Clinical trial NCT01049373: Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: low-back
pain
chronic
constitution
diathesism
homoeopathy
fixed combination
herbal preparation
chronic low back pain lasting more than 6 months
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbH
Sponsor class: INDUSTRY
First posted: 2010-01-14
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Change in FFbH-R Between Screening and Week 15
timeFrame: between screening and 15 weeks treatment
Secondary outcomes:
measure: Change in FFbH-R Between Screening and 2 Weeks
timeFrame: between screening and 2 weeks treatment
measure: Change in Pain Score (SES), Subscale "Sensoric Pain"
timeFrame: following 2 weeks treatment
measure: Change in Pain Score (SES), Subscale "Sensoric Pain"
timeFrame: following 15 weeks treatment
measure: Change in Strength of Pain (Visual Analog Scale VAS)
timeFrame: following 2 weeks treatment
measure: Change in Strength of Pain (Visual Analog Scale VAS)
timeFrame: following 15 weeks treatment
measure: Change in State of Health (BF-S)
timeFrame: following 2 weeks treatment
measure: Change in State of Health (BF-S)
timeFrame: following 15 weeks treatment
measure: Change in Oswestry Score
timeFrame: following 2 weeks treatment
measure: Change in Oswestry Score
timeFrame: following 15 weeks treatment
measure: Change in Short Form Health Survey 12 Items (SF-12)
timeFrame: following 2 weeks treatment
measure: Change in Short Form Health Survey 12 Items (SF-12) Ment
timeFrame: following 15 weeks treat
measure: Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF)
timeFrame: following 15 weeks treatment
measure: Amount of Analgesics Used
timeFrame: 15 weeks treatment
measure: Number of Days With Incapability to Work
timeFrame: 15 weeks treatment
measure: Number of ADRs
timeFrame: within 15 weeks treatment
Other outcomes:
Locations:
city: Hattingen
country: Germany
facility: Department of Naturopathy, Blankenstein Hospital
Study officials:
affiliation: Department of True Naturopathy, Blankenstein Hospital; Im Vogelsang 5-11; D-45527 Hattingen; Germany;
name: Andre M Beer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Josef Hospital. Gudrunstr. 56, 44791 Bochum, Germany
name: Juergen Kraemer, Prof
role: STUDY_DIRECTOR
affiliation: Pascoe Pharmazeutische Praeparate GmbH
name: Anja Braschoss, MD
role: STUDY_CHAIR
References: