Osteonecrosis of the femoral head Musculoskeletal Diseases
Conditions
Interventions
Participants in both the trial and control groups will receive treatment at the same frequency and duration: twice per week with a 2–3-day interval between sessions, over a period of 4 weeks, for a to
sizes: 0.35×40 mm and 0.35×75 mm
Womeda Medical Device Technology Co., Ltd., Suzhou) will be inserted into the designated acupoints to a depth of 30–45 mm. EA equipment will adopt the HANS acupoint nerve stimulator (model HANS-200E,
Sponsors
Luoyang Orthopedic-Traumatological Hospital of Henan Province
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for ONFH 2. Aged between 20 and 65 years, inclusive 3. No surgery anticipated or planned within the next 4 months 4. History of ONFH-related pain persisting for more than 3 months 5. Target hip visual analog scale (VAS) score =40 mm, with the contralateral hip score being lower than that of the target hip. The target hip is defined as the affected side in cases of unilateral ONFH, and as the hip with the higher pre-randomization VAS score in bilateral ONFH 6. Willingness to participate in the study and provision of signed informed consent
Exclusion criteria
Exclusion criteria: 1. Presence of systemic or local conditions that may interfere with the assessment of ONFH-related pain or hip function, including systemic joint disorders (e.g., rheumatoid arthritis), chronic inflammatory or connective tissue diseases, other hip pathologies (e.g., developmental dysplasia of the hip), lumbar spine disorders (e.g., lumbar disc herniation), or any other condition that may impact efficacy evaluation 2. Combination of serious organic diseases (e.g., serious cardiovascular and cerebrovascular diseases, tumors), diagnosed psychiatric disorders (e.g., anxiety disorders), or intellectual disability 3. Previous experience with EA for any indication 4. History of total hip arthroplasty on the affected side, or any surgical intervention on the target hip (e.g., hip-preserving surgery) within 12 months prior to screening 5. Any acupuncture-related therapy (e.g., acupuncture, moxibustion) or shockwave therapy applied to the target hip within 3 months before screening 6. History of invasive interventions (e.g., intra-articular injection) to the target hip within 6 months prior to screening 7. Pregnant or lactating women, or women planning to conceive within the next 4 months 8. Known or suspected history of needle syncope (needle phobia) 9. Known or suspected metal allergy 10. Currently undergoing corticosteroid treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants with a clinically meaningful reduction in pain at the end of treatment (Week 4 ± 1 day). A clinically meaningful reduction is defined as a decrease of =20 mm or =33% from baseline on a 0–100 mm Visual Analog Scale (VAS). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain intensity measured using the 0–100 mm VAS score at baseline, Week 4, Week 8, Week 12, and Week 16. 2. The proportion of participants achieving clinically significant pain improvement (=20 mm or =33% reduction from baseline on the 0–100 mm VAS score, calculated from raw VAS data) at Week 8, Week 12, and Week 16. 3. Function of the target hip evaluated using the modified Harris Hip Score (mHHS) at baseline, Week 4, Week 8, Week 12, and Week 16. 4. Pain sensitization assessed through Pressure Pain Threshold (PPT) and Temporal Summation (TS) testing at baseline, Week 4, Week 8, Week 12, and Week 16. 5. Psychological status, assessed using validated questionnaires at baseline, Week 4, Week 8, Week 12, and Week 16: 5.1. Depression severity measured using the Patient Health Questionnaire-9 (PHQ-9). 5.2. Anxiety symptoms measured using the Generalized Anxiety Disorder-7 (GAD-7). 5.3. Pain-related cognitive-emotional exaggeration measured using the Pain Catastrophizing Scale (PCS). 5.4. Confidence in managing pain measured using the Pain Self-Efficacy Questionnaire (PSEQ). 6. Health-related quality of life evaluated using the 12-item Short Form Health Survey (SF-12) at baseline, Week 4, Week 8, Week 12, and Week 16. Added 17/09/2025: 7. Frequency of rescue analgesic medication use: The frequency and dosage of analgesic medication (Celecoxib) taken by participants will be recorded. Data will be collected at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. 8. Incidence of adverse events (AEs): The number and proportion of participants experiencing adverse events (e.g., dizziness, local pain at the needling site, bleeding, and, in rare cases, infection or skin irritation) will be recorded. Safety data will be monitored continuously and summarized at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Causality with the intervention will be assessed by the investigators. | — |
Countries
China
Contacts
Public ContactZhipeng Li
Outcome results
None listed