Low Back Pain
Conditions
Keywords
low-back, pain, chronic, constitution, diathesism, homoeopathy, fixed combination, herbal preparation, chronic low back pain lasting more than 6 months
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.
Interventions
DRUGHDC
(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.
DRUGPlacebo solution
10 drops, t.i.d, 15 weeks
Sponsors
Pascoe Pharmazeutische Praeparate GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FFbH-R Between Screening and Week 15 | between screening and 15 weeks treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score (SES), Subscale Sensoric Pain | following 2 weeks treatment | 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 Strength of Pain (Visual Analog Scale VAS) | following 2 weeks treatment | — |
| Change in State of Health (BF-S) | following 2 weeks treatment | — |
| Change in Oswestry Score | following 2 weeks treatment | — |
| Change in Short Form Health Survey 12 Items (SF-12) | following 2 weeks treatment | — |
| Change in FFbH-R Between Screening and 2 Weeks | between screening and 2 weeks treatment | 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) |
| 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 | within 15 weeks treatment | frequency of ADR with a probable or possible causal relationship |
| Change in Short Form Health Survey 12 Items (SF-12) Ment | following 15 weeks treat | — |
Countries
Germany
Participant flow
Recruitment details
hospital, 5.12.2003 - 5.5.2007 (first patient in / last patient out)
Pre-assignment details
screening visit (up to one week before baseline)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 112 |
| Placebo Solution 10 drops t.i.d. for 15 weeks | 109 |
| Total | 221 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 |
| Overall Study | Lost to Follow-up | 9 | 4 |
| Overall Study | no evaluable study values | 9 | 21 |
| Overall Study | Non-cooperation | 0 | 1 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Protocol Violation | 9 | 9 |
| Overall Study | Withdrawal by Subject | 8 | 5 |
Baseline characteristics
| Characteristic | Lymphdiaral Basistropfen (HDC) | Placebo Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 27 Participants | 31 Participants | 58 Participants |
| Age, Categorical Between 18 and 65 years | 85 Participants | 78 Participants | 163 Participants |
| Sex: Female, Male Female | 96 Participants | 97 Participants | 193 Participants |
| Sex: Female, Male Male | 16 Participants | 12 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 43 / 112 | 39 / 109 |
| serious Total, serious adverse events | 6 / 112 | 7 / 109 |
Outcome results
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)
Time frame: between screening and 15 weeks treatment
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lymphdiaral Basistropfen (HDC) | Change in FFbH-R Between Screening and Week 15 | 8.8 units on a scale | Standard Deviation 15 |
| Placebo Solution | Change in FFbH-R Between Screening and Week 15 | 4.1 units on a scale | Standard Deviation 15.3 |
p-value: 0.0426Wilcoxon (Mann-Whitney)
Secondary
Amount of Analgesics Used
Time frame: 15 weeks treatment
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)
Time frame: between screening and 2 weeks treatment
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lymphdiaral Basistropfen (HDC) | Change in FFbH-R Between Screening and 2 Weeks | 3.9 units on a scale | Standard Deviation 12.8 |
| Placebo Solution | Change in FFbH-R Between Screening and 2 Weeks | 0.6 units on a scale | Standard Deviation 12.7 |
p-value: 0.0757Wilcoxon (Mann-Whitney)
Secondary
Change in Oswestry Score
Time frame: following 15 weeks treatment
Secondary
Change in Oswestry Score
Time frame: following 2 weeks treatment
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)
Time frame: following 2 weeks treatment
Population: Only patients with assessable values at present time point were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lymphdiaral Basistropfen (HDC) | Change in Pain Score (SES), Subscale Sensoric Pain | -4.2 units on a scale | Standard Deviation 7.5 |
| Placebo Solution | Change in Pain Score (SES), Subscale Sensoric Pain | -1.8 units on a scale | Standard Deviation 5.4 |
p-value: 0.0465Wilcoxon (Mann-Whitney)
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)
Time frame: following 15 weeks treatment
Population: Only patients with assessable values at present time point were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lymphdiaral Basistropfen (HDC) | Change in Pain Score (SES), Subscale Sensoric Pain | -5.4 units on a scale | Standard Deviation 6.8 |
| Placebo Solution | Change in Pain Score (SES), Subscale Sensoric Pain | -3.9 units on a scale | Standard Deviation 7.3 |
p-value: 0.04443Wilcoxon (Mann-Whitney)
Secondary
Change in Short Form Health Survey 12 Items (SF-12)
Time frame: following 2 weeks treatment
Secondary
Change in Short Form Health Survey 12 Items (SF-12) Ment
Time frame: following 15 weeks treat
Secondary
Change in State of Health (BF-S)
Time frame: following 15 weeks treatment
Secondary
Change in State of Health (BF-S)
Time frame: following 2 weeks treatment
Secondary
Change in Strength of Pain (Visual Analog Scale VAS)
Time frame: following 15 weeks treatment
Secondary
Change in Strength of Pain (Visual Analog Scale VAS)
Time frame: following 2 weeks treatment
Secondary
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
Secondary
Number of ADRs
frequency of ADR with a probable or possible causal relationship
Time frame: within 15 weeks treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lymphdiaral Basistropfen (HDC) | Number of ADRs | 8 adverse reactions |
| Placebo Solution | Number of ADRs | 7 adverse reactions |
Secondary
Number of Days With Incapability to Work
Time frame: 15 weeks treatment