Traditional Mongolian Medicine Bone-Setting Versus Surgery for Humeral Surgical Neck Fracture

NCT07769398 | Completed

• 2 other identifiers: 24-25/10-012022YFC3501003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study was to compare Traditional Mongolian Medicine (TMM) bone-setting with open reduction and internal fixation (ORIF) surgery for adults with humeral surgical neck fracture. The study examined whether the two treatment approaches were associated with different patterns of pain relief and recovery of shoulder function during 6 months of follow-up. Participants received either TMM bone-setting or ORIF surgery. Treatment selection was based on patient preference and clinical judgement rather than random assignment. Researchers assessed pain and shoulder function at 1, 3, and 6 months after treatment using the Visual Analogue Scale for pain and the Constant-Murley shoulder score.

Conditions

Proximal Humerus Fracture

Keywords

Humeral Surgical Neck Fracture; Neer 2-Part Fracture; Traditional Mongolian Medicine; Bone-Setting; Open Reduction and Internal Fixation; Shoulder Function

Outcome Measures

Primary Outcomes (2)

• Mean Visual Analogue Scale Pain Score

  Shoulder pain was assessed using a 10-cm Visual Analogue Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Mean scores were compared between the two treatment groups at each follow-up assessment.

  1 month, 3 months, and 6 months post-treatment

• Mean Constant-Murley Total Score

  Shoulder function was assessed using the Constant-Murley score, ranging from 0 to 100 points. The score includes pain (0-15 points), activities of daily living (0-20), active range of motion (0-40), and abduction strength (0-25). Higher total scores indicate better shoulder function. Mean total scores were compared between treatment groups.

  1 month, 3 months, and 6 months post-treatment

Study Arms (2)

Traditional Mongolian Medicine Bone-Setting

EXPERIMENTAL

Participants received Traditional Mongolian Medicine bone-setting consisting of closed manual reduction followed by external fixation using wooden splints, pressure padding, and bandage ties. Post-fixation clinical assessment and radiographic confirmation of fracture alignment were performed. No herbal, botanical, alcohol-based, or other topical medicinal preparation was used.

Other: Traditional Mongolian Medicine Bone-Setting

Open Reduction and Internal Fixation

ACTIVE COMPARATOR

Participants underwent open reduction and internal fixation with proximal humerus locking plate fixation, followed by routine postoperative care and progressive rehabilitation.

Procedure: Open Reduction and Internal Fixation

Interventions

Traditional Mongolian Medicine Bone-Setting OTHER

Traditional Mongolian Medicine bone-setting consisted of closed manual reduction of the humeral surgical neck fracture followed by external fixation with wooden splints, pressure pads, and bandage ties. Splint placement and tightness were adjusted according to fracture alignment and the patient's clinical condition. After fixation, distal circulation, skin color and temperature, sensation, swelling, and pain were assessed, and fracture alignment was confirmed radiographically. No herbal paste, botanical preparation, alcohol-based spray or rub, or other topical medicinal preparation was used.

Traditional Mongolian Medicine Bone-Setting

Open Reduction and Internal Fixation PROCEDURE

Open reduction and internal fixation of the humeral surgical neck fracture using a proximal humerus locking plate system under general anesthesia, followed by routine postoperative care and progressive rehabilitation.

Open Reduction and Internal Fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older,
• Radiographically confirmed humeral surgical neck fracture (Neer 2-part),
• Presentation within 7 days of injury,
• Ability to provide informed consent,
• Willingness to comply with the follow-up schedule,

You may not qualify if:

• Open fracture,
• Pathological fracture, including fracture due to malignancy or metabolic bone disease,
• Ipsilateral upper-extremity fracture or injury requiring separate treatment,
• Previous fracture or surgery of the affected shoulder,
• Neurovascular injury requiring immediate surgical intervention,
• Cognitive impairment precluding informed consent or outcome assessment,
• Medical contraindication to either treatment modality, including active infection precluding surgery or a skin condition precluding splinting for TMM treatment

Sponsors & Collaborators

• Mongolian National University of Medical Sciences: lead
• The Affiliated Hospital of Inner Mongolia Medical University: collaborator

Study Sites (1)

Department of Scientific Research, International Mongolian Medicine Hospital

Hohhot, Inner Mongolia, China

Location

MeSH Terms

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 18, 2026
• Study Start: June 30, 2025
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication of the primary study results and available for 5 years.
• Access Criteria: Data will be available to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the corresponding author and study investigators for scientific merit, ethical appropriateness, and compliance with participant privacy requirements. Approved researchers may be required to sign a data-use agreement. Only de-identified data will be shared.

Locations

CN (1)