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Outcomes of Frozen Shoulder Treated With Small Needle-Knife Through Microcirculation and Pulse Analysis.

Outcomes of a Specially Designed Needle (Small Needle-Knife) Treating Frozen Shoulder Based on Analysis of Microcirculation and Pulse Changes

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06139276
Enrollment
120
Registered
2023-11-18
Start date
2024-01-01
Completion date
2025-12-31
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frozen Shoulder

Keywords

Frozen Shoulder, Acupotomy, Small Needle-Knife, Adhesive Capsulitis, Laser Doppler Flowmetry, Photoplethysmography, Blood Pressure Waveform

Brief 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.

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.

Interventions

PROCEDURESmall Needle-Knife

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.

OTHERStandard treatment

Standard treatment

Sponsors

National Taiwan University of Science and Technology
CollaboratorOTHER
National Yang Ming Chiao Tung University
CollaboratorOTHER
Taipei City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Pain VAS90 daysThe intensity of the pain along a continuum from 'no pain' to 'worst pain' imaginable with visual analog scale.
ROM90 daysGlenohumeral range of motion(ROM) of the affected shoulder.

Secondary

MeasureTime frameDescription
LDF90 daysThe 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.
WHOQOL-BREF90 daysA self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment.
PPG90 daysPhotoplethysmography(PPG), which is a non-invasive method used to detect blood volume changes in the microvascular bed of tissue
BPW90 daysBlood 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.
SPADI90 daysShoulder Pain and Disability Index (SPADI) is a 13-item patient completed instrument. Its categories include pain (5 items) and disability (8 items).

Contacts

Primary ContactMing Jen Wang, MD
wanters0800@gmail.com886-2-27093600
Backup ContactChao Zong Chen, MD
Leon.ccchen@gmail.com886-979306080

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026