Condition category
Musculoskeletal Diseases
Date applied
01/06/2006
Date assigned
18/07/2006
Last edited
28/10/2008
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

Ms Nina Zaproudina

ORCID ID

Contact details

P.O.Box 1627
Kuopio
70210
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

EFTBS

Study hypothesis

To compare effectiveness of traditional bone setting and physical therapy treatments.

Ethics approval

Study and consent form were approved by the Ethics Commitee of Kuopio University Hospital, Finland (reference: 89/2002), approval recieved on 20/08/2002.

Study design

Randomised, prospective, controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Non-specific low back pain

Intervention

Two different treatments:
1. Traditional bone setting
2. Physical therapy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Dynamic Electromyogram (EMG) recording pain intensity

Secondary outcome measures

1. Blood pressure
2. Oswestry Disability Questionnaire
3. Finger-floor distance as well as lateral bending
4. Rimon's brief depression scale

Overall trial start date

01/03/2003

Overall trial end date

01/08/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70 subjects

Participant exclusion criteria

1. Severe neurological, metabolic or cardiovascular diseases
2. Back surgery
3. Mental diseases
4. Major structural abnormality
5. Pregnancy

Recruitment start date

01/03/2003

Recruitment end date

01/08/2003

Locations

Countries of recruitment

Finland

Trial participating centre

P.O.Box 1627
Kuopio
70210
Finland

Sponsor information

Organisation

Finland's Slot Machine Association (Finland)

Sponsor details

Turuntie 42
P.O. Box 32
Espoo
Helsinki
02601
Finland

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Finland's Slot Machine Association

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17693333

Publication citations

  1. Results

    Zaproudina N, Hänninen OO, Airaksinen O, Effectiveness of traditional bone setting in chronic neck pain: randomized clinical trial., J Manipulative Physiol Ther, 30, 6, 432-437, doi: 10.1016/j.jmpt.2007.05.004.

Additional files

Editorial Notes