Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000795695
Ethics application status
Approved
Date submitted
4/07/2014
Date registered
28/07/2014
Date last updated
14/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of chiropractic care on synchronised pelvic floor muscle contraction
Scientific title
The effects of chiropractic care compared to passive movement on pelvic floor muscle function in women with non-synchronised pelvic floor muscle contractions
Secondary ID [1] 284923 0
Nil
Universal Trial Number (UTN)
U111111571251
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-synchronised pelvic floor muscle contractions 292395 0
Condition category
Condition code
Reproductive Health and Childbirth 292713 292713 0 0
Childbirth and postnatal care
Renal and Urogenital 292765 292765 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individuals who are identified as having non-synchronous pelvic floor muscle contraction during the baseline/control session will be assessed a second time within one month of the initial assessment. At the second assessment all measures will be recorded before and after lumbopelvic chiropractic adjustments. The order of the various measures will be pseudo-randomised (e.g. order of assessment of maximal voluntary contractions, submaximal contractions and voluntary coughs). No control setup will be performed during the second assessment as control data will be available from the first assessment. All of the spinal adjustments to be carried out in this study will be high-velocity, low-amplitude thrusts to the spine. This is a standard adjustment technique used by manipulative physicians, physiotherapists, and chiropractors. The mechanical properties of this type of CNS perturbation have been investigated; and although the actual force applied to the subject's spine depends on the therapist, the patient, and the spinal location of the adjustment, the general shape of the force-time history of spinal adjustments is very consistent (Hessell, Herzog, Conway, & McEwen, 1990) and the duration of the thrust is always less than 200 milliseconds (for review see Herzog, 1996).The high-velocity type of adjustment was chosen specifically because previous research (Herzog, Conway, Zhang, Gail, & Guimaraes, 1995) has shown that reflex EMG activation observed after adjustments only occurred after high-velocity, low-amplitude adjustments (as compared with lower-velocity mobilizations). This adjustment technique has also been previously used in studies that have investigated neurophysiological effects of spinal adjustments (for review see Haavik & Murphy, 2012).

After each individual segmental adjustment the spine will be re-checked in order to determine if the subsequent levels identified as subluxated still require an adjustment. The levels of the spine adjusted for each subject will be recorded in an experimental log book.

The adjustment intervention will take approximately 5 minutes and will be administered once.
Intervention code [1] 289746 0
Treatment: Other
Comparator / control treatment
We will assess the effects of positioning a subject in a side-posture position as done during a spinal adjustment. This movement will consist of the same type of side posture set-up that a chiropractor positions a patient in prior to the delivery of the adjustive thrust. No thrust will be applied to the spine during this control movement. This control movement is not intended as a sham manipulation, but rather as a control for the potential physiological changes that could occur when lying on the adjustment bench, and the touch of the chiropractor. The subject will be positioned in the lateral decubitus position, as will be done for the adjustment intervention. The free superior leg will also be flexed at the knee and the pelvis so as to flex the lumbar spine. The pisiform bone of the clinician’s inferior (in relation to the subjects head) hand will contact any lumbar spinal segment over the spinous process, or the PSIS of the sacroiliac joint. However, no thrust will be applied. One session will be required which will take approximately 5 minutes.
Control group
Active

Outcomes
Primary outcome [1] 292553 0
Commercially available intra-vaginal EMG probes (Sugar International, Auriol, France) will be used to detect contraction onset times from the left and right side of the deep pelvic floor muscles to be compared with the superficial ones. The EMG signals will be amplified with a band pass filter of 10 to 500 Hz. Data will be sampled by the 14 bit analog-to-digital converter at a rate of 1,000 samples per second, stored on a computer.


Recording will be made of voluntary and involuntary pelvic floor muscle activity before, during and/or after several tasks, manoeuvres and movements including maximum voluntary contractions (MVCs) of their pelvic floor muscles, maximal intra-abdominal pressure (IAP) efforts (i.e. Valsalva manoeuvres), and voluntary coughs. The outcome of interest is the synchronisation of pelvic floor muscle contractions.

Individuals who are identified as having non-synchronous pelvic floor muscle contraction using the above protocol will be assessed a second time within one month of the initial assessment using the same protocol as above. At the second assessment all measures will be recorded before and after lumbopelvic adjustments.
Timepoint [1] 292553 0
Pre and post a single intervention session
Secondary outcome [1] 309213 0
None
Timepoint [1] 309213 0
None

Eligibility
Key inclusion criteria
* Women aged 18-55 with non-synchronised pelvic floor muscle contractions, as observed during ultrasound examination,
* A body mass index of less than 25 kg/m2 to achieve reliable EMG recordings
* Normal perineal sensibility
* Detectable non-synchronised pelvic floor muscle contractions, as observed during electromyography (EMG) examination.
(Participants in this trial will be included whether they are pregnant or not)
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any history of pelvic floor dysfunction, stress incontinence, pelvic organ prolapse, pelvic floor muscle avulsions, etc.
* Women with vaginal, urethral or bladder infection,
* Significant back pain in the last 3 months
* Known neurological diseases
* If currently taking antidepressant, analgesic or sedative medication.
* Known contraindication to receiving chiropractic adjustments. This includes a history of recent trauma, or known conditions such as inflammatory or infectious arthropathies, or bone malignancies.
* Previous adverse reactions to spinal adjustments

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers will be recruited into the trial and recordings will be made of voluntary and involuntary pelvic floor muscle activity before, during and/or after several tasks, manoeuvres and movements. If non-synchronsied muscle activity is observed a second assessment will take place that involves a chiropractic intervention pre and post the pelvic floor muscle function assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Basic science trial. Non-random allocation will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
To assess the effects of chiropractic adjustments on the dependent variables a multifactorial repeated measures ANOVA will be used for each of the dependent measures (contraction of left vs right pelvic floor muscles and deep vs superficial pelvic floor muscles), with “TIME” (pre and post intervention measures) and INTERVENTION (Chiro vs control intervention) as factors. A priori pairwise comparisons of the pre and post intervention data will be carried out when an interactive effect is significant. All statistical analysis will be carried out using IBM SPSS Statistics Version 21.0.0.0 software (IBM Corp, Armonk, NY). Significance will be set at P = .05.

Based on previous research we expect an effect size of 0.8. Power calculations suggest that to detect an anticipated effect size of 0.8 (estimates have been based on previous research) with an alpha of 0.05 and a power of 0.8, 15 subjects will be required to participate in the intervention arm of this study. Previous studies have revealed that between 14-20% of subjects considered to be normal exhibit non-synchronous patterns of pelvic muscle contraction. We therefore anticipate that we will need to screen 90 subjects to identify the 15 subjects required to participate in this study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/08/2014
Actual
28/08/2014
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
8
Final
Recruitment outside Australia
Country [1] 6195 0
New Zealand
State/province [1] 6195 0
Auckland

Funding & Sponsors
Funding source category [1] 289547 0
Charities/Societies/Foundations
Name [1] 289547 0
Australian Spinal Research Foundation
Country [1] 289547 0
Australia
Primary sponsor type
University
Name
New Zealand College of Chiropractic
Address
6 Harrison Road
Ellerslie
Auckland 1060
Country
New Zealand
Secondary sponsor category [1] 288232 0
None
Name [1] 288232 0
Address [1] 288232 0
Country [1] 288232 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291287 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 291287 0
Ethics committee country [1] 291287 0
New Zealand
Date submitted for ethics approval [1] 291287 0
21/05/2014
Approval date [1] 291287 0
30/06/2014
Ethics approval number [1] 291287 0
14/NTA/75

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49698 0
Dr Heidi Haavik
Address 49698 0
New Zealand College of Chiropractic
6 Harrison Road
Ellerslie
Auckland 1060
Country 49698 0
New Zealand
Phone 49698 0
+6495266789
Fax 49698 0
Email 49698 0
[email protected]
Contact person for public queries
Name 49699 0
Heidi Haavik
Address 49699 0
New Zealand College of Chiropractic
6 Harrison Road
Ellerslie
Auckland 1060
Country 49699 0
New Zealand
Phone 49699 0
+6495266789
Fax 49699 0
Email 49699 0
[email protected]
Contact person for scientific queries
Name 49700 0
Heidi Haavik
Address 49700 0
New Zealand College of Chiropractic
6 Harrison Road
Ellerslie
Auckland 1060
Country 49700 0
New Zealand
Phone 49700 0
+6495266789
Fax 49700 0
Email 49700 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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