Traditional Chinese Medicine in Routine care of Orthopaedic Rehabilitation - sustainability and acceptance by patients of the German Pension Fund
| ISRCTN | ISRCTN40932605 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40932605 |
| Protocol serial number | 07001 |
| Sponsor | Refonet (Germany) |
| Funder | Refonet (Germany) (Project no.: 07001) |
- Submission date
- 16/03/2009
- Registration date
- 20/04/2009
- Last edited
- 20/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Orthopaedic Rehabilitation Centre
Lahntalklink Bad Ems
Adolf-Bach-Promenade 11
Bad Ems
D-56130
Germany
| Phone | +49 (0)2603 976 2600 |
|---|---|
| w.kuehn@lahntalklinik.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | TCMROR |
| Study objectives | 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) |
| Health condition(s) or problem(s) studied | 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(s) |
1. Improvement in health-related quality of life: |
| Key secondary outcome measure(s) |
1. Treatment satisfaction: |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 520 |
| Key inclusion criteria | 1. Chronic back pain and/or arthritis pain 2. Both males and females, aged 30 to 60 years |
| Key exclusion criteria | 1. Pension required 2. Spinal or joint surgery in the last three month 3. Psychiatric diseases 4. Epilepsy 5. Coagulopathy 6. Pregnancy |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
D-56130
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
