Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial

NCT02013427 | Completed Phase 4 Results DMC

• 2 other identifiers: STU00080585R01AT007987-01A1
• Study Type: interventional
• Target: 82
• 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; back; pain; brain; MRI

Outcome Measures

Primary Outcomes (1)

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

  The primary outcome was changes (% change) in self-reported pain levels using VAS - from 0 (no pain) to 10 (worst imaginable pain). Results are presented as largest percentage (%) change in pain before and after the interventions (baseline and post-intervention, 6 weeks). Percentage change is calculated with post-intervention pain minus baseline pain, divided by baseline pain i.e. (post - baseline) / baseline.

  6 weeks

Study Arms (3)

Observational

NO INTERVENTION

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.

Naproxen & Omeprazole

ACTIVE COMPARATOR

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 Only

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

Take one 500mg naproxen capsule twice a day.

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

Naproxen & Omeprazole

Placebo DRUG

Take one placebo capsule twice a day.

Also known as: Sugar Pill

Placebo Only

Omeprazole DRUG

Take one 20mg omeprazole capsule twice a day.

Also known as: Prilosec, losepine

Naproxen & Omeprazole

Eligibility Criteria

• Age: 18 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 signs and symptoms of radiculopathy: positive straight leg raising test with dermatomal radiation and/or myotomal weakness and/or reflex asymmetry; pain must radiate into buttock or below.
• Male or female, age greater than18 years, with no racial/ethnic restrictions.
• Must have a Visual Analog Scale (VAS) pain score \>50 mm (of 100 mm maximum) at the baseline visit (for which 0mm = no pain, and 100 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.

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 II score of \>28.
• 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.
• Regular use of low dose aspirin.

Sponsors & Collaborators

• Northwestern University: 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 (3)

• Branco P, Berger S, Abdullah T, Vachon-Presseau E, Cecchi G, Apkarian AV. Predicting placebo analgesia in patients with chronic pain using natural language processing: a preliminary validation study. Pain. 2023 May 1;164(5):1078-1086. doi: 10.1097/j.pain.0000000000002808. Epub 2022 Oct 18.

  PMID: 36524810 DERIVED

• 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

• Berger SE, Branco P, Vachon-Presseau E, Abdullah TB, Cecchi G, Apkarian AV. Quantitative language features identify placebo responders in chronic back pain. Pain. 2021 Jun 1;162(6):1692-1704. doi: 10.1097/j.pain.0000000000002175.

  PMID: 33433145 DERIVED

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Pain

Interventions

Naproxen; Sugars; Omeprazole

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; Carbohydrates; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Apkar Vania Apkarian
• Organization: Northwestern University

a-apkarian@northwestern.edu

+1 312 503 0404

Study Officials

• Apkar 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: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 17, 2013
• Study Start: October 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 3, 2023
• Results First Posted: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)