Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000908336
Ethics application status
Approved
Date submitted
16/06/2017
Date registered
21/06/2017
Date last updated
5/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the efficacy of strength and conditioning programs to prevent common technique training injuries in chiropractic students: A pilot study.
Scientific title
Testing the efficacy of strength and conditioning programs to prevent common technique training injuries in chiropractic students: A pilot study.
Secondary ID [1] 292213 0
None
Universal Trial Number (UTN)
U1111-1198-0263
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanical Shoulder Pain 303705 0
Mechanical Low Back Pain 303706 0
Repetitive Stress Injury of the Wrist 303707 0
Condition category
Condition code
Musculoskeletal 303077 303077 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 303095 303095 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, whilst the control group will complete 30 minutes of moderate intensity walking 3 days per week.
After the 12-week period, all participants will undergo the same assessments completed at the baseline. Participants adherence will be monitored via an exercise diary.
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. Intensity will be 13/20 RPE. 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.
Exercises are provided to the participants in the form of online videos on a dedicated YouTube channel. This was chosen for ease of access. These videos have detailed descriptions and demonstrations of each exercise, as well as describing the intended intensity.
Intervention code [1] 298368 0
Prevention
Intervention code [2] 298386 0
Lifestyle
Comparator / control treatment
The control group will perform 30 minutes of moderate intensity walking 3 days per week.
Control group
Active

Outcomes
Primary outcome [1] 302459 0
Injury Rate - measured via a brief questionnaire designed specifically for this study, which asks about shoulder, wrist or low back pain in the past 4 weeks. It will ask for information in terms of how long the pain lasted for, how severe it was, and did it stop them from practicing their manual therapy skills. This will be issued at the beginning and every 4 weeks during the trial.
This is a composite primary outcome.
Timepoint [1] 302459 0
Baseline, 4 weeks, 8 weeks, and 12 weeks (primary timepoint).
Secondary outcome [1] 336069 0
Strength - via 1RM testing and grip strength dynamometry
Timepoint [1] 336069 0
12 weeks

Eligibility
Key inclusion criteria
Female and/or male students that are studying Chiropractic on either a full or part-time basis will take part in this study. The participants will be taken from the current 4th-year cohort.
Participants can be any age, but cannot be suffering from on-going musculoskeletal pain in the shoulder, neck or low back region or have a reported physical disability.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently suffering on-going musculoskeletal pain in shoulder, neck or low back.
Have a reported 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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple random number generator.
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
Statistical analysis will only be used for a sample size calculation as this study is underpowered to test the efficacy of the strength program.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2017
Actual
1/08/2017
Date of last participant enrolment
Anticipated
4/08/2017
Actual
4/08/2017
Date of last data collection
Anticipated
30/11/2017
Actual
30/11/2017
Sample size
Target
10
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 16452 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 296753 0
University
Name [1] 296753 0
Murdoch University
Country [1] 296753 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street, Murdoch, 6150, WA
Country
Australia
Secondary sponsor category [1] 295729 0
None
Name [1] 295729 0
Address [1] 295729 0
Country [1] 295729 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297977 0
Murdoch University - Human Ethics Committee
Ethics committee address [1] 297977 0
Ethics committee country [1] 297977 0
Australia
Date submitted for ethics approval [1] 297977 0
19/06/2017
Approval date [1] 297977 0
26/06/2017
Ethics approval number [1] 297977 0
2017/146

Summary
Brief summary
The purpose of this pilot study is to determine the feasibility of a larger scale study and the potential for its subsequent success. Particularly, implementing a strength and conditioning program into various curricula to attempt to prevent future injuries in the manual therapy professions.
All participants will undergo a series of baseline measures over seven days. This will include demographic information, history of musculoskeletal injury, and maximal strength of muscle groups, which will be estimated using the multiple repetition test procedure (5-10 submaximal strength test) instead of traditional one repetition maximum test (1RM). 1RM will be calculated for each of: strict shoulder press (SP), bench press, seated row, Latissimus Dorsi pull down, deadlift, and back racked lunge. Participants will be instructed on correct usage of equipment prior to the testing session and given time to familiarize themselves with the equipment. A warm up will be completed prior to testing. Thereafter, 3-5 separate single attempts will be performed. Subjects will lift a weight initially 40%-60% of the perceived 1-RM. The increments of weight are dependent upon the effort required for the lift. The weight added will become smaller as the effort to lift the weight increases. If subjects are able to perform more lifts than designated by the testing protocol, subjects are allowed a minimum of four min rest and then reassessed. Participants will be instructed to perform each exercise to acute muscular exhaustion or form fatigue. Any repetitions that are not performed with a full range of motion will be discarded. When the subject can only lift the weight five to ten times, that weight and the number of repetitions are considered to estimate the 1-RM.
Grip strength dynamometry will be performed during the strength testing procedure.

After completion of all baseline measures, each participant will be randomly assigned to either the intervention (n=5) or comparison (n=5) group using a random number generator.
Intervention group participants will undergo a 12-week strength and conditioning program, whilst the control group will perform 30 minutes of moderate intensity walking 3 days per week.

After the 12-week period all participants will undergo the same assessments completed at the baseline.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75646 0
Mr Christopher Hodgetts
Address 75646 0
Murdoch University
90 South Street, Murdoch, 6150, WA.
ECL2.061
Country 75646 0
Australia
Phone 75646 0
+61 8 93601231
Fax 75646 0
Email 75646 0
[email protected]
Contact person for public queries
Name 75647 0
Christopher Hodgetts
Address 75647 0
Murdoch University
90 South Street, Murdoch, 6150, WA.
ECL2.061
Country 75647 0
Australia
Phone 75647 0
+61 8 93601231
Fax 75647 0
Email 75647 0
[email protected]
Contact person for scientific queries
Name 75648 0
Christopher Hodgetts
Address 75648 0
Murdoch University
90 South Street, Murdoch, 6150, WA.
ECL2.061
Country 75648 0
Australia
Phone 75648 0
+61 8 93601231
Fax 75648 0
Email 75648 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
No additional documents have been identified.