Effect of Acupuncture on Chronic Nonspecific Neck Pain and Insomnia

NCT ID: NCT06996210

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-03-27

Brief Summary

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

Conditions

Neck Pain Chronic; Insomnia Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

acupuncture group

Participants in the acupuncture group will receive treatment at DU 20 [Baihui], EX-HN15 [Jingbailao], GB 12 [Wangu], Shangyintang (On the head, 1 B-cun superior to Yintang), HT7 [Shenmen], KI 3 [Taixi] and Ashi Point.

The treatment will last 30 minutes for each session, 3 sessions per week (ideally every other day) for a succession of 4 weeks.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: DEVICE

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 acupuncture (SA) group

Participants in the SA group will receive treatment at sham DU 20, sham EX-sham HN15, sham GB 12, sham Shangyintang , sham HT7 and sham KI 3. The treatment will last 30 minutes for each session, 3 sessions per week (ideally every other day) for a succession of 4 weeks.

Group Type: SHAM_COMPARATOR

sham acupuncture

Intervention Type: DEVICE

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.

Interventions

Acupuncture

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.

Intervention Type: DEVICE

sham acupuncture

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing University of Chinese Medicine

OTHER

Sponsor Role: collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Liu Zhishun

professer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhishun Liu

Role: PRINCIPAL_INVESTIGATOR

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Guangxia Shi

Role: PRINCIPAL_INVESTIGATOR

Beijing University of Chinese Meidicine

Central Contacts

Zhishun Liu

Role: CONTACT

zhishunjournal@163.com

+861088002331

SIXING LIU

Role: CONTACT

sixingliu@sina.cn

+8613521617871

Other Identifiers

2025-090-KY

Identifier Type: -

Identifier Source: org_study_id