RCT for the Efficacy of Soothing Cream Jel in Improving Upper Limb Pain and Motion

The Chinese University of Hong Kong

Status and phase: Enrolling; Phase 2

Conditions: Upper Extremity Problem

Treatments: Other: Placebo; Drug: SJC

Study type: Interventional

Funder types: Other

Identifiers

NCT05799391

SCJ study

Details and patient eligibility

About

This is a randomized, double-blinded, placebo-controlled clinical trial. This trial is used to evaluate the efficacy of soothing cream jel on chronic upper limb pain and the range of motion.

Full description

Potential subjects will be screened according to the eligibility criteria after signing the informed consent form. Subjects who fulfill the requirements will be randomized into either the treatment group or the placebo group. And receive either soothing cream jel or placebo cream jel for 2 weeks. Then followed by a post-treatment for 2 weeks.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-60;
2. Participates in regular physical activity, at least once a week for 30 minutes;
3. Chronic pain in the shoulder or elbow longer than 3 months;
4. 11-items Numeric pain rating scale ≥4; and
5. Willing to provide written informed consent.

Exclusion criteria

1. The patient had received previous physiotherapy, acupuncture, Tui Na massage, or bone-setting treatment for distal upper limb pain within the past 2 weeks;
2. The pain was due to a fracture or known complex regional pain syndrome.
3. History of upper limb surgery;
4. Known severe medical conditions (e.g. rheumatoid arthritis, osteoporosis, cardiac, renal, hepatic, hematological diseases, vertigo, seizure, infection, malignancy, neurological impairment);
5. Concomitant drugs of NSAIDs, any kind of painkillers, or anti-inflammatory drugs 15 days prior to randomization;
6. Known impaired hematological profile and liver / renal function;
7. Known allergic history to any topical cream;
8. Known pregnant or lactating; or
9. Unable to complete questionnaires

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Active treatment (Soothing cream jel)

Experimental group

Description:

Soothing cream jel

Treatment:

Drug: SJC

Placebo

Placebo Comparator group

Description:

Placebo cream jel

Treatment:

Other: Placebo