Observation on the curative effect of transcutaneous acupoint electrical stimulation in preventing and treating disuse osteoporosis and muscle atrophy in patients with immobilization after foot and ankle injury

Phase 1

Recruiting

• Conditions: Disuse osteoporosis

• Registration Number: ITMCTR2100004478
• Lead Sponsor: Beijing Luhe Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnostic criteria
Key points for the diagnosis of foot and ankle injury:
(1) Imaging and related diagnoses are fractures of the distal tibia, fibula, talus, metatarsal, etc., for patients who require bed immobilization after surgery or have undergone external fixation;
(2) Due to medical conditions, the affected foot cannot bear weight early.
(3) Exclude other causes or drugs that affect bone metabolism and cause foot and ankle injuries.
2. Inclusion criteria
(1) Comply with the above-mentioned diagnostic essentials and braking needs for foot and ankle injuries;
(2) No history of serious digestive system disease, kidney disease, connective tissue disease, malignant tumor, and no history of other diseases affecting bone metabolism;
(3) Age compliance: 18 years old <= age <40 years old;
(4) Recruiting patients with clear consciousness, no mental disorders, and no serious heart, liver, or kidney diseases;
(5) Sign the informed consent and voluntarily participate in this experiment.
(6) Internal fixation of the fracture should not exceed 15cm above the ankle.

Exclusion Criteria

(1) Combined with endocrine diseases that affect bone metabolism (thyroid, parathyroid, gonadal and adrenal diseases, etc.), immune diseases such as rheumatoid arthritis, and digestive tract, liver and kidney diseases that affect calcium and vitamin D absorption, frequently Malignant diseases such as sexual myeloma.
(2) Long-term use of glucocorticoids, antiepileptic drugs, estrogen, heparin, progesterone and other drugs that affect bone metabolism, various congenital and acquired bone metabolism disorders.
(3) Those who take calcium, calcitonin, vitamin D and other drugs that affect bone metabolism within 30 days.
(4) Those with physical disabilities or severe infections, those with pathological, old fractures or other fractures, and those with severe heart, liver, kidney, lung, blood, and endocrine system diseases.
(5) Pregnant and lactating women.
(6) Those who have a stent placed in the body or have a history of joint replacement.
(7) Patients with known heart diseases and patients with pacemakers.
(8) Patients who have been treated with this study protocol in the past 30 days.
(9) People with allergies, poor compliance or mental disorders who cannot cooperate with this research.
(10) Newly diagnosed patients requiring calcium intervention treatment.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skeletal muscle echo intensity value;Ultrasound skeletal muscle image and cross-sectional area;Skeletal muscle thickness;Bone Metabolism Markers;Skeletal muscle echo intensity value;

Secondary Outcome Measures

Name	Time	Method
Skeletal muscle circumference;Bone density;Skeletal muscle circumference;