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NCT Number: NCT07769398

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

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.

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Key information

Conditions

Proximal Humerus Fracture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Scientific Research, International Mongolian Medicine Hospital

Hohhot, Inner Mongolia, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Mean Visual Analogue Scale Pain Score

    Time frame: 1 month, 3 months, and 6 months post-treatment

    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.

  2. Mean Constant-Murley Total Score

    Time frame: 1 month, 3 months, and 6 months post-treatment

    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.

Sponsors and collaborators

Lead sponsor

Mongolian National University of Medical Sciences

Other

Collaborators

  • The Affiliated Hospital of Inner Mongolia Medical University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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