Percent Change in Pain Assessed by Visual Analogue Scale (VAS)

  Self-report pain using a VAS scale (0-10) : 0 represents no pain and 10 the worst imaginable pain. Results are presented as percentage (%) change in pain before and after the intervention (baseline and post-intervention, 12 weeks). Percentage change is calculated with post-intervention pain minus baseline pain, divided by baseline pain i.e. (post - baseline) / baseline.

  12 weeks

Study Arms (3)

No Treatment Intervention

NO INTERVENTION

Observational Subjects randomized to this arm will be asked to discontinue their current pain medications for the length of the study. This arm is not blinded, as both study staff and participants will be aware that they are not receiving a study treatment.

Active Treatment Intervention

ACTIVE COMPARATOR

Naproxen \& Omeprazole Subjects randomized to this arm will be asked to discontinue their current pain medications and take one 500mg naproxen capsule and one 40mg omeprazole capsule twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment).

Drug: Naproxen; Drug: Omeprazole

Placebo Treatment Intervention

PLACEBO COMPARATOR

Subjects randomized to this arm will be asked to discontinue their current pain medications and take two placebo capsules twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment)

Drug: Placebo

Interventions

Naproxen DRUG

Subjects enrolled in the active treatment arm will receive 500mg of Naproxen prescribed twice daily, once in the morning and evening.

Also known as: Aleve, Anaprox, Antalgin, Feminax Ultra, Flanax, Inza, Midol Extended Relief, Nalgesin, Naposin, Naprelan, Naprogesic, Naprosyn, Narocin, Proxen, Soproxen, Synflex, Xenobid

Active Treatment Intervention

Omeprazole DRUG

Subjects enrolled in the active treatment arm will receive 20mg of Omeprazole prescribed twice daily, once in the morning and evening. Furthermore, subjects should take this one hour before a meal.

Also known as: Prilosec, Iosepine

Active Treatment Intervention

Placebo DRUG

Subjects enrolled in the inactive treatment arm will receive two prescriptions, however, there are no active ingredients and are intended to look identical to the active treatment. Therefore, subjects will be instructed exactly the same way as if they were ingesting the active treatment.

Also known as: Sugar Pill

Placebo Treatment Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of low back pain for a minimum of 6 months with or without signs and symptoms of radiculopathy
• Male or female, between the ages of 18 and 75 years, with no racial or ethnic restrictions
• Must have a Visual Analog Scale (VAS) pain score of 5 mm (of 10 mm maximum) at the screening visit (for which 0mm = no pain, and 10 mm = worst pain imaginable);
• Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires;
• Must be in generally stable health;
• Must sign an informed consent document after a complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate
• Must have, on average, 5/10 units (VAS scale) of pain over the course of a two-week period prior to visit 1; rounding up from 4.5/10 is permissible.
• Must be willing to complete daily smart phone/computer app ratings.

You may not qualify if:

• Low back pain associated with any systemic signs or symptoms, e.g., fever, chills;
• Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of tumor in the back;
• Other comorbid chronic pain or neurological conditions;
• Involvement in litigation regarding their back pain or having a disability claim or receiving workman's compensation or seeking either as a result of their low back pain;
• Diagnosis of current depression or psychiatric disorder requiring treatment, or such a diagnosis in the previous 6 months;
• Beck Depression Inventory (BDI) Ia score greater or equal to 19 for two consecutive completions; if the first score meets this criteria, the participant must be re-tested before his/her next visit, but if the second score does not meet this criteria, the participant will be included and followed closely throughout the study
• Use of therapeutic doses of antidepressant medications (i.e., tricyclic depressants, SSRIs, SNRIs; low doses used for sleep may be allowed);
• Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy;
• History of gastrointestinal ulcer during the past year;
• History of myocardial infarction in the past year;
• Uncontrolled hypertension;
• Renal insufficiency;
• Allergic to, or non-tolerant of, NSAIDs;
• History of aspirin-sensitive asthma;
• Current use of recreational drugs or history of alcohol or drug abuse;

Sponsors & Collaborators

• Apkar Apkarian: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Vachon-Presseau E, Abdullah TB, Berger SE, Huang L, Griffith JW, Schnitzer TJ, Apkarian AV. Validating a biosignature-predicting placebo pill response in chronic pain in the settings of a randomized controlled trial. Pain. 2022 May 1;163(5):910-922. doi: 10.1097/j.pain.0000000000002450.

  PMID: 34433773 DERIVED

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Pain

Interventions

Naproxen; Omeprazole; Sugars

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Limitations and Caveats

This study has several limitations including: 1. The biosignature was poor predictability of individual participants' magnitude of pain relief, e 2. The univariate analyses suggest that some features of the model could be further optimized

Results Point of Contact

• Title: Apkar Vania Apkarian
• Organization: Northwestern University

a-apkarian@northwestern.edu

312-503-0404

Study Officials

• Apkar V Apkarian, PhD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Physiology, Anesthesiology and Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 7, 2022
• Results First Posted: November 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)