Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001217291
Ethics application status
Approved
Date submitted
27/02/2018
Date registered
20/07/2018
Date last updated
23/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of chiropractic care in Alzheimer's patients
Scientific title
The effects of chiropractic care on functional outcomes, somatosensory processing and motor control in patients who suffer from Alzheimer's Disease
Secondary ID [1] 288972 0
None
Universal Trial Number (UTN)
U1111-1181-7699
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
 298365 0
Condition category
Condition code
Neurological 298470 298470 0 0
Alzheimer's disease
Physical Medicine / Rehabilitation 306027 306027 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a crossover study, where individuals act as their own control. There are two sessions, one intervention session and one control session. The intervention is a single session of chiropractic care. The control session consists of passive head movements. Both sessions will take approximately ten minutes.

Chiropractic assessment:
The entire spine and both sacroiliac joints will be assessed for vertebral subluxation, and manipulated/adjusted where deemed necessary, by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine prior to and after each chiropractic adjustment session include assessing for tenderness to palpation of the relevant joints, manually palpating for restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints. All of these biomechanical characteristics are used by the chiropractors as clinical indicators of vertebral subluxations and vary between individuals, depending on their subluxation indicators. All of the spinal adjustments carried out in this study will be high-velocity, low-amplitude thrusts to the spine or pelvic joints. These are standard adjustment techniques used by chiropractors. The mechanical properties of this intervention has been investigated; and although the actual force applied to the subject's spine depends on the chiropractor, the patient, and the spinal location of the adjustment, the general shape of the force-time history of spinal adjustments is very consistent and the duration of the thrust is always less than 200 milliseconds. The high velocity type of adjustments chosen specifically because previous research has shown that reflex electromyographic 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 the neurophysiological effects of chiropractic care. Within 30 minutes of receiving the intervention the participant will be reassessed using the same outcome measurement procedures. The participants will then be reassessed after a 7 day washout period with the alternate intervention applied between pre/post assessments.
Intervention code [1] 294459 0
Rehabilitation
Comparator / control treatment
The control is a single session. The subject’s head and/or spine will be moved in ways that include passive and active movements, similar to what is done by the chiropractor that provide actual chiropractic care during the experimental intervention. Thus this control intervention involves the subject being moved into the adjustment setup positions similar to how the chiropractor would normally setup a subject prior to applying the thrust to the spine to achieve the adjustment. No spinal adjustments will be performed during any control intervention. This control intervention is intended to act as a sham treatment session as well as to act as a physiological control for possible changes occurring due to the cutaneous, muscular or vestibular input that would occur with the type of passive and active movements involved in preparing a subject/patient for an adjustment.
Control group
Active

Outcomes
Primary outcome [1] 297958 0
Somatosensory Evoked potential SEPs extracted from brain signals recorded using 64 channels of EEG.
Timepoint [1] 297958 0
Immediately pre and post spinal manipulation session and immediately pre and post control intervention.
Secondary outcome [1] 322763 0
We will use composite secondary measure consisting of Resting state EEG - functional connectivity, brain activity in different EEG bands, inter-hemispheric coherence.
Timepoint [1] 322763 0
Immediately pre and post spinal manipulation session and immediately pre and post control intervention.

Eligibility
Key inclusion criteria
15-20 participants will be recruited to participate in each of these studies. Participants will be inpatients or outpatients at Shifa International Hospital, in Islamabad or Railway Hospital, Rawalpindi, Pakistan. To be eligible to participate volunteers must suffer from Alzheimer Disease and at least 8 weeks prior to their involvement in the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Volunteers will be ineligible to participate if they exhibit no evidence of spinal dysfunction, have absolute contraindications to spinal manipulation, have experienced previous significant adverse reactions to chiropractic care, or if they are deemed unsuitable to receive chiropractic care by their treating physicians.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
To address our hypotheses crossover design, Each participant will attend two study sessions and act as their own controls in a cross-over experimental design. The data from two sessions will be compared to look for changes in SEPs and brain cross-talk (resting state EEG) differences in two sessions. The groups will receive either a control intervention or a chiropractic adjustment intervention during the two sessions they attend. The order of which intervention they receive will be randomized.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be reported as mean ± SD. To assess the effect of chiropractic adjustments on the dependent variables a multifactorial repeated measures ANOVA will be used for each of the dependent measures (SEP peak amplitudes, latencies and MMP components), with ‘TIME’ (pre and post intervention measures) and ‘INTERVETION’ (Chiro vs control) 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 = 0.05. Repeated measures ANOVA will also be applied to compare MU parameters before and after intervention; and between subjects groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/04/2016
Date of last participant enrolment
Anticipated
Actual
5/05/2016
Date of last data collection
Anticipated
Actual
12/05/2016
Sample size
Target
15
Accrual to date
Final
14
Recruitment outside Australia
Country [1] 7800 0
Pakistan
State/province [1] 7800 0
Islamabad

Funding & Sponsors
Funding source category [1] 293329 0
Other Collaborative groups
Name [1] 293329 0
New Zealand College of Chiropractic
Country [1] 293329 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
New Zealand College of Chiropractic
Address
6 Harrison Road
Mt Wellington
Auckland, 1060
New Zealand
Country
New Zealand
Secondary sponsor category [1] 292146 0
None
Name [1] 292146 0
Address [1] 292146 0
Country [1] 292146 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294798 0
Riphah International University in Islamabad
Ethics committee address [1] 294798 0
Ethics committee country [1] 294798 0
Pakistan
Date submitted for ethics approval [1] 294798 0
28/03/2016
Approval date [1] 294798 0
05/04/2016
Ethics approval number [1] 294798 0

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

Contacts
Principal investigator
Name 65090 0
Dr Imran Niazi
Address 65090 0
New Zealand College of Chiropractic
6 Harrison Road Mount Wellington Auckland 1060
Country 65090 0
New Zealand
Phone 65090 0
+6495266789
Fax 65090 0
Email 65090 0
[email protected]
Contact person for public queries
Name 65091 0
Kelly Holt
Address 65091 0
New Zealand College of Chiropractic
6 Harrison Road Mount Wellington Auckland 1060
Country 65091 0
New Zealand
Phone 65091 0
+6495266789
Fax 65091 0
Email 65091 0
[email protected]
Contact person for scientific queries
Name 65092 0
Kelly Holt
Address 65092 0
New Zealand College of Chiropractic
6 Harrison Road Mount Wellington Auckland 1060
Country 65092 0
New Zealand
Phone 65092 0
+6495266789
Fax 65092 0
Email 65092 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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