Efficacy of soothing cream gel on the range of motion and chronic pain at shoulder and elbow: Protocol of a Double-blinded, Randomized, Placebo-controlled Trial

Abstract

Abstract Background: Upper limb problems are very common, which affects about 4-35% of people worldwide. Among the joints of the upper limbs, the point prevalence of shoulder pain was 7-26% and elbow pain was 11%. Due to the pain symptom, it will affect the range of motion of the joints and even the quality of life of those populations. Nowadays, the treatment for pain symptoms usually includes nonsteroidal anti-inflammatory drugs or corticosteroids. However, the relapse rate and the treatment cost are very high. Therefore, many patients seek non-pharmaceutical therapies or complementary and alternative medicine to relieve the symptoms. To offset this shortcoming, topical treatment is another option for upper limb problems with fewer side effects. Objective: To evaluate the efficacy of soothing cream gel (SCG) on the range of motion and chronic pain at the shoulder and elbow. Methods: Soothing cream gel and placebo gel will be used in this double-blinded, randomized, placebo-controlled trial. The soothing cream gel consists of Vitis Vinifera essence, Melaleuca Viridiflora essential oil, and Eucalyptus Globulus essential oil, and is produced and packed by a manufacturer with a Good Manufacturing Practice certificate. Placebo cream gel is provided by the same manufacturer, it does not contain any active ingredients but will match the appearance, texture and smell as closely as the soothing cream gel. A total of 70 participants who suffer from upper limb problems and fulfil the eligibility criteria will be randomized into the treatment group (soothing cream gel) or the placebo group (placebo gel) for 2 weeks. The range of motion of the upper limb will be measured as the primary outcome; active flexion and abduction will be measured by a goniometer for the shoulder and active flexion and extension will be measured for the elbow. The primary efficacy analyses will be based on the full analysis set (FAS) following the intention-to-treat principle. Discussion:The study medication used in this trial is an extraction of some botanicals, which have inflammatory and analgesic effects. We expected that the soothing cream gel could refresh the sore and fatigued muscles and improve the participants’ motor ability of the affected upper limb. Besides, we hope to provide evidence of an effective and safe treatment for this prevalent health problem. Trial registration: This trial was registered at ClinicalTrials.gov on 7 June 2023, with the registration ID: NCT05799391.