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Trial registered on ANZCTR


Registration number
ACTRN12617001638325p
Ethics application status
Not yet submitted
Date submitted
8/11/2017
Date registered
18/12/2017
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a strength and conditioning program to prevent common manipulative technique training injuries in chiropractic students: a randomised controlled trial.
Scientific title
Testing a strength and conditioning program to prevent common manipulative technique training injuries in chiropractic students: a randomised controlled trial.
Secondary ID [1] 293318 0
None
Universal Trial Number (UTN)
U1111-1204-8112
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mechanical shoulder pain 305405 0
mechanical low back pain 305406 0
repetitive stress injury of the wrist 305407 0
Condition category
Condition code
Musculoskeletal 304688 304688 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 304740 304740 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group participants will undergo an individual, unsupervised 12-week strength and conditioning program which centres around improving strength and endurance of the musculature surrounding the joints identified as being at risk of injury. After the 12-week period, all participants will undergo the same assessments completed at the baseline.
The intervention program is to be performed 3 days per week, at a time convenient to the participant. Exercises will be performed as 3 sets of 15 repetitions, with 1minute rest periods between sets. Exercises include: internal/external shoulder rotation, scapulothoracic wall slide, push-ups, latissimus dorsi pull downs, shoulder press, seated rows, wrist flexion, wrist extension, radial deviation, ulnar deviation, weighted wrist rotations, stress ball squeezes, lunges, crab walks, and deadlifts. Participants will be provided with a length of theraband, which will act as resistance for the exercises.
The exercises will follow a 3 second eccentric, 1-second pause, 3 second concentric tempo and will be performed at an intensity of 13/20 RPE. Participants will be given an information letter describing the exercises and their parameters at a 1 hour face-to-face information session administered by a registered chiropractor. This will occur at baseline and they will have an opportunity to ask questions at this point. Participants will also have access to video recordings and audio descriptions of the exercises.
Each exercise session will take approximately 1 hour.
An exercise diary will be completed by those in the active and controls groups. Furthermore, they will be required to report the dates and duration of their specific exercises above in an exercise diary provided, in order to monitor and keep record of compliance.
Intervention code [1] 299576 0
Prevention
Comparator / control treatment
These participants will be required complete unsupervised walking 3 times a week for 30 minutes at a moderate intensity (13/20 RPE) for the duration of the program (12 weeks). This will be in addition to their regular exercise regime. Furthermore, they will be required to report the dates and duration of their walking on the exercise diary provided, in order to monitor and keep a record of compliance.
Control group
Active

Outcomes
Primary outcome [1] 303901 0
Lower back, shoulder and wrist pain severity- assessed by 100mm Visual Analogue Scale (VAS). This is part of a brief questionnaire designed especially for this study, which asks about shoulder, wrist or low back pain. The questionnaire will be administered at baseline and every 4 weeks during the trial, i.e. 3 times over 12 weeks.
This is a composite primary outcome.
Timepoint [1] 303901 0
4 weeks, 8 weeks and 12 weeks (primary endpoint)
Primary outcome [2] 304009 0
Lower back, shoulder and wrist pain duration assessed via a questionnaire specifically designed for this study. Options are <48 hours, 48 hours - 1 week, 1-2 weeks, or Still present.
This is a composite primary outcome.
Timepoint [2] 304009 0
4 weeks, 8 weeks and 12 weeks (primary endpoint)
Primary outcome [3] 304010 0
How did the pain affect the participant's ability to perform manual skills as assessed via a 5-point Likert scale, which was part of a questionnaire specifically designed for this study.
Timepoint [3] 304010 0
4 weeks, 8 weeks and 12 weeks (primary endpoint)
Secondary outcome [1] 340397 0
Baseline maximal strength of muscle groups will be estimated using the multiple repetition test procedure (5-10 submaximal strength test) instead of a traditional 1RM test. In this test the maximum amount of repetitions measured for a particular load will be used to estimate the 1RM from the formula 1RM= load (kg)/(1.0278 - 0.0278 x reps). Sub-maximal 1RM testing for strict shoulder press, bench press, seated row, Latissimus Dorsi pull down, deadlift, and back racked lunge
Timepoint [1] 340397 0
12 weeks
Secondary outcome [2] 340533 0
Grip strength dynamometry will be performed during the strength testing procedure. Participants will be given two attempts to familiarise themselves with the device. Then they will perform three attempts on each side with a 30-second rest between each. The highest measure will be taken for each hand
Timepoint [2] 340533 0
12 weeks
Secondary outcome [3] 340536 0
Endurance - This will be assessed base on the participants result in the Submaximal Strength test. This will be a raw figure rather than a calculation. The same load will be repeated at the 12 week follow up to assess whether endurance has increased for that particular movement. Sub-maximal testing will be completed for strict shoulder press, bench press, seated row, Latissimus Dorsi pull down, deadlift, and back racked lunge.
Timepoint [3] 340536 0
12 weeks

Eligibility
Key inclusion criteria
Potential participants will be both female and/or male students who are studying chiropractic on either a full or part-time basis will take part in this study. Participants will be over 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants will be excluded from this study if they are currently suffering from musculoskeletal pain in the shoulder, neck or low back region or have done so in the past 3 months or have a reported chronic physical disability.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The researcher who determined if a subject was eligible for inclusion in the trial will be unaware, when the decision is made, to which group the subject would be allocated. The sequence will be concealed in opaque envelopes until the interventions have been assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be achieved using Research Randomizer (https://www.randomizer.org/). The participants will be randomised into two, equal sized block groups. A member of the research team will be responsible for enrolling participants and implementing the randomisation process.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics for demographic and outcome data will be based on frequency distributions for categorical data and means and standard deviations or medians, interquartile ranges, and ranges for continuous data, as appropriate. Univariate analysis for treatment group comparisons will include Chi-squared and Fisher exact tests for categorical comparisons, and t-tests or non-parametric Mann-Whitney U or Wilcoxon signed rank tests for continuous outcomes. After adjusting for baseline measures, changes in injury rates and muscle strength and endurance over the course of the study will be compared between groups using repeated measures ANOVA or linear mixed models, depending on the final dataset. Data will be analysed using IBM SPSS version 24.0 (Armonk, NY) and p-values <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2018
Actual
Date of last participant enrolment
Anticipated
31/05/2018
Actual
Date of last data collection
Anticipated
31/08/2018
Actual
Sample size
Target
212
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 18064 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 297942 0
University
Name [1] 297942 0
Murdoch University
Country [1] 297942 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South St, Murdoch, 6150, WA
Country
Australia
Secondary sponsor category [1] 297005 0
None
Name [1] 297005 0
Address [1] 297005 0
Country [1] 297005 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298988 0
Murdoch University - Human Ethics Committee
Ethics committee address [1] 298988 0
Ethics committee country [1] 298988 0
Australia
Date submitted for ethics approval [1] 298988 0
31/01/2018
Approval date [1] 298988 0
Ethics approval number [1] 298988 0

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

Contacts
Principal investigator
Name 78906 0
Mr Christopher Hodgetts
Address 78906 0
Murdoch University
90 South St, Murdoch, 6150, WA
Country 78906 0
Australia
Phone 78906 0
+61 8 93601231
Fax 78906 0
Email 78906 0
[email protected]
Contact person for public queries
Name 78907 0
Christopher Hodgetts
Address 78907 0
Murdoch University
90 South St, Murdoch, 6150, WA
Country 78907 0
Australia
Phone 78907 0
+61 8 93601231
Fax 78907 0
Email 78907 0
[email protected]
Contact person for scientific queries
Name 78908 0
Christopher Hodgetts
Address 78908 0
Murdoch University
90 South St, Murdoch, 6150, WA
Country 78908 0
Australia
Phone 78908 0
+61 8 93601231
Fax 78908 0
Email 78908 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
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Documents added automatically
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