Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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Low-back pain is often provoked by inflammatory edema in the region of the facet joints. In naturopathy, a fixed homeopathic drug combination (HDC) is established in the treatment of edema and swellings. For the first time, the efficacy of HDC was investigated in the treatment of low-back pain. Objective: To examine the efficacy and safety of HDC medication vs. placebo in the treatment of chronic low back pain considering constitution and diathesism in a double-blind, randomized controlled clinical trial.

Official Title
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Efficacy and Safety of Lymphdiaral Basistropfen (a Fixed Homoeopathic Remedy [HDC]) in the Treatment of Chronic Low-back Pain Considering Constitution and Diathesism: a Double Blind, Randomised, Placebo Controlled, Single-centre Study

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: HDC
* Drug: Placebo solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lymphdiaral Basistropfen (HDC)<br>HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks. | Drug: HDC<br>* (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X),10 drops t.i.d. for 15 weeks.<br>* Other names: Lymphdiaral Basistropfen;|
| Placebo Comparator: Placebo Solution<br>10 drops t.i.d. for 15 weeks | Drug: Placebo solution<br>* 10 drops, t.i.d, 15 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FFbH-R Between Screening and Week 15 | Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH for close to everyday diagnostics of functional impairment by back pain. It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living. Change in FFbH-R between screening and week 15 Scale ranges from 0 (=worst) to 100(=best) | between screening and 15 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FFbH-R Between Screening and 2 Weeks | Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH for close to everyday diagnostics of functional impairment by back pain. It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living. Change in FFbH-R between screening and 2 weeks Scale ranges from 0 (=worst) to 100(=best) | between screening and 2 weeks treatment | 
| Change in Pain Score (SES), Subscale Sensoric Pain | Pain Perception Scale (SES) The SES is a patient questionnaire, which consists of 24 questions, both the affective (14 questions) and sensoric (10 questions) depict aspects. Difference between V1 minus V-1 in the subscale sensoric pain Scale ranges from 10(=best) to 40(=worst) | following 2 weeks treatment | 
| Change in Pain Score (SES), Subscale Sensoric Pain | Pain Perception Scale (SES) The SES is a patient questionnaire, which consists of 24 questions, both the affective (14 questions) and sensoric (10 questions) depict aspects. Difference between screening and 15 weeks in the subscale sensoric pain Scale ranges from 10(=best) to 40(=worst) | following 15 weeks treatment | 
| Change in Strength of Pain (Visual Analog Scale VAS) |  | following 2 weeks treatment | 
| Change in Strength of Pain (Visual Analog Scale VAS) |  | following 15 weeks treatment | 
| Change in State of Health (BF-S) |  | following 2 weeks treatment | 
| Change in State of Health (BF-S) |  | following 15 weeks treatment | 
| Change in Oswestry Score |  | following 2 weeks treatment | 
| Change in Oswestry Score |  | following 15 weeks treatment | 
| Change in Short Form Health Survey 12 Items (SF-12) |  | following 2 weeks treatment | 
| Change in Short Form Health Survey 12 Items (SF-12) Ment |  | following 15 weeks treat | 
| Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF) |  | following 15 weeks treatment | 
| Amount of Analgesics Used |  | 15 weeks treatment | 
| Number of Days With Incapability to Work |  | 15 weeks treatment | 
| Number of ADRs | frequency of ADR with a probable or possible causal relationship | within 15 weeks treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-back, pain, chronic, constitution, diathesism, homoeopathy, fixed combination, herbal preparation, chronic low back pain lasting more than 6 months