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
Secondary identifying numbers 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

Study website

Contact information

Dr Werner Kühn
Scientific

Orthopedic Rehabilitation Center
Lahntalklinik Bad Ems
Adolf-Bach-Promenade 11
Bad Ems
D-56130
Germany

Phone +49 (0) 2603 976 2600
Email w.kuehn@lahntalklinik.de

Study information

Study designProspective, randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study objectivesBy 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) studiedChronic back pain
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Traditional Chinese medicine
Primary outcome measure1. Reduction of the pain
2. Reduction of the analgesic consumption
Secondary outcome measures1. Decrease in the amount of times there is an inability to work
2. Improvement of the subjective employment prognosis
Overall study start date01/01/2006
Completion date30/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants270 participants (135 group A, 135 group B)
Key inclusion criteria1. 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 criteria1. Acute slipped disk in the last three months
2. Pension required
3. Spinal column operation in the past
Date of first enrolment01/01/2006
Date of final enrolment30/06/2008

Locations

Countries of recruitment

  • Germany

Study participating centre

Orthopedic Rehabilitation Center
Bad Ems
D-56130
Germany

Sponsor information

Refonet (Germany)
Research organisation

Burgweg 3
Bad Neuenahr-Ahrweiler
D-53445
Germany

Phone +49 (0) 264 190 620
Email service@refonet.de
Website http://www.refonet.de
ROR logo "ROR" https://ror.org/04yeh2x21

Funders

Funder type

Research organisation

Refonet, project no. 04003

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan