Effect of Acupuncture on Chronic Nonspecific Neck Pain and Insomnia

N/ANot Yet RecruitingNCT06996210

Guang'anmen Hospital of China Academy of Chinese Medical Sciences124 enrolled

Overview

The study aims to assess the efficacy and safety of acupuncture among patients with chronic nonspecific neck pain and insomnia, compared with sham acupuncture.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

124

Conditions

Neck Pain Chronic Insomnia Chronic

Interventions

AcupunctureDEVICE

The needles will be inserted to 12.5-30 mm in acupoints through adhesive pads. Needles will be lifted, thrusted and twirled gently for 3 times to achieve deqi sensation and manipulated every ten minutes.

sham acupunctureDEVICE

The needle will be inserted to 2-3mm in sham Baihui acupoint. For the remaining sham acupoints, needles will be inserted into the pad and reaching the skin. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effect of the needle tip penetrating the skin.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18 to 75 years old; 2. Meet the diagnostic criteria for both chronic nonspecific neck pain and chronic insomnia; 3. The patient's average 24-hour overall neck pain intensity score on the NRS is ≥3; 4. The patient's Insomnia Severity Index (ISI) score is ≥10; 5. The patient is willing to participate in the study and has signed the informed consent form. Exclusion Criteria: 1. Specific neck pain with a clear etiology, including trauma, tumor, connective tissue disease, rheumatic disease, metabolic and endocrine disorders, neuropathy, spinal cord disease, fracture, or vertebral misalignment; 2. Positive Spurling test, neck flexion test, upper limb traction test, or foraminal distraction test. Neck pain accompanied by radiating pain in the upper limbs or radicular compression symptoms, or acute exacerbation of neck pain; 3. Neck pain accompanied by sensory disturbances or other neurological symptoms, or ankylosis of the facet joints; 4. Previous history of cervical spine surgery; 5. Previous history of head and neck trauma, such as whiplash injury; 6. Insomnia caused by medications (e.g., caffeine, corticosteroids), withdrawal reactions, or other underlying conditions (e.g., hyperthyroidism, severe anxiety/depressive disorders); 7. Long-term use of analgesics, muscle relaxants, or hormones, or presence of other pain more severe than neck pain; 8. Other sleep disorders, such as sleep apnea syndrome, or shift workers; 9. Presence of psychiatric disorders (e.g., depression), cognitive impairment, or language disorders; 10. Patients with drug dependency; 11. Received acupuncture treatment within the past month; 12. Severe cardiovascular, hepatic, renal, hematologic, autoimmune diseases, infectious diseases, poor general nutritional status, malignancy, or patients in the terminal stage of severe illness; 13. Pregnant or planning to become pregnant within the next year, breastfeeding, or postpartum ≤12 months.

Outcomes

Primary Outcomes

The change in average 24h overall neck pain intensity measured by NRS from baseline over the past week

The NRS score ranges from 0 to 10, with higher scores indicating more severe pain.

Time frame: week 5

The change from baseline in the Chinese version of the Insomnia Severity Index (ISI-C) scores.

The Chinese version of the Insomnia Severity Index (ISI-C) will be used to assess the severity of patients' self-perceived insomnia symptoms. Each item is rated on a scale from 0 to 4, with a total score ranging from 0 to 28. Based on the total score, the severity of insomnia can be categorized into four levels: a score of 0-7 indicates "no clinically significant insomnia," 8-14 indicates "subclinical insomnia," 15-21 indicates "clinical insomnia (moderate)," and 22-28 indicates "clinical insomnia (severe)."

Time frame: week 5

Secondary Outcomes

The change in average 24h overall neck pain intensity measured by NRS from baseline over the past week

The NRS score ranges from 0 to 10, with higher scores indicating more severe pain.

Time frame: week 9 and 16

The change from baseline in the ISI-C scores.

The ISI-C will be used to assess the severity of patients' self-perceived insomnia symptoms. Each item is rated on a scale from 0 to 4, with a total score ranging from 0 to 28. Based on the total score, the severity of insomnia can be categorized into four levels: a score of 0-7 indicates "no clinically significant insomnia," 8-14 indicates "subclinical insomnia," 15-21 indicates "clinical insomnia (moderate)," and 22-28 indicates "clinical insomnia (severe)."

Time frame: week 9 and 16

The proportion of participants with at least 30% reduction in NRS scores from baseline

The NRS score ranges from 0 to 10, with higher scores indicating more severe pain.

Central Contacts

Zhishun Liu

CONTACT

+861088002331 zhishunjournal@163.com

SIXING LIU

CONTACT

+8613521617871 sixingliu@sina.cn

Data from ClinicalTrials.gov

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