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The safety and effectiveness of HK.SWT-007 shock wave therapy machine in the treatment of hip joint pain caused by femoral head necrosis

The safety and effectiveness of shock wave in the treatment of hip joint pain caused by femoral head necrosis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047844
Enrollment
Unknown
Registered
2021-06-27
Start date
2021-06-21
Completion date
Unknown
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip joint pain caused by femoral head necrosis

Interventions

Test group:Shock wave therapy

Sponsors

Third Medical Center of the Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Diagnosis of femoral head necrosis ARCO stage I-IV by MRI image results, MRI image results within 4 weeks before the screening period are available; 3. Unwilling to accept surgical treatment, agree not to use non-study treatments related to hip pain during the study, such as drugs and other physical therapy not related to the trial; 4. Voluntarily participate in this clinical trial, abide by the requirements of this clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe heart disease, arrhythmia and high blood pressure; 2. A pacemaker is installed; 3. Patients with coagulation dysfunction of uncured bleeding diseases; 4. Use of anti-immune agents; 5. Various tumor patients on the shock wave path; 6. Patients with thrombosis on the shock wave path; 7. Pregnant women; 8. Patients with local infection and skin ulceration at the incident site of the shock wave; 9. Patients with joint fluid leakage; 10. The investigator determines that it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Harris score increase;

Secondary

MeasureTime frame
Harris score improvement value;VAS pain score improvement value;WOMAC score improvement value;SF-36 score improvement value;

Countries

China

Contacts

Public ContactXing Gengyan

Chinese People's Liberation Army General Hospital

XGY1350138@163.com+86 13501384316

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026