Effect of Acupuncture on Chronic Nonspecific Neck Pain and Insomnia

NCT06996210 | Not Yet Recruiting

• 1 other identifier: 2025-090-KY
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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)."

  week 5

Secondary Outcomes (13)

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

  week 9 and 16

• The change from baseline in the ISI-C scores.

  week 9 and 16

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

  week 5, 9 and 16

• The proportion of participants with at least 6 points reduction in ISI-C scores from baseline

  week 5, 9 and 16

• The change from baseline in the total score of the Neck Disability Index (NDI).

  week 5, 9 and 16

Other Outcomes (2)

• Expectance assessment

  baseline

• Incidence of advers events

  through study completion, an average of 16 weeks

Study Arms (2)

acupuncture group

EXPERIMENTAL

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.

Device: Acupuncture

Sham acupuncture (SA) group

SHAM COMPARATOR

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.

Device: sham acupuncture

Interventions

Acupuncture 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.

acupuncture group

sham acupuncture 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.

Sham acupuncture (SA) group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years old;
• Meet the diagnostic criteria for both chronic nonspecific neck pain and chronic insomnia;
• The patient's average 24-hour overall neck pain intensity score on the NRS is ≥3;
• The patient's Insomnia Severity Index (ISI) score is ≥10;
• The patient is willing to participate in the study and has signed the informed consent form.

You may not qualify if:

• 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;
• 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;
• Neck pain accompanied by sensory disturbances or other neurological symptoms, or ankylosis of the facet joints;
• Previous history of cervical spine surgery;
• Previous history of head and neck trauma, such as whiplash injury;
• Insomnia caused by medications (e.g., caffeine, corticosteroids), withdrawal reactions, or other underlying conditions (e.g., hyperthyroidism, severe anxiety/depressive disorders);
• Long-term use of analgesics, muscle relaxants, or hormones, or presence of other pain more severe than neck pain;
• Other sleep disorders, such as sleep apnea syndrome, or shift workers;
• Presence of psychiatric disorders (e.g., depression), cognitive impairment, or language disorders;
• Patients with drug dependency;
• Received acupuncture treatment within the past month;
• Severe cardiovascular, hepatic, renal, hematologic, autoimmune diseases, infectious diseases, poor general nutritional status, malignancy, or patients in the terminal stage of severe illness;
• Pregnant or planning to become pregnant within the next year, breastfeeding, or postpartum ≤12 months.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• Beijing University of Chinese Medicine: collaborator

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Zhishun Liu

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

• Guangxia Shi

  Beijing University of Chinese Meidicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhishun Liu

CONTACT

+861088002331; zhishunjournal@163.com

SIXING LIU

CONTACT

+8613521617871; sixingliu@sina.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professer

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 30, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 27, 2027
• Study Completion (Estimated): March 27, 2028
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available with the publication until six months after publication.
• Access Criteria: A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal. Researchers whose proposal has been approved. Researchers whose proposal has been approved will sign a data access agreement.