Adhesive CapsulitisNCT05292482
Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Adhesive Capsulitis : A Pilot Study
A study testing pharmacopuncture therapy and physical therapy in people with Adhesive Capsulitis, run by Jaseng Hospital of Korean Medicine at 1 site in South Korea.
Trial summary
This is a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for adhesive capsulitis. Read more about this study
- Who is it for?
- Ages 19 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- pharmacopuncture therapy and physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Apr 2022to 6 Dec 2022
- Phase
- Interventional
- 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 19 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Limitation of the shoulder movement (active or passive)
- Numeric Rating Scale (NRS) of neck pain is more than 5
- Symptoms of adhesive capsulitis for more than 1 month
- Discrimination findings which can explain clinical symptoms on shoulder MRI or CT
- 19-69 years old
- participants who agreed and wrote informed consents
Who cannot join
- Case of being diagnosed with a specific serious disease that may cause shoulder pain(Fracture, Dislocation, etc.)
- Cause of pain due to soft tissue disease, not the spine(Cancer, fibromyalgia, RA, goat, or etc.) Other chronic diseases(stroke, MI, kidney disease, diabetic neuropathy, dimentia, epilepsy, or etc.) that may interfere with the interpretation of therapeutic effects or outcomes
- Participants taking steroid, immunosuppressant, psychotropic medication, or taking other drugs that may affect outcomes
- Inappropriate or unsafe pharmacopuncture therapy; hemorrhagic disease, taking anticoagulant drug, or severe diabetes patients who are likely to be infected
- Participants who took NSAIDs or pharmacopuncture, acupuncture, physical therapy within 1 week
- Pregnant, planning to get pregnant or lactating women
Show all 10Show fewer
- Participants who had undergone shoulder surgery within 3 months
- Participants who had participated in other clinical trial within 1 month, had participated in other study within 6 months from the date of selection, or have plan for participation in other trial during follow up period of this trial
- Participants who can not write informed consent
- Participants who is difficult to participate in the trial according to investigator's decision
Trial locations and contacts
1 site in 1 country.
About this study
This is a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for adhesive capsulitis.
Read the detailed description
Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (25:25) for pharmacopuncture therapy and physical therapy group. Participants of each group will receive twice a week for total 6 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions.
- Conditions
- Adhesive Capsulitis
- Being tested
- pharmacopuncture therapy, physical therapy
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacopuncture therapyProcedure or surgery
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
physical therapyProcedure or surgery
This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.
| Study group | Role | What they receive |
|---|---|---|
| pharmacopunture therapy | Experimental | The physicians will choose the type and volume of pharmacopuncture according to participants' conditions and inject it at the proper acupoints they choose. Receives: Procedure: pharmacopuncture therapy |
| physical therapy | Active comparator | The physicians will choose the type and time of physical therapy according to participants' conditions. Receives: Procedure: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS) of shoulder pain
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Measured: week 7
Secondary outcomes (6)
Visual analogue scale (VAS) of shoulder pain
Visual analogue scale of shoulder pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.
Measured: week 1, 2, 3, 4, 5, 6, 7, 13
ROM(Range of motion)
The range of shoulder movement shows the function of the shoulder capsule.
Measured: week 1, 2, 3, 4, 5, 6, 7, 13
SPADI
SPADI is a functional disability questionnaire. The possible range of each item score is 0 to 10. Total score range is 0 (better outcome) to 100 (worse outcome).
Measured: week 1, 7, 13
PGIC
Participants rate the improvement after treatment on a 7-point Likert scale (1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)
Measured: week 7, 13
SF-12 v2
The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
Measured: week 1, 7, 13
EQ-5D-5L
The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about)
Measured: week 1, 7, 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start20 Apr 2022
- Primary completion25 Oct 2022
- Study completion6 Dec 2022
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 Adhesive CapsulitisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Hospital of Korean Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine
- Responsible party
- Sponsor
- Investigators
- Kyoung Sun Park, Ph.D, Principal investigator, Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292482
- Sponsor's protocol ID
- JS-CT-2022-01
- Status last verified
- Dec 2022
- First submitted
- 15 Mar 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim D, Park KS, Kim SA, Seo JY, Cho HW, Lee YJ, Yang C, Ha IH, Han CH. Pharmacopuncture therapy for adhesive capsulitis: A pragmatic randomized controlled pilot study. Integr Med Res. 2024 Sep;13(3):101065. doi: 10.1016/j.imr.2024.101065. Epub 2024 Jun 21.
PubMed 39224580
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Adhesive Capsulitis : A Pilot Study
- ClinicalTrials.gov ID
- NCT05292482
- Acronym / sponsor ID
- JS-CT-2022-01
- Conditions
- Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jaseng Hospital of Korean MedicineUniversity, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 23 Mar 2022 (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 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for adhesive capsulitis.
Detailed description
Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (25:25) for pharmacopuncture therapy and physical therapy group. Participants of each group will receive twice a week for total 6 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pharmacopunture therapy | Experimental | Procedure: pharmacopuncture therapyThe physicians will choose the type and volume of pharmacopuncture according to participants' conditions and inject it at the proper acupoints they choose. |
| physical therapy | Active comparator | Procedure: physical therapyThe physicians will choose the type and time of physical therapy according to participants' conditions. |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Limitation of the shoulder movement (active or passive)
- Numeric Rating Scale (NRS) of neck pain is more than 5
- Symptoms of adhesive capsulitis for more than 1 month
- Discrimination findings which can explain clinical symptoms on shoulder MRI or CT
- 19-69 years old
Key exclusion criteria (10 listed)
- Case of being diagnosed with a specific serious disease that may cause shoulder pain(Fracture, Dislocation, etc.)
- Cause of pain due to soft tissue disease, not the spine(Cancer, fibromyalgia, RA, goat, or etc.) Other chronic diseases(stroke, MI, kidney disease, diabetic neuropathy, dimentia, epilepsy, or etc.) that may interfere with the interpretation of therapeutic effects or outcomes
- Participants taking steroid, immunosuppressant, psychotropic medication, or taking other drugs that may affect outcomes
- Inappropriate or unsafe pharmacopuncture therapy; hemorrhagic disease, taking anticoagulant drug, or severe diabetes patients who are likely to be infected
- Participants who took NSAIDs or pharmacopuncture, acupuncture, physical therapy within 1 week
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 |
|---|---|---|
| pharmacopuncture therapyThis is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions. | Procedure or surgery | pharmacopunture therapy |
| physical therapyThis is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions. | Procedure or surgery | physical therapy |
Primary outcome
Numeric rating scale (NRS) of shoulder pain
Time frame: week 7
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
6 secondary outcomes
Visual analogue scale (VAS) of shoulder pain
Time frame: week 1, 2, 3, 4, 5, 6, 7, 13
ROM(Range of motion)
Time frame: week 1, 2, 3, 4, 5, 6, 7, 13
SPADI
Time frame: week 1, 7, 13
PGIC
Time frame: week 7, 13
SF-12 v2
Time frame: week 1, 7, 13
EQ-5D-5L
Time frame: week 1, 7, 13
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 15 Jun 2023.
- Derived from this study: PubMed 39224580Kim D, Park KS, Kim SA, Seo JY, Cho HW, Lee YJ, Yang C, Ha IH, Han CH. Pharmacopuncture therapy for adhesive capsulitis: A pragmatic randomized controlled pilot study. Integr Med Res. 2024 Sep;13(3):101065. doi: 10.1016/j.imr.2024.101065. Epub 2024 Jun 21.
- Individual participant dataSharing planned: No
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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.
Kyoung Sun Park, Ph.D principal investigator
Jaseng Hospital of Korean Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacopuncture therapy and physical therapy in people with Adhesive Capsulitis, run by Jaseng Hospital of Korean Medicine at 1 site in South Korea.
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 6 inclusion and 10 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 15 Jun 2023. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Numeric rating scale (NRS) of shoulder pain (time frame: week 7). 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 NCT05292482, 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 15 Jun 2023.