Achilles TendinopathyPhyCATNCT03743441
Physiotherapy Treatment for Chronic Achilles Tendinopathy
A study testing Low-level Laser Therapy, Exercise therapy and Cryotherapy in people with Achilles Tendinopathy, run by University of Bergen at 1 site in Norway.
Trial summary
Laser treatment with the proper dosage has been found effective in the treatment of chronic Achilles tendinopathy, and animal research indicate that a combination of cryotherapy followed by LLLT could yield an even better result. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Low-level Laser Therapy, Exercise therapy and Cryotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteNorway
- Study dates
- 1 Aug 2017to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Achilles tendinopathy with a minimum duration of three months, pathological appearance of the Achilles tendon with thickened tendon and structural changes of the tendons matrix.
Who cannot join
- Cortisone injection within the last 6 months, systemic inflammatory disease, previous suture/surgery of the Achilles tendon, pregnancy or familial hypercholesterolemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Randomized Controlled Trial of Physiotherapy Treatment for Chronic Achilles Tendinopathy
Laser treatment with the proper dosage has been found effective in the treatment of chronic Achilles tendinopathy, and animal research indicate that a combination of cryotherapy followed by LLLT could yield an even better result.
Thus, the main purpose of this project is to test if the addition of low level laser therapy can enhance the treatment result of exercise and cryotherapy in patients with chronic Achilles tendinopathy, yielding less pain and higher function.
- Conditions
- Achilles Tendinopathy
- Being tested
- Low-level Laser Therapy, Sham Low-level Laser Therapy, Exercise therapy, Cryotherapy
- Keywords
- Chronic tendinopathy, Low-level Laser Therapy, LLLT, Photobiomodulation, Cryotherapy, Exercise therapy, Randomized Clinical Trial, RCT, Placebo-controlled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level Laser TherapyOther
Also called Photobiomodulation
LLLT, 904 nm wavelength, 3 Joules per treatment point in accordance with World Association for Laser Therapy (WALT) guidelines.
Sham Low-level Laser TherapyOther
Also called Sham Photobiomodulation
Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).
Exercise therapyOther
Concentric and eccentric exercises with a total duration of approximately 20 minutes.
CryotherapyOther
Twenty minutes of cryotherapy applied to the Achilles tendon.
| Study group | Role | What they receive |
|---|---|---|
| Exercise + Cryotherapy + LLLT | Active comparator | Not described Receives: Other: Low-level Laser Therapy; Other: Exercise therapy; Other: Cryotherapy |
| Exercise + Cryotherapy + Sham LLLT | Sham comparator | Not described Receives: Other: Sham Low-level Laser Therapy; Other: Exercise therapy; Other: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The VISA-A questionnaire: An index of the severity of Achilles tendinopathy
Range 0-100
Measured: Change from baseline to week 4 and 12
Pain (Numerical Rating Scale)
Range 0-10
Measured: Change from baseline to week 4 and 12
Secondary outcomes (8)
Pain pressure threshold algometry
Algometer placed upon the Achilles tendon at the most sensitive spot identified by palpation. If it is unclear what the most sensitive spot is, the algometer is placed 2 cm proximal from the calcaneus.
Measured: Change from baseline to week 4 and 12
Palpation tenderness
The Achilles tendon is palpated by the assessor while the participant is lying prone. The participant indicates whether the pressure produces pain by answering yes/no.
Measured: Change from baseline to week 4 and 12
Single legged heel raise
The participant stands solely on one leg and lifts the heel of the floor. The distance from the heel to the floor is measured.
Measured: Change from baseline to week 4 and 12
Jump for distance
One leg take-off and landing
Measured: Change from baseline to week 4 and 12
Thickness of the Achilles tendon
Measured with real time ultrasonography in a longitudinal and sagittal view.
Measured: Change from baseline to week 4 and 12
Neovascularization in the Achilles tendon
Doppler activity measured with real time ultrasonography in a longitudinal and sagittal view.
Measured: Change from baseline to week 4 and 12
Qualitative assessment of structural changes of the Achilles tendon
Structural changes are assessed by real time ultrasonography. The structural changes of the Achilles tendon is scored as absent, mild, moderate, or severe.
Measured: Change from baseline to week 4 and 12
Qualitative assessment of effusion within of the Achilles tendon
Amount of effusion is assessed by real time ultrasonography. The amount of effusion within and around the Achilles tendon is scored as absent, mild, moderate, or severe.
Measured: Change from baseline to week 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Aug 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Vale do Paraíba, Norwegian Fund for Postgraduate Training in Physiotherapy
- Responsible party
- Sponsor
- Investigators
- Ingvill F Naterstad, MSc, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743441
- Sponsor's protocol ID
- 20161107
- Acronym
- PhyCAT
- Status last verified
- Oct 2020
- First submitted
- 6 Nov 2018
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Controlled Trial of Physiotherapy Treatment for Chronic Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT03743441
- Acronym / sponsor ID
- PhyCAT / 20161107
- Conditions
- Achilles Tendinopathy
- Keywords
- Chronic tendinopathy, Low-level Laser Therapy, LLLT, Photobiomodulation, Cryotherapy, Exercise therapy, Randomized Clinical Trial, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Universidade do Vale do Paraíba, Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laser treatment with the proper dosage has been found effective in the treatment of chronic Achilles tendinopathy, and animal research indicate that a combination of cryotherapy followed by LLLT could yield an even better result.
Thus, the main purpose of this project is to test if the addition of low level laser therapy can enhance the treatment result of exercise and cryotherapy in patients with chronic Achilles tendinopathy, yielding less pain and higher function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + Cryotherapy + LLLT | Active comparator | Other: Low-level Laser Therapy, Other: Exercise therapy, Other: Cryotherapy |
| Exercise + Cryotherapy + Sham LLLT | Sham comparator | Other: Sham Low-level Laser Therapy, Other: Exercise therapy, Other: Cryotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Achilles tendinopathy with a minimum duration of three months, pathological appearance of the Achilles tendon with thickened tendon and structural changes of the tendons matrix.
Key exclusion criteria (1 listed)
- Cortisone injection within the last 6 months, systemic inflammatory disease, previous suture/surgery of the Achilles tendon, pregnancy or familial hypercholesterolemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-level Laser TherapyAlso: PhotobiomodulationLLLT, 904 nm wavelength, 3 Joules per treatment point in accordance with World Association for Laser Therapy (WALT) guidelines. | Other | Exercise + Cryotherapy + LLLT |
| Sham Low-level Laser TherapyAlso: Sham PhotobiomodulationSame procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power). | Other | Exercise + Cryotherapy + Sham LLLT |
| Exercise therapyConcentric and eccentric exercises with a total duration of approximately 20 minutes. | Other | Exercise + Cryotherapy + LLLT, Exercise + Cryotherapy + Sham LLLT |
| CryotherapyTwenty minutes of cryotherapy applied to the Achilles tendon. | Other | Exercise + Cryotherapy + LLLT, Exercise + Cryotherapy + Sham LLLT |
Primary outcome
The VISA-A questionnaire: An index of the severity of Achilles tendinopathy
Time frame: Change from baseline to week 4 and 12
Range 0-100
Pain (Numerical Rating Scale)
Time frame: Change from baseline to week 4 and 12
Range 0-10
8 secondary outcomes
Pain pressure threshold algometry
Time frame: Change from baseline to week 4 and 12
Palpation tenderness
Time frame: Change from baseline to week 4 and 12
Single legged heel raise
Time frame: Change from baseline to week 4 and 12
Jump for distance
Time frame: Change from baseline to week 4 and 12
Thickness of the Achilles tendon
Time frame: Change from baseline to week 4 and 12
Neovascularization in the Achilles tendon
Time frame: Change from baseline to week 4 and 12
Qualitative assessment of structural changes of the Achilles tendon
Time frame: Change from baseline to week 4 and 12
Qualitative assessment of effusion within of the Achilles tendon
Time frame: Change from baseline to week 4 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Achilles Tendinopathy
Not yet recruitingObservational study
Open Versus Fully Endoscopic Calcaneoplasty With Achilles Tendon Insertional Reconstruction for Haglund Syndrome
Haglund Syndrome, Insertional Achilles Tendinopathy
Recruiting
Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy
Achilles Insertional Tendinopathy, Achilles Tendinopathy
Enrolling by invitationObservational study
Achilles Non-SNIS REGENETEN
Complete Mid-portion Achilles Rupture
Not yet recruitingObservational study
Human Tendon Tissue Collection
Tendinopathy, Musculoskeletal Diseases or Conditions
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingvill F Naterstad, MSc principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level Laser Therapy, Exercise therapy and Cryotherapy in people with Achilles Tendinopathy, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The VISA-A questionnaire: An index of the severity of Achilles tendinopathy (time frame: Change from baseline to week 4 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.