Achilles PainRFMNCT03274557
Radiofrequence Microtenotomy for Treatment of Achilles Tendinose
A study testing RFM in people with Achilles Pain, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Prospective randomized controlled study using radio-frequency microtenotomy or physical therapy (eccentric training) for treatment of Achilles tendinose Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Achilles Pain
- What is being tested?
- RFM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 2 Jan 2017to 30 Dec 2018
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with pain in Achilles tendon for at least 6 weeks.
- MR / ultrasound confirms diagnosis tendinose.
- Pain in sport and daily activities
Who cannot join
- Other co-morbidity that constitutes contraindication for surgery, serious illness, bad compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Achilles Tendinose
Prospective randomized controlled study using radio-frequency microtenotomy or physical therapy (eccentric training) for treatment of Achilles tendinose
Read the detailed description
Achilless tendinosis is a major clinical problem. There is a need for new studies to map the effectiveness of treatment. This study will compare treatment effectiveness between traditional physical therapy with surgical treatment using (RFM). The tendinosis grade will be evaluated using MRI and /or ultrasound before and after intervention. The outcome measurment include VAS and function using ( FAOS FOOT \& ANKLE SURVEY) at 6,12 weeks and 6, 12 months after intervention.
- Conditions
- Achilles Pain
- Being tested
- RFM
- Keywords
- Achilles, tendinose, tendinopathy, pain
- Medical subject headings
- Tendinopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFMProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency microtenotomy | Active comparator | Treatment of Achilles tendinose with radio-frequency microtenotomy Receives: Procedure: RFM |
| Phusical therapy | Active comparator | Supervised eccentric training Receives: Procedure: RFM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Pain reduction. Change of pain from baseline measured with VAS
Measured: 6.12 weeks and 6,12 months
Secondary outcomes (1)
Function
Change from baseline in functionality measured by (FAOS) FOOT \& ANKLE SURVEY
Measured: 6.12 weeks and 6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start2 Jan 2017
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Achilles PainStudies 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
- Model description
- To evaluate improvement of VAS and functionality before and after treatment of Achilles tendinosis using radiofrequency-plasma based microtenotomy in comparison to traditional physical therapy.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274557
- Sponsor's protocol ID
- 2014/1277/REK sør-øst
- Acronym
- RFM
- Status last verified
- Sep 2017
- First submitted
- 4 Sep 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al-Ani Z, Meknas D, Kartus JT, Lyngedal O, Meknas K. Radiofrequency Microtenotomy or Physical Therapy for Achilles Tendinopathy: Results of a Randomized Clinical Trial. Orthop J Sports Med. 2021 Dec 20;9(12):23259671211062555. doi: 10.1177/23259671211062555. eCollection 2021 Dec.
PubMed 34988234
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Achilles Tendinose
- ClinicalTrials.gov ID
- NCT03274557
- Acronym / sponsor ID
- RFM / 2014/1277/REK sør-øst
- Conditions
- Achilles Pain
- Keywords
- Achilles, tendinose, tendinopathy, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 7 Sep 2017 (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.
Prospective randomized controlled study using radio-frequency microtenotomy or physical therapy (eccentric training) for treatment of Achilles tendinose
Detailed description
Achilless tendinosis is a major clinical problem. There is a need for new studies to map the effectiveness of treatment. This study will compare treatment effectiveness between traditional physical therapy with surgical treatment using (RFM). The tendinosis grade will be evaluated using MRI and /or ultrasound before and after intervention. The outcome measurment include VAS and function using ( FAOS FOOT \& ANKLE SURVEY) at 6,12 weeks and 6, 12 months after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- To evaluate improvement of VAS and functionality before and after treatment of Achilles tendinosis using radiofrequency-plasma based microtenotomy in comparison to traditional physical therapy.
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency microtenotomy | Active comparator | Procedure: RFMTreatment of Achilles tendinose with radio-frequency microtenotomy |
| Phusical therapy | Active comparator | Procedure: RFMSupervised eccentric training |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with pain in Achilles tendon for at least 6 weeks.
- MR / ultrasound confirms diagnosis tendinose.
- Pain in sport and daily activities
Key exclusion criteria (1 listed)
- Other co-morbidity that constitutes contraindication for surgery, serious illness, bad compliance
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 |
|---|---|---|
| RFM | Procedure or surgery | Phusical therapy, Radiofrequency microtenotomy |
Primary outcome
Pain reduction
Time frame: 6.12 weeks and 6,12 months
Pain reduction. Change of pain from baseline measured with VAS
1 secondary outcome
Function
Time frame: 6.12 weeks and 6,12 months
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 Feb 2019.
- Derived from this study: PubMed 34988234Al-Ani Z, Meknas D, Kartus JT, Lyngedal O, Meknas K. Radiofrequency Microtenotomy or Physical Therapy for Achilles Tendinopathy: Results of a Randomized Clinical Trial. Orthop J Sports Med. 2021 Dec 20;9(12):23259671211062555. doi: 10.1177/23259671211062555. eCollection 2021 Dec.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFM in people with Achilles Pain, run by University Hospital of North Norway 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 3 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 Feb 2019. 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. 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?
Pain reduction (time frame: 6.12 weeks and 6,12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03274557, which also lists 1 linked publication.
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 Feb 2019.