EpicondylitisEPIROLLNCT07615972
Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis
A study testing Active comparator, auto massage twice a day and automassge with an empty roller Puressentiel in people with Epicondylitis, run by Puressentiel.
Trial summary
Tennis elbow, also known as lateral epicondylitis, is a pathology of the enthesis of tendons attaching near or directly on the lateral epicondyle of the humerus. Lateral epicondylitis is characterized by progressive pain localized on the outer edge of the elbow, reproduced by palpation, stretching, and/or isometric… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epicondylitis
- What is being tested?
- Active comparator, auto massage twice a day and automassge with an empty roller Puressentiel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Inclusion Criteria:• Lateral epicondylitis of more than 3 months' duration, isolated and confirmed by clinical and ultrasonographic examination.
- Failure of at least one prior rehabilitation treatment.
- No ongoing physical treatment (shockwave therapy, physiotherapy) for at least 6 weeks, including a well-conducted rehabilitation.
- Adults aged over 18 years.
Exclusion Criteria:• Manual workers in active employment conducive to lateral epicondylitis.
- Occupational injury.
- Patients who have received at least one treatment with PRP (platelet-rich plasma) or any other regenerative treatment.
- Uncontrolled inflammatory or metabolic diseases.
- Neuropsychological disorders preventing proper completion of the protocol.
- Age under 18 years.
- Person unable to understand French.
- Associated osteoarticular and neurological pathologies of the upper limb.
- Known allergy to any component of the essential oils used.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Analgesic and Functional Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis
Tennis elbow, also known as lateral epicondylitis, is a pathology of the enthesis of tendons attaching near or directly on the lateral epicondyle of the humerus. Lateral epicondylitis is characterized by progressive pain localized on the outer edge of the elbow, reproduced by palpation, stretching, and/or isometric resistance contraction of the lateral epicondylar muscles. This pain may be accompanied by a deficit in muscle strength compared to the opposite side. The diagnosis is mainly clinical, although imaging tests may be considered in cases of doubt or if the pain persists despite appropriate therapeutic management. There is no specific treatment for tennis elbow that has been proven to be effective. However, starting treatment can speed up the return to sporting activities and prevent the condition from becoming chronic. This study aims to fill this gap by evaluating the effectiveness of a simple and natural treatment for the symptoms of tennis elbow: a roller equipped with a ball that facilitates self-massage with simultaneous diffusion of an essential oil-based emulsion.
Objective : To evaluate the analgesic and functional efficacy of a roller device that facilitates mechanical self-massage through the simultaneous diffusion of an emulsion composed mainly of essential oils in the treatment of chronic lateral epicondylitis.
Read more
Participants : Lateral epicondylitis lasting more than 3 months, isolated and confirmed by clinical examination and ultrasound, in subjects aged 18 years and older.
Procedures : Clinical examination to confirm the diagnosis of lateral epicondylitis (specific tests for pain on stretching and palpation, elimination of differential diagnoses), and ultrasound.
- Assessment using the PRTEE (Patient-Rated Tennis Elbow Evaluation) questionnaire (French version).
- Assessment using the numerical pain rating scale (0-10),
- Assessment of the location associated with the pain.
- Treatment instructions: 2 daily applications, morning and evening, involving mechanical friction of the epicondylar and muscular area for 2 minutes, i.e., a total of 2 x 70 roller rotations (70 roller rotations on the tendon and 70 roller rotations on the muscle) for 3 months. The same parameters will be assessed one month, two months, and three months after use of the device. Patients will be randomized to receive either an Articulations \& Muscles (AM) roller or a Control (T) roller.
- Assessment of analgesic and anti-inflammatory consumption. Each participant will be given a daily monitoring diary to record their analgesic and anti-inflammatory intake.
Read the detailed description
6.1 Type of Study
International multicenter interventional, single-blind, randomized, controlled, parallel-group study in centers with practitioners trained in diagnosis.
Randomization is achieved by dedicated software.
6.2 Primary Endpoint
- Improvement in PRTEE questionnaire scores [10, 11, 12] before and after application of the Control roller (T) or the Joints \& Muscles roller (AM) combined with simultaneous delivery of an emulsion composed notably of essential oils. An improvement of 20% [13] (minimum clinically significant threshold for epicondylitis) in the PRTEE score will be used as the success criterion.
- Improvement of the score at 1 month, 2 months, and 3 months.
6.3 Secondary Endpoints
- Reduction in pain assessed by a numerical rating scale (0-10).
- Reduction in analgesic and anti-inflammatory consumption.
- Assessment of device tolerability.
6.4 Calculation of the number of participants
The primary endpoint is clinical response, defined as a ≥ 20% reduction in the PRTEE score from baseline. For each patient, the month in which the first response is observed is assessed - month 1, month 2, or month 3. If there is no response at these three time points, the patient remains included in the analysis. The model then takes into account the fact that the patient did not respond at three months and that their clinical progression beyond that point remains unknown.
Sample size:
The power of the Cox model was evaluated based on a simulation of a response 2 times faster in the active group (10%, 15%, and 20% reduction in score at 1, 2, and 3 months versus 5%, 7%, and 10% in the control group). With 40 and 30 patients per group, we obtain a power of 0.83 and 0.72 at the 0.05 level, respectively.
The following will therefore be included:
80 patients, randomly divided into two groups: Group 1: 40 patients with Control roller (T) Group 2: 40 patients with Joints and Muscles roller (AM) and essential oil-based solution
Consultation C1 (Baseline):
- Provision of information and signing of informed consent (see Appendix 1 and 2).
- Verification of inclusion and exclusion criteria.
- Assessment via PRTEE questionnaire.
- Assessment via numerical pain rating scale (0-10).
- Assessment of pain location.
- Provision of treatment instructions: 2 daily applications morning and evening by mechanical self-massage of the epicondylar and muscular area for 2 minutes, i.e. 2 × 70 roller passes in total (70 on the tendon and 70 on the muscle), for 3 months (an explanatory video provided via QR code in an appendix given to patients and assessors).
- Assessment of analgesic and anti-inflammatory consumption. A daily monitoring diary will be given to each participant to record intake.
- Provision of 3 Rollers.
Consultation C2 (1 month):
- Assessment via PRTEE questionnaire.
- Assessment via numerical pain rating scale (0-10).
- Assessment of analgesic and anti-inflammatory consumption.
- Provision of 3 Rollers.
Consultation C3 (2 months):
- Assessment via PRTEE questionnaire.
- Assessment via numerical pain rating scale (0-10).
- Assessment of analgesic and anti-inflammatory consumption.
- Provision of 3 Rollers.
Consultation C4 (3 months):
- Assessment via PRTEE questionnaire.
- Assessment via numerical pain rating scale (0-10).
- Assessment of analgesic and anti-inflammatory consumption.
- Provision of the numerical pain rating scale, in preparation for the telephone consultation.
Optional Telephone Consultation C5 (6 months):
- Assessment via PRTEE questionnaire.
- Assessment via numerical pain rating scale (0-10).
- Conditions
- Epicondylitis
- Being tested
- Active comparator, auto massage twice a day, automassge with an empty roller Puressentiel
- Keywords
- Epicondylitis, Auto massage, Essential oils
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active comparatorDevice
Active automassage with roller Puressentiel
auto massage twice a dayDevice
automassage twice a day with a non active roller Puressentiel
automassge with an empty roller PuressentielDevice
To evaluate the analgesic and functional efficacy of a roller device that facilitates mechanical self-massage through the simultaneous diffusion of an emulsion composed mainly of essential oils in the treatment of chronic lateral epicondylitis.
| Study group | Role | What they receive |
|---|---|---|
| active roller Puressentiel with essentiel oils | Active comparator | Automassage with the active roller Puressentiel Receives: Device: Active comparator; Device: auto massage twice a day; Device: automassge with an empty roller Puressentiel |
| Automassage with an empty roller Puressentiel | Active comparator | Automassage with an empty roller Puressentiel Receives: Device: Active comparator; Device: auto massage twice a day; Device: automassge with an empty roller Puressentiel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRTEE questionnaire (Patient-Rated Tennis Elbow Evaluation)
Change in Ptient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire scores before and after application of the Control roller (T) or the Joints \& Muscles roller (AM) combined with simultaneous delivery of an emulsion composed notably of essential oils. The maximum score (worse) being 100 and the minimum sore (best) being 0. An improvement of 20% [13] (minimum clinically significant threshold for epicondylitis) in the PRTEE score will be used as the success criterion
Measured: Improvement of the score at 1 month, 2 months, and 3 months
Secondary outcomes (2)
Pain assessed by a visual numerical rating scale
Reduction in pain assessed by a numerical rating scale (0-10), O being the best and 10 being the worse
Measured: Improvement of the score at 1 month, 2 months, and 3 months.
Tolerance
Report of side effects on a diary
Measured: Report at 1, 2 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion28 May 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpicondylitisStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puressentiel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615972
- Sponsor's protocol ID
- Puressentiel 2025-A02179-40
- Acronym
- EPIROLL
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 29 May 2026
- 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic and Functional Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT07615972
- Acronym / sponsor ID
- EPIROLL / Puressentiel 2025-A02179-40
- Conditions
- Epicondylitis
- Keywords
- Epicondylitis, Auto massage, Essential oils
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- PuressentielIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 28 May 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 29 May 2026 (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.
Tennis elbow, also known as lateral epicondylitis, is a pathology of the enthesis of tendons attaching near or directly on the lateral epicondyle of the humerus. Lateral epicondylitis is characterized by progressive pain localized on the outer edge of the elbow, reproduced by palpation, stretching, and/or isometric resistance contraction of the lateral epicondylar muscles. This pain may be accompanied by a deficit in muscle strength compared to the opposite side. The diagnosis is mainly clinical, although imaging tests may be considered in cases of doubt or if the pain persists despite appropriate therapeutic management. There is no specific treatment for tennis elbow that has been proven to be effective. However, starting treatment can speed up the return to sporting activities and prevent the condition from becoming chronic. This study aims to fill this gap by evaluating the effectiveness of a simple and natural treatment for the symptoms of tennis elbow: a roller equipped with a ball that facilitates self-massage with simultaneous diffusion of an essential oil-based emulsion.
Objective : To evaluate the analgesic and functional efficacy of a roller device that facilitates mechanical self-massage through the simultaneous diffusion of an emulsion composed mainly of essential oils in the treatment of chronic lateral epicondylitis.
Participants : Lateral epicondylitis lasting more than 3 months, isolated and confirmed by clinical examination and ultrasound, in subjects aged 18 years and older.
Procedures : Clinical examination to confirm the diagnosis of lateral epicondylitis (specific tests for pain on stretching and palpation, elimination of differential diagnoses), and ultrasound.
- Assessment using the PRTEE (Patient-Rated Tennis Elbow Evaluation) questionnaire (French version).
- Assessment using the numerical pain rating scale (0-10),
- Assessment of the location associated with the pain.
- Treatment instructions: 2 daily applications, morning and evening, involving mechanical friction of the epicondylar and muscular area for 2 minutes, i.e., a total of 2 x 70 roller rotations (70 roller rotations on the tendon and 70 roller rotations on the muscle) for 3 months. The same parameters will be assessed one month, two months, and three months after use of the device. Patients will be randomized to receive either an Articulations \& Muscles (AM) roller or a Control (T) roller.
- Assessment of analgesic and anti-inflammatory consumption. Each participant will be given a daily monitoring diary to record their analgesic and anti-inflammatory intake.
Detailed description
6.1 Type of Study
International multicenter interventional, single-blind, randomized, controlled, parallel-group study in centers with practitioners trained in diagnosis.
Randomization is achieved by dedicated software.
6.2 Primary Endpoint
- Improvement in PRTEE questionnaire scores [10, 11, 12] before and after application of the Control roller (T) or the Joints \& Muscles roller (AM) combined with simultaneous delivery of an emulsion composed notably of essential oils. An improvement of 20% [13] (minimum clinically significant threshold for epicondylitis) in the PRTEE score will be used as the success criterion.
- Improvement of the score at 1 month, 2 months, and 3 months.
6.3 Secondary Endpoints
- Reduction in pain assessed by a numerical rating scale (0-10).
- Reduction in analgesic and anti-inflammatory consumption.
- Assessment of device tolerability.
6.4 Calculation of the number of participants
The primary endpoint is clinical response, defined as a ≥ 20% reduction in the PRTEE score from baseline. For each patient, the month in which the first response is observed is assessed - month 1, month 2, or month 3. If there is no response at these three time points, the patient remains included in the analysis. The model then takes into account the fact that the patient did not respond at three months and that their clinical progression beyond that point remains unknown.
Sample size:
The power of the Cox model was evaluated based on a simulation of a response 2 times faster in the active group (10%, 15%, and 20% reduction in score at 1, 2, and 3 months versus 5%, 7%, and 10% in the control group). With 40 and 30 patients per group, we obtain a power of 0.83 and 0.72 at the 0.05 level, respectively.
The following will therefore be included:
80 patients, randomly divided into two groups: Group 1: 40 patients with Control roller (T) Group 2: 40 patients with Joints and Muscles roller (AM) and essential oil-based solution
Consultation C1 (Baseline):
- Provision of information and signing of informed consent (see Appendix 1 and 2).
- Verification of inclusion and exclusion criteria.
- Assessment via PRTEE questionnaire.
- Assessment via numerical pain rating scale (0-10).
- Assessment of pain location.
- Provision of treatment instructions: 2 daily applications morning and evening by mechanical self-massage of the epicondylar and muscular area for 2 minutes, i.e. 2 × 70 roller passes in total (70 on the tendon and 70 on the muscle), for 3 months (an explanatory video provided via QR code in an appendix given to patients and assessors).
- Assessment of analgesic and anti-inflammatory consumption. A daily monitoring diary will be given to each participant to record intake.
- Provision of 3 Rollers.
Consultation C2 (1 month):
- Assessment via PRTEE questionnaire.
- Assessment via numerical pain rating scale (0-10).
- Assessment of analgesic and anti-inflammatory consumption.
- Provision of 3 Rollers.
Consultation C3 (2 months):
- Assessment via PRTEE questionnaire.
- Assessment via numerical pain rating scale (0-10).
- Assessment of analgesic and anti-inflammatory consumption.
- Provision of 3 Rollers.
Consultation C4 (3 months):
- Assessment via PRTEE questionnaire.
- Assessment via numerical pain rating scale (0-10).
- Assessment of analgesic and anti-inflammatory consumption.
- Provision of the numerical pain rating scale, in preparation for the telephone consultation.
Optional Telephone Consultation C5 (6 months):
- Assessment via PRTEE questionnaire.
- Assessment via numerical pain rating scale (0-10).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active roller Puressentiel with essentiel oils | Active comparator | Device: Active comparator, Device: auto massage twice a day, Device: automassge with an empty roller PuressentielAutomassage with the active roller Puressentiel |
| Automassage with an empty roller Puressentiel | Active comparator | Device: Active comparator, Device: auto massage twice a day, Device: automassge with an empty roller PuressentielAutomassage with an empty roller Puressentiel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Active comparatorActive automassage with roller Puressentiel | Device | Automassage with an empty roller Puressentiel, active roller Puressentiel with essentiel oils |
| auto massage twice a dayautomassage twice a day with a non active roller Puressentiel | Device | Automassage with an empty roller Puressentiel, active roller Puressentiel with essentiel oils |
| automassge with an empty roller PuressentielTo evaluate the analgesic and functional efficacy of a roller device that facilitates mechanical self-massage through the simultaneous diffusion of an emulsion composed mainly of essential oils in the treatment of chronic lateral epicondylitis. | Device | Automassage with an empty roller Puressentiel, active roller Puressentiel with essentiel oils |
Primary outcome
PRTEE questionnaire (Patient-Rated Tennis Elbow Evaluation)
Time frame: Improvement of the score at 1 month, 2 months, and 3 months
Change in Ptient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire scores before and after application of the Control roller (T) or the Joints \& Muscles roller (AM) combined with simultaneous delivery of an emulsion composed notably of essential oils. The maximum score (worse) being 100 and the minimum sore (best) being 0. An improvement of 20% [13] (minimum clinically significant threshold for epicondylitis) in the PRTEE score will be used as the success criterion
2 secondary outcomes
Pain assessed by a visual numerical rating scale
Time frame: Improvement of the score at 1 month, 2 months, and 3 months.
Tolerance
Time frame: Report at 1, 2 and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
Related trials for Epicondylitis
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
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.
Questions about this trial
What is this clinical trial studying?
A study testing Active comparator, auto massage twice a day and automassge with an empty roller Puressentiel in people with Epicondylitis, run by Puressentiel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 29 May 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Barizien, MD (+33 1 4625 73 73, n.barizien@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRTEE questionnaire (Patient-Rated Tennis Elbow Evaluation) (time frame: Improvement of the score at 1 month, 2 months, and 3 months). 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 29 May 2026.