Upper Extremity ProblemPhase 2NCT05799391
RCT for the Efficacy of Soothing Cream Jel in Improving Upper Limb Pain and Motion
A Phase 2 study testing SJC in people with Upper Extremity Problem, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Upper Extremity Problem
- What is being tested?
- SJC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Jul 2023to 10 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Known allergic history to any topical cream;
- Known pregnant or lactating; or
- Unable to complete questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Upper Extremity Problem
- Being tested
- SJC, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SJCDrug
Also called Soothing cream jel
Soothing cream jel
PlaceboOther
Placebo cream jel
| Study group | Role | What they receive |
|---|---|---|
| Active treatment (Soothing cream jel) | Experimental | Soothing cream jel Receives: Drug: SJC |
| Placebo | Placebo comparator | Placebo cream jel Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to week 2
Secondary outcomes (14)
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.
Measured: 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")
Measured: 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")
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start10 Jul 2023
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity ProblemStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Soothing cream jel or placebo cream jel
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Lin Zhixiu, Chinese University of Hong Kong
- Investigators
- Zhixiu Lin, Principal investigator, Hong Kong Institute of Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799391
- Sponsor's protocol ID
- SCJ study
- Status last verified
- Jul 2026
- First submitted
- 23 Mar 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and the statistical analysis plan are available after completion of the study and reporting of the results.
Publications
Lo CW, Sum KWR, Leung FLE, Yang Y, Chan KL, Lam KK, Lau KW, Sum CH, Lin WL, Ho SH, Lin ZX. Efficacy of soothing cream gel in the range of motion and chronic pain at the shoulder and elbow: protocol of a double-blinded, randomised, placebo-controlled trial. BMJ Open. 2024 Jul 5;14(7):e085856. doi: 10.1136/bmjopen-2024-085856.
PubMed 38969378
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05799391
- Acronym / sponsor ID
- SCJ study
- Conditions
- Upper Extremity Problem
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Soothing cream jel or placebo cream jel
| Arm | Type | Receives |
|---|---|---|
| Active treatment (Soothing cream jel) | Experimental | Drug: SJCSoothing cream jel |
| Placebo | Placebo comparator | Other: PlaceboPlacebo cream jel |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SJCAlso: Soothing cream jelSoothing cream jel | Drug | Active treatment (Soothing cream jel) |
| PlaceboPlacebo cream jel | Other | Placebo |
Primary outcome
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.
14 secondary outcomes
Chang of the range of motion
Time frame: From baseline to week 4
Change of Numeric pain rating scale (NPRS)
Time frame: 2 weeks
Change of Numeric pain rating scale (NPRS)
Time frame: 4 weeks
Handgrip strength
Time frame: 2 weeks
Handgrip strength
Time frame: 4 weeks
Back-scratch test
Time frame: 2 weeks
Back-scratch test
Time frame: 4 weeks
Score change of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASESp-S)
Time frame: 2 weeks
Score change of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASESp-S)
Time frame: 4 weeks
Score change of American Shoulder and Elbow Surgeons Standardized Elbow Assessment Form (ASESp-E)
Time frame: 2 weeks
Score change of American Shoulder and Elbow Surgeons Standardized Elbow Assessment Form (ASESp-E)
Time frame: 4 weeks
Score change of 36-Item Short Form Survey (SF-36v2)
Time frame: 2 weeks
Score change of 36-Item Short Form Survey (SF-36v2)
Time frame: 4 weeks
Rescue drugs or treatments used for pain symptoms
Time frame: From baseline to week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Derived from this study: PubMed 38969378Lo CW, Sum KWR, Leung FLE, Yang Y, Chan KL, Lam KK, Lau KW, Sum CH, Lin WL, Ho SH, Lin ZX. Efficacy of soothing cream gel in the range of motion and chronic pain at the shoulder and elbow: protocol of a double-blinded, randomised, placebo-controlled trial. BMJ Open. 2024 Jul 5;14(7):e085856. doi: 10.1136/bmjopen-2024-085856.
- Individual participant dataSharing planned: Yes. The study protocol and the statistical analysis plan are available after completion of the study and reporting of the results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhixiu Lin principal investigator
Hong Kong Institute of Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SJC in people with Upper Extremity Problem, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the range of motion (time frame: From baseline to week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05799391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.