Head repositioning accuracy and posturography related to cervical facet nerve blockade and spinal manipulative therapy in healthy volunteers: a feasibility study

ISRCTN ISRCTN49222271
DOI https://doi.org/10.1186/ISRCTN49222271
Protocol serial number BL1SKHS
Sponsor Scandinavian College of Chiropractic (Sweden)
Funder Scandinavian College of Chiropractic (Sweden)
Submission date
21/06/2007
Registration date
05/11/2007
Last edited
10/06/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lars Björndahl
Scientific

Råsundavägen 101
Solna
16957
Sweden

Study information

Primary study designInterventional
Study designThis randomised, single-blinded feasibility study used some features adopted from the Single-Subject Research Design (SSRD), with multiple baseline measurements.
Secondary study designRandomised controlled trial
Scientific titleHead repositioning accuracy and posturography related to cervical facet nerve blockade and spinal manipulative therapy in healthy volunteers: a feasibility study
Study objectivesThree 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(s)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)
Health condition(s) or problem(s) studiedNeck proprioception and balance
InterventionAll 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

No secondary outcome measures

Completion date10/09/2007

Eligibility

Participant type(s)Healthy volunteer
Age groupNot Specified
SexAll
Target sample size at registration6
Total final enrolment6
Key inclusion criteriaHealthy volunteers.
Key exclusion criteria1. History of cervical trauma
2. Whiplash associated disorders
3. Recent problems with chronic neck pain
Date of first enrolment21/05/2007
Date of final enrolment10/09/2007

Locations

Countries of recruitment

  • Sweden

Study participating centre

Råsundavägen 101
Solna
16957
Sweden

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/03/2009 10/06/2021 Yes No

Editorial Notes

10/06/2021: Publication reference and total final enrolment added.