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

NCT05799391 | Recruiting Phase 2 DMC

• 1 other identifier: SCJ study
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Extremity Problem

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Chang of the range of motion

  From baseline to week 4

• Change of Numeric pain rating scale (NPRS)

  2 weeks

• Change of Numeric pain rating scale (NPRS)

  4 weeks

• Handgrip strength

  2 weeks

• Handgrip strength

  4 weeks

Study Arms (2)

Active treatment (Soothing cream jel)

EXPERIMENTAL

Soothing cream jel

Drug: SJC

Placebo

PLACEBO COMPARATOR

Placebo cream jel

Other: Placebo

Interventions

SJC DRUG

Soothing cream jel

Also known as: Soothing cream jel

Active treatment (Soothing cream jel)

Placebo OTHER

Placebo cream jel

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• items Numeric pain rating scale ≥4; and
• Willing to provide written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Hong Kong Institute of Integrative Medicine

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• 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.

  PMID: 38969378 DERIVED

Study Officials

• Zhixiu Lin

  Hong Kong Institute of Integrative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cho Wing Lo

CONTACT

35053476; louislo@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Soothing cream jel or placebo cream jel

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: July 10, 2023
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completion of the study and reporting of the results.
• Access Criteria: The principal investigator of this trial will be responsible for accessing the request.

Locations

HK (1)