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

Traditional Mongolian Medicine Bone-Setting Versus Open Reduction and Internal Fixation for Humeral Surgical Neck Fracture: A Prospective Non-Randomized Comparative Cohort Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07769398
Enrollment
60
Registered
2026-08-18
Start date
2025-06-30
Completion date
2026-05-31
Last updated
2026-08-18

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

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

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.

Detailed description

This was a prospective, single-center, non-randomized comparative study conducted at the Inner Mongolia International Mongolian Medicine Hospital, Hohhot, Inner Mongolia, China. Sixty adults with radiographically confirmed Neer 2-part humeral surgical neck fracture were included, with 30 receiving Traditional Mongolian Medicine bone-setting and 30 undergoing open reduction and internal fixation surgery. Treatment selection was based on patient preference and clinical judgement. The Traditional Mongolian Medicine bone-setting intervention consisted of closed manual reduction followed by external fixation using wooden splints, pressure padding, and bandage ties. Post-fixation assessment included evaluation of distal circulation, skin condition, sensation, pain, and swelling, followed by radiographic confirmation of fracture alignment. No herbal paste, botanical preparation, alcohol-based spray or rub, or other topical medicinal preparation was administered as part of the study intervention. The comparator was open reduction and internal fixation using locking plate fixation with postoperative rehabilitation. Participants were followed for 6 months. The study evaluated longitudinal differences in pain and shoulder function between the two treatment groups.

Interventions

OTHERTraditional Mongolian Medicine Bone-Setting

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.

PROCEDUREOpen Reduction and Internal Fixation

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.

Sponsors

Mongolian National University of Medical Sciences
Lead SponsorOTHER
The Affiliated Hospital of Inner Mongolia Medical University
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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,

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Mean Visual Analogue Scale Pain Score1 month, 3 months, and 6 months post-treatmentShoulder 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.
Mean Constant-Murley Total Score1 month, 3 months, and 6 months post-treatmentShoulder 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026