Condition category
Musculoskeletal Diseases
Date applied
16/03/2009
Date assigned
20/04/2009
Last edited
20/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Other

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2009

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Chronic back pain and/or arthritis pain
2. Both males and females, aged 30 to 60 years

Participant type

Patient

Age group

Adult

Gender

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

Trial 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

http://www.refonet.de

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes