EUCTR2006-003621-87-DE
Active, not recruiting
Not Applicable
Double-blind, placebo-controlled, randomised, parallel-groups, multi-centre clinical trial for the evaluation of efficacy and safety of an ointment of comfrey extract in comparison to placebo in the treatment of acute upper or low back pain
DrugsKytta-Salbe f
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Merck Selbstmedikation GmbH
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age range 18\-60 years.
- •2\. Good general condition.
- •3\. Written informed consent.
- •4\. Acute back pain (either upper or low back pain), not in combination.
- •5\. Sensitivity to algometric pressure on the site contralateral to the painful trigger point at least 2\.5 N/cm².
- •6\. Basic value of the pressure algometry on the trigger point shall not exceed 50% of the respective value of the site contralateral to the painful trigger point.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Upper or low back pain that is attributable to any identifiable cause (e. g. disc prolapse, spondylolisthesis, osteomalacia, or inflammatory arthritis).
- •2\. Any recent trauma.
- •3\. Any recent strains of the back muscles documented by the clinical evaluation and anamnesis.
- •4\. Chronic back pain.
- •5\. Likelihood of prolapsed spinal disc documented by clinical symptoms (pain irradiation to peripheral areas, paraesthesia, clinically detectable impairment of muscle strength of related areas).
- •6\. Back pain caused by metabolic or neurological diseases documented by anamnesis (i.e. toxic neuropathy).
- •7\. Diabetes Mellitus.
- •8\. Risk factors for spinal infection.
- •9\. Recent onset of bladder dysfunction or severe or progressive neurological deficit in the low extremity (as a possible indication of prolapsed disk).
- •10\. Concomitant use of any anti\-inflammatory drugs, heparinoids or analgesics including herbal preparations (glucocorticosteroids, NSAIDs, etc.) for the same indication or other indications (e.g. rheumatoid arthritis).
Outcomes
Primary Outcomes
Not specified
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