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

Low Back Pain Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049373
• Other study ID #: PSC144/03
• Secondary ID: ISRCTN88642122
• Status: Completed
• Phase: Phase 3
• First received: January 12, 2010
• Last updated: August 3, 2012
• Start date: December 2003
• Est. completion date: May 2007

Study information

• Verified date: June 2012
• Source: Pascoe Pharmazeutische Praeparate GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• Placebo solution
10 drops, t.i.d, 15 weeks

Locations

Country	Name	City	State
Germany	Department of Naturopathy, Blankenstein Hospital	Hattingen

Sponsors (1)

Lead Sponsor	Collaborator
Pascoe Pharmazeutische Praeparate GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change in Strength of Pain (Visual Analog Scale VAS)		following 2 weeks treatment	No
Secondary	Change in Strength of Pain (Visual Analog Scale VAS)		following 15 weeks treatment	No
Secondary	Change in State of Health (BF-S)		following 2 weeks treatment	No
Secondary	Change in State of Health (BF-S)		following 15 weeks treatment	No
Secondary	Change in Oswestry Score		following 2 weeks treatment	No
Secondary	Change in Oswestry Score		following 15 weeks treatment	No
Secondary	Change in Short Form Health Survey 12 Items (SF-12)		following 2 weeks treatment	No
Secondary	Change in Short Form Health Survey 12 Items (SF-12) Ment		following 15 weeks treat	No
Secondary	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	No
Secondary	Amount of Analgesics Used		15 weeks treatment	No
Secondary	Number of Days With Incapability to Work		15 weeks treatment	No
Secondary	Number of ADRs	frequency of ADR with a probable or possible causal relationship	within 15 weeks treatment	Yes