Insertional Achilles TendinopathyNCT03683641
Extracorporeal Shockwave Therapy in Insertional Achilles Tendinopathy
A study testing Extracorporeal Shock Wave Therapy in people with Insertional Achilles Tendinopathy, run by Mahidol University.
Trial summary
There is still limited number of studies in the literature provides insufficient evidence to support the use of ESWT in the treatment of insertional Achilles tendinopathy and the contribution of a placebo effect to the shock waves was not assessed by previous study. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insertional Achilles Tendinopathy
- What is being tested?
- Extracorporeal Shock Wave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 4 Jul 2016to 31 Jul 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed as insertional Achilles tendinopathy
- Have symptom at least 6 months
- Willing to participate
Who cannot join
- History of peritendinous steroid injections within 4 weeks
- Neurological conditions
- Local skin infection
- Ankle arthritis, traumatic, inflammation or deformity of ankle
- History of ankle surgery
- Contraindication for ESWT : Hemophilia, Coagulopathy
About this study
There is still limited number of studies in the literature provides insufficient evidence to support the use of ESWT in the treatment of insertional Achilles tendinopathy and the contribution of a placebo effect to the shock waves was not assessed by previous study. So the investigators conducted a double-blinded randomized-controlled trial at the orthopedic out-patient clinic, Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital between December 2016 and June 2018. Hypothesized that ESWT might be effective on insertional Achilles tendinopathy
Read the detailed description
Participants aged 18-70 years old who were diagnosed as insertional Achilles tendinopathy by foot and ankle specialists: had symptoms of pain and swelling at Achilles insertion more than 6 months; failed other standard conservative treatments for 3 months, i.e., rest, medication, activity modification, stretching exercise, and heel lift orthosis; be able to complete questionnaires; and willing to participate were enrolled. A computerized block-of-four random numbers were generated into 2 groups; ESWT and placebo (sham) group. Investigators concealed the treatment allocation by sequential sealed opaque envelops. The sealed opaque envelops were opened just before the assigned treatment began. The outcome assessment in this study was seven times at pre-intervention, 2nd, 3rd, 4th, 6th, 12th and 24th weeks. The participants had to complete questionnaire of VAS and VAS-FA Thai version. The investigators used mean and standard deviation for continuous variables, and frequency (%) for categorical data. For non-normally distributed variables, median and range was presented. Continuous data of both interventions was compared using either unpaired t-test or Mann-Whitney U test based on normal distribution. While categorical data was compared using Fisher's exact test. Repeated measures with Bonferroni post hoc analysis was applied for each intervention according to times of follow-up, and between groups. Bartlett's test for equal variances was checked the assumption before using analysis of variance. If the data did not meet the assumption, non-parametric Kruskal-Wallis was performed. The investigators used STATA 15.0 Program, College Station, Texas, USA for all statistical analysis. P-value < 0.05 defined as a significant level. Sample size was estimated using STATA 15.0 Program based on alpha error 0.05, beta error 0.2, mean VAS in controls 5.0, mean VAS in intervention group 3.5, standard deviation (SD) of both group 2.3,(13) pre-intervention assessment for 1 time, post-intervention assessment for 6 times, correlation between the first and the last VAS assessment 0.8. The calculated sample size was 12 per group. With 20% increment for loss of follow-up, the final sample size was 15 per group. All of them remained in the randomized groups and analyzed as intention-to-treat basis.
- Conditions
- Insertional Achilles Tendinopathy
- Being tested
- Extracorporeal Shock Wave Therapy, Sham Control group
- Keywords
- Insertional Achilles Tendinopathy, Extracorporeal Shock Wave Therapy, Double-blind Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave TherapyDevice
Use ESWT on chronic insertional Achilles tendinopathy
Sham Control groupDevice
Use sham ESWT on chronic insertional Achilles tendinopathy
| Study group | Role | What they receive |
|---|---|---|
| Shock Wave group | Active comparator | Applying shock wave to patient's Achilles tendon insertion Receives: Device: Extracorporeal Shock Wave Therapy |
| Sham Control group | Sham comparator | Applying sham shock wave to patient's Achilles tendon insertion Receives: Device: Sham Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual Analog Scale of Pain on Achilles tendon, range 0-10, 0 means no pain and 10 is the most severe pain
Measured: Up to 24 weeks
Secondary outcomes (3)
Visual Analog Scale - Foot and Ankle Thai version
Range 0-100, 0 is worse, 100 is the best. Having 20 questions. Categorized into Pain, Function and other complaints
Measured: Up to 24 weeks
The amount of rescue drug use
Tablet/day,if amount of drug use is higher mean it is worse
Measured: Up to 24 weeks
Complications
Investigator collected complication such as pain during procedure, tendon rupture, or surgical rate and calculated the NNH
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start4 Jul 2016
- Primary completion28 Jun 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insertional Achilles TendinopathyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683641
- Sponsor's protocol ID
- MURA2016/427
- Status last verified
- Sep 2018
- First submitted
- 4 Sep 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shockwave Therapy in Insertional Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT03683641
- Acronym / sponsor ID
- MURA2016/427
- Conditions
- Insertional Achilles Tendinopathy
- Keywords
- Insertional Achilles Tendinopathy, Extracorporeal Shock Wave Therapy, Double-blind Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 4 Jul 2016 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 25 Sep 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.
There is still limited number of studies in the literature provides insufficient evidence to support the use of ESWT in the treatment of insertional Achilles tendinopathy and the contribution of a placebo effect to the shock waves was not assessed by previous study. So the investigators conducted a double-blinded randomized-controlled trial at the orthopedic out-patient clinic, Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital between December 2016 and June 2018. Hypothesized that ESWT might be effective on insertional Achilles tendinopathy
Detailed description
Participants aged 18-70 years old who were diagnosed as insertional Achilles tendinopathy by foot and ankle specialists: had symptoms of pain and swelling at Achilles insertion more than 6 months; failed other standard conservative treatments for 3 months, i.e., rest, medication, activity modification, stretching exercise, and heel lift orthosis; be able to complete questionnaires; and willing to participate were enrolled. A computerized block-of-four random numbers were generated into 2 groups; ESWT and placebo (sham) group. Investigators concealed the treatment allocation by sequential sealed opaque envelops. The sealed opaque envelops were opened just before the assigned treatment began. The outcome assessment in this study was seven times at pre-intervention, 2nd, 3rd, 4th, 6th, 12th and 24th weeks. The participants had to complete questionnaire of VAS and VAS-FA Thai version. The investigators used mean and standard deviation for continuous variables, and frequency (%) for categorical data. For non-normally distributed variables, median and range was presented. Continuous data of both interventions was compared using either unpaired t-test or Mann-Whitney U test based on normal distribution. While categorical data was compared using Fisher's exact test. Repeated measures with Bonferroni post hoc analysis was applied for each intervention according to times of follow-up, and between groups. Bartlett's test for equal variances was checked the assumption before using analysis of variance. If the data did not meet the assumption, non-parametric Kruskal-Wallis was performed. The investigators used STATA 15.0 Program, College Station, Texas, USA for all statistical analysis. P-value < 0.05 defined as a significant level. Sample size was estimated using STATA 15.0 Program based on alpha error 0.05, beta error 0.2, mean VAS in controls 5.0, mean VAS in intervention group 3.5, standard deviation (SD) of both group 2.3,(13) pre-intervention assessment for 1 time, post-intervention assessment for 6 times, correlation between the first and the last VAS assessment 0.8. The calculated sample size was 12 per group. With 20% increment for loss of follow-up, the final sample size was 15 per group. All of them remained in the randomized groups and analyzed as intention-to-treat basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shock Wave group | Active comparator | Device: Extracorporeal Shock Wave TherapyApplying shock wave to patient's Achilles tendon insertion |
| Sham Control group | Sham comparator | Device: Sham Control groupApplying sham shock wave to patient's Achilles tendon insertion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed as insertional Achilles tendinopathy
- Have symptom at least 6 months
- Willing to participate
Key exclusion criteria (6 listed)
- History of peritendinous steroid injections within 4 weeks
- Neurological conditions
- Local skin infection
- Ankle arthritis, traumatic, inflammation or deformity of ankle
- History of ankle surgery
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 |
|---|---|---|
| Extracorporeal Shock Wave TherapyUse ESWT on chronic insertional Achilles tendinopathy | Device | Shock Wave group |
| Sham Control groupUse sham ESWT on chronic insertional Achilles tendinopathy | Device | Sham Control group |
Primary outcome
Visual Analog Scale
Time frame: Up to 24 weeks
Visual Analog Scale of Pain on Achilles tendon, range 0-10, 0 means no pain and 10 is the most severe pain
3 secondary outcomes
Visual Analog Scale - Foot and Ankle Thai version
Time frame: Up to 24 weeks
The amount of rescue drug use
Time frame: Up to 24 weeks
Complications
Time frame: Up to 52 weeks
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 25 Sep 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy in people with Insertional Achilles Tendinopathy, run by Mahidol University.
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 6 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 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual Analog Scale (time frame: Up to 24 weeks). 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 25 Sep 2018.