Effectiveness of Reducing Tendon Compression in the Treatment of Insertional Achilles Tendinopathy

Insertional Achilles Tendinopathy Clinical Trial

— GhenTendon  

Official title:

Effectiveness of Reducing Tendon Compression in the Treatment of Insertional Achilles Tendinopathy: a Randomised Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05456620
• Other study ID #: BC-11818
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 5, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Insertional Achilles tendinopathy is a disabling injury that is common in running athletes. Exercise therapy is considered the best treatment option, but there is still no agreement on the modalities. For example, it is thought that compression overload may be a major cause of tendinopathy and should therefore be restricted during rehabilitation. However, this recommendation is based on expert opinion and not on hard scientific evidence. Therefore, this randomised controlled trial (RCT) will investigate whether a therapy that limits the amount of compression of the tendon during a progressive tendon-loading rehabilitation protocol actually has better outcomes in athletes with insertional Achilles tendinopathy. 28 athletes with insertional Achilles tendinopathy will be randomised into two treatment groups; (1) an experimental 12-week rehabilitation protocol in which the amount of tendon compression is limited and (2) a 12-week control rehabilitation protocol in which the amount of tendon compression is not limited and is rather high. Both treatments consist of supervised progressive tendon-loading exercise therapy and patient education. In addition, the experimental group will also receive heel inserts to limit the amount of dorsiflexion during sports or daily activities. At baseline, at 12 weeks (end of intervention) and at 24 weeks (follow-up), pain, functionality, structure and intratendinous pressure will be determined.

Description:

Achilles tendinopathy is a debilitating injury that is common among athletes, especially those involved in running sports. Around 30% of all runners exhibit Achilles tendinopathy with an annual incidence of 7-9%. Of these patients, roughly one-third will have insertional Achilles tendinopathy (IAT). Several mechanisms are considered to play a role in the aetiology of Achilles tendinopathy, yet a prominent role seems present for excessive overload. Traditionally, the nature of this overload is thought to be purely tensile. However, the Achilles tendon can also be exposed to compressive loads at the insertion when the tendon wraps around the posterior prominence of the calcaneus during dorsiflexion of the ankle. The formation of fibrocartilage-like tissue, which is typically found in histological examination of tendinopathy, can be considered as an adaptation to this compressive load, driven by the tenocyte's mechanotransduction process. Therefore, it is recommended to reduce the amount of compressive load on the tendon during rehabilitation while exerting sufficient tensile load. However, these recommendations are mainly based on a pilot study and expert opinion. Therefore, this RCT investigates whether a therapy in which the amount of tendon compression is restricted during a progressive tendon-loading rehabilitation protocol actually has better outcomes in terms of pain scores, functionality and structure of the Achilles tendon in athletes with insertional Achilles tendinopathy. Limiting the amount of tendon compression on the Achilles tendon insertion will be achieved by (1) patient education, (2) heel inserts and (3) an adapted exercise regimen.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 18-60 years old
• Diagnosed with insertional Achilles Tendinopathy by a sports medicine physician
• Have experienced symptoms for more than 3 months and less than 3 years
• Playing running-based sports at least twice a week

Exclusion Criteria:

• Have a history of Achilles tendon rupture or surgery
• Have other disorders of the Achilles tendon or ankle (mid-portional Achilles tendinopathy, paratenonitis, osteoarthritis,...)
• Have rheumatological disorder (e.g. Spondylitis Ankylosis)
• Have metabolic or endocrine disorders, such as type I or type II diabetes
• Have had an Achilles injection in the past 3 months
• Have other conditions that prevent following an active exercise programme
• Have already been treated with physiotherapy, shockwave therapy or orthotics in the past 3 months
• Medication use with (fluoro)quinolones antibiotic in the past 2 years
• Currently pregnant

Related Conditions & MeSH terms

• Insertional Achilles Tendinopathy
• Tendinopathy

Intervention

Other:
• Exercise therapy
The intervention treatment consists of a progressive 4-stage, criteria-based exercise protocol, in which the amount of tendon compression is limited. This includes: Education: Specific information on the importance of limiting tendon compression during rehabilitation, as well as general information on load management, the importance of active exercise therapy and setting expectations. Orthotic treatment: heel inserts to reduce ankle dorsiflexion during daily activities and sports Physiotherapy: Progressive tendon-loading exercise therapy (4 phases) restricting the amount of tendon compression by limiting dorsiflexion of the ankle and prohibiting stretching
• Exercise therapy (usual care)
The control treatment consists of a progressive 4-phase, criteria-based exercise protocol, in which the amount of tendon compression is not limited. This includes: Education: general information on load management, the importance of active exercise therapy and setting expectations. No orthotic treatment. Physiotherapy: Progressive tendon-loading exercise therapy (4 phases) without any restriction around tendon compression and encouraging stretching

Locations

Country	Name	City	State
Belgium	Department of rehabilitation sciences	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of the Victorian Institute of Sports Assessment-Achilles Questionnaire (VISA-A) score over 12 weeks	The VISA-A score is a measure of pain and lower limb function (disability) associated with Achilles tendinopathy. A higher score indicates a better outcome and a 10 point increase is accepted as being clinically meaningful.	12 weeks (at the end of intervention)
Primary	The change of the Victorian Institute of Sports Assessment-Achilles Questionnaire (VISA-A) score over 24 weeks	The VISA-A score is a measure of pain and lower limb function (disability) associated with Achilles tendinopathy. A higher score indicates a better outcome and a 10 point increase is accepted as being clinically meaningful.	24 weeks (at follow-up)
Secondary	Subjective patient satisfaction	Patient overall rating: excellent / good / fair / poor	This will be assessed at the end of the intervention (week 12) and at follow-up (week 24).
Secondary	Return to sports rate	Participation: return to desired sport on pre-injury level / return to desired sport but on a lower level / return to sports but not desired sport / no return to sports	This will be assessed at the end of the intervention (week 12) and at follow-up (week 24).
Secondary	Hop test	Self-reported pain rating on a Visual Analogue Scale (VAS) during a single leg hop test	This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).
Secondary	Lower Extremity Functional Scale	The lower extremity functional scale (LEFS) is a valid patient-rated outcome measure for the measurement of lower extremity function.	This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).
Secondary	Tampa scale for kinesiophobia (TSK)	The TSK is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury.	This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).
Secondary	Heel-raise test	Participants will have to perform heel raises in standing position until thay are fatigued.	This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).
Secondary	Health status using the EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire	The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire.	This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).
Secondary	Pain rating (VAS) during activities of daily living	Self-reported pain (VAS, 0-100 mm) during activities of daily living over the last seven days. A higher score indicates more pain.	This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).
Secondary	Ultrasound examination to assess the tendon structure	Anteroposterior thickness - Neovascularisation (modified-Öhberg scale)	This will be assessed at the start (week 0), at the end of the intervention (week 12) and at follow-up (week 24).
Secondary	Compliance	Compliance to the exercise programme and orthotics (total percentage of prescription) will be assessed using a short online questionnaire.	This will be assessed weekly until the end of the intervention.
Secondary	Pain monitoring	Numeric Pain Rating Scale (NRS, 0-10) during exercises, after exercises and in the morning will be assessed. A higher score indicates more pain.	This will be assessed weekly until the end of the intervention.
Secondary	Adverse effects	Adverse effects resulting from the intervention	This will be assessed weekly until the end of the intervention.
Secondary	Credibility/Expectations Questionnaire	As participants are not blinded about their assigned intervention, it is important to determine their beliefs about the treatment. With this in mind, participants will complete the Credibility/Expectations Questionnaire (CEQ) after being assigned to an intervention group.	This wel be assessed at the start of the intervention (week 0)