Double-blind, randomised, multi-centre, placebo-controlled clinical trial to investigate the efficacy and safety of a combination of comfrey root extract plus methyl nicotinate versus a preparation containing methyl nicotinate alone or placebo in patients with conditions of acute upper or low back pai

Phase 3

• Conditions: M54.5; M54.6; Low back pain; Pain in thoracic spine

• Registration Number: DRKS00000326
• Lead Sponsor: Merck Selbstmedikation GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-29
• Study Completion: 2011-05-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 379

Inclusion Criteria

At Visit 1, male or female patients have to fulfil the following inclusion criteria:
1. Age range 18-45 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. Back pain on active standardised movement of at least 50 mm on a 100 mm Visual Analogue Scale (VAS).
7. 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.

Exclusion Criteria

The patients must not meet any of the following 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 an amnesis.
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).
11. Analgesics or NSAIDs applied by any route of administration within 10 days before study entry or corticoid drugs applied by any route of administration within 60 days before study entry.
12. Any other concomitant treatment (e.g. cosmetics, ointments at the treated area) or medication, that interferes with the conduct of the trial.
13. Known intolerance or hypersensitivity (allergy) to comfrey extract, peanut, soya, methyl nicotinate, parabenes or one of the other ingredients of the trial treatments, including known toxic reactions.
14. Local skin affections that do not allow the application of the test cream.
15. Participation in a clinical trial within the previous 30 days before enrolment in the trial, participation in this study before or simultaneous participation in another clinical trial.
16. Pregnancy or lactation period.
17. Women with childbearing potential without an effective contraceptive method.
18. Abuse of alcohol, medicaments or illicit drugs.
19. Any patient in the investigators opinion not considered suitable for enrolment.
20. Legal incapacity or limited legal capacity to give informed consent.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ociceptive Pain measurement for upper and low back pain: area-under-the-curve (AUC) of the Visual Analogue Scale (VAS) on active standardised movement values at Visits 1 to 4

Secondary Outcome Measures

Name	Time	Method
Back pain on rest, patients assessment on VAS at Visits 1, 2, 3 and 4 || Pressure algometry in the trigger point, pain-time curve; AUC over 5 days, mechanical LG 100 N CHATILLON Algometer, measurements at Visits 1-4 || Global assessment of efficacy by patient at Visit 4 using a following 5- points classification || Global assessment of efficacy by investigator at Visit 4 using a 5-points classification || Consumption of analgesic medication, documented by the investigator at each visit, indirect parameter for the efficacy of treatment || Functional impairment measured with the Oswestry Disability Index (10 questions, patient questionnaire) at Visit 1, 3 and 4