NCT07615972

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Jun 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Sep 2028

First Submitted

Initial submission to the registry

May 18, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 18, 2026

Last Update Submit

May 25, 2026

Conditions

Epicondylitis

Keywords

EpicondylitisAuto massageEssential oils

Outcome Measures

Primary Outcomes (1)

  • 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

    Improvement of the score at 1 month, 2 months, and 3 months

Secondary Outcomes (2)

  • Pain assessed by a visual numerical rating scale

    Improvement of the score at 1 month, 2 months, and 3 months.

  • Tolerance

    Report at 1, 2 and 3 months

Study Arms (2)

active roller Puressentiel with essentiel oils

ACTIVE COMPARATOR

Automassage with the active roller Puressentiel

Device: Active comparatorDevice: auto massage twice a dayDevice: automassge with an empty roller Puressentiel

Automassage with an empty roller Puressentiel

ACTIVE COMPARATOR

Automassage with an empty roller Puressentiel

Device: Active comparatorDevice: auto massage twice a dayDevice: automassge with an empty roller Puressentiel

Interventions

Active comparatorDEVICE

Active automassage with roller Puressentiel

Automassage with an empty roller Puressentielactive roller Puressentiel with essentiel oils
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.

Automassage with an empty roller Puressentielactive roller Puressentiel with essentiel oils
auto massage twice a dayDEVICE

automassage twice a day with a non active roller Puressentiel

Automassage with an empty roller Puressentielactive roller Puressentiel with essentiel oils

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Nicolas Barizien, MD

CONTACT

+33 1 4625 73 73n.barizien@hopital-foch.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 29, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

May 28, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share