Condition category
Nervous System Diseases
Date applied
21/06/2007
Date assigned
05/11/2007
Last edited
05/11/2007
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 Lars Björndahl

ORCID ID

Contact details

Råsundavägen 101
Solna
16957
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BL1SKHS

Study information

Scientific title

Acronym

Study hypothesis

Three working hypotheses formed the basis for the project:
1. Unilateral facet nerve anaesthesia is expected to elicit disturbed Head Repositioning Accuracy (HRA) and decreased postural control in healthy subjects
2. Disturbed HRA and altered postural control would also be expected after Spinal Manipulative Therapy (SMT) in the cervical spine
3. The disturbances would be caused by abnormal afferent input from the joints

Ethics approval

Ethics approval received from:
1. Institutional Review Board of the Scandinavian College of Chiropractic in May 2004 (ref: BL1SKHS)
2. Research Ethical Board of the Swedish Chiropractic Association in May 2007 (ref: BL1KFSFeK)

Study design

This randomised, single-blinded feasibility study used some features adopted from the Single-Subject Research Design (SSRD), with multiple baseline measurements.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Other

Patient information sheet

Condition

Neck proprioception and balance

Intervention

All participants were subjected to unilateral facet nerve blockade (injection of a local anaesthetic) and cervical spinal manipulative chiropractic therapy. There was no control group in this trial. Instead, subjects acted as their own controls by using multiple baseline measurements.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Cervical proprioceptive functions and static posture were assessed by examining HRA and Computerised Posturography (CPG), respectively.

Sequence of measurements for Group 1:
1. Four baseline measurements
2. One measurement immediately after facet blockade
3. One measurement 24 hours after facet blockade
4. One baseline measurement
5. One measurement immediately after cervical spinal manipulative chiropractic therapy

Sequence of measurements for Group 2:
1. Two baseline measurements
2. One measurement immediately after cervical spinal manipulative chiropractic therapy
3. One baseline measurement
4. One measurement immediately after facet blockade
5. One measurement 24 hours after facet blockade
6. Two baseline measurements

Secondary outcome measures

No secondary outcome measures

Overall trial start date

21/05/2007

Overall trial end date

10/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy volunteers.

Participant type

Healthy volunteer

Age group

Not Specified

Gender

Both

Target number of participants

6 (one woman and five men)

Participant exclusion criteria

1. History of cervical trauma
2. Whiplash associated disorders
3. Recent problems with chronic neck pain

Recruitment start date

21/05/2007

Recruitment end date

10/09/2007

Locations

Countries of recruitment

Sweden

Trial participating centre

Råsundavägen 101
Solna
16957
Sweden

Sponsor information

Organisation

Scandinavian College of Chiropractic (Sweden)

Sponsor details

Råsundavägen 101
Solna
16957
Sweden

Sponsor type

University/education

Website

http://www.kiropraktik.edu/

Funders

Funder type

University/education

Funder name

Scandinavian College of Chiropractic (Sweden)

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