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

Frozen Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06139276
• Other study ID #: TCHIRB-11206008
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Taipei City Hospital
• Contact: Ming Jen Wang, MD
• Phone: 886-2-27093600
• Email: wanters0800[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder

Intervention

Procedure:
• Small 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.

Other:
• Standard treatment
Standard treatment

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Taipei City Hospital	National Taiwan University of Science and Technology, National Yang Ming Chiao Tung University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain VAS	The intensity of the pain along a continuum from 'no pain' to 'worst pain' imaginable with visual analog scale.	90 days
Primary	ROM	Glenohumeral range of motion(ROM) of the affected shoulder.	90 days
Secondary	WHOQOL-BREF	A self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment.	90 days
Secondary	SPADI	Shoulder Pain and Disability Index (SPADI) is a 13-item patient completed instrument. Its categories include "pain" (5 items) and "disability" (8 items).	90 days
Secondary	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.	90 days
Secondary	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.	90 days
Secondary	PPG	Photoplethysmography(PPG), which is a non-invasive method used to detect blood volume changes in the microvascular bed of tissue	90 days