Neck PainPhase 2NCT00325312
Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain
A Phase 2 study testing carbon dioxide, subcutaneous application in people with Neck Pain, run by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster at 1 site in Germany.
Trial summary
The purpose of the trial is to evaluate whether patients with acute non specific neck pain get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to sham ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- carbon dioxide, subcutaneous application
- Type of treatment
- Injection or infusion
- How many people
- 114 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2001to Mar 2003
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- participants must report neck pain lasting for less than 7 days
- participants must report a current pain intensity of ≥ 40 mm on a 100 mm visual analogue scale.
- participants must state local neck muscles tenderness during clinical examination at one or more locations
Who cannot join
- neck pain of specific etiology (e.g., radiculopathy, infection, inflammation, primary tumor, or metastases)
- whiplash injury
- former neck surgery
- pregnancy
- breast feeding.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Praxis für Allgemeinmedizin Thomas Heißner
Lohmen, Saxony, 01847
About this study
Official title: Evaluation of the Efficacy of Subcutaneous Carbon Dioxide Insufflations for Treating Acute Non Specific Neck Pain in General Practice
The purpose of the trial is to evaluate whether patients with acute non specific neck pain get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to sham ultrasound.
Read the detailed description
Subcutaneous carbon dioxide insufflations popular in Central und Eastern Europe are a safe and inexpensive treatment modality in complementary medicine and are used mainly in musculoskeletal pain and vascular conditions. However, no rigorous trial exists on their efficacy.
The study is designed as a double blind sham controlled randomized trial to evaluate whether patients with acute non specific neck pain get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to sham ultrasound.Since acute non specific neck pain is often self limiting, speed of recovery rather than outcome at fixed points in time is evaluated.
Participants receive either a maximum number of 9 subcutaneous carbon dioxide insufflations or a maximum number of 9 sham ultrasound administered by 4 therapists in a randomized order, thrice weekly. Carbon dioxide gas is insufflated subcutaneously at the locations of neck muscle tenderness. Per tender location 25 ml carbon dioxide gas is administered.
Primary outcome measure is recorded daily by means of a diary. Analysis is done by intention to treat. Differences in time curves are tested using the logrank test. Time curves are graphically displayed by a 1 minus survival Kaplan-Meier plot.
- Conditions
- Neck Pain
- Being tested
- carbon dioxide, subcutaneous application
- Keywords
- Neck Pain, Complementary Therapies, Subcutaneous Carbon Dioxide Insufflations, Acute Treatment
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon dioxide, subcutaneous applicationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
time to neck pain relief
Secondary outcomes (6)
time to a 50% reduction in pain intensity
affective pain
sensory pain
pain intensity
treatment failure
recurrence of neck pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study startJan 2001
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck 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
- Double blind
- Enrolment
- 114 participants
Sponsor and investigators
- Lead sponsor
- Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
- Sponsor type
- Other government
- Investigators
- Thomas Brockow, MD, Principal investigator, FBK Bad Elster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325312
- Sponsor's protocol ID
- SCI-2
- Status last verified
- May 2006
- First submitted
- 11 May 2006
- Last updated
- 15 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Subcutaneous Carbon Dioxide Insufflations for Treating Acute Non Specific Neck Pain in General Practice
- ClinicalTrials.gov ID
- NCT00325312
- Acronym / sponsor ID
- SCI-2
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Complementary Therapies, Subcutaneous Carbon Dioxide Insufflations, Acute Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants
- Lead sponsor
- Forschungsinstitut für Balneologie und Kurortwissenschaft Bad ElsterOther government
- Study start
- Jan 2001
- Study completion
- Mar 2003
- First posted
- 12 May 2006 (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 purpose of the trial is to evaluate whether patients with acute non specific neck pain get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to sham ultrasound.
Detailed description
Subcutaneous carbon dioxide insufflations popular in Central und Eastern Europe are a safe and inexpensive treatment modality in complementary medicine and are used mainly in musculoskeletal pain and vascular conditions. However, no rigorous trial exists on their efficacy.
The study is designed as a double blind sham controlled randomized trial to evaluate whether patients with acute non specific neck pain get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to sham ultrasound.Since acute non specific neck pain is often self limiting, speed of recovery rather than outcome at fixed points in time is evaluated.
Participants receive either a maximum number of 9 subcutaneous carbon dioxide insufflations or a maximum number of 9 sham ultrasound administered by 4 therapists in a randomized order, thrice weekly. Carbon dioxide gas is insufflated subcutaneously at the locations of neck muscle tenderness. Per tender location 25 ml carbon dioxide gas is administered.
Primary outcome measure is recorded daily by means of a diary. Analysis is done by intention to treat. Differences in time curves are tested using the logrank test. Time curves are graphically displayed by a 1 minus survival Kaplan-Meier plot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- participants must report neck pain lasting for less than 7 days
- participants must report a current pain intensity of ≥ 40 mm on a 100 mm visual analogue scale.
- participants must state local neck muscles tenderness during clinical examination at one or more locations
Key exclusion criteria (5 listed)
- neck pain of specific etiology (e.g., radiculopathy, infection, inflammation, primary tumor, or metastases)
- whiplash injury
- former neck surgery
- pregnancy
- breast feeding.
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 |
|---|---|---|
| carbon dioxide, subcutaneous application | Drug | – |
Primary outcome
time to neck pain relief
6 secondary outcomes
time to a 50% reduction in pain intensity
affective pain
sensory pain
pain intensity
treatment failure
recurrence of neck pain
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 15 May 2006.
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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.
Thomas Brockow, MD principal investigator
FBK Bad Elster
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 carbon dioxide, subcutaneous application in people with Neck Pain, run by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster at 1 site in Germany.
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 5 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 15 May 2006. 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 Germany. 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?
time to neck pain relief. 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 15 May 2006.