Phase 3
Completed N=221
Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain
Source: ClinicalTrials.gov NCT01049373 ↗Enrolled (actual)
221
Serious AEs
5.9%
Results posted
Sep 2012
Primary outcomePrimary: Change in FFbH-R Between Screening and Week 15 — 8.8; 4.1 units on a scale — p=0.0426
Summary
To evaluate superiority of HDC in comparison to placebo in the treatment of chronic low-back pain in relation to pain, functional impairment, quality of life, and state of health during a 15-week treatment period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in FFbH-R Between Screening and Week 15 |
8.8; 4.1 | 0.0426 sig |
| SECONDARY Change in FFbH-R Between Screening and 2 Weeks |
3.9; 0.6 | 0.0757 |
| SECONDARY Change in Pain Score (SES), Subscale "Sensoric Pain" |
-5.4; -3.9 | 0.04443 sig |
| SECONDARY Change in Strength of Pain (Visual Analog Scale VAS) |
— | — |
| SECONDARY Change in State of Health (BF-S) |
— | — |
| SECONDARY Change in Oswestry Score |
— | — |
| SECONDARY Change in Short Form Health Survey 12 Items (SF-12) |
— | — |
| SECONDARY Change in Short Form Health Survey 12 Items (SF-12) Ment |
— | — |
| SECONDARY Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF) |
— | — |
| SECONDARY Amount of Analgesics Used |
— | — |
| SECONDARY Number of Days With Incapability to Work |
— | — |
| SECONDARY Number of ADRs |
8; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients
- Aged 18 - 75 years
- Chronic low-back pain lasting at least for 6 months
- Hanover functional ability questionnaire (FFbH-R) score less than 70%
- At least one of the following diagnoses:
- Chronic lumbar ischialgia with or without radicular radiation
- Chronic degenerative lumbar syndrome
- Spondylarthrosis
- Chronic facet syndrome
- Lumbago with protrusion of the intervertebral disc
- Lumbar radiculopathy
- Lumbar and other intervertebral disc impairments with radiculopathy
- Back pain at different locations of the spine
- Written, informed consent
Exclusion Criteria
- Participation in another clinical trial/GCP-trial within 30 days prior to screening
- Participation in this trial in an earlier time
- Treatment with lymphdiaral basistropfen within 3 month prior to enrolment
- Pregnancy and lactation
- Non-compliance
- Incapability to understand the sense of the study
- Abuse of analgesics, opiates or other drugs
- Chronic pain that are as strong as or even stronger than the pain caused by the low-back and that need to be treated with analgesics
- Malign diseases
- Pathological neurological states
- Epilepsy
- Operation of the spine within 3 month prior to enrolment
- Fractures of the spine
- Bechterew's disease
- Alcohol abuse
- Consuming diseases
- Cachexia
- Palsy of the legs or anal sphincter due to acute impairment of the intervertebral disc
- Catheterisation or CT-controlled intra-articular injection in the lumbar region
- Hypersensitivity against one of the ingredients or excipients of the study drugs or against composite plants in general
- Systemic, progressive diseases like tuberculosis, leucosis, collagenosis, multiple sclerosis, acquired immune deficiency syndrome (AIDS), human immunodeficiency virus (HIV) infection, or other auto-immune diseases
Data sourced from ClinicalTrials.gov (NCT01049373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.