Neck Pain ChronicNCT06996210
Effect of Acupuncture on Chronic Nonspecific Neck Pain and Insomnia
A study testing Acupuncture in people with Neck Pain Chronic and Insomnia Chronic, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neck Pain Chronic, Insomnia Chronic
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 27 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Acupuncture in Treating Comorbid Chronic Nonspecific Neck Pain and Insomnia
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
- Being tested
- Acupuncture, sham acupuncture
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)."
Measured: week 5
Secondary outcomes (13)
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.
Measured: 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)."
Measured: 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.
Measured: week 5, 9 and 16
The proportion of participants with at least 6 points reduction in ISI-C scores from baseline
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)."
Measured: week 5, 9 and 16
The change from baseline in the total score of the Neck Disability Index (NDI).
Neck Disability Index (NDI) consists of 10 items, with a total score ranging from 0 to 50. A higher score indicates a greater impact of neck pain on quality of life.
Measured: week 5, 9 and 16
The proportion of participants with at least 10 points reduction in NDI scores from baseline
NDI consists of 10 items, with a total score ranging from 0 to 50. A higher score indicates a greater impact of neck pain on quality of life.
Measured: week 5, 9 and 16
The change from baseline in the maximum pain intensity score on the NRS during six directions of neck movement.
The NRS score ranges from 0 to 10, with higher scores indicating more severe pain.
Measured: week 5, 9 and 16
The change from baseline in the Pittsburgh Sleep Quality Index (PSQI).
The PSQI has a total score ranging from 0 to 21. A higher score indicates poorer sleep quality. Specifically, a total score of 0-5 indicates very good sleep quality; 6-10 indicates fairly good sleep quality; 11-15 indicates average sleep quality; and 16-21 indicates poor sleep quality.
Measured: week 5, 9 and 16
The change from baseline in the Hospital Anxiety and Depression Scale (HADS) scores.
The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
Measured: week 5, 9 and 16
The proportion of responders per the Patient Global Impression of Change (PGI-C)
The PGI-C evaluates the overall treatment effect perceived by patients themselves. The change can be rated in 7 levels, including "very much better", "moderately better, "a little better", "no change", "a little worse", "moderately worse" or "very much worse".
Measured: week 5 and 16
The percentage of patients who used rescue analgesics and sedative-hypnotics.
The percentage of patients who used emergency analgesics and sedative-hypnotics.
Measured: week 5, 9 and 16
The total number of days of using rescue analgesics and sedative-hypnotics.
The total number of days of using rescue analgesics and sedative-hypnotics.
Measured: week 5, 9 and 16
Blinding assessment
In this trial, two types of acupuncture treatments were used: traditional acupuncture, which has a stronger sensation of needle insertion, and modern acupuncture, which has a weaker sensation of needle insertion. Patients were asked which type of therapy they thought they had received.
Measured: Within 5 minutes after the last treatment at week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion27 Dec 2027 (estimated)
- Study completion27 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck Pain ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chinese Medicine
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical SciencesGuangxia Shi, Principal investigator, Beijing University of Chinese Meidicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996210
- Sponsor's protocol ID
- 2025-090-KY
- Status last verified
- Jul 2025
- First submitted
- 14 May 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data and data dictionary will be available with the publication until six months after publication. A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement.
Publications
Liu S, Chen H, Shen X, Lun H, Fan J, Wang W, Shi G, Liu Z. Acupuncture for Comorbid Chronic Nonspecific Neck Pain and Chronic Insomnia: Protocol for a Multicenter, Randomized, Sham-Controlled Trial. J Pain Res. 2026 Apr 17;19:598575. doi: 10.2147/JPR.S598575. eCollection 2026.
PubMed 42110592
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture in Treating Comorbid Chronic Nonspecific Neck Pain and Insomnia
- ClinicalTrials.gov ID
- NCT06996210
- Acronym / sponsor ID
- 2025-090-KY
- Conditions
- Neck Pain Chronic, Insomnia Chronic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 27 Dec 2027 (estimated)
- Study completion
- 27 Mar 2028 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture group | Experimental | Device: AcupunctureParticipants 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. |
| Sham acupuncture (SA) group | Sham comparator | Device: sham acupunctureParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureThe 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. | Device | acupuncture group |
| sham acupunctureThe 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. | Device | Sham acupuncture (SA) group |
Primary outcome
The change in average 24h overall neck pain intensity measured by NRS from baseline over the past week
Time frame: week 5
The NRS score ranges from 0 to 10, with higher scores indicating more severe pain.
The change from baseline in the Chinese version of the Insomnia Severity Index (ISI-C) scores.
Time frame: week 5
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)."
13 secondary outcomes
The change in average 24h overall neck pain intensity measured by NRS from baseline over the past week
Time frame: week 9 and 16
The change from baseline in the ISI-C scores.
Time frame: week 9 and 16
The proportion of participants with at least 30% reduction in NRS scores from baseline
Time frame: week 5, 9 and 16
The proportion of participants with at least 6 points reduction in ISI-C scores from baseline
Time frame: week 5, 9 and 16
The change from baseline in the total score of the Neck Disability Index (NDI).
Time frame: week 5, 9 and 16
The proportion of participants with at least 10 points reduction in NDI scores from baseline
Time frame: week 5, 9 and 16
The change from baseline in the maximum pain intensity score on the NRS during six directions of neck movement.
Time frame: week 5, 9 and 16
The change from baseline in the Pittsburgh Sleep Quality Index (PSQI).
Time frame: week 5, 9 and 16
The change from baseline in the Hospital Anxiety and Depression Scale (HADS) scores.
Time frame: week 5, 9 and 16
The proportion of responders per the Patient Global Impression of Change (PGI-C)
Time frame: week 5 and 16
The percentage of patients who used rescue analgesics and sedative-hypnotics.
Time frame: week 5, 9 and 16
The total number of days of using rescue analgesics and sedative-hypnotics.
Time frame: week 5, 9 and 16
Blinding assessment
Time frame: Within 5 minutes after the last treatment at week 4.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Derived from this study: PubMed 42110592Liu S, Chen H, Shen X, Lun H, Fan J, Wang W, Shi G, Liu Z. Acupuncture for Comorbid Chronic Nonspecific Neck Pain and Chronic Insomnia: Protocol for a Multicenter, Randomized, Sham-Controlled Trial. J Pain Res. 2026 Apr 17;19:598575. doi: 10.2147/JPR.S598575. eCollection 2026.
- Individual participant dataSharing planned: Yes. Deidentified participant data and data dictionary will be available with the publication until six months after publication. A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhishun Liu principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Guangxia Shi principal investigator
Beijing University of Chinese Meidicine
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Neck Pain Chronic and Insomnia Chronic, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhishun Liu (+861088002331, zhishunjournal@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in average 24h overall neck pain intensity measured by NRS from baseline over the past week (time frame: week 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06996210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.