Condition category
Musculoskeletal Diseases
Date applied
05/07/2006
Date assigned
28/07/2006
Last edited
28/07/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.refonet.de

Contact information

Type

Scientific

Primary contact

Dr Werner Kühn

ORCID ID

Contact details

Orthopedic Rehabilitation Center
Lahntalklinik 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

04003

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics Committee of the Physicians Chamber, Rheinland-Pfalz, Mainz on 17/11/2005 (reference number 837.258.05).

Study design

Prospective, randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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 names

Traditional Chinese medicine

Primary outcome measures

1. Reduction of the pain
2. Reduction of the analgesic consumption

Secondary outcome measures

1. Decrease in the amount of times there is an inability to work
2. Improvement of the subjective employment prognosis

Overall trial start date

01/01/2006

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

270 participants (135 group A, 135 group B)

Participant exclusion criteria

1. Acute slipped disk in the last three months
2. Pension required
3. Spinal column operation in the past

Recruitment start date

01/01/2006

Recruitment end date

30/06/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Orthopedic Rehabilitation Center
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, project no. 04003

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