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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01263652
Other study ID # SpinePainIMPO
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 31, 2010
Est. completion date June 1, 2019

Study information

Verified date May 2020
Source Western Galilee Hospital-Nahariya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 15 Years to 100 Years
Eligibility Inclusion Criteria:

- Patients with chronic and acute back pain

Exclusion Criteria:

- Recent Spine Surgery

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Diclofenac hydroxyethylpyrrolidine
IM/PO
orphenadrine
IM/PO orphenadrine
Tramadol
IM/PO tramadol
Dipyrone
PO/IM Dipyrone

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Western Galilee Hospital-Nahariya

Outcome

Type Measure Description Time frame Safety issue
Primary pain scores on visual analog scale up to 7 days for each patient per hospitalization visual analog scale will be mesuered before and one hour following every pain medication delivery
Secondary Patient Questionnaire assessing pain and pain relief A questionnaire will be filled immediately before and one hour following analgesic administration Before administaration of pain control medication and one hour following analgesic administration
Secondary patient preference Questionnaire every patient will be asked for his prefered analgesic delivery method before first analgesic administration at the current hositalization
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