Effect of Acupuncture on Chronic Nonspecific Neck Pain and Insomnia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences
About this trial
The study aims to assess the efficacy and safety of acupuncture among patients with chronic nonspecific neck pain and insomnia, compared with sham acupuncture.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture
DeviceThe 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
DeviceThe 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.
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: acupuncture groupExperimental treatment 1 intervention
Group B: Sham acupuncture (SA) groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 52
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 5Secondary outcomes
1
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 162
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 163
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.
Time frame
week 5, 9 and 164
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)."
Time frame
week 5, 9 and 16Other outcomes
1
Expectance assessment
Patients wIll be asked to predict how their chronic neck pain will change in one month (much better, somewhat better, uncertain, somewhat worse, much worse); and how their insomnia will change (much better, somewhat better, uncertain, somewhat worse, much worse).
Time frame
baseline2
Incidence of advers events
Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions or not.
Time frame
through study completion, an average of 16 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Lead sponsor
Beijing University of Chinese Medicine
Collaborator
Source ClinicalTrials.gov
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