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Completed

NCT Number: NCT07240623

Comparison of Manual Acupuncture at Distal Acupoints Versus 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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Traditional Medicine Hospital of Ho Chi Minh City

Ho Chi Minh City, Xuan Hoa Ward, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Manual acupuncture at distal acupoints

Procedure

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.

Other names: Manual acupuncture, Distal acupoints

Electroacupuncture at local acupoints

Procedure

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.

Other names: Electroacupuncture, Local acupoints

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    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.

Other outcomes

  1. Number of paracetamol tablets used

    Time frame: Recorded daily during the 10-day treatment period

    Participants were allowed to take one 500 mg tablet of paracetamol at ≥6-hour intervals if the pain exceeded their tolerance, with a maximum dose of 1500 mg/day. The number of tablets used per day was recorded.

Sponsors and collaborators

Lead sponsor

School of Medicine - Vietnam National University at Ho Chi Minh city

Other

Registry information

Official study 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

Acronym: DALA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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