Achilles TendinopathyNCT06134856
A Study Examining Changes in Pain After Manual Therapy in People With Achilles Tendon Pain
A study testing Ankle mobilization in people with Achilles Tendinopathy and Ankle Strain, run by Philadelphia College of Osteopathic Medicine at 1 site in United States.
Trial summary
The purpose of this research is to find out how pain sensation may change in the Achilles tendon after the use of manual physical therapy. The testing itself will use a device that gradually produces a sensation of heat or cold on your skin, which we will place directly over your Achilles Tendon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendinopathy, Ankle Strain, Achilles Tendon Pain
- What is being tested?
- Ankle mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2023to 5 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who self-report pain in the back of the heel (Achilles tendon) persisting for at least 3 months.
- Prior to inclusion in the study, subjects will undergo a brief clinical screen by the investigators to confirm the signs of Achilles tendinopathy. This screen will consist of assessing for tenderness to palpation in the Achilles tendon and the Royal London Hospital Test (Tenderness to pressure is assessed with the subject in maximal active dorsiflexion and is positive if reduced in this position as compared to the resting state.)
Who cannot join
- History of any surgery distal to the fibular head on the involved lower extremity
- Cortisone injection to the painful Achilles tendon within the last 6 months
- History of diagnosed ankle joint or connective tissue instability
- Current pregnancy
- Age under 18 years of age
- Unable or unwilling to give consent for test and/or treatment procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia College of Osteopathic Medicine-GA
Suwanee, Georgia, 30024
About this study
Official title: Quantitative Sensory Testing Changes Following Talocrural Joint Manipulation in People With Achilles Tendinopathy; A Randomized Controlled Trial
The purpose of this research is to find out how pain sensation may change in the Achilles tendon after the use of manual physical therapy. The testing itself will use a device that gradually produces a sensation of heat or cold on your skin, which we will place directly over your Achilles Tendon. You will let the researcher know when the heat or cold becomes what you would describe as "slight discomfort," at which point the pressure will be stopped. Testing will be completed three (3) times in a row. The device has built-in programming which ensures that the heat or cold applied will be safe, even though it may be briefly uncomfortable. After this first testing the researchers will perform 1-3 repetitions of the ankle joint mobilization/manipulation. This technique involves the researcher providing a small quick stretching movement downwards at the ankle. This is a common therapeutic technique utilized by Physical Therapists, chiropractors, and physicians and is considered very safe. After this treatment we will perform the same measurements of hot and cold discomfort on your Achilles tendon
Read the detailed description
While healthcare's understanding of sensory processing changes has grown significantly in the last several years, numerous gaps in the literature exist. In particular, lower extremity tendinopathies, while common, have not been well studied through the lens of potential sensory sensitizations. The prevalence of Achilles Tendinopathy has been reported to be around 6%, meaning that Millions of individuals in the United States will have these issues at any given time. Historically, clinical management of the condition has been challenging. This study aims to provide data for clinicians to better inform treatment strategies by increasing knowledge of the neurosensory changes that may accompany the condition.
After subjects complete informed consent, they will then answer a brief intake screening form asking for demographic information and symptom history to confirm eligibility. The clinical screening will then be performed to confirm signs of Achilles tendinopathy, namely assessment for tenderness to palpation in the Achilles Tendon, the the Royal London Hospital Test. The Royal London Hospital Test consists of assessing for tenderness in the Achilles tendon with the ankle in a relaxed position, and then again with the subject in maximal active dorsiflexion. A positive test is noted when tenderness is reduced in the maximally dorsiflexed position as compared to the rest state. Once eligibility is confirmed, a subject number will be assigned. Prior to beginning data collection, a random number generation program will be used to determine which subject numbers will be placed into the intervention and control groups. All participants will begin data collection with standardized assessment of heat and cold pain thresholds. Heat and cold pain threshold testing will be performed using the Medoc TSA Air2, with calibration performed before each data collection session. Data collection will be performed in accordance with the protocols set forth by the German Research Network on Neuropathic Pain (DFNS.) Participants will be instructed to press the input button to stop the trial when the heat or cold pain stimulus becomes what each subject would describe as pain or discomfort.
Subjects will be instructed that it is a threshold test, not a tolerance test, thus they are asked to press the stop trial button at the beginning of pain, not at their maximal tolerable amount. All trials will be completed three times with a pre-determined 15 second rest between trials. All three trials will be averaged for data analysis purposes. Subjects assigned to the intervention group will then receive a talocrural joint high velocity, low amplitude thrush mobilization/manipulation. Standardized technique for this procedure involves the subject long-sitting with their back supported on the treatment table. The provider will then passively dorsiflex and evert the ankle to the point at which a joint tension end-feel is obtained.
A small amplitude of movement is rapidly provided by the provider in a caudal direction. The provider may attempt up to three treatment thrust impulses, or until an audible cavitation is heard, indicating joint movement. Even without an audible cavitation, no more than three impulses will be provided. Some research in other body regions indicates that treatment effect is present even in those with whom audible joint cavitation is not noted. (10) Subjects in the control group will receive 1 minute of passive ankle movement into ankle dorsiflexion. The researcher will not move the subject's ankle into a point where tissue stretch/tension is perceived. This will serve as an appropriate sham treatment since it still involves the subjects perception of treatment and includes the hands-on element of manual therapy, without the use of any tissue intervention which would theoretically effect change.
Immediately following the application of the intervention or sham all participants will be re-tested for heat and cold pain thresholds in the same manner utilized at baseline. For ethical purposes, subjects assigned to the control group will also receive the intervention following data collection.
- Being tested
- Ankle mobilization, Sham treatment
- Keywords
- Achilles, Tendinopathy, Tendonitis, Ankle, 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.
Ankle mobilizationProcedure or surgery
Ankle joint mobilization as described in treatment arm description
Sham treatmentProcedure or surgery
Light passive movement of the foot and ankle, avoiding the end-ranges which may actually elicit a mechanical change
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects assigned to the intervention group will then receive a talocrural joint high velocity, low amplitude thrush mobilization/manipulation. Standardized technique for this procedure involves the subject long-sitting with their back supported on the treatment table. The provider will then passively dorsiflex and evert the ankle to the point at which a joint tension end-feel is obtained.
A small amplitude of movement is rapidly provided by the provider in a caudal direction. The provider may attempt up to three treatment thrust impulses, or until an audible cavitation is heard, indicating joint movement. Even without an audible cavitation, no more than three impulses will be provided. Some research in other body regions indicates that treatment effect is present even in those with whom audible joint cavitation is not noted. Receives: Procedure: Ankle mobilization |
| Control | Sham comparator | Subjects in the control group will receive 1 minute of passive ankle movement into ankle dorsiflexion. The researcher will not move the subjects ankle into a point where tissue stretch/tension is perceived. This will serve as an appropriate sham treatment since it still involves the subjects perception of treatment and includes the hands-on element of manual therapy, without the use of any tissue intervention which would theoretically effect change. Receives: Procedure: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heat and Cold Thresholds
Outcome variables will be mean scores for 3 trials each of heat and cold pain threshold, measured in degrees centigrade, initially and immediately (within 5 minutes) after the intervention or sham intervention, with analysis of threshold change measured in the post-test as compared to the baseline data.
Measured: Baseline and 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start5 Dec 2023
- Primary completion28 Nov 2024
- Study completion5 Mar 2025
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
- Model description
- Randomized control trial, treatment group and control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philadelphia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott W Lowe, Principal investigator, PCOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134856
- Sponsor's protocol ID
- PC02117
- Status last verified
- Aug 2024
- First submitted
- 7 Nov 2023
- Last updated
- 28 Mar 2025
- 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 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Sensory Testing Changes Following Talocrural Joint Manipulation in People With Achilles Tendinopathy; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06134856
- Acronym / sponsor ID
- PC02117
- Keywords
- Achilles, Tendinopathy, Tendonitis, Ankle, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Philadelphia College of Osteopathic MedicineUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 28 Nov 2024 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 18 Nov 2023 (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.
The purpose of this research is to find out how pain sensation may change in the Achilles tendon after the use of manual physical therapy. The testing itself will use a device that gradually produces a sensation of heat or cold on your skin, which we will place directly over your Achilles Tendon. You will let the researcher know when the heat or cold becomes what you would describe as "slight discomfort," at which point the pressure will be stopped. Testing will be completed three (3) times in a row. The device has built-in programming which ensures that the heat or cold applied will be safe, even though it may be briefly uncomfortable. After this first testing the researchers will perform 1-3 repetitions of the ankle joint mobilization/manipulation. This technique involves the researcher providing a small quick stretching movement downwards at the ankle. This is a common therapeutic technique utilized by Physical Therapists, chiropractors, and physicians and is considered very safe. After this treatment we will perform the same measurements of hot and cold discomfort on your Achilles tendon
Detailed description
While healthcare's understanding of sensory processing changes has grown significantly in the last several years, numerous gaps in the literature exist. In particular, lower extremity tendinopathies, while common, have not been well studied through the lens of potential sensory sensitizations. The prevalence of Achilles Tendinopathy has been reported to be around 6%, meaning that Millions of individuals in the United States will have these issues at any given time. Historically, clinical management of the condition has been challenging. This study aims to provide data for clinicians to better inform treatment strategies by increasing knowledge of the neurosensory changes that may accompany the condition.
After subjects complete informed consent, they will then answer a brief intake screening form asking for demographic information and symptom history to confirm eligibility. The clinical screening will then be performed to confirm signs of Achilles tendinopathy, namely assessment for tenderness to palpation in the Achilles Tendon, the the Royal London Hospital Test. The Royal London Hospital Test consists of assessing for tenderness in the Achilles tendon with the ankle in a relaxed position, and then again with the subject in maximal active dorsiflexion. A positive test is noted when tenderness is reduced in the maximally dorsiflexed position as compared to the rest state. Once eligibility is confirmed, a subject number will be assigned. Prior to beginning data collection, a random number generation program will be used to determine which subject numbers will be placed into the intervention and control groups. All participants will begin data collection with standardized assessment of heat and cold pain thresholds. Heat and cold pain threshold testing will be performed using the Medoc TSA Air2, with calibration performed before each data collection session. Data collection will be performed in accordance with the protocols set forth by the German Research Network on Neuropathic Pain (DFNS.) Participants will be instructed to press the input button to stop the trial when the heat or cold pain stimulus becomes what each subject would describe as pain or discomfort.
Subjects will be instructed that it is a threshold test, not a tolerance test, thus they are asked to press the stop trial button at the beginning of pain, not at their maximal tolerable amount. All trials will be completed three times with a pre-determined 15 second rest between trials. All three trials will be averaged for data analysis purposes. Subjects assigned to the intervention group will then receive a talocrural joint high velocity, low amplitude thrush mobilization/manipulation. Standardized technique for this procedure involves the subject long-sitting with their back supported on the treatment table. The provider will then passively dorsiflex and evert the ankle to the point at which a joint tension end-feel is obtained.
A small amplitude of movement is rapidly provided by the provider in a caudal direction. The provider may attempt up to three treatment thrust impulses, or until an audible cavitation is heard, indicating joint movement. Even without an audible cavitation, no more than three impulses will be provided. Some research in other body regions indicates that treatment effect is present even in those with whom audible joint cavitation is not noted. (10) Subjects in the control group will receive 1 minute of passive ankle movement into ankle dorsiflexion. The researcher will not move the subject's ankle into a point where tissue stretch/tension is perceived. This will serve as an appropriate sham treatment since it still involves the subjects perception of treatment and includes the hands-on element of manual therapy, without the use of any tissue intervention which would theoretically effect change.
Immediately following the application of the intervention or sham all participants will be re-tested for heat and cold pain thresholds in the same manner utilized at baseline. For ethical purposes, subjects assigned to the control group will also receive the intervention following data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized control trial, treatment group and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Ankle mobilizationSubjects assigned to the intervention group will then receive a talocrural joint high velocity, low amplitude thrush mobilization/manipulation. Standardized technique for this procedure involves the subject long-sitting with their back supported on the treatment table. The provider will then passively dorsiflex and evert the ankle to the point at which a joint tension end-feel is obtained. A small amplitude of movement is rapidly provided by the provider in a caudal direction. The provider may attempt up to three treatment thrust impulses, or until an audible cavitation is heard, indicating joint movement. Even without an audible cavitation, no more than three impulses will be provided. Some research in other body regions indicates that treatment effect is present even in those with whom audible joint cavitation is not noted. |
| Control | Sham comparator | Procedure: Sham treatmentSubjects in the control group will receive 1 minute of passive ankle movement into ankle dorsiflexion. The researcher will not move the subjects ankle into a point where tissue stretch/tension is perceived. This will serve as an appropriate sham treatment since it still involves the subjects perception of treatment and includes the hands-on element of manual therapy, without the use of any tissue intervention which would theoretically effect change. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals who self-report pain in the back of the heel (Achilles tendon) persisting for at least 3 months.
- Prior to inclusion in the study, subjects will undergo a brief clinical screen by the investigators to confirm the signs of Achilles tendinopathy. This screen will consist of assessing for tenderness to palpation in the Achilles tendon and the Royal London Hospital Test (Tenderness to pressure is assessed with the subject in maximal active dorsiflexion and is positive if reduced in this position as compared to the resting state.)
Key exclusion criteria (6 listed)
- History of any surgery distal to the fibular head on the involved lower extremity
- Cortisone injection to the painful Achilles tendon within the last 6 months
- History of diagnosed ankle joint or connective tissue instability
- Current pregnancy
- Age under 18 years of age
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 |
|---|---|---|
| Ankle mobilizationAnkle joint mobilization as described in treatment arm description | Procedure or surgery | Intervention |
| Sham treatmentLight passive movement of the foot and ankle, avoiding the end-ranges which may actually elicit a mechanical change | Procedure or surgery | Control |
Primary outcome
Heat and Cold Thresholds
Time frame: Baseline and 1 hour
Outcome variables will be mean scores for 3 trials each of heat and cold pain threshold, measured in degrees centigrade, initially and immediately (within 5 minutes) after the intervention or sham intervention, with analysis of threshold change measured in the post-test as compared to the baseline data.
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 28 Mar 2025.
- 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.
Scott W Lowe principal investigator
PCOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle mobilization in people with Achilles Tendinopathy and Ankle Strain, run by Philadelphia College of Osteopathic Medicine at 1 site in United States.
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 2 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 28 Mar 2025. 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 United States. 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?
Heat and Cold Thresholds (time frame: Baseline and 1 hour). 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 28 Mar 2025.