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
Secondary identifying numbers	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

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

Orthopaedic Rehabilitation Centre
Lahntalklink 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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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
Completion date	30/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Orthopaedic Rehabilitation Centre

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"	https://ror.org/04yeh2x21

Funders

Funder type

Research organisation

Refonet (Germany) (Project no.: 07001)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan