Comparison of Manual Acupuncture at Distal Acupoints Versus Electroacupuncture at Local Acupoints in Patients With Acute Neck Pain Due to Cervical Spondylosis (DALA)

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.

Study Overview

• Status: Completed
• Conditions: Cervical Spondylosis; Neck Pain Musculoskeletal; Acute Neck Pain; Degenerative Cervical Spine
• Intervention / Treatment: Procedure: Manual acupuncture at distal acupoints; Procedure: Electroacupuncture at local acupoints

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Xuan Hoa Ward
    • Ho Chi Minh City, Xuan Hoa Ward, Vietnam
      • Traditional Medicine Hospital of Ho Chi Minh City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manual Acupuncture; 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.	Procedure: Manual acupuncture at 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.; Other Names: Manual acupuncture; Distal acupoints
Active Comparator: Electroacupuncture; 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.	Procedure: Electroacupuncture at 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.; Other Names: Electroacupuncture; Local acupoints

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline and after each daily treatment for 10 consecutive days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Monitored immediately after each treatment session and at the end of the 10-day treatment period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of paracetamol tablets used	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.	Recorded daily during the 10-day treatment period

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): May 15, 2025

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylosis; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Combined Modality Therapy; Anesthesia; Analgesia; Acupuncture Therapy; Transcutaneous Electric Nerve Stimulation; Electroacupuncture
• Other Study ID Numbers: 3836/QĐ-ĐHYD; IRB No. IRB-VN01002 (Other Identifier: Approved by the Institutional Review Board of University of Medicine and Pharmacy at Ho Chi Minh)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No