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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- School of Medicine - Vietnam National University at Ho Chi Minh city
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Change in pain intensity (VAS score)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Adverse events related to acupuncture or electroacupuncture(Monitored immediately after each treatment session and at the end of the 10-day treatment period)
Investigators
Nguyen Ky Xuan Nhi
Medical Specialist
University of Medicine and Pharmacy at Ho Chi Minh City