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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frozen Shoulder
• Intervention / Treatment: Other: Standard treatment; Procedure: Small Needle-Knife

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Jen Wang, MD; Phone Number: 5213 886-2-27093600; Email: wanters0800@gmail.com
• Study Contact Backup: Name: Chao Zong Chen, MD; Phone Number: 886-979306080; Email: Leon.ccchen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Small Needle-Knife; 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.	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 Names: Acupotomy
Active Comparator: Standard treatment; 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.	Other: Standard treatment; Standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain VAS	The intensity of the pain along a continuum from 'no pain' to 'worst pain' imaginable with visual analog scale.	90 days
ROM	Glenohumeral range of motion(ROM) of the affected shoulder.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
PPG	Photoplethysmography(PPG), which is a non-invasive method used to detect blood volume changes in the microvascular bed of tissue	90 days

Collaborators and Investigators

• Sponsor: Taipei City Hospital
• Collaborators: National Yang Ming Chiao Tung University; National Taiwan University of Science and Technology
• Investigators: Principal Investigator: Ming Jen Wang, MD, Taipei City Hospital, Renai Branch, Chinese Medicine Department

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Photoplethysmography; Adhesive Capsulitis; Frozen Shoulder; Laser Doppler Flowmetry; Acupotomy; Small Needle-Knife; Blood Pressure Waveform
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: TCHIRB-11206008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No