Integration of the traditional Chinese medicine into the orthopedic rehabilitation - effects on pain and employment prognosis for patients with chronic back pain
| ISRCTN | ISRCTN59155637 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59155637 |
| Protocol serial number | 04003 |
| Sponsor | Refonet (Germany) |
| Funder | Refonet, project no. 04003 |
- Submission date
- 05/07/2006
- Registration date
- 28/07/2006
- Last edited
- 28/07/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Werner Kühn
Scientific
Scientific
Orthopedic Rehabilitation Center
Lahntalklinik 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 | Prospective, randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Traditional Chinese medicine |
| Primary outcome measure(s) |
1. Reduction of the pain |
| Key secondary outcome measure(s) |
1. Decrease in the amount of times there is an inability to work |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 270 |
| Key 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) |
| Key exclusion criteria | 1. Acute slipped disk in the last three months 2. Pension required 3. Spinal column operation in the past |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Orthopedic Rehabilitation Center
Bad Ems
D-56130
Germany
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? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
