Effectiveness of Finnish Traditional Bone Setting

ISRCTN	ISRCTN13338472
DOI	https://doi.org/10.1186/ISRCTN13338472
Protocol serial number	N/A
Sponsor	Finland's Slot Machine Association (Finland)
Funder	Finland's Slot Machine Association

Submission date: 01/06/2006
Registration date: 18/07/2006
Last edited: 28/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Nina Zaproudina
Scientific

P.O.Box 1627
Kuopio
70210
Finland

Study information

Primary study design	Interventional
Study design	Randomised, prospective, controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	EFTBS
Study objectives	To compare effectiveness of traditional bone setting and physical therapy treatments.
Ethics approval(s)	Study and consent form were approved by the Ethics Commitee of Kuopio University Hospital, Finland (reference: 89/2002), approval recieved on 20/08/2002.
Health condition(s) or problem(s) studied	Non-specific low back pain
Intervention	Two different treatments: 1. Traditional bone setting 2. Physical therapy
Intervention type	Other
Primary outcome measure(s)	Dynamic Electromyogram (EMG) recording pain intensity
Key secondary outcome measure(s)	1. Blood pressure 2. Oswestry Disability Questionnaire 3. Finger-floor distance as well as lateral bending 4. Rimon's brief depression scale
Completion date	01/08/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	70
Key inclusion criteria	1. Aged 20 to 60 years 2. Low back pain that restricts functioning 3. Low back pain present on at least half the days in a 12-month period in single or multiple episodes
Key exclusion criteria	1. Severe neurological, metabolic or cardiovascular diseases 2. Back surgery 3. Mental diseases 4. Major structural abnormality 5. Pregnancy
Date of first enrolment	01/03/2003
Date of final enrolment	01/08/2003

Locations

Countries of recruitment

Finland

Study participating centre

P.O.Box 1627

Kuopio
70210
Finland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2007		Yes	No