Contact information
Type
Scientific
Contact name
Dr Werner Kühn
ORCID ID
Contact details
Orthopedic Rehabilitation Center
Lahntalklinik Bad Ems
Adolf-Bach-Promenade 11
Bad Ems
D-56130
Germany
+49 (0) 2603 976 2600
w.kuehn@lahntalklinik.de
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
04003
Study information
Scientific title
Acronym
Study hypothesis
By additional therapy elements of Traditional Chinese Medicine (TCM) within an orthopedic rehabilitation procedure over four weeks with chronic back pain inpatients, a higher reduction of pain and analgesic consumption can be achieved, as well as a decrease in the amount of times there is an inability to work and improvement of the subjective employment prognosis.
Ethics approval(s)
Ethics Committee of the Physicians Chamber, Rheinland-Pfalz, Mainz on 17/11/2005 (reference number 837.258.05).
Study design
Prospective, randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Condition
Chronic back pain
Intervention
The patients of group A are treated exclusively according to schooled medical therapy concept for four weeks. The patients of group B are treated with elements of the TCM additionally. These contain acupuncture and tuina- massage twice in each case per week
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Traditional Chinese medicine
Primary outcome measure
1. Reduction of the pain
2. Reduction of the analgesic consumption
Secondary outcome measures
1. Decrease in the amount of times there is an inability to work
2. Improvement of the subjective employment prognosis
Overall study start date
01/01/2006
Overall study end date
30/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 30 to 55 years
2. Able to gain employment
3. Chronic back pain
4. Medication: not opioid analgesics (World Health Organisation stage I)
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
270 participants (135 group A, 135 group B)
Participant exclusion criteria
1. Acute slipped disk in the last three months
2. Pension required
3. Spinal column operation in the past
Recruitment start date
01/01/2006
Recruitment end date
30/06/2008
Locations
Countries of recruitment
Germany
Study participating centre
Orthopedic Rehabilitation Center
Bad Ems
D-56130
Germany
Sponsor information
Organisation
Refonet (Germany)
Sponsor details
Burgweg 3
Bad Neuenahr-Ahrweiler
D-53445
Germany
+49 (0) 264 190 620
service@refonet.de
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
Refonet, project no. 04003
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|