ANZCTR - Registration

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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]

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

Mechanical Low Back Pain

Repetitive Stress Injury of the Wrist

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

Prevention

Intervention code [2]

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]

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]

Baseline, 4 weeks, 8 weeks, and 12 weeks (primary timepoint).

Secondary outcome [1]

Strength - via 1RM testing and grip strength dynamometry

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6150 - Murdoch

Funding & Sponsors

Funding source category [1]

University

Name [1]

Murdoch University

Address [1]

90 South Street, Murdoch, 6150, WA

Country [1]

Australia

Primary sponsor type

University

Name

Murdoch University

Address

90 South Street, Murdoch, 6150, WA

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Murdoch University - Human Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/06/2017

Approval date [1]

26/06/2017

Ethics approval number [1]

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

Mr Christopher Hodgetts

Address

Murdoch University
90 South Street, Murdoch, 6150, WA.
ECL2.061

Country

Australia

Phone

+61 8 93601231

Fax

c.hodgetts@murdoch.edu.au

Contact person for public queries

Name

Christopher Hodgetts

Address

Murdoch University
90 South Street, Murdoch, 6150, WA.
ECL2.061

Country

Australia

Phone

+61 8 93601231

Fax

c.hodgetts@murdoch.edu.au

Contact person for scientific queries

Name

Christopher Hodgetts

Address

Murdoch University
90 South Street, Murdoch, 6150, WA.
ECL2.061

Country

Australia

Phone

+61 8 93601231

Fax

c.hodgetts@murdoch.edu.au

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.

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