Chronic Low Back PainPhase 2NCT02022124
Open Label Placebo in the Treatment of Low Back Pain
A Phase 2 study testing Microcrystalline cellulose (open-label inert substance) in people with Chronic Low Back Pain, run by Hospital de Egas Moniz at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Microcrystalline cellulose (open-label inert substance)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 sitePortugal
- Study dates
- Nov 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- 18 years or older
- Low back pain complaints for a min. of 3 months
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Chronic low back pain (cLBP) is a debilitating and costly condition that affects 1.2 million Portuguese with an estimated cost in the United Stated of $50 billion. Randomized controlled trials has shown that placebo interventions can dramatically reduce chronic low back pain and its associated disability. Generally, it is assumed that response to placebo requires concealment or deception, which presents a dilemma to the clinician. In clinical practice, how can patients benefit from an available, effective and potentially cost-effective intervention without being deceived? This study seeks to determine ethically acceptable open-label placebo treatment (with full informed consent) can lead to meaningful benefits. The primary study will involve 80 patients with cLBP who will be randomly assigned to a three-week course of either non-deceptive open-label placebo pills in the context of a persuasive rationale + treatment as usual or to be continued on their treatment-as-usual. Primary outcome measures will be pain intensity and symptom bothersomeness on the previous week. Additionally, the study will investigate a possible association between the genetic variation of the catechol-O-methyltransferase (COMT polymorphisms) with the hypothesized observed placebo effect on cLBP patients. Participants will be followed for 3 weeks with a mid-point (11 days) visit. Patients who receive only usual care for the first three weeks will be eligible to elect a three week course of treatment with open-label placebo after which they will be assessed. This study has been submitted and approved by the following review board: Comissão de Ética do Centro Hospitalar de Lisboa Ocidental (Lisbon West Hospitals Centre's Ethical Committee) Institutional Review Board.
- Conditions
- Chronic Low Back Pain
- Being tested
- Microcrystalline cellulose (open-label inert substance)
- Keywords
- chronic low back pain, open-label placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
assessed by an 11-point Numeric Rating Scale (NRS)
Measured: previous week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Egas Moniz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Carvalho, Hospital de Egas Moniz
- Investigators
- Claudia Carvalho, PhD, Principal investigator, ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022124
- Sponsor's protocol ID
- 88/CES-2013
- Status last verified
- Jan 2016
- First submitted
- 21 Nov 2013
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Placebo in the Treatment of Low Back Pain
- ClinicalTrials.gov ID
- NCT02022124
- Acronym / sponsor ID
- 88/CES-2013
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic low back pain, open-label placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Hospital de Egas MonizUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic low back pain (cLBP) is a debilitating and costly condition that affects 1.2 million Portuguese with an estimated cost in the United Stated of $50 billion. Randomized controlled trials has shown that placebo interventions can dramatically reduce chronic low back pain and its associated disability. Generally, it is assumed that response to placebo requires concealment or deception, which presents a dilemma to the clinician. In clinical practice, how can patients benefit from an available, effective and potentially cost-effective intervention without being deceived? This study seeks to determine ethically acceptable open-label placebo treatment (with full informed consent) can lead to meaningful benefits. The primary study will involve 80 patients with cLBP who will be randomly assigned to a three-week course of either non-deceptive open-label placebo pills in the context of a persuasive rationale + treatment as usual or to be continued on their treatment-as-usual. Primary outcome measures will be pain intensity and symptom bothersomeness on the previous week. Additionally, the study will investigate a possible association between the genetic variation of the catechol-O-methyltransferase (COMT polymorphisms) with the hypothesized observed placebo effect on cLBP patients. Participants will be followed for 3 weeks with a mid-point (11 days) visit. Patients who receive only usual care for the first three weeks will be eligible to elect a three week course of treatment with open-label placebo after which they will be assessed. This study has been submitted and approved by the following review board: Comissão de Ética do Centro Hospitalar de Lisboa Ocidental (Lisbon West Hospitals Centre's Ethical Committee) Institutional Review Board.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microcrystalline cellulose (open-label inert substance) | Experimental | Drug: Microcrystalline cellulose (open-label inert substance)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female
- 18 years or older
- Low back pain complaints for a min. of 3 months
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microcrystalline cellulose (open-label inert substance)The intervention will be an inert substance, microcrystalline cellulose in a capsule. Participants will take two capsules daily. | Drug | microcrystalline cellulose (open-label inert substance) |
Primary outcome
pain intensity
Time frame: previous week
assessed by an 11-point Numeric Rating Scale (NRS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Carvalho, PhD principal investigator
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Microcrystalline cellulose (open-label inert substance) in people with Chronic Low Back Pain, run by Hospital de Egas Moniz at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: previous week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2016.