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Comparison of a Physiotherapy versus Extracorporeal Shockwave Therapy (ESWT) for treatment of Hamstring Tendon pain.

A Pilot Randomised Trial Comparing Individualised Physiotherapy versus Shockwave Therapy for Proximal Hamstring Tendinopathy

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000846820
Enrollment
100
Registered
2021-07-01
Start date
2022-08-16
Completion date
2022-08-01
Last updated
2022-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Proximal hamstring tendinopathy (PHT) is a common condition in the active and sporting population. It can also occur in less active individuals. There is limited research regarding the efficacy of various treatment options for this condition. One study has shown improved pain and function from shockwave therapy, however the comparison group in this trial were provided with non-specific treatments as well as treatments mechanistically hypothesisied to be detrimental to this condition. A research trial is planned to compare individualised physiotherapy to shockwave therapy for PHT.

Interventions

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 recommen

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.

Sponsors

LaTrobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026