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

NCT06139276 | Unknown

• 1 other identifier: TCHIRB-11206008
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Frozen Shoulder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• WHOQOL-BREF

  90 days

• SPADI

  90 days

• LDF

  90 days

• BPW

  90 days

• PPG

  90 days

Study Arms (2)

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.

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.

Other: Standard treatment

Interventions

Small Needle-Knife PROCEDURE

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.

Also known as: Acupotomy

Small Needle-Knife

Standard treatment OTHER

Standard treatment

Standard treatment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei City Hospital: lead
• National Taiwan University of Science and Technology: collaborator
• National Yang Ming Chiao Tung University: collaborator

MeSH Terms

Conditions

Bursitis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ming Jen Wang, MD

  Taipei City Hospital, Renai Branch, Chinese Medicine Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Jen Wang, MD

CONTACT

886-2-27093600; wanters0800@gmail.com

Chao Zong Chen, MD

CONTACT

886-979306080; Leon.ccchen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share