Frozen ShoulderNCT06139276
Outcomes of Frozen Shoulder Treated With Small Needle-Knife Through Microcirculation and Pulse Analysis.
A study testing Small Needle-Knife and Standard treatment in people with Frozen Shoulder, run by Taipei City Hospital.
Trial summary
The aim is to investigate whether adding small needle-knife therapy to standard Western medicine enhances the treatment of frozen shoulder by evaluating its impact on microcirculation and meridian unblocking. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Small Needle-Knife and Standard treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2025
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Limited shoulder joint mobility in various angles (forward flexion, abduction, external rotation, and internal rotation), persisting for over two months.
- Persistent pain on the affected shoulder even without rest.
- Willing and consenting to participate in this research.
Who cannot join
- Degenerative shoulder joint arthritis (osteoarthritis).
- Rheumatoid arthritis.
- Fracture of the humerus, clavicle, scapula, shoulder acromioclavicular dislocation, shoulder dislocation.
- Cervical radiculopathy.
- Thoracic outlet syndrome.
- Restricted shoulder joint mobility due to stroke, spinal cord injury, or other factors.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcomes of a Specially Designed Needle (Small Needle-Knife) Treating Frozen Shoulder Based on Analysis of Microcirculation and Pulse Changes
The aim is to investigate whether adding small needle-knife therapy to standard Western medicine enhances the treatment of frozen shoulder by evaluating its impact on microcirculation and meridian unblocking.
Read the detailed description
The aim of this research is to investigate whether the combination of small needle-knife therapy with conventional Western medicine treatment can enhance therapeutic effects compared to conventional treatment methods. In addition to clinical measurements of joint mobility and relevant scales, this study integrates instruments such as Laser Doppler Flowmetry (LDF) and pulse diagnosis devices. These non-invasive methods are employed to evaluate the microcirculation performance of patients with frozen shoulder before and after conventional Western medicine treatment or combined treatment with small needle-knife therapy. The objective is to understand the effects of small needle-knife therapy on the microcirculation and meridian unblocking in frozen shoulder patients.
- Conditions
- Frozen Shoulder
- Being tested
- Small Needle-Knife, Standard treatment
- Keywords
- Frozen Shoulder, Acupotomy, Small Needle-Knife, Adhesive Capsulitis, Laser Doppler Flowmetry, Photoplethysmography, Blood Pressure Waveform
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Needle-KnifeProcedure or surgery
Also called Acupotomy
The small needle-knife therapy originated from the ancient Chinese acupuncture instrument known as the "Pi needle" from the "Nine Needles," which resembled a sword, had two sharp edges, and was originally used for abscess drainage. It is currently widely applied in treating conditions such as myofascial adhesions, chronic pain, or nerve compression.
The small needle-knife features a flat and rounded tip design, with its handle made of solid steel. This construction provides excellent toughness and flexibility, minimizing tissue damage, and facilitating microadhesiolysis, an intervention aimed at releasing adhesions.
Standard treatmentOther
Standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Small Needle-Knife | Experimental | The small needle-knife (SNF) group undergoes rehabilitation treatment, with additional small needle-knife treatment once a week after acupuncture needle insertion at the Tiaokou (ST38) and Chengshan (BL57) acupoints. This treatment regimen will span over a duration of 3 weeks. Receives: Procedure: Small Needle-Knife |
| Standard treatment | Active comparator | Rehabilitation treatment (based on the physician's assessment of the patient's clinical condition, using methods such as heat therapy, electrotherapy, manual therapy, or joint injections) at least once a week. This treatment regimen will span over a duration of 3 weeks. Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain VAS
The intensity of the pain along a continuum from 'no pain' to 'worst pain' imaginable with visual analog scale.
Measured: 90 days
ROM
Glenohumeral range of motion(ROM) of the affected shoulder.
Measured: 90 days
Secondary outcomes (5)
WHOQOL-BREF
A self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment.
Measured: 90 days
SPADI
Shoulder Pain and Disability Index (SPADI) is a 13-item patient completed instrument. Its categories include "pain" (5 items) and "disability" (8 items).
Measured: 90 days
LDF
The Laser Doppler Flowmetry (LDF) is a widely used technology for monitoring microcirculatory status. Due to its excellent frequency response, ease of use, and tissue specificity, it is highly suitable for non-invasive microcirculatory examinations and be applied to detect microcirculation in frozen shoulder cases.
Measured: 90 days
BPW
Blood pressure waveform(BPW) is a graphical representation or visual display of the changes in blood pressure over time measured through a radial artery pressure sensor.
Measured: 90 days
PPG
Photoplethysmography(PPG), which is a non-invasive method used to detect blood volume changes in the microvascular bed of tissue
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies 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
- Model description
- This study plans to collect 120 individuals diagnosed with frozen shoulder by both Western and Traditional Chinese medicine practitioners, randomized in a 1:1 ratio to receive either standard treatment or a combination of small needle-knife therapy and standard treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Collaborators
- National Taiwan University of Science and Technology, National Yang Ming Chiao Tung University
- Responsible party
- Sponsor
- Investigators
- Ming Jen Wang, MD, Principal investigator, Taipei City Hospital, Renai Branch, Chinese Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139276
- Sponsor's protocol ID
- TCHIRB-11206008
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of a Specially Designed Needle (Small Needle-Knife) Treating Frozen Shoulder Based on Analysis of Microcirculation and Pulse Changes
- ClinicalTrials.gov ID
- NCT06139276
- Acronym / sponsor ID
- TCHIRB-11206008
- Conditions
- Frozen Shoulder
- Keywords
- Frozen Shoulder, Acupotomy, Small Needle-Knife, Adhesive Capsulitis, Laser Doppler Flowmetry, Photoplethysmography, Blood Pressure Waveform
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Collaborators
- National Taiwan University of Science and Technology, National Yang Ming Chiao Tung University
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Nov 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.
The aim is to investigate whether adding small needle-knife therapy to standard Western medicine enhances the treatment of frozen shoulder by evaluating its impact on microcirculation and meridian unblocking.
Detailed description
The aim of this research is to investigate whether the combination of small needle-knife therapy with conventional Western medicine treatment can enhance therapeutic effects compared to conventional treatment methods. In addition to clinical measurements of joint mobility and relevant scales, this study integrates instruments such as Laser Doppler Flowmetry (LDF) and pulse diagnosis devices. These non-invasive methods are employed to evaluate the microcirculation performance of patients with frozen shoulder before and after conventional Western medicine treatment or combined treatment with small needle-knife therapy. The objective is to understand the effects of small needle-knife therapy on the microcirculation and meridian unblocking in frozen shoulder patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study plans to collect 120 individuals diagnosed with frozen shoulder by both Western and Traditional Chinese medicine practitioners, randomized in a 1:1 ratio to receive either standard treatment or a combination of small needle-knife therapy and standard treatment.
| Arm | Type | Receives |
|---|---|---|
| Small Needle-Knife | Experimental | Procedure: Small Needle-KnifeThe small needle-knife (SNF) group undergoes rehabilitation treatment, with additional small needle-knife treatment once a week after acupuncture needle insertion at the Tiaokou (ST38) and Chengshan (BL57) acupoints. This treatment regimen will span over a duration of 3 weeks. |
| Standard treatment | Active comparator | Other: Standard treatmentRehabilitation treatment (based on the physician's assessment of the patient's clinical condition, using methods such as heat therapy, electrotherapy, manual therapy, or joint injections) at least once a week. This treatment regimen will span over a duration of 3 weeks. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Limited shoulder joint mobility in various angles (forward flexion, abduction, external rotation, and internal rotation), persisting for over two months.
- Persistent pain on the affected shoulder even without rest.
- Willing and consenting to participate in this research.
Key exclusion criteria (6 listed)
- Degenerative shoulder joint arthritis (osteoarthritis).
- Rheumatoid arthritis.
- Fracture of the humerus, clavicle, scapula, shoulder acromioclavicular dislocation, shoulder dislocation.
- Cervical radiculopathy.
- Thoracic outlet syndrome.
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 |
|---|---|---|
| Small Needle-KnifeAlso: AcupotomyThe small needle-knife therapy originated from the ancient Chinese acupuncture instrument known as the "Pi needle" from the "Nine Needles," which resembled a sword, had two sharp edges, and was originally used for abscess drainage. It is currently widely applied in treating conditions such as myofascial adhesions, chronic pain, or nerve compression. The small needle-knife features a flat and rounded tip design, with its handle made of solid steel. This construction provides excellent toughness and flexibility, minimizing tissue damage, and facilitating microadhesiolysis, an intervention aimed at releasing adhesions. | Procedure or surgery | Small Needle-Knife |
| Standard treatmentStandard treatment | Other | Standard treatment |
Primary outcome
Pain VAS
Time frame: 90 days
The intensity of the pain along a continuum from 'no pain' to 'worst pain' imaginable with visual analog scale.
ROM
Time frame: 90 days
Glenohumeral range of motion(ROM) of the affected shoulder.
5 secondary outcomes
WHOQOL-BREF
Time frame: 90 days
SPADI
Time frame: 90 days
LDF
Time frame: 90 days
BPW
Time frame: 90 days
PPG
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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.
Ming Jen Wang, MD principal investigator
Taipei City Hospital, Renai Branch, Chinese Medicine Department
Questions about this trial
What is this clinical trial studying?
A study testing Small Needle-Knife and Standard treatment in people with Frozen Shoulder, run by Taipei City Hospital.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Jen Wang, MD (886-2-27093600 ext. 5213, wanters0800@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain VAS (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.