An interventional study of Small Needle-Knife and Standard treatment in Frozen Shoulder, sponsored by Taipei City Hospital. Not yet recruiting. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Taipei City Hospital · Not applicable, Interventional, and Treatment
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.
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.
383 studies on the registry are indexed under Bursitis; 111 are open to participants now.
This study's planned enrollment of 120 is above the median of 44 across 346 interventional studies indexed under Bursitis.
Browse Bursitis studies →Taipei City Hospital is the lead sponsor of 57 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
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
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
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
Standard treatment
Pain VAS
The intensity of the pain along a continuum from 'no pain' to 'worst pain' imaginable with visual analog scale.
Time frame: 90 days
ROM
Glenohumeral range of motion(ROM) of the affected shoulder.
Time frame: 90 days
WHOQOL-BREF
A self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 90 days
PPG
Photoplethysmography(PPG), which is a non-invasive method used to detect blood volume changes in the microvascular bed of tissue
Time frame: 90 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2024; primary completion for Dec 2024, 11 months later.
Of 217 non-industry interventional studies with no phase under Bursitis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's planned 11 months is close to that.
Counting every sponsor, half of 217 studies reached it within 10 months; a quarter within 5 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Taipei City Hospital