Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain (144)

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: HDC; Drug: Placebo solution

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Hattingen, Germany, D-45527
    • Department of Naturopathy, Blankenstein Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

  1. Chronic lumbar ischialgia with or without radicular radiation
  2. Chronic degenerative lumbar syndrome
  3. Spondylarthrosis
  4. Chronic facet syndrome
  5. Lumbago with protrusion of the intervertebral disc
  6. Lumbar radiculopathy
  7. Lumbar and other intervertebral disc impairments with radiculopathy
  8. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lymphdiaral Basistropfen (HDC); 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; (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.; Other Names: Lymphdiaral Basistropfen
Placebo Comparator: Placebo Solution; 10 drops t.i.d. for 15 weeks	Drug: Placebo solution; 10 drops, t.i.d, 15 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pascoe Pharmazeutische Praeparate GmbH
• Investigators: Principal Investigator: Andre M Beer, MD, PhD, Department of True Naturopathy, Blankenstein Hospital; Im Vogelsang 5-11; D-45527 Hattingen; Germany;; Study Director: Juergen Kraemer, Prof, St. Josef Hospital. Gudrunstr. 56, 44791 Bochum, Germany; Study Chair: Anja Braschoss, MD, Pascoe Pharmazeutische Praeparate GmbH

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: January 12, 2010
• First Submitted That Met QC Criteria: January 13, 2010
• First Posted (Estimate): January 14, 2010

Study Record Updates

• Last Update Posted (Estimate): September 6, 2012
• Last Update Submitted That Met QC Criteria: August 3, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: pain; chronic; fixed combination; herbal preparation; low-back; constitution; diathesism; homoeopathy; chronic low back pain lasting more than 6 months
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: PSC144/03; ISRCTN88642122 (Registry Identifier: ISRCTN)