Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001102460
Ethics application status
Approved
Date submitted
11/08/2016
Date registered
15/08/2016
Date last updated
25/10/2022
Date data sharing statement initially provided
25/10/2022
Date results information initially provided
25/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in Pain Sensitivity Following Cervical or Lumbar Spinal Manipulative Therapy in Spinal Pain Patients: A Randomised Trial
Scientific title
Changes in Pressure Pain Threshold Following Cervical or Lumbar Spinal Manipulative Therapy in Spinal Pain Patients: A Randomised Trial
Secondary ID [1] 289911 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Pain 299876 0
Spinal Manipulative Therapy 299877 0
Condition category
Condition code
Alternative and Complementary Medicine 299781 299781 0 0
Other alternative and complementary medicine
Physical Medicine / Rehabilitation 299804 299804 0 0
Other physical medicine / rehabilitation
Musculoskeletal 302954 302954 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
On a single occasion, each participant will be randomised to receive one of the following two interventions:
A) a single cervical high-velocity low-amplitude spinal manipulation technique known as the index pillar push, targeted at the C5-C6 facet joint on the most symptomatic side.
B) a single lumbar high-velocity low-amplitude spinal manipulation technique known as the hypothenar mamillary push, targeted at the L5-S1 facet joint on the most symptomatic side.
Each intervention will take approximately 1 minute to complete. Interventions will be performed in a private research room, on a chiropractic examination table, by a chiropractor with a minimum of 3 years clinical experience.
Multiple registered chiropractors will provide the interventions. They will receive training to standardise the techniques and participant interaction. Training will be in the form of a single 30 minute small group workshop. Topics will include a refresher on the specific manipulation techniques being used (the chiropractors will already be at least well familiar with the techniques), how to interact with participants in a reassuring but neutral manner. This will be run by a researcher with clinical experience as a chiropractor.
Intervention code [1] 295592 0
Treatment: Other
Comparator / control treatment
Participants will be randomised to either the cervical or lumbar manipulation group
Control group
Active

Outcomes
Primary outcome [1] 299250 0
Pressure pain threshold will be measured using a digital pressure algometer with a 1cm2 rubber probe (Wagner FPIX 50, USA), bilaterally at the medial gastrocnemius muscle, L5 paraspinal musculature, deltoid muscle, and C5 paraspinal musculature.
Timepoint [1] 299250 0
Pressure pain threshold will be measured at each site immediately following intervention, and again 15 minutes, 30 minutes, 45 minutes, and 60 minutes after intervention.
Secondary outcome [1] 326684 0
None
Timepoint [1] 326684 0
None

Eligibility
Key inclusion criteria
a) Current, episodic, or chronic spinal pain in both the neck and low back. Episodic is defined as at least 3 episodes of pain in the last 12 months, and chronic is defined as at least 3 months of ongoing pain in the last 12 months.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Any contraindications to cervical or lumbar SMT
b) Have had spinal manipulative therapy within the previous week
c) Have cervical or lumbar radiculopathy, neurological symptoms, or a neurological condition
d) Have fibromyalgia or chronic widespread pain
e) Have an inflammatory joint condition (e.g. rheumatoid arthritis)
f) Have a bleeding disorder or take anticoagulant medication (e.g. warfarin)

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)
The clinician providing the intervention will randomise the participant to one of two groups with the use of sequentially numbered, sealed, opaque envelopes containing randomised ones or twos. Group one will receive a cervical spinal manipulation and group two will receive a lumbar spinal manipulation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The ones and twos will be generated and placed into the sequential envelopes using an online random number generator with 1:1 allocation, by a researcher not involved in data collection (http://www.graphpad.com/quickcalcs/).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on the study by Waller et al. 2015, to see a 15% change (effect size 0.64) in pressure pain threshold at the lumbar spine, based on 80% power and with alpha at 5%, a sample size of 40 per group (80 total) will be required.
Repeated measures ANCOVAs will be run with factors of time and group to investigate within- and between-group change. Covariates for the ANCOVA will include two psychosocial questionnaires.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/10/2016
Actual
24/02/2017
Date of last participant enrolment
Anticipated
31/12/2017
Actual
17/06/2017
Date of last data collection
Anticipated
31/12/2017
Actual
17/06/2017
Sample size
Target
80
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294279 0
University
Name [1] 294279 0
Murdoch University
Country [1] 294279 0
Australia
Primary sponsor type
University
Name
School of Health Professions, Murdoch University
Address
90 South St
Murdoch WA
6150
Country
Australia
Secondary sponsor category [1] 293128 0
None
Name [1] 293128 0
Address [1] 293128 0
Country [1] 293128 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295711 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 295711 0
Murdoch University
90 South St
Murdoch WA
6150
Ethics committee country [1] 295711 0
Australia
Date submitted for ethics approval [1] 295711 0
01/09/2016
Approval date [1] 295711 0
03/10/2016
Ethics approval number [1] 295711 0
2016/178

Summary
Brief summary
This study will be a randomised trial investigating whether changes in sensitivity to pressure pain are different when comparing spinal manipulation (a manual therapy technique) of the neck and the low back. It will measure any changes in pain sensitivity over 1 hour, and will measure pain sensitivity in 4 different areas of the body to study how widespread any changes are.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68186 0
A/Prof Bruce F Walker
Address 68186 0
Murdoch University
90 South St
Murdoch WA
6150
Country 68186 0
Australia
Phone 68186 0
+61 8 9360 1297
Fax 68186 0
Email 68186 0
[email protected]
Contact person for public queries
Name 68187 0
Ms Sasha L Dorron
Address 68187 0
Murdoch University
90 South St
Murdoch WA
6150
Country 68187 0
Australia
Phone 68187 0
+61 8 9360 2114
Fax 68187 0
Email 68187 0
[email protected]
Contact person for scientific queries
Name 68188 0
Ms Sasha L Dorron
Address 68188 0
Murdoch University
90 South St
Murdoch WA
6150
Country 68188 0
Australia
Phone 68188 0
+61 8 9360 2114
Fax 68188 0
Email 68188 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.