Low Back PainPhase 3MODISCNCT01694134
Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.
A Phase 3 study testing Hydrocortancyl. and Lidocaine in people with Low Back Pain and Lumbago, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. A correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain, Lumbago, Modic I Discopathy
- What is being tested?
- Hydrocortancyl. and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2012to 20 Mar 2017
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years
- Signed Informed consent
- Low back pain for more than 6 months associated with Modic I discopathy (diagnosed by MRI)
Who cannot join
- Past history of lumbar surgery
- Patient under anticoagulant or antisludge treatment, or with coagulation troubles
- Patient with unbalanced diabetes mellitus (blood glucose > 1.30 g/l)
- Patient with unstabilized high blood pressure (> 160/95 mmHg)
- Patient with evolving infection
- Patient with iodine allergy or one of the Hydrocortancyl® or Lidocaine components
Show all 15Show fewer
- Porphyria, hypersensitivity to local anaesthetic
- Patient with sphincter troubles showing a cauda equine syndrome
- Untreated psychotic state
- Pregnant women or of childbearing age without effective contraception means
- Impossible 6 months follow-up
- Participation to another trial
- Vulnerable persons protected by the law
- Persons under guardianship
- Persons unable to express their consent
Trial locations and contacts
1 site in 1 country.
About this study
The treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. A correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. In this study, the main objective is to assess the efficacy of an intradiscal injection of corticoids versus local anaesthetic on the treatment of pain of patients with low back pain associated to a Modic I discopathy.
Read the detailed description
This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.
- Conditions
- Low Back Pain, Lumbago, Modic I Discopathy
- Being tested
- Hydrocortancyl., Lidocaine
- Keywords
- Discopathy, Modic I, Corticoids, Local Anaesthetic, Intradiscal injection
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortancyl.Drug
Patients will receive an intradiscal injection of hydrocortancyl.
LidocaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Corticoids | Active comparator | A group of patients will receive an intradiscal injection of Hydrocortancyl. Receives: Drug: Hydrocortancyl. |
| Local anaesthetic | Sham comparator | A group of patients will receive an intradiscal injection of Lidocaine. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment: VAS
The pain will be assessed by the visual analog scale (VAS).
Measured: 1 month
Secondary outcomes (6)
Pain assessment: VAS
The pain will be assessed by the visual analog scale (VAS).
Measured: 1 week, 2 weeks, 3 weeks, 3 months, 6 months
Quality of life assessment: SF-36
Quality of life will be assessed by the self-questionnaire SF-36.
Measured: 1 month, 3 months, 6 months
Consumption of analgesics and NSAIDs assessment
Measured: 1 month, 3 months,6 months
Specific low back pain parameters assessment
Low back pain parameters will be assessed by the Dallas scale.The Dallas Pain Questionnaire (DPQ) assesses the impact of low back pain (LBP) on four components (0-100) of daily life .
Measured: 1 month, 3 months,6 months
Specific low back pain parameters assessment
Low back pain parameters will be assessed by the Oswestry scale. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Measured: 1 month, 3 months,6 months
Employment status
Employment or non-employment status will be noted
Measured: 1 month, 3 months,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study start12 Jul 2012
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694134
- Sponsor's protocol ID
- 8833
- Acronym
- MODISC
- Status last verified
- Jan 2020
- First submitted
- 22 Sep 2012
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.
- ClinicalTrials.gov ID
- NCT01694134
- Acronym / sponsor ID
- MODISC / 8833
- Conditions
- Low Back Pain, Lumbago, Modic I Discopathy
- Keywords
- Discopathy, Modic I, Corticoids, Local Anaesthetic, Intradiscal injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 12 Jul 2012 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 26 Sep 2012 (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.
The treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. A correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. In this study, the main objective is to assess the efficacy of an intradiscal injection of corticoids versus local anaesthetic on the treatment of pain of patients with low back pain associated to a Modic I discopathy.
Detailed description
This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticoids | Active comparator | Drug: Hydrocortancyl.A group of patients will receive an intradiscal injection of Hydrocortancyl. |
| Local anaesthetic | Sham comparator | Drug: LidocaineA group of patients will receive an intradiscal injection of Lidocaine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 80 years
- Signed Informed consent
- Low back pain for more than 6 months associated with Modic I discopathy (diagnosed by MRI)
Key exclusion criteria (15 listed)
- Past history of lumbar surgery
- Patient under anticoagulant or antisludge treatment, or with coagulation troubles
- Patient with unbalanced diabetes mellitus (blood glucose > 1.30 g/l)
- Patient with unstabilized high blood pressure (> 160/95 mmHg)
- Patient with evolving infection
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 |
|---|---|---|
| Hydrocortancyl.Patients will receive an intradiscal injection of hydrocortancyl. | Drug | Corticoids |
| Lidocaine | Drug | Local anaesthetic |
Primary outcome
Pain assessment: VAS
Time frame: 1 month
The pain will be assessed by the visual analog scale (VAS).
6 secondary outcomes
Pain assessment: VAS
Time frame: 1 week, 2 weeks, 3 weeks, 3 months, 6 months
Quality of life assessment: SF-36
Time frame: 1 month, 3 months, 6 months
Consumption of analgesics and NSAIDs assessment
Time frame: 1 month, 3 months,6 months
Specific low back pain parameters assessment
Time frame: 1 month, 3 months,6 months
Specific low back pain parameters assessment
Time frame: 1 month, 3 months,6 months
Employment status
Time frame: 1 month, 3 months,6 months
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 5 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrocortancyl. and Lidocaine in people with Low Back Pain and Lumbago, run by University Hospital, Montpellier at 1 site in France.
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 15 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 5 Feb 2020. 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 France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 assessment: VAS (time frame: 1 month). 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 5 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.