Outcomes of Frozen Shoulder Treated With Small Needle-Knife Through Microcirculation and Pulse Analysis.
- Conditions
- Frozen Shoulder
- Interventions
- Procedure: Small Needle-KnifeOther: Standard treatment
- Registration Number
- NCT06139276
- Lead Sponsor
- Taipei City Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Small Needle-Knife 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. Standard treatment 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.
- Primary Outcome Measures
Name Time Method Pain VAS 90 days The intensity of the pain along a continuum from 'no pain' to 'worst pain' imaginable with visual analog scale.
ROM 90 days Glenohumeral range of motion(ROM) of the affected shoulder.
- Secondary Outcome Measures
Name Time Method BPW 90 days 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.
LDF 90 days 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.
WHOQOL-BREF 90 days A self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment.
SPADI 90 days Shoulder Pain and Disability Index (SPADI) is a 13-item patient completed instrument. Its categories include "pain" (5 items) and "disability" (8 items).
PPG 90 days Photoplethysmography(PPG), which is a non-invasive method used to detect blood volume changes in the microvascular bed of tissue