Effect of Acupuncture Intervention on Chronic Musculoskeletal Pain in Hemodialysis-Dependent Kidney Failure Patients: Study Protocol for a Randomized Controlled Clinical Trial
Bibliographic record
Abstract
Cuina Yan,1 Hui-Rong Liu,2 Qi Kong,1 Jia-Yi Gan,3 Kun Liu,4 Wei-Guo Yao,4 Xing-Mei Yao1 1Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 2Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 3Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 4Jinshan Branch of Shanghai Sixth People’s Hospital, Shanghai, People’s Republic of ChinaCorrespondence: Xing-Mei Yao, Putuo Hospital, Shanghai University of Traditional Chinese Medicine, No. 164 Lanxi Road, Putuo District, Shanghai, 200062, People’s Republic of China, Email yao.xingmei@163.com Wei-Guo Yao, Jinshan Branch of Shanghai Sixth People’s Hospital, No. 147, Jiankang Road, JinShan District, Shanghai, 201599, People’s Republic of China, Email saynever2004@163.comBackground: Chronic musculoskeletal pain is prevalent in individuals with hemodialysis-dependent renal failure (HDKF). The current opioid crisis highlights the urgent need for effective non-pharmacological pain management. Acupuncture, identified as a non-pharmacological intervention in clinical settings, holds promise for alleviating chronic musculoskeletal pain in HDKF patients, but well-designed studies assessing its specific effects in this population are lacking. This study aims to comprehensively evaluate the efficacy and safety of acupuncture as a treatment modality for HDKF patients with chronic musculoskeletal pain.Methods: This trial, conducted at a single center, follows a parallel, three-arm design with randomization and sham control. 90 hDKF patients with chronic musculoskeletal pain will be assigned randomly to three groups (acupuncture, sham acupuncture, and waiting-list control) in a 1:1:1 ratio. The acupuncture and sham acupuncture groups will undergo 24 treatment sessions over eight weeks, while the waiting-list control group will receive no acupuncture. The primary outcome measures changes in the Numeric Rating Scale (NRS) score from baseline at the end of treatment, with secondary outcomes including the Edmonton Symptom Assessment System (revised version) (ESAS-r), Palliative care Outcome Scale (rental) (POS-renal), and hospital anxiety and depression scale (HADS). Adverse events will be recorded throughout the study, and all randomized patients will be included in the intention-to-treat analysis.Discussion: The outcomes of this research aim to advance the systematic management of chronic musculoskeletal pain in HDKF patients through non-pharmacological interventions. Moreover, it will contribute insights into personalized treatment strategies, integrating individual expectations and genetic biomarkers to provide “precision” acupuncture for HDKF patients experiencing chronic musculoskeletal pain.Trial Registration: The trial registration number is ChiCTR2400080488. This trial was prospectively registered on 30 January 2024 in the Chinese Clinical Trial Registry.Keywords: acupuncture, HDKF, pain, clinical trial
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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 | 0.012 | 0.013 |
| Meta-epidemiology (narrow) | 0.006 | 0.002 |
| Meta-epidemiology (broad) | 0.013 | 0.006 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.005 | 0.005 |
| Insufficient payload (model declined to judge) | 0.050 | 0.006 |
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".