Evaluating Effectiveness of Fu’s Subcutaneous Needling for the Pain Nature and Quality of Life in Patients with Knee Osteoarthritis: A Study Protocol of Randomized Clinical Trial
Bibliographic record
Abstract
Po-En Chiu,1,2,* Zhonghua Fu,3,* Guan-Wei Jian,4,5 Ching-Hsuan Huang,2,6 Te-Mao Li,2 Li-Wei Chou7– 9 1Department of Chinese Medicine, Chang Bing Show Chwan Memorial Hospital, Changhua, Taiwan; 2School of Chinese Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan; 3Institute of Fu’s Subcutaneous Needling, Beijing University of Chinese Medicine, Beijing, People’s Republic of China; 4Graduate Institute of Acupuncture Science, China Medical University, Taichung, Taiwan; 5Department of Chinese Medicine, Sinying Hospital, Ministry of Health and Welfare, Tainan, Taiwan; 6Department of Chinese Traumatology Medicine, China Medical University Hospital, Taichung, Taiwan; 7Department of Physical Medicine and Rehabilitation, China Medical University Hospital, Taichung, Taiwan; 8Department of Physical Therapy and Graduate Institute of Rehabilitation Science, China Medical University, Taichung, Taiwan; 9Department of Physical Medicine and Rehabilitation, Asia University Hospital, Asia University, Taichung, Taiwan*These authors contributed equally to this workCorrespondence: Li-Wei ChouDepartment of Physical Medicine and Rehabilitation, China Medical University Hospital, No. 2 Yuh-Der Road, Taichung, 40447, TaiwanTel +886-4-22052121-2381Fax +886-4-22026041Email chouliwe@gmail.comBackground: Knee osteoarthritis (OA) is a common clinical disease. Knee pain is the major symptom of knee OA and the primary reason why patients seek treatment. Fu’s subcutaneous needling (FSN) has been used to treat knee OA for more than 20 years. However, the establishment of treatment methods and rigorous evaluation of FSN’s efficacy are still lacking. A randomized single-blind clinical trial will be conducted to evaluate whether FSN treatment can immediately alleviate pain due to knee OA surrounding the patella and the curative effective of 1-week and 2-week treatments. In addition, the feasibility and initial effect of FSN treatment for patients with knee OA will be discussed.Materials and Methods: Patients with confirmed knee OA, as diagnosed by doctors using X-ray films or from clinical symptoms, who are over 50 years old will be participants recruited. They will be randomly assigned either FSN treatment or transcutaneous electrical nerve stimulation treatment. In addition, their pressure pain threshold, muscle tone of lower leg muscle, and physical ability will be measured. Participants will be asked to complete the questionnaires of Western Ontario and McMaster Universities Osteoarthritis Index and Lequesne’ index as the measurements for quality of life.Results: The findings of this study will reveal whether FSN or transcutaneous electrical nerve stimulation is clinically efficacious for treating pain due to knee OA, with respect to muscle stiffness, gait, dynamic balance, the pressure pain threshold, and quality of life before and after treatment.Study Registration: This study is approved by the Research Ethics Committee of China Medical University & Hospital, Taichung, Taiwan (CMUH107-REC3-027) and registered at the ClinicalTrials.gov Protocol Registration and Results System (registration number NCT04356651).Keywords: dry needling, Fu’s subcutaneous needling, knee osteoarthritis, myofascial trigger point, tightened muscle
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.017 | 0.012 |
| Meta-epidemiology (narrow) | 0.004 | 0.001 |
| Meta-epidemiology (broad) | 0.009 | 0.006 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.017 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".