Pain ReliefNCT01263652
Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients
A study testing Diclofenac hydroxyethylpyrrolidine, orphenadrine and Tramadol in people with Pain Relief, run by Western Galilee Hospital-Nahariya.
Trial summary
The investigators will conduct a randomized double blind study, to determine whether patient analgesic delivery mode preference affects pain reduction quality in non-surgical spine patients. The patients will receive both intra-muscular and oral non-narcotic analgesics and placebo. Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Pain Relief
- What is being tested?
- Diclofenac hydroxyethylpyrrolidine, orphenadrine and Tramadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2010to 1 Jun 2019
- Phase
- Interventional
- 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 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with chronic and acute back pain
Who cannot join
- Recent Spine Surgery
About this study
Official title: The Relationship Between Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients
The investigators will conduct a randomized double blind study, to determine whether patient analgesic delivery mode preference affects pain reduction quality in non-surgical spine patients.
The patients will receive both intra-muscular and oral non-narcotic analgesics and placebo. During the study period, pain reduction parameters will be collected. At the end of the study period, the investigators will attempt to find a correlation between pre-study patient preferences and the quality of the pain reduction achieved.
- Conditions
- Pain Relief
- Being tested
- Diclofenac hydroxyethylpyrrolidine, orphenadrine, Tramadol, Dipyrone
- Keywords
- Pain, intramuscular, oral, spine, preference
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac hydroxyethylpyrrolidineDrug
Also called Voltaren, Abitren
IM/PO
orphenadrineDrug
Also called Flexin
IM/PO orphenadrine
TramadolDrug
Also called Tramadex, Tramal
IM/PO tramadol
DipyroneDrug
Also called Optalgin, Phanalgin
PO/IM Dipyrone
| Study group | Role | What they receive |
|---|---|---|
| IMmed | Active comparator | Patients receiving intra-muscular medication and oral placebo Receives: Drug: Diclofenac hydroxyethylpyrrolidine; Drug: orphenadrine; Drug: Tramadol; Drug: Dipyrone |
| POmed | Active comparator | Patients receiving intra-muscular placebo and oral medication Receives: Drug: Diclofenac hydroxyethylpyrrolidine; Drug: orphenadrine; Drug: Tramadol; Drug: Dipyrone |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores on visual analog scale
up to 7 days for each patient per hospitalization
Measured: visual analog scale will be mesuered before and one hour following every pain medication delivery
Secondary outcomes (2)
Patient Questionnaire assessing pain and pain relief
A questionnaire will be filled immediately before and one hour following analgesic administration
Measured: Before administaration of pain control medication and one hour following analgesic administration
patient preference Questionnaire
every patient will be asked for his prefered analgesic delivery method
Measured: before first analgesic administration at the current hositalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study start31 Dec 2010 (estimated)
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Why it stopped: inability to complete recruitment as planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ReliefStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nimrod Rahamimov, Western Galilee Hospital-Nahariya
- Investigators
- Nimrod Rahamimov, M.D., Principal investigator, Western Galilee Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263652
- Sponsor's protocol ID
- SpinePainIMPO
- Status last verified
- May 2020
- First submitted
- 6 Oct 2010
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients
- ClinicalTrials.gov ID
- NCT01263652
- Acronym / sponsor ID
- SpinePainIMPO
- Conditions
- Pain Relief
- Keywords
- Pain, intramuscular, oral, spine, preference
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: inability to complete recruitment as planned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 31 Dec 2010 (estimated)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 21 Dec 2010 (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 investigators will conduct a randomized double blind study, to determine whether patient analgesic delivery mode preference affects pain reduction quality in non-surgical spine patients.
The patients will receive both intra-muscular and oral non-narcotic analgesics and placebo. During the study period, pain reduction parameters will be collected. At the end of the study period, the investigators will attempt to find a correlation between pre-study patient preferences and the quality of the pain reduction achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMmed | Active comparator | Drug: Diclofenac hydroxyethylpyrrolidine, Drug: orphenadrine, Drug: Tramadol, Drug: DipyronePatients receiving intra-muscular medication and oral placebo |
| POmed | Active comparator | Drug: Diclofenac hydroxyethylpyrrolidine, Drug: orphenadrine, Drug: Tramadol, Drug: DipyronePatients receiving intra-muscular placebo and oral medication |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic and acute back pain
Key exclusion criteria (1 listed)
- Recent Spine Surgery
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 |
|---|---|---|
| Diclofenac hydroxyethylpyrrolidineAlso: Voltaren, AbitrenIM/PO | Drug | IMmed, POmed |
| orphenadrineAlso: FlexinIM/PO orphenadrine | Drug | IMmed, POmed |
| TramadolAlso: Tramadex, TramalIM/PO tramadol | Drug | IMmed, POmed |
| DipyroneAlso: Optalgin, PhanalginPO/IM Dipyrone | Drug | IMmed, POmed |
Primary outcome
pain scores on visual analog scale
Time frame: visual analog scale will be mesuered before and one hour following every pain medication delivery
up to 7 days for each patient per hospitalization
2 secondary outcomes
Patient Questionnaire assessing pain and pain relief
Time frame: Before administaration of pain control medication and one hour following analgesic administration
patient preference Questionnaire
Time frame: before first analgesic administration at the current hositalization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 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.
Nimrod Rahamimov, M.D. principal investigator
Western Galilee Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Diclofenac hydroxyethylpyrrolidine, orphenadrine and Tramadol in people with Pain Relief, run by Western Galilee Hospital-Nahariya.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 scores on visual analog scale (time frame: visual analog scale will be mesuered before and one hour following every pain medication delivery). 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 27 May 2020.