- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05799391
RCT for the Efficacy of Soothing Cream Jel in Improving Upper Limb Pain and Motion
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Cho Wing Lo
- Phone Number: 35053476
- Email: louislo@cuhk.edu.hk
Study Locations
-
-
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Hong Kong, Hong Kong
- Recruiting
- Hong Kong Institute of Integrative Medicine
-
Contact:
- Zhixiu LIN
- Phone Number: 28733252
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active treatment (Soothing cream jel)
Soothing cream jel
|
Soothing cream jel
Other Names:
|
Placebo Comparator: Placebo
Placebo cream jel
|
Placebo cream jel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of the range of motion
Time Frame: From baseline to week 2
|
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
Time Frame: From baseline to week 4
|
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)
Time Frame: 2 weeks
|
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)
Time Frame: 4 weeks
|
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
Time Frame: 2 weeks
|
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
Time Frame: 4 weeks
|
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
Time Frame: 2 weeks
|
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
Time Frame: 4 weeks
|
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)
Time Frame: 2 weeks
|
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)
Time Frame: 4 weeks
|
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)
Time Frame: 2 weeks
|
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)
Time Frame: 4 weeks
|
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)
Time Frame: 2 weeks
|
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)
Time Frame: 4 weeks
|
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
Time Frame: From baseline to week 4
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zhixiu Lin, Hong Kong Institute of Integrative Medicine
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SCJ study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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