Contact information
Type
Scientific
Contact name
Dr Werner Kühn
ORCID ID
Contact details
Orthopaedic Rehabilitation Centre
Lahntalklink 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
07001
Study information
Scientific title
Traditional Chinese Medicine in Routine care of Orthopaedic Rehabilitation - sustainability and acceptance by patients of the German Pension Fund: a randomised controlled trial
Acronym
TCMROR
Study hypothesis
By integrated therapy elements of the traditional Chinese medicine within an inpatient orthopaedic rehabilitation procedure over three weeks, there is a greater improvement of health-related quality of life and subjective employment forecast six month after treatment.
More details can be found at: http://www.refonet.de/projekte/laufendeprojekte_7001.php
Ethics approval(s)
Ethics Committee of the Physicians Chamber, Rheinland Pfalz, Mainz, approved on 14/01/2009 (ref: 837.433.08)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic back pain and/or osteoarthritis of one or more joints
Intervention
Participants are randomised to Groups A and B (randomisation ratio: 1:1). Both groups are treated according to usual school medical therapy concept for three weeks.
For Group B, in this treatment programme, the elements of traditional Chinese medicine are integrated. These include acupuncture, tuina-massage, herbal therapy, qi gong or tai chi and consultations to way of life and dietetics.
Total duration of interventions: 3 weeks/per participant. Six month after treatment there is a follow-up questioning (for both groups).
Intervention type
Other
Primary outcome measure
1. Improvement in health-related quality of life:
1.1. SF-12® Health Survey at T1 and T3
1.2. Interview at T1 and T2
2. Improvement in subjective employment forecast:
2.1. Subjective employment forecast (Subjektive Prognose der Erwerbstätigkeit [SPE]) questionnaire at T1 and T3
2.2. Interview at T1 and T2
T1 = Baseline
T2 = At 3 weeks
T3 = At 6 months
Secondary outcome measures
1. Treatment satisfaction:
1.1. Patient Satisfaction Questionnaire (Fragebogen zu Patientenzufriedenheit [ZUF-8])
1.2. Interview
2. Acceptance of the traditional Chinese therapy:
2.1. Questionnaire: wish of treatment with a renewed rehabilitation
2.2. Patient Satisfaction Questionnaire (Fragebogen zu Patientenzufriedenheit [ZUF-8])
All secondary outcome measures will be assessed at T2.
T1 = Baseline
T2 = At 3 weeks
T3 = At 6 months
Overall study start date
01/01/2009
Overall study end date
30/06/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Chronic back pain and/or arthritis pain
2. Both males and females, aged 30 to 60 years
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
520
Participant exclusion criteria
1. Pension required
2. Spinal or joint surgery in the last three month
3. Psychiatric diseases
4. Epilepsy
5. Coagulopathy
6. Pregnancy
Recruitment start date
01/01/2009
Recruitment end date
30/06/2011
Locations
Countries of recruitment
Germany
Study participating centre
Orthopaedic Rehabilitation Centre
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 (Germany) (Project no.: 07001)
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? |
|---|