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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:
NCT01049373
First received: January 12, 2010
Last updated: August 3, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Drug: HDC
Drug: Placebo solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pascoe Pharmazeutische Praeparate GmbH:

Primary Outcome Measures:
  • Change in FFbH-R Between Screening and Week 15 [ Time Frame: between screening and 15 weeks treatment ] [ Designated as safety issue: No ]

    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)



Secondary Outcome Measures:
  • Change in FFbH-R Between Screening and 2 Weeks [ Time Frame: between screening and 2 weeks treatment ] [ Designated as safety issue: No ]

    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)


  • Change in Pain Score (SES), Subscale "Sensoric Pain" [ Time Frame: following 2 weeks treatment ] [ Designated as safety issue: No ]

    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)


  • Change in Pain Score (SES), Subscale "Sensoric Pain" [ Time Frame: following 15 weeks treatment ] [ Designated as safety issue: No ]

    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)


  • Change in Strength of Pain (Visual Analog Scale VAS) [ Time Frame: following 2 weeks treatment ] [ Designated as safety issue: No ]
  • Change in Strength of Pain (Visual Analog Scale VAS) [ Time Frame: following 15 weeks treatment ] [ Designated as safety issue: No ]
  • Change in State of Health (BF-S) [ Time Frame: following 2 weeks treatment ] [ Designated as safety issue: No ]
  • Change in State of Health (BF-S) [ Time Frame: following 15 weeks treatment ] [ Designated as safety issue: No ]
  • Change in Oswestry Score [ Time Frame: following 2 weeks treatment ] [ Designated as safety issue: No ]
  • Change in Oswestry Score [ Time Frame: following 15 weeks treatment ] [ Designated as safety issue: No ]
  • Change in Short Form Health Survey 12 Items (SF-12) [ Time Frame: following 2 weeks treatment ] [ Designated as safety issue: No ]
  • Change in Short Form Health Survey 12 Items (SF-12) Ment [ Time Frame: following 15 weeks treat ] [ Designated as safety issue: No ]
  • Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF) [ Time Frame: following 15 weeks treatment ] [ Designated as safety issue: No ]
  • Amount of Analgesics Used [ Time Frame: 15 weeks treatment ] [ Designated as safety issue: No ]
  • Number of Days With Incapability to Work [ Time Frame: 15 weeks treatment ] [ Designated as safety issue: No ]
  • Number of ADRs [ Time Frame: within 15 weeks treatment ] [ Designated as safety issue: Yes ]
    frequency of ADR with a probable or possible causal relationship


Enrollment: 221
Study Start Date: December 2003
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lymphdiaral Basistropfen
Placebo Comparator: Placebo Solution
10 drops t.i.d. for 15 weeks
Drug: Placebo solution
10 drops, t.i.d, 15 weeks
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049373

Locations
Germany
Department of Naturopathy, Blankenstein Hospital
Hattingen, Germany, D-45527
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT01049373     History of Changes
Other Study ID Numbers: PSC144/03, ISRCTN88642122
Study First Received: January 12, 2010
Results First Received: May 10, 2012
Last Updated: August 3, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pascoe Pharmazeutische Praeparate GmbH:
low-back
pain
chronic
constitution
diathesism
homoeopathy
fixed combination
herbal preparation
chronic low back pain lasting more than 6 months

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014