Open Label Placebo in the Treatment of Low Back Pain

NCT02022124 | Completed Phase 2 DMC

• 1 other identifier: 88/CES-2013
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will be randomized to receive open-label (honestly described placebo) immediately at baseline or be eligible to receive the open-label treatment three weeks after the baseline measurements. Therefore all patients will be eligible to receive open-label placebo treatment for their chronic low back pain during the course of the study.

Conditions

Chronic Low Back Pain

Keywords

chronic low back pain; open-label placebo

Outcome Measures

Primary Outcomes (1)

• pain intensity

  assessed by an 11-point Numeric Rating Scale (NRS)

  previous week

Study Arms (2)

microcrystalline cellulose (open-label inert substance)

EXPERIMENTAL

3-week course of non-deceptive placebo using placebo pills plus the usual regime that the patients had been prescribed at the time of intake.

Drug: Microcrystalline cellulose (open-label inert substance)

Usual care treatment

NO INTERVENTION

This arm will entail a 3-week course of the stable treatment the patient is following at time of intake.

Interventions

Microcrystalline cellulose (open-label inert substance) DRUG

The intervention will be an inert substance, microcrystalline cellulose in a capsule. Participants will take two capsules daily.

microcrystalline cellulose (open-label inert substance)

Eligibility Criteria

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

You may qualify if:

• Male or female
• years or older
• Low back pain complaints for a min. of 3 months

You may not qualify if:

• use of strong opioid analgesic and/or anticonvulsant medication;
• specific causes of back pain namely cancer, fractures and infections;
• complicated back problems (e.g. prior back surgery);
• conditions making treatment difficult (e.g. paralysis, psychoses);
• conditions that might confound treatment effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis);
• concurrent care from other providers;
• conditions that affect safety of patient (e.g. pregnancy);
• concurrent medical legal issues.

Sponsors & Collaborators

• Hospital de Egas Moniz: lead

Study Sites (1)

Hospital de Egas Moniz

Lisbon, 1349-019, Portugal

Location

MeSH Terms

Interventions

microcrystalline cellulose

Study Officials

• Claudia Carvalho, PhD

  ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: December 27, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 22, 2016

Record last verified: 2016-01

Locations

PT (1)