An interventional study of Traditional Mongolian Medicine Bone-Setting and Open Reduction and Internal Fixation in Proximal Humerus Fracture, sponsored by Mongolian National University of Medical Sciences. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Mongolian National University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
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.
105 studies on the registry are indexed under Humeral Fractures; 19 are open to participants now.
This study's enrollment of 60 is close to the median of 55 across 63 interventional studies indexed under Humeral Fractures.
Browse Humeral Fractures studies →Mongolian National University of Medical Sciences is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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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
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
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 of the humeral surgical neck fracture using a proximal humerus locking plate system under general anesthesia, followed by routine postoperative care and progressive rehabilitation.
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.
Time frame: 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.
Time frame: 1 month, 3 months, and 6 months post-treatment
Plan to share: Yes — De-identified individual participant data underlying the results reported in the primary publication will be made available to qualified researchers upon reasonable request, subject to applicable ethical, privacy, and institutional requirements.
Supporting information: 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.
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Mongolian National University of Medical Sciences