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

Study Overview
=================
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.

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

Conditions
-----------------
Upper Extremity Problem

Intervention / Treatment
-----------------
* Drug: SJC
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-60; Participates in regular physical activity, at least once a week for 30 minutes; Chronic pain in the shoulder or elbow longer than 3 months; 11-items Numeric pain rating scale ≥4; and Willing to provide written informed consent. Exclusion Criteria: The patient had received previous physiotherapy, acupuncture, Tui Na massage, or bone-setting treatment for distal upper limb pain within the past 2 weeks; The pain was due to a fracture or known complex regional pain syndrome. History of upper limb surgery; Known severe medical conditions (e.g. rheumatoid arthritis, osteoporosis, cardiac, renal, hepatic, hematological diseases, vertigo, seizure, infection, malignancy, neurological impairment); Concomitant drugs of NSAIDs, any kind of painkillers, or anti-inflammatory drugs 15 days prior to randomization; Known impaired hematological profile and liver / renal function; Known allergic history to any topical cream; Known pregnant or lactating; or Unable to complete questionnaires

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Soothing cream jel or placebo cream jel
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment (Soothing cream jel)<br>Soothing cream jel | Drug: SJC<br>* Soothing cream jel<br>* Other names: Soothing cream jel;|
| Placebo Comparator: Placebo<br>Placebo cream jel | Other: Placebo<br>* Placebo cream jel<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the range of motion | The range of motion of upper (shoulder or elbow) will be measured by a digital goniometer. For the shoulder, active flexion and abduction ROMs are measured using a goniometer while the participants are standing. For the elbow, both flexion and extension will be measured by a goniometer in a standing position. | From baseline to week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chang of the range of motion | The range of motion of upper (shoulder or elbow) will be measured by a digital goniometer. For the shoulder, active flexion and abduction ROMs are measured using a goniometer while the participants are standing. For the elbow, both flexion and extension will be measured by a goniometer in a standing position. | From baseline to week 4 | 
| Change of Numeric pain rating scale (NPRS) | It contains 11 items in which subjects select a whole number (0-10 integers) that best reflects the average intensity of subjects' pain in the past week. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) | 2 weeks | 
| Change of Numeric pain rating scale (NPRS) | It contains 11 items in which subjects select a whole number (0-10 integers) that best reflects the average intensity of subjects' pain in the past week. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) | 4 weeks | 
| Handgrip strength | Handgrip strengths are measured by a dynamometer, on the dominant hand of the participant. Participants are instructed to hold the device with the arm at the right angle and elbow to the side of the body. The maximum effort will be taken from three attempts. | 2 weeks | 
| Handgrip strength | Handgrip strengths are measured by a dynamometer, on the dominant hand of the participant. Participants are instructed to hold the device with the arm at the right angle and elbow to the side of the body. The maximum effort will be taken from three attempts. | 4 weeks | 
| Back-scratch test | The back-scratch test is used to measure the overall shoulder ROM. It is performed by measuring the distance between (or the overlap of) the middle fingers of both hands behind the back with a ruler. | 2 weeks | 
| Back-scratch test | The back-scratch test is used to measure the overall shoulder ROM. It is performed by measuring the distance between (or the overlap of) the middle fingers of both hands behind the back with a ruler. | 4 weeks | 
| Score change of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASESp-S) | The ASESp-S consists of 18 questions from 3 sections: pain, instability and activities of daily living (ADL). Among the 18 questions, 11 self-report items represented functional ADL dimension (10 items) and pain dimension (1 item). The ADL section was scored on a 4-points-graded ordinal scale, ranging from 0 (unable to do) to 3 (not difficult) and cumulative scores were collected. The pain section was derived from the 10-points-graded visual analog scale (VAS) ranging from 0 (no pain) to 10 (maximum pain). | 2 weeks | 
| Score change of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASESp-S) | The ASESp-S consists of 18 questions from 3 sections: pain, instability and activities of daily living (ADL). Among the 18 questions, 11 self-report items represented functional ADL dimension (10 items) and pain dimension (1 item). The ADL section was scored on a 4-points-graded ordinal scale, ranging from 0 (unable to do) to 3 (not difficult) and cumulative scores were collected. The pain section was derived from the 10-points-graded visual analog scale (VAS) ranging from 0 (no pain) to 10 (maximum pain). | 4 weeks | 
| Score change of American Shoulder and Elbow Surgeons Standardized Elbow Assessment Form (ASESp-E) | The ASESp-E consists of 3 sections: pain, function, and satisfaction. Patients are asked about the spot of pain in their elbow and asked to rate pain on a visual analog scale (VAS) in different situations, such as the worst of pain, at rest, lifting a heavy object, doing a task with repeated elbow movements and at night. The VAS ranges from 0 (no pain) to 10 (maximum pain). In the function section, patients are asked to rate their ability to perform 10 ADL and their usual work and sporting activities with the scale from 0 (unable to do) to 3 (not difficult). | 2 weeks | 
| Score change of American Shoulder and Elbow Surgeons Standardized Elbow Assessment Form (ASESp-E) | The ASESp-E consists of 3 sections: pain, function, and satisfaction. Patients are asked about the spot of pain in their elbow and asked to rate pain on a visual analog scale (VAS) in different situations, such as the worst of pain, at rest, lifting a heavy object, doing a task with repeated elbow movements and at night. The VAS ranges from 0 (no pain) to 10 (maximum pain). In the function section, patients are asked to rate their ability to perform 10 ADL and their usual work and sporting activities with the scale from 0 (unable to do) to 3 (not difficult). | 4 weeks | 
| Score change of 36-Item Short Form Survey (SF-36v2) | SF36 is a generic instrument to measure general health status. It will be used to assess the patient's health status using 8 different dimensions including vitality, physical functioning, bodily pain, general health perceptions, role limitations due to physical health, role limitations due to emotional health, social role functioning and mental health. The possible score ranges from 0 to 100 points whereby 0 points represent the greatest possible limitation of health, while 100 points represent the absence of health restrictions. | 2 weeks | 
| Score change of 36-Item Short Form Survey (SF-36v2) | SF36 is a generic instrument to measure general health status. It will be used to assess the patient's health status using 8 different dimensions including vitality, physical functioning, bodily pain, general health perceptions, role limitations due to physical health, role limitations due to emotional health, social role functioning and mental health. The possible score ranges from 0 to 100 points whereby 0 points represent the greatest possible limitation of health, while 100 points represent the absence of health restrictions. | 4 weeks | 
| Rescue drugs or treatments used for pain symptoms | If participants used any other drugs or treatments for the pain symptom during the whole study period, those drug names or treatments would be recorded. | From baseline to week 4 |