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The Effect of Auricular Directional Magnetotherapy in the Treatment of Occupational Cervical Insomnia: a Randomized, Placebo-Controlled Trial.

The Effect of Auricular Directional Magnetotherapy in the Treatment of Occupational Cervical Insomnia: a Randomized, Placebo-Controlled Trial.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002722
Enrollment
Unknown
Registered
2019-10-29
Start date
2019-12-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Occupational cervical insomnia

Interventions

Sponsors

Tianjin Occupational Diseases Precaution and Therapeutic Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 55 Years

Inclusion criteria

Inclusion criteria: Diagnostic Criteria According to Guide of Grading Diagnosis and Treatment of Cervical Spondylosis in Anhui Province (2016 Edition), all patients will be examined with X-ray, CT, MRI and TCD of cervical spine in or out of the hospital, and diagnosed as "cervical spondylosis" or "cervical degenerative change" in combination with clinical manifestations. Refer to the diagnosis basis of insomnia in Clinical Practice Guide of Insomnia in Traditional Chinese Medicine (WHO / WPO, 2016 Edition) and Diagnostic & Efficacy Standard of Medical Diseases in Traditional Chinese Medicine (ZY/T001.1-94, 2016 Edition) . Refer to the diagnosis basis of insomnia in Chinese Classification of Mental Disorders-3 (CCMD-3): Insomnia is the main symptom of the patients, secondary to difficulty in falling asleep and light sleep, easy to wake up and dreamy, early wake-up and not easy to sleep again after wake-up, discomfort after wake-up and daytime fatigue, often accompanied by anxiety, fidgety, and sweating, resulting in the decline of the efficiency of mental activities, hindering social functions. The course standard is at least 3 times a week and lasts at least 1 month, and secondary insomnia caused by organic and mental disorders is excluded. Patients with headache, dizziness, palpitation and chest distress, shoud be combined with ECG, B ultrasound, brain CT or MRI examination to eliminate the primary cardiovascular and cerebrovascular diseases. Inclusion Criteria 1. Those who meet diagnostic criteria above. 2. Employees and freelancers aged 25-55 years old, regardless of gender, who need long-term bend over desk, forward leaning seat and video terminal operation. 3. One of the main clinical manifestations was insomnia, without or only with mild to moderate neck shoulder backache, numbness of upper limbs, dizziness, chest distress, retching, etc.. 4. According to the Pittsburgh Sleep Quality Index (PSQI), the total score is more than 7, that is, insomnia patients who are difficult to self-healing. 5. The patient is willing to participate in the trial, the family members have no objection and assist the patient to cooperate with the treatment, and sign the informed consent. 6. Those who had received other treatment before admission to the group were given a elution period of no less than one week.

Exclusion criteria

Exclusion criteria: 1. The underage and the middle-aged and old people who have the related symptoms due to the overuse of computers, TVs, smartphones, iPads and other causes of poor sitting and lying posture. 2. Patients with cervical spondylotic myelopathy, cervical trauma and operation history, congenital abnormality of spine, nerve function defect and systemic osteoarthropathy. 3. Each type of cervical spondylosis is accompanied by severe symptoms such as pain, limb numbness and dizziness, which should be treated as the main treatment direction, and insomnia as the secondary symptoms. (If above symptoms are relieved after treatment and insomnia is not relieved, they can be included again.) 4. Patients who suffer from ischemic cerebrovascular disease (including TIA) due to insufficient blood supply of carotid / vertebrobasilar system, or other systemic diseases such as heart disease, hypertension, diabetes, hyperthyroidism, hematopathy, tumor and so on, thus affecting sleep. 5. Patients with mental illness, or those who are confronted with personal, family and social negative stimulation recently. 6. Auricle deformity, or eczema, herpes, trauma, frostbite, abscess and ulceration in skin of acupoint area. 7. Those who are allergic to magnetic and metal materials, or intolerant to sticking stimulation. 8. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI);

Secondary

MeasureTime frame
the MOS item short from health survey (SF-36);

Countries

China

Contacts

Public ContactBin Liu

Tianjin Occupational Diseases Precaution and Therapeutic Hospital

13002240798@163.com+86 13002240798

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026