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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
221
(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.
10 drops, t.i.d, 15 weeks
Department of Naturopathy, Blankenstein Hospital
Hattingen, Germany
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)
Time frame: between screening and 15 weeks treatment
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)
Time frame: 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)
Time frame: 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)
Time frame: following 15 weeks treatment
Change in Strength of Pain (Visual Analog Scale VAS)
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Time frame: following 2 weeks treatment
Change in Strength of Pain (Visual Analog Scale VAS)
Time frame: following 15 weeks treatment
Change in State of Health (BF-S)
Time frame: following 2 weeks treatment
Change in State of Health (BF-S)
Time frame: following 15 weeks treatment
Change in Oswestry Score
Time frame: following 2 weeks treatment
Change in Oswestry Score
Time frame: following 15 weeks treatment
Change in Short Form Health Survey 12 Items (SF-12)
Time frame: following 2 weeks treatment
Change in Short Form Health Survey 12 Items (SF-12) Ment
Time frame: 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)
Time frame: following 15 weeks treatment
Amount of Analgesics Used
Time frame: 15 weeks treatment
Number of Days With Incapability to Work
Time frame: 15 weeks treatment
Number of ADRs
frequency of ADR with a probable or possible causal relationship
Time frame: within 15 weeks treatment