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
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