Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis (EPIROLL)

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).