Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000906954
Ethics application status
Approved
Date submitted
17/06/2020
Date registered
14/09/2020
Date last updated
14/09/2020
Date data sharing statement initially provided
14/09/2020
Date results information initially provided
14/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of Medial Tibial Stress Syndrome using an
Investigational Lower Leg Device. A Randomised
Controlled Trial.
Scientific title
Treatment of Medial Tibial Stress Syndrome using an
Investigational Lower Leg Device. A Randomised
Controlled Trial Investigating Pain Severity and Return to Sport.
Secondary ID [1] 301533 0
None
Universal Trial Number (UTN)
U1111-1253-6880
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medial tibial stress syndrome 317895 0
Condition category
Condition code
Physical Medicine / Rehabilitation 315932 315932 0 0
Physiotherapy
Musculoskeletal 315933 315933 0 0
Other muscular and skeletal disorders
Injuries and Accidents 316271 316271 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study was to determine whether current MTSS treatment methods with an adjuvant novel device are more effective in treating MTSS pain symptoms than the current treatment methods without the device.
The investigational device is an external orthosis comprised of a calf sleeve with 3 rubber ellipsoids that compressed the musculotendinous junctions of the soleus muscle with the aid of circumferential elastic strapping (posterior to fibular head, mid-diaphysis of posteromedial tibia, Achilles tendon). Another rubber component in the shape of a 10cm rod compressed the posteromedial border of the distal one-third of the tibia. It is therefore applied like a sock reaching from proximal tibial to distal tibia, it is worn up to 2hrs at a time before exercise and up to 2hrs after exercise each day and up to 4hrs in 2x2hr periods on days where no exercise takes place. Participants in the study completed weekly diaries that recorded device usage in detail. They wore the device and recorded device usage over a 6 month period.
Participants already engaging in treatment for their MTSS were not discouraged from continuing these activities. These included stretching and calf strengthening exercises, dry needling, rest, icing, orthotics for shoes. These were administered according to the physicians treating the patients prior to the study.
Intervention code [1] 317836 0
Treatment: Devices
Comparator / control treatment
The placebo device appeared visually identical, however, it lacked the functional rubber components of the true device. Therefore, it consisted of a spandex sleeve with 4 circumferential elastic straps that were tightened to apply firm pressure. Our research team believed this would be an ideal placebo as previous research has demonstrated there is no clinical benefit of using compressive garments for MTSS.
Control group
Placebo

Outcomes
Primary outcome [1] 324138 0
Primary outcome = Medial tibial Syndrome Severity Score as per Winters M, Moen MH, Zimmermann WO, Lindeboom R, Weir A, Backx FJG, Bakker EWP. The medial tibial stress syndrome score: a new patient-reported outcome measure. Br J Sports Med. 2016;50:1192-1199.
Timepoint [1] 324138 0
Weekly from baseline week 0, weeks 1-6, week 8, week 12, week 24.
Secondary outcome [1] 383847 0
Time to return to full-time sporting activities
Timepoint [1] 383847 0
Weekly from baseline week 0, weeks 1-6, week 8, week 12, week 24. Assessed using specific MTSS severity score questionnaire
Secondary outcome [2] 385720 0
recurrence of symptoms after return to full-time activities
Timepoint [2] 385720 0
Weekly from baseline week 0, weeks 1-6, week 8, week 12, week 24. Assessed using specific MTSS severity score questionnaire
Secondary outcome [3] 385721 0
session frequency
Timepoint [3] 385721 0
Weekly from baseline week 0, weeks 1-6, week 8, week 12, week 24. Assessed using questionnaire. This questionnaire was designed specifically for this study.
Secondary outcome [4] 385722 0
rated perceived exertion
Timepoint [4] 385722 0
Weekly from baseline week 0, weeks 1-6, week 8, week 12, week 24. Assessed using questionnaire to rate their perceived exertion out of 10 for the previous week. RPE is a recognised, validated method.
Secondary outcome [5] 385723 0
device usage
Timepoint [5] 385723 0
Weekly from baseline week 0, weeks 1-6, week 8, week 12, week 24. Assessed using questionnaire detailing use before and after exercises per leg, and on days when not exercising for each leg. This questionnaire was designed specifically for this study.

Eligibility
Key inclusion criteria
• Symptomatic medial tibial stress syndrome of at least 6 weeks duration, diagnosed on the basis of:
o History of diffuse, dull shin pain that is associated with exercise,
o Palpable tenderness of the posteromedial tibial border
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Diagnosis of stress fracture in the previous 6 months
• Clinical suspicion of a current stress fracture due to localised point tenderness on the anterior or medial border of the tibia unless ruled out by an MRI (MRI negative for bone stress reaction)
• Signs of plantar fasciitis including heel pain on first steps in the morning and tenderness to palpation over the posteromedial calcaneal tuberosity
• Previous diagnosis of compartment syndrome
• Suspicion of chronic exertional compartment syndrome on the basis of history of shin or calf pain brought on at a predictable point in activity, that worsens if exercise continues and is relieved by rest, unless excluded with compartment pressure testing
• Clinical signs of complex regional pain syndrome including pain out of proportion to the inciting event, allodynia, hyperalgesia, diffuse oedema, skin changes and difference in temperature between limbs
• Previous diagnosis of popliteal artery entrapment syndrome
• Clinical suspicion of popliteal artery entrapment syndrome based on disappearance of pedal pulses on repetitive plantarflexion
• Clinical suspicion of radicular leg pain including history of back pain associated with the leg pain and/or reproduction of leg pain on SLR testing with added dorsiflexion
• Neurological disease affecting the lower leg
• Coagulation disease
• Pregnancy

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)
Computer randomised participants with Central randomisation by computer to ensure allocation concealment. Devices were fitted on participants by a single clinician. Data was collected and analysed by a clinician blinded to group allocations of each participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparisons were made within groups at each time point using Wilcoxon signed-rank tests for categorical data. Comparisons between groups were made at each time point using Mann-Whitney rank-sum tests for categorical data and a Student’s T Test for continuous data. Bivariate Spearman’s Tests for correlation were conducted to determine a relationship between different variables. Ordinal logistic regression analysis was performed to identify variables that independently affected MTSS Scores at each time point in the study. The level of significance was set at p < 0.05 for all statistical analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
Actual
30/06/2018
Date of last data collection
Anticipated
Actual
31/01/2019
Sample size
Target
23
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305972 0
Commercial sector/Industry
Name [1] 305972 0
Solushin Pty Ltd
Country [1] 305972 0
Australia
Primary sponsor type
Individual
Name
William McNamara
Address
The Wollongong Hospital
Loftus Street Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 306432 0
Other Collaborative groups
Name [1] 306432 0
Sydney Sports Medicine Centre
Address [1] 306432 0
6 Figtree Dr, Sydney Olympic Park NSW 2127
Country [1] 306432 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306212 0
Bellberry Limited
Ethics committee address [1] 306212 0
123 Glen Osmond Rd, Eastwood SA 5063
Ethics committee country [1] 306212 0
Australia
Date submitted for ethics approval [1] 306212 0
07/09/2016
Approval date [1] 306212 0
17/02/2017
Ethics approval number [1] 306212 0
2016-07-610

Summary
Brief summary
Background: Medial tibial stress syndrome affects 4-20% of the population with increased incidence in athletes and the military. It has a complex aetiology of bone loading and fascial traction and is often difficult to treat. Stretching, calf strengthening, load management and rest have shown benefit, however, there remains a group of patients who do not benefit from these methods and for many athletes and military personnel prolonged rest is not ideal.

Hypothesis: The purpose of this study was to examine the effect of an investigational device on MTSS symptoms compared to a placebo.

Study Design: A prospective double-blinded randomised placebo-controlled trial.

Methods: Included participants were those with symptomatic MTSS lasting 6 weeks or more. Excluded were those with other lower limb or systemic pathologies. Fourteen participants formed the study cohort. Participants were required to wear the devices daily for up to 2hrs, before and after exercise. Additional treatment modalities were recorded.
The primary outcome was a MTSS Severity Score at the initial assessment and 1-6, 8, 12, and 24 weeks. Secondary outcomes were return to activity, exercise frequency and device usage data collected at the same time points.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103114 0
Dr William McNamara
Address 103114 0
The Wollongong Hospital
Loftus Street Wollongong NSW 2500
Country 103114 0
Australia
Phone 103114 0
+61437219211
Fax 103114 0
Email 103114 0
[email protected]
Contact person for public queries
Name 103115 0
Dr William McNamara
Address 103115 0
The Wollongong Hospital
Loftus Street Wollongong NSW 2500
Country 103115 0
Australia
Phone 103115 0
+61437219211
Fax 103115 0
Email 103115 0
[email protected]
Contact person for scientific queries
Name 103116 0
Dr William McNamara
Address 103116 0
The Wollongong Hospital
Loftus Street Wollongong NSW 2500
Country 103116 0
Australia
Phone 103116 0
+61437219211
Fax 103116 0
Email 103116 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As agreed with our ethics committee, individual data will not be provided.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8243Ethical approval    380014-(Uploaded-15-07-2020-21-19-22)-Study-related document.pdf
8244Study protocol    380014-(Uploaded-15-07-2020-21-19-54)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTreatment of medial tibial stress syndrome using an investigational lower leg brace. A pilot for a randomised controlled trial.2023https://dx.doi.org/10.1136/bmjinnov-2022-001054
N.B. These documents automatically identified may not have been verified by the study sponsor.