Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000846820
Ethics application status
Approved
Date submitted
16/05/2021
Date registered
1/07/2021
Date last updated
6/06/2022
Date data sharing statement initially provided
1/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of a Physiotherapy versus Extracorporeal Shockwave Therapy (ESWT) for treatment of Hamstring Tendon pain.
Scientific title
A Pilot Randomised Trial Comparing Individualised Physiotherapy versus Shockwave Therapy for Proximal Hamstring Tendinopathy
Secondary ID [1] 292133 0
None
Universal Trial Number (UTN)
U1111-1261-8019
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Proximal Hamstring Tendinopathy 303573 0
Condition category
Condition code
Musculoskeletal 302981 302981 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 302982 302982 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PHYSIOTHERAPY intervention
Intervention in the individualised PHYSIOTHERAPY group will relate to known or hypothesised mechanisms underpinning the condition and have been informed by treatment shown to be effective in other lower limb tendinopathies. A key component of the program is a multi-stage, graded, individualised, strengthening/rehabilitation program, with consideration given to sporting and occupational demands. Graded reintroduction of compressive forces in loading programs is recommended for PHT and other lower limb tendinopathies and will be incorporated in the individualised PHYSIOTHERAPY treatment algorithms.
Pain monitoring, both during and latent to loading, is a key component of the program. Use of a pain ‘ceiling’ during rehabilitation is thought to provide a safe guideline for exercise loads and avoids the need for a prolonged period of rest in which only pain free activity is allowed. A significant increase in symptoms lasting over 24 hours after activity is thought to indicate excessive loading of the tendon although the biological mechanism of this response is unknown.
Stage 1 of the PHYSIOTHERAPY intervention will comprise isometric hamstring exercise aiming to safely commencing strengthening the hamstring complex and reduce pain levels. Stage 2 will incorporate progressive isotonic strengthening exercises of the hamstring musculature. Later stages will add strengthening of agonist muscles (calf, hip extensors, hip abductors and adductor magnus), and reintroduction of compressive load by increasing the hip flexion angle of hamstring strengthening exercises. High speed (energy storage and release) exercises will be included if required for the participant. Exercises options that are specific to sporting/occupational demands will be chosen where possible. Retraining of lower limb kinetic chain movements (e.g. lunge, squat, running) and lumbopelvic control rehabilitation will be incorporated if indicated by the assessment of the treating physiotherapist in line with recommendations for other lower limb tendinopathies. Progression to later stages of the program will be criteria driven with emphasis on absence of latent pain increase from rehabilitation. Return to sport advice will be provided. The treatment protocols have been developed by the research team including a clinical/research expert in this area (JC)

The duration of the intervention is 12 weeks, with sessions provided at 0, 1, 2, 3, 6 and 12 weeks after randomisation. The first session is 60 minutes, and the remainder 30 minutes. All sessions will be undertaken in a one to one format in a physiotherapy clinic.

Participating physiotherapists and treatment fidelity
Physiotherapists from private practices in Victoria will provide treatment for both groups. To be eligible, the physiotherapists will need to have at least 2 years of clinical experience. Physiotherapists will then participate in a small group, 4-hour training session provided by the lead researcher (AR). The program will include review of previously provided material, and simulation of explanations and treatments to be used in the trial.
Treating physiotherapists will be provided with a treatment manual (designed specifically for this study) detailing treatment algorithms, protocols and participant information sheets. Treatment methods will be clearly defined and standardised via a detailed session-by-session electronic clinical notes template that contains a series of decision-making algorithms. The algorithms and clinical notes will ensure that essential elements of the treatment program are consistently applied by all physiotherapists across all participants, while still allowing some opportunity for the treatment to be tailored to individual participants. The template will require treating physiotherapists to provide objective assessment findings, justification and rationale for clinical decision making, detail of treatment provision/prescription and response to treatment. Physiotherapists will be required to complete electronic clinical notes for each session which detail assessment findings, treatment provided, clinical decision-making justification and any adverse events from shockwave treatment or the exercise program.
A quarterly face-to-face (or online if required due to COVID restrictions) meeting will be undertaken for 60 minutes involving all treating physiotherapists for the duration of the trial to review de-identified cases in the context of the treatment protocol. Evaluation of treatment fidelity and adherence by the physiotherapists for specific rehabilitation techniques will be achieved by checking the physiotherapist’s clinical notes for each participant after the second and fourth sessions of the program.
Intervention code [1] 298287 0
Rehabilitation
Comparator / control treatment
SHOCKWAVE intervention

Intervention in the SHOCKWAVE group will follow the approach of Cacchio et al 2011 consisting of four sessions of ESWT in accordance with a standardised protocol. The final two sessions will be used to review relevant information sheets and plan for return to normal activities.
Although the trial by Cacchio et al used only radial shockwave, both radial (EMS Swiss Dolorclast, Milano, Italy) and semi-focused shockwave (Dornier, Germany) will be used given previous research has found no difference in outcomes between the two different devices in tendinopathy. Shockwave dosage will be 2000 shocks per session at the highest tolerable intensity which appears to be a safe and effective dose.

The duration of the intervention is 12 weeks, with sessions provided at 0, 1, 2, 3, 6 and 12 weeks after randomisation. Shockwave will be provided in the first 4 sessions only. The final two sessions (at week 6 and 12) are used to review previous education, and plan for return to sport and other previously provocative activities. The first session is 60 minutes, and the remainder 30 minutes. All sessions will be undertaken in a one to one format in a physiotherapy clinic.

Participating physiotherapists and treatment fidelity
Physiotherapists from private practices in Victoria will provide treatment for both groups. To be eligible, the physiotherapists will need to have at least 2 years of clinical experience. Physiotherapists will then participate in a small group, 4-hour training session provided by the lead researcher (AR). The program will include review of previously provided material, and simulation of explanations and treatments to be used in the trial.
Treating physiotherapists will be provided with a treatment manual detailing treatment algorithms, protocols and participant information sheets. Treatment methods will be clearly defined and standardised via a detailed session-by-session electronic clinical notes template that contains a series of decision-making algorithms. The algorithms and clinical notes will ensure that essential elements of the treatment program are consistently applied by all physiotherapists across all participants, while still allowing some opportunity for the treatment to be tailored to individual participants. The template will require treating physiotherapists to provide objective assessment findings, justification and rationale for clinical decision making, detail of treatment provision/prescription and response to treatment. Physiotherapists will be required to complete electronic clinical notes for each session which detail assessment findings, treatment provided, clinical decision-making justification and any adverse events from shockwave treatment or the exercise program.
A quarterly face-to-face meeting will be undertaken for 60 minutes involving all treating physiotherapists for the duration of the trial to review de-identified cases in the context of the treatment protocol. Evaluation of treatment fidelity and adherence by the physiotherapists for specific rehabilitation techniques will be achieved by checking the physiotherapist’s clinical notes for each participant after the second and fourth sessions of the program.
Control group
Active

Outcomes
Primary outcome [1] 302364 0
Global rating of change
Metric/Method of measurement: A 7-point Likert scale, with participants rating their overall change from baseline.
Timepoint [1] 302364 0
12 weeks after randomisation
Primary outcome [2] 326902 0
Severity of hamstring tendon symptoms
Metric/Method of measurement: Victorian Institute of Sport – Hamstring questionnaire (VISA-H).
Timepoint [2] 326902 0
12 weeks after randomisation
Secondary outcome [1] 335739 0
Global rating of change
Metric/Method of measurement: A 7-point Likert scale, with participants rating their overall change from baseline.
Timepoint [1] 335739 0
4, 26 and 52 weeks post randomisation
Secondary outcome [2] 335740 0
Severity of hamstring tendon symptoms
Metric/Method of measurement: Victorian Institute of Sport – Hamstring questionnaire (VISA-H).
Timepoint [2] 335740 0
4, 26 and 52 weeks post randomisation
Secondary outcome [3] 393048 0
Sitting tolerance
Metric/Method of measurement: Patient Specific Functional Scale
Timepoint [3] 393048 0
4, 12, 26 and 52 weeks after randomisation
Secondary outcome [4] 393049 0
Functional restrictions
Metric/method of measurement: modified Physical Activity Level Scale.
Timepoint [4] 393049 0
4, 12, 26 and 52 weeks after randomisation
Secondary outcome [5] 393051 0
Eccentric hamstring strength
Metric/method of measurement: NordBoard (Vald Performance, Albion Queensland)
Timepoint [5] 393051 0
12 weeks after randomisation
Secondary outcome [6] 393052 0
Psychosocial risk factors
Metric/method of measurement: Orebro Musculoskeletal Pain Screening Questionnaire
Timepoint [6] 393052 0
4, 12, 26 and 52 weeks after randomisation
Secondary outcome [7] 393054 0
Kinesiophobia
Metric/method of measurement: modified Tampa scale
Timepoint [7] 393054 0
4, 12, 26 and 52 weeks after randomisation
Secondary outcome [8] 393055 0
Severity of symptoms
Metric/method of measurement: Numerical pain rating scale
Timepoint [8] 393055 0
4, 12, 26 and 52 weeks after randomisation
Secondary outcome [9] 393056 0
Self-reported adherence to rehabilitation
Metric/method of measurement: Exercise Adherence Rating Scale
Timepoint [9] 393056 0
4, 12, 26 and 52 weeks after randomisation
Secondary outcome [10] 393057 0
Satisfaction with treatment:
Metric/method of measurement: 5 point Likert scale
Timepoint [10] 393057 0
4, 12, 26 and 52 weeks after randomisation
Secondary outcome [11] 393058 0
Satisfaction with results of treatment:
Metric/method of measurement: 5 point Likert scale
Timepoint [11] 393058 0
4, 12, 26 and 52 weeks after randomisation
Secondary outcome [12] 393059 0
Quality of life
Metric/method of measurement: EuroQoL-5D
Timepoint [12] 393059 0
4, 12, 26 and 52 weeks after randomisation
Secondary outcome [13] 396756 0
Pain Catastrophization

Metric/method of measurement: Pain Catastrophizing Scale
Timepoint [13] 396756 0
4, 12, 26 and 52 weeks after randomisation

Eligibility
Key inclusion criteria
Inclusion Criteria

Initial Phone Screening
1. Reports of relatively localised (defined as an area smaller than a tennis ball) ischial tuberosity region pain of gradual onset and at least 3 months in duration.
2. Willingness to participate in six sessions of intervention over a 12-week period.
3. Age between 18 and 65 inclusive.
4. Fluency in English sufficient to complete questionnaires and to enable understanding to the intervention.
5. Agreeing to refrain from other interventions for the treatment period of the trial, aside from consultation with medical practitioners, and medication.
6. Planned absence for a period of >2 weeks during the treatment period (such as overseas holiday).

Clinical examination screening
7. A clear increase in activity levels precipitating onset of symptoms determined based on clinical interview.
8. Positive findings (reproduction of lower buttock pain) with three or more of four diagnostic criteria:
o Single-leg arabesque
o Supine single leg bridge with heel on standardised height platform (bent knee)
o Self reported PHT symptoms with prolonged sitting <30 minutes.
o Modified bent-knee hamstring stretch test.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Initial Phone Screening
1. Previous surgery to the hamstring complex, as we wish to study treatment effects independent to the effects of surgical procedures.
2. Previous injection to the hamstring tendon within the previous 6 weeks, as we wish to study treatment effects independent to the effects of injections.
3. Treatment with ESWT for PHT in the last 3 months, as we wish to study treatment effects independent to the effects of ESWT.
4. Contraindications to receiving ESWT.
5. Current pregnancy, or recent childbirth (within 6 months) as this could impair ability to undertake testing and intervention.
6. Diagnosis with autoimmune disease as we do not wish to evaluate tendon response where there is a potential autoimmune influence
7. Already received more than two sessions of physiotherapy with any of the trial physiotherapists prior to enrolment, as these therapists are likely to use many components of the trial treatment protocol on their clinical caseload.
8. An active compensation claim for the injury, as this may have a negative influence on the response to treatment.

Clinical examination screening
9. Pain that is predominantly due to lumbar dysfunction including lumbar spine radiculopathy, or lumbar spine somatic referral
10. Pain that is reasoned from clinical examination to be predominantly due to other structures or conditions, including sciatic nerve entrapment, ischiofemoral impingement, hip joint, local sciatic nerve irritation, and adductor magnus tendinopathy

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)
Central (offsite) allocation to groups from a computer generated allocation sequence, performed by a researcher (AH) at La Trobe University who will have no contact with volunteers or trial participants and is located remotely to the treatment clinics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated electronically using random block sizes. Randomisation will be stratified for age (<50 years of age vs >= 50 years of age), as systemic factors associated with menopause (common above this age) may influence response to some components of treatment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
We aim to recruit 100 participants for this pilot trial. There are limited data for the VISA-H or other relevant outcome measures for PHT to inform sample size calculations. A sample size of 100 was therefore chosen on the basis of feasibility. A sample size of 100 would provide 80% power to detect a between-group standardised mean difference of at least 0.6 on the VISA-H, allowing for a 10% loss to follow up. This pilot RCT will provide useful data to inform sample size calculations for future trials on PHT.

Following trial completion, data from all follow-up points (4, 12, 26- and 52-weeks following randomisation) will be analysed focussing on between-group treatment effects (with 95% confidence intervals). SPSS will be used to conduct analyses. Alpha will be set at 0.05 using a two-tailed hypothesis.
Intention to treat principles will be used for all analyses; participants will be analysed based on their original allocation regardless of their adherence with treatment or number of sessions attended. Missing data will be managed by maximum likelihood estimation within linear mixed models.
Continuous data will be analysed using linear mixed models (with the group x time interaction estimating the treatment effect). Ordinal data will be analysed using the Mann Whitney U test.
A responder analysis will also be undertaken to determine the proportion of participants who achieved clinically important changes on outcome measures. For these purposes, the minimum clinically important difference (MCID) will be defined as 12 points on the VISA-H questionnaire, at least ‘much improved’ on the global rating of change scale. The MCID value for the VISA-H was used as it is similar to MCID values on other VISA scales and seemed appropriate based on the authors’ experience. For responder analyses, the risk ratio, risk difference and number needed to treat will be calculated along with 95% confidence intervals. Statistical significance for the responder analyses will be evaluated using Chi square analysis.



Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/08/2022
Actual
Date of last participant enrolment
Anticipated
1/08/2022
Actual
Date of last data collection
Anticipated
1/08/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 16376 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 297168 0
Commercial sector/Industry
Name [1] 297168 0
Advance Healthcare
Country [1] 297168 0
Australia
Primary sponsor type
University
Name
LaTrobe University
Address
Kingsbury Drive
Bundoora, Vic 3083
Country
Australia
Secondary sponsor category [1] 309340 0
None
Name [1] 309340 0
Address [1] 309340 0
Country [1] 309340 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297896 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 297896 0
Ethics committee country [1] 297896 0
Australia
Date submitted for ethics approval [1] 297896 0
30/03/2020
Approval date [1] 297896 0
10/05/2021
Ethics approval number [1] 297896 0
HEC21049

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

Contacts
Principal investigator
Name 75398 0
Mr Aidan Rich
Address 75398 0
La Trobe University
Kingsbury Drive
Bundoora Vic 3083
Country 75398 0
Australia
Phone 75398 0
+61428506126
Fax 75398 0
Email 75398 0
[email protected]
Contact person for public queries
Name 75399 0
Aidan Rich
Address 75399 0
La Trobe University
Kingsbury Drive
Bundoora Vic 3083
Country 75399 0
Australia
Phone 75399 0
+61428506126
Fax 75399 0
Email 75399 0
[email protected]
Contact person for scientific queries
Name 75400 0
Aidan Rich
Address 75400 0
La Trobe University
Kingsbury Drive
Bundoora Vic 3083
Country 75400 0
Australia
Phone 75400 0
+61428506126
Fax 75400 0
Email 75400 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only will be available to be shared.
When will data be available (start and end dates)?
De-identified data will be available once study results have been published, no end date is determined.
Available to whom?
De-identified data is available to any interested parties on request.
Available for what types of analyses?
De-identified data is available for IPD meta-analyses.
How or where can data be obtained?
De-identified data can be obtained on request from the chief investigator, Andrew Hahne, email [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11563Study protocolThe study protocol is being prepared to be published.  



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA pilot randomised trial comparing individualised physiotherapy versus shockwave therapy for proximal hamstring tendinopathy: a protocol.2023https://dx.doi.org/10.1186/s40634-023-00615-x
N.B. These documents automatically identified may not have been verified by the study sponsor.