Clinical trial NCT05799391: RCT for the Efficacy of Soothing Cream Jel in Improving Upper Limb Pain and Motion
Official title: Efficacy of Soothing Cream Jel in Improving the Range of Motion and Chronic Pain at Shoulder and Elbow: A Double-blinded, Randomized, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Upper Extremity Problem
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Soothing cream jel or placebo cream jel
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of the range of motion
timeFrame: From baseline to week 2
Secondary outcomes:
measure: Chang of the range of motion
timeFrame: From baseline to week 4
measure: Change of Numeric pain rating scale (NPRS)
timeFrame: 2 weeks
measure: Change of Numeric pain rating scale (NPRS)
timeFrame: 4 weeks
measure: Handgrip strength
timeFrame: 2 weeks
measure: Handgrip strength
timeFrame: 4 weeks
measure: Back-scratch test
timeFrame: 2 weeks
measure: Back-scratch test
timeFrame: 4 weeks
measure: Score change of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASESp-S)
timeFrame: 2 weeks
measure: Score change of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASESp-S)
timeFrame: 4 weeks
measure: Score change of American Shoulder and Elbow Surgeons Standardized Elbow Assessment Form (ASESp-E)
timeFrame: 2 weeks
measure: Score change of American Shoulder and Elbow Surgeons Standardized Elbow Assessment Form (ASESp-E)
timeFrame: 4 weeks
measure: Score change of 36-Item Short Form Survey (SF-36v2)
timeFrame: 2 weeks
measure: Score change of 36-Item Short Form Survey (SF-36v2)
timeFrame: 4 weeks
measure: Rescue drugs or treatments used for pain symptoms
timeFrame: From baseline to week 4
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Institute of Integrative Medicine
Study officials:
affiliation: Hong Kong Institute of Integrative Medicine
name: Zhixiu Lin
role: PRINCIPAL_INVESTIGATOR
References: