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Manipulation Under Anesthesia for Treating Postoperative Elbow Stiffness: A Randomized Controlled Trial

Manipulation Under Anesthesia for Treating Postoperative Elbow Stiffness: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109445
Enrollment
Unknown
Registered
2025-09-18
Start date
2021-03-26
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Postoperative Elbow Stiffnes

Interventions

Manipulation under anesthesia combined with rehabilitation therapy:Patients randomly assigned to the intervention group will undergo manual release under anesthesia for elbow stiffness (MUA), followed

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years (with skeletal maturity), with no upper age limit, provided the patient meets medical criteria for anesthesia tolerance. 2. History of acute elbow fractures (including distal humerus, proximal ulna [olecranon], and/or proximal radius [radial head/neck] fractures) treated with open reduction and internal fixation (ORIF), which may be accompanied by elbow dislocation. Documentation of the fracture and surgical procedure (operative reports, imaging records) must be provided. 3. Persistent restricted range of motion (ROM) 3–6 months post-ORIF, defined as a flexion-extension arc 30° and/or flexion 30°). Written records must confirm ROM deficits despite standardized rehabilitation therapy. 4. Radiographic evidence of fracture union or stable fixation (no hardware loosening) 3–6 months post-ORIF, ensuring the safety of manipulative release procedures. 5. Stiffness causing difficulty in performing daily activities (e.g., inability to reach the head, eat, or maintain perineal hygiene), with baseline functional disability scores (e.g., DASH questionnaire) documented. 6. Willingness to provide informed consent, comply with the trial protocol (including randomization and rehabilitation plans), understand the intervention, and commit to 1-year follow-up.

Exclusion criteria

Exclusion criteria: 1. Imaging reveals extensive periarticular ossification bridges or severe motion restriction (requiring surgical excision). 2. Presence of bony block (e.g., complete joint ankylosis) or mechanical impingement from internal fixation devices limiting mobility (requiring surgical release). 3. Imaging-confirmed nonunion of fractures or failure/loosening of internal fixation. 4. Clinical assessment indicates significant instability (e.g., ligament injury causing subluxation/dislocation). 5. History of elbow release surgery or manipulative release following ORIF (open reduction internal fixation). 6. Moderate-to-severe ulnar neuropathy or other surgically indicated nerve injuries (mild sensory abnormalities require cautious evaluation). 7. Active infection in the affected elbow (e.g., septic arthritis); chronic infections in remission require case-by-case assessment. 8. Severe underlying conditions precluding anesthesia tolerance (e.g., unstable cardiac disease, uncontrolled hypertension). 9. Pregnancy (due to anesthesia and imaging contraindications); preoperative pregnancy testing required for women of childbearing age. 10. Inability to complete rehabilitation or follow-up (e.g., remote residence, psychiatric/cognitive impairment affecting compliance). Prisoners or others unable to guarantee follow-up are also excluded.

Design outcomes

Primary

MeasureTime frame
Percentage of ROM recovery;

Secondary

MeasureTime frame
ROM of elbow;VAS;Strength Test;

Countries

China

Contacts

Public ContactHuang Lihua

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

huanglihua906@163.com+86 189 3975 9175

Outcome results

None listed

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