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

NCT07240623 | Completed DMC

• 2 other identifiers: 3836/QĐ-ĐHYDIRB No. IRB-VN01002
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Adverse events related to acupuncture or electroacupuncture

  Monitored immediately after each treatment session and at the end of the 10-day treatment period

Other Outcomes (1)

• Number of paracetamol tablets used

  Recorded daily during the 10-day treatment period

Study Arms (2)

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.

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.

Procedure: Electroacupuncture at local acupoints

Interventions

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.

Also known as: Manual acupuncture, Distal acupoints

Manual Acupuncture

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.

Also known as: Electroacupuncture, Local acupoints

Electroacupuncture

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Traditional Medicine Hospital of Ho Chi Minh City

Ho Chi Minh City, Xuan Hoa Ward, Vietnam

Location

MeSH Terms

Conditions

Spondylosis

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Specialist

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 21, 2025
• Study Start: September 25, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 15, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)