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

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

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 design	Prospective, randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Traditional Chinese medicine
Primary outcome measure	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 study start date	01/01/2006
Completion date	30/06/2008

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	270 participants (135 group A, 135 group B)
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

Orthopedic Rehabilitation Center

Bad Ems
D-56130
Germany

Refonet (Germany)
Research organisation

Burgweg 3
Bad Neuenahr-Ahrweiler
D-53445
Germany

Research organisation

Refonet, project no. 04003

No information available

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