Clinical trial NCT06139276: Outcomes of Frozen Shoulder Treated With Small Needle-Knife Through Microcirculation and Pulse Analysis.
Official title: Outcomes of a Specially Designed Needle (Small Needle-Knife) Treating Frozen Shoulder Based on Analysis of Microcirculation and Pulse Changes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frozen Shoulder
Keywords: Frozen Shoulder
Acupotomy
Small Needle-Knife
Adhesive Capsulitis
Laser Doppler Flowmetry
Photoplethysmography
Blood Pressure Waveform
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National Taiwan University of Science and Technology
name: National Yang Ming Chiao Tung University
First posted: 2023-11-18
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain VAS
timeFrame: 90 days
measure: ROM
timeFrame: 90 days
Secondary outcomes:
measure: WHOQOL-BREF
timeFrame: 90 days
measure: SPADI
timeFrame: 90 days
measure: LDF
timeFrame: 90 days
measure: BPW
timeFrame: 90 days
measure: PPG
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Taipei City Hospital, Renai Branch, Chinese Medicine Department
name: Ming Jen Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: