Outcomes of a Specially Designed Needle (Small Needle-Knife) Treating Frozen Shoulder Based on Analysis of Microcirculation and Pulse Changes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Taipei City Hospital
- Enrollment
- 120
- Primary Endpoint
- Pain VAS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Small Needle-Knife (Procedure)
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.
Intervention: Standard treatment (Other)
Outcomes
Primary Outcomes
Pain VAS
Time Frame: 90 days
The intensity of the pain along a continuum from 'no pain' to 'worst pain' imaginable with visual analog scale.
ROM
Time Frame: 90 days
Glenohumeral range of motion(ROM) of the affected shoulder.
Secondary Outcomes
- BPW(90 days)
- WHOQOL-BREF(90 days)
- SPADI(90 days)
- LDF(90 days)
- PPG(90 days)