Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT00952068
Eligibility Criteria:
Inclusion Criteria:
* Males or females in generally good health aged 18-80 years with acute low back pain are eligible for this study.
* Patients must have pain of moderate to severe intensity on the patient rating of pain intensity scale without analgesia.
* Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
* Must have signed and dated an REB-approved written Informed Consent form which was also signed and dated by the Investigator prior to study participation.
Exclusion Criteria:
* Known history or symptoms suspicious of:
* Spinal fracture
* Cancer (i.e. constitutional symptoms such as recent unexplained chills or weight loss)
* Spinal infection (e.g. IV drug abuse, immunosuppression)
* Cauda equina syndrome
* Spina bifida
* Foot drop
* Spinal surgery within 1 year of study entry
* Body Mass Index (BMI) \> 37
* Continuous chronic back pain
* More severe pain in a region other than the lower back
* Treatment of the back pain with non-pharmacological therapy (e.g. acupuncture chiropractic adjustment, Transcutaneous Electrical Nerve Stimulation, physiotherapy etc.) in the 3 weeks prior to study entry
* Use of any sedative hypnotics, topical preparations/medications and anaesthetics or muscle relaxants within 5 half-lives of the dose of study medication
* Use of any analgesic within 6 hours of the dose of study medication. In rare cases, if a patient is in moderate to severe pain despite having taken a short-acting analgesic and if at least 2 hours have passed since the dose of short-acting analgesic, the patient may be entered.
* A major illness, requiring hospitalisation during the 3 months before commencement of the screening period
* Unwillingness to stop taking pain medication other than the study medication
* Previous failure of treatment with tramadol or discontinuation of treatment with tramadol due to adverse events
* Treatment within the last 3 weeks with any of the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors (SSRIs); serotonin-norepinephrine reuptake inhibitors (SNRIs) or any other drug that reduces seizure threshold
* Treatment with another investigational agent within the last 30 days
* History of seizure disorder other than Infantile Febrile Seizures
* Previous or current opioid dependency
* Bowel disease causing malabsorption
* Pregnant or lactating women
* Known significant liver disease or symptoms of significant liver disease
* Known significant renal disease or symptoms of significant renal disease
* Current or past substance abuse or dependence, other than nicotine
* Allergy to tramadol or any structurally similar drugs (e.g. opiates)
* Any other condition that, in the opinion of the Investigators, would adversely affect the patient's ability to complete the study or its measures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00952068
Study Brief:
Protocol Section:
NCT00952068