Cervical SpondylosisDALANCT07240623
Comparison of Manual Acupuncture at Distal Acupoints Versus Electroacupuncture at Local Acupoints in Patients With Acute Neck Pain Due to Cervical Spondylosis
A study testing Manual acupuncture at distal acupoints and Electroacupuncture at local acupoints in people with Cervical Spondylosis and Acute Neck Pain, run by School of Medicine - Vietnam National University at Ho Chi Minh city at 1 site in Vietnam.
Trial summary
This study is a randomized, single-blind, controlled clinical trial involving two groups: manual acupuncture and electroacupuncture, with 62 participants in each group. All participants received treatment once daily for 10 consecutive days, combined with at least 10 minutes of active cervical spine exercises per… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Cervical Spondylosis, Acute Neck Pain, Neck Pain Musculoskeletal
- What is being tested?
- Manual acupuncture at distal acupoints and Electroacupuncture at local acupoints
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteVietnam
- Study dates
- 25 Sep 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute onset of neck pain lasting less than 6 weeks.
- Pain intensity ≥ 50 mm on the Visual Analogue Scale (VAS).
- Presence of limitation in at least one cervical range of motion (ROM).
- Radiographic diagnosis of cervical spondylosis based on Kellgren and Lawrence criteria.
Who cannot join
- Patients with infection, cachexia, or psychiatric disorders.
- Currently using analgesic medication.
- Cervical movement limitation persisting for more than 6 weeks.
- History of or indication for cervical spine surgery.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Traditional Medicine Hospital of Ho Chi Minh City
Ho Chi Minh City, Xuan Hoa Ward
About this study
Official title: A Randomized Controlled Single-blind Clinical Trial Comparing the Therapeutic Effects of Manual Acupuncture at Distal Acupoints With Electroacupuncture at Local Acupoints in Patients With Acute Neck Pain Due to Cervical Spondylosis
This study is a randomized, single-blind, controlled clinical trial involving two groups: manual acupuncture and electroacupuncture, with 62 participants in each group. All participants received treatment once daily for 10 consecutive days, combined with at least 10 minutes of active cervical spine exercises per session.
Participants were allowed to take one 500 mg tablet of paracetamol if the pain exceeded their tolerance threshold, with a minimum interval of 6 hours between doses and a maximum daily dose of 1,500 mg. The number of tablets taken each day was recorded. No other analgesic interventions were permitted during the study period.
The objective of this study was to compare and evaluate the effectiveness of the two interventions in improving pain intensity (VAS score) and limitations of cervical range of motion after each treatment session. In addition, adverse events were monitored and recorded after every intervention.
- Conditions
- Cervical Spondylosis, Acute Neck Pain, Neck Pain Musculoskeletal, Degenerative Cervical Spine
- Being tested
- Manual acupuncture at distal acupoints, Electroacupuncture at local acupoints
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual acupuncture at distal acupointsProcedure or surgery
Also called Manual acupuncture, Distal acupoints
Manual acupuncture applied for 25 minutes at distal acupoints selected based on meridian diagnosis (SI3, SI5, TE4, BL60, BL62, GB40) on the contralateral side of the pain. During needle retention, participants performed active cervical spine movements (flexion, extension, lateral flexion, and rotation) for at least 10 minutes.
Electroacupuncture at local acupointsProcedure or surgery
Also called Electroacupuncture, Local acupoints
Electroacupuncture applied for 25 minutes at local acupoints (GB20-SI15 and GB21-LU7) on the painful side. After needle removal, participants performed active cervical spine movements (flexion, extension, lateral flexion, and rotation) for at least 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Manual Acupuncture | Active comparator | Participants receive manual acupuncture at distal acupoints (SI3, SI5, TE4, BL60, BL62, GB40) on the contralateral side of the painful neck area for 25 minutes. During needle retention, patients perform active cervical spine movements (flexion, extension, lateral flexion, and rotation) for at least 10 minutes. Receives: Procedure: Manual acupuncture at distal acupoints |
| Electroacupuncture | Active comparator | Participants receive electroacupuncture for 25 minutes at local acupoints (GB20-SI15 and GB21-LU7) on the painful side. After needle removal, patients perform active cervical spine movements (flexion, extension, lateral flexion, and rotation) for at least 10 minutes. Receives: Procedure: Electroacupuncture at local acupoints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity (VAS score)
Pain intensity is assessed using a 100 mm Visual Analogue Scale (VAS), where ≤4 indicates no pain and 100 indicates the worst imaginable pain. The change in VAS score from baseline to each treatment day is recorded for comparison between groups.
Measured: Baseline and after each daily treatment for 10 consecutive days
Change in cervical range of motion (ROM) limitation score
The cervical range of motion (ROM) was measured for six movements: flexion, extension, right and left lateral flexion, and right and left rotation. Each movement was assessed using a goniometer, and the measured angles were converted into a limitation score ranging from 0 to 4 according to the following grading system:
- 0 - Normal ROM (flexion 45°-55°, extension 60°-70°, lateral flexion 40°-50°, rotation 60°-70°)
- 1 - Mild limitation (flexion 40°-44°, extension 55°-59°, lateral flexion 35°-39°, rotation 55°-59°)
- 2 - Moderate limitation (flexion 35°-39°, extension 50°-54°, lateral flexion 30°-34°, rotation 50°-54°)
- 3 - Severe limitation (flexion 30°-34°, extension 45°-49°, lateral flexion 25°-29°, rotation 45°-49°)
- 4 - Very severe limitation (<30° flexion, <45° extension, <25° lateral flexion, <45° rotation) The total limitation score was calculated as the sum of all six movement scores, with higher scores indicating greater cervical movement restriction.
Measured: Baseline and after each daily treatment for 10 consecutive days
Secondary outcomes (1)
Adverse events related to acupuncture or electroacupuncture
Any adverse events such as local pain, swelling, dizziness, or fainting were observed and recorded after each treatment session. Severity and frequency were summarized descriptively.
Measured: Monitored immediately after each treatment session and at the end of the 10-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start25 Sep 2024
- Primary completion30 Apr 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- School of Medicine - Vietnam National University at Ho Chi Minh city
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Ky Xuan Nhi, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240623
- Sponsor's protocol ID
- 3836/QĐ-ĐHYD
- Other IDs
- IRB No. IRB-VN01002
- Acronym
- DALA
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Single-blind Clinical Trial Comparing the Therapeutic Effects of Manual Acupuncture at Distal Acupoints With Electroacupuncture at Local Acupoints in Patients With Acute Neck Pain Due to Cervical Spondylosis
- ClinicalTrials.gov ID
- NCT07240623
- Acronym / sponsor ID
- DALA / 3836/QĐ-ĐHYD
- Conditions
- Cervical Spondylosis, Acute Neck Pain, Neck Pain Musculoskeletal, Degenerative Cervical Spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- School of Medicine - Vietnam National University at Ho Chi Minh cityUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 21 Nov 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.
This study is a randomized, single-blind, controlled clinical trial involving two groups: manual acupuncture and electroacupuncture, with 62 participants in each group. All participants received treatment once daily for 10 consecutive days, combined with at least 10 minutes of active cervical spine exercises per session.
Participants were allowed to take one 500 mg tablet of paracetamol if the pain exceeded their tolerance threshold, with a minimum interval of 6 hours between doses and a maximum daily dose of 1,500 mg. The number of tablets taken each day was recorded. No other analgesic interventions were permitted during the study period.
The objective of this study was to compare and evaluate the effectiveness of the two interventions in improving pain intensity (VAS score) and limitations of cervical range of motion after each treatment session. In addition, adverse events were monitored and recorded after every intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Acupuncture | Active comparator | Procedure: Manual acupuncture at distal acupointsParticipants receive manual acupuncture at distal acupoints (SI3, SI5, TE4, BL60, BL62, GB40) on the contralateral side of the painful neck area for 25 minutes. During needle retention, patients perform active cervical spine movements (flexion, extension, lateral flexion, and rotation) for at least 10 minutes. |
| Electroacupuncture | Active comparator | Procedure: Electroacupuncture at local acupointsParticipants receive electroacupuncture for 25 minutes at local acupoints (GB20-SI15 and GB21-LU7) on the painful side. After needle removal, patients perform active cervical spine movements (flexion, extension, lateral flexion, and rotation) for at least 10 minutes. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute onset of neck pain lasting less than 6 weeks.
- Pain intensity ≥ 50 mm on the Visual Analogue Scale (VAS).
- Presence of limitation in at least one cervical range of motion (ROM).
- Radiographic diagnosis of cervical spondylosis based on Kellgren and Lawrence criteria.
Key exclusion criteria (4 listed)
- Patients with infection, cachexia, or psychiatric disorders.
- Currently using analgesic medication.
- Cervical movement limitation persisting for more than 6 weeks.
- History of or indication for cervical spine surgery.
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 |
|---|---|---|
| Manual acupuncture at distal acupointsAlso: Manual acupuncture, Distal acupointsManual acupuncture applied for 25 minutes at distal acupoints selected based on meridian diagnosis (SI3, SI5, TE4, BL60, BL62, GB40) on the contralateral side of the pain. During needle retention, participants performed active cervical spine movements (flexion, extension, lateral flexion, and rotation) for at least 10 minutes. | Procedure or surgery | Manual Acupuncture |
| Electroacupuncture at local acupointsAlso: Electroacupuncture, Local acupointsElectroacupuncture applied for 25 minutes at local acupoints (GB20-SI15 and GB21-LU7) on the painful side. After needle removal, participants performed active cervical spine movements (flexion, extension, lateral flexion, and rotation) for at least 10 minutes. | Procedure or surgery | Electroacupuncture |
Primary outcome
Change in pain intensity (VAS score)
Time frame: Baseline and after each daily treatment for 10 consecutive days
Pain intensity is assessed using a 100 mm Visual Analogue Scale (VAS), where ≤4 indicates no pain and 100 indicates the worst imaginable pain. The change in VAS score from baseline to each treatment day is recorded for comparison between groups.
Change in cervical range of motion (ROM) limitation score
Time frame: Baseline and after each daily treatment for 10 consecutive days
The cervical range of motion (ROM) was measured for six movements: flexion, extension, right and left lateral flexion, and right and left rotation. Each movement was assessed using a goniometer, and the measured angles were converted into a limitation score ranging from 0 to 4 according to the following grading system: * 0 - Normal ROM (flexion 45°-55°, extension 60°-70°, lateral flexion 40°-50°, rotation 60°-70°) * 1 - Mild limitation (flexion 40°-44°, extension 55°-59°, lateral flexion 35°-39°, rotation 55°-59°) * 2 - Moderate limitation (flexion 35°-39°, extension 50°-54°, lateral flexion 30°-34°, rotation 50°-54°) * 3 - Severe limitation (flexion 30°-34°, extension 45°-49°, lateral flexion 25°-29°, rotation 45°-49°) * 4 - Very severe limitation (<30° flexion, <45° extension, <25° lateral flexion, <45° rotation) The total limitation score was calculated as the sum of all six movement scores, with higher scores indicating greater cervical movement restriction.
1 secondary outcome
Adverse events related to acupuncture or electroacupuncture
Time frame: Monitored immediately after each treatment session and at the end of the 10-day treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual acupuncture at distal acupoints and Electroacupuncture at local acupoints in people with Cervical Spondylosis and Acute Neck Pain, run by School of Medicine - Vietnam National University at Ho Chi Minh city at 1 site in Vietnam.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (VAS score) (time frame: Baseline and after each daily treatment for 10 consecutive days). 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?
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 21 Nov 2025.