- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06893185
Cupping Therapy for Neck Pain in Cervical Spondylosis
Effectiveness of Cupping Therapy in Managing Neck Pain and Improving Cervical Mobility in Cervical Spondylosis Patients: A Randomized Clinical Trial
Cervical spondylosis is one of the common causes of chronic neck pain. It can significantly affect the quality of life, lead to disabilities, and increase the economic burden on patients. Treatment mainly includes pain relievers, non-steroidal anti-inflammatory drugs (NSAIDs), muscle relaxants or physical therapy. The condition tends to recur frequently; therefore, long-term use of medication can lead to unwanted effects on the digestive system, kidneys, and cardiovascular system.
Dry cupping therapy is a non-pharmacological method that has been shown to be effective in pain management. Cupping therapy has the advantage of being applicable to patients who are afraid of needles and has a wide area of effect.
Given the limitations in evaluating treatment effectiveness and safety, along with the lack of published research discussing the analgesic effects of dry cupping for neck pain caused by cervical spondylosis, the investigators conducted the study on pain reduction and safety of cupping therapy in patients with neck pain caused by cervical spondylosis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients diagnosed with cervical spondylosis who have neck pain will be registered for this study. They will be treated with electroacupuncture or cupping therapy.
The intervention period is two weeks. Electroacupuncture will be performed five times a week while cupping therapy will be performed once every 3 days.
Data on the Visual Analog Scale (VAS) and side effects of electroacupuncture and cupping therapy will be recorded before the study and weekly for 2 weeks.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Phuong Ngoc Ha Dang
- Phone Number: +84961964963
- Email: dangphuong1607@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals between the ages of 20 and 60 years, outpatient treatment.
- Individuals diagnosed with cervical spondylosis.
- Individuals report pain intensity between 3 and 8 according to on the Visual Analogue Scale (VAS) on the screening visit day.
- Experiencing neck pain for no longer than four weeks.
- Individuals who volunteered to participate in the study and signed a consent form.
Exclusion Criteria:
- Patients diagnosed with acute or chronic neck pain due to specific causes or with root compression syndrome, spinal cord compression syndrome, or vertebral artery syndrome.
- Patients loss of normal cervical curvature or deformity.
- Individuals with a history of neck trauma, cervical vertebra fracture, or cervical spine surgery, congenital spinal abnormalities, systemic bone and joint diseases.
- Patients have undergone cupping therapy, plastering, or drug inhalation within one week prior to participating in the study.
- Patients used of medications that could affect research outcomes within one week: Pain relievers, muscle relaxants, traditional medicines for treating neck pain.
- Patients suffer from a mental illness or lacks consciousness.
- Patients have a pacemaker, or any metal devices such as screws or plates.
- Patients currently using anticoagulant medications or has a bleeding disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dry cupping Group
Dry cupping therapy every 3 days for a total of two weeks (5 sessions)
|
Dry cupping therapy will perform on the skin areas containing the EX-B2, A-shi, and GB21 acupuncture points every 3 days for 2 weeks.
|
|
Active Comparator: Electroacupuncture Group
Electroacupuncture five times a week for a total of two weeks (10 sessions)
|
Electroacupuncture therapy will be performed five times a week for 2 weeks.
The acupoints are the Huatuojiaji (EX-B2), A-shi, and Jianjing (GB21).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change of the Visual Analog Scale (VAS)
Time Frame: Assessments were conducted before intervention and after each intervention week throughout the two weeks (Week 0, Week 1, Week 2)
|
Symptom scores will be assessed based on a visual analogue scale (VAS).
It usually consists of a 10 cm line anchored at each end by descriptors.
Patients will be classified into 1 of 4 groups (no pain (0 cm), mild pain (1-3 cm), moderate pain (4-7 cm), severe pain (8-10 cm)).
|
Assessments were conducted before intervention and after each intervention week throughout the two weeks (Week 0, Week 1, Week 2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of intervention-related adverse events
Time Frame: Assessments were conducted after each intervention week throughout the two weeks.
|
While dry cupping therapy and electroacupuncture is generally considered safe, some patients may experience minor side effects at the application site.
These can include ecchymosis or burns.
Rarely, more serious complications like dizziness, headaches, and fatigue may occur.
The study will closely monitor and document any unexpected adverse events associated with the procedure.
|
Assessments were conducted after each intervention week throughout the two weeks.
|
|
Active range of motion of the cervical spine
Time Frame: Assessments were conducted before intervention and after each intervention week throughout the two weeks (Week 0, Week 1, Week 2)
|
Active range of motion is measured using a goniometer.
During measurement, the patient sits upright with hips and knees flexed at 90 degrees, both feet flat on the floor, and arms relaxed alongside the body.
Cervical spine movements include flexion, extension, left and right lateral flexion, and left and right rotation.
|
Assessments were conducted before intervention and after each intervention week throughout the two weeks (Week 0, Week 1, Week 2)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Kim S, Lee SH, Kim MR, Kim EJ, Hwang DS, Lee J, Shin JS, Ha IH, Lee YJ. Is cupping therapy effective in patients with neck pain? A systematic review and meta-analysis. BMJ Open. 2018 Nov 5;8(11):e021070. doi: 10.1136/bmjopen-2017-021070.
- Haldeman S, Carroll L, Cassidy JD. Findings from the bone and joint decade 2000 to 2010 task force on neck pain and its associated disorders. J Occup Environ Med. 2010 Apr;52(4):424-7. doi: 10.1097/JOM.0b013e3181d44f3b.
- Kim S, Kim E, Jung G, Lee S, Kim JG. The hemodynamic changes during cupping therapy monitored by using an optical sensor embedded cup. J Biophotonics. 2019 May;12(5):e201800286. doi: 10.1002/jbio.201800286. Epub 2019 Jan 28.
- Gao C, Wang M, He L, He Y, Li T. Alternations of hemodynamic parameters during Chinese cupping therapy assessed by an embedded near-infrared spectroscopy monitor. Biomed Opt Express. 2018 Dec 12;10(1):196-203. doi: 10.1364/BOE.10.000196. eCollection 2019 Jan 1.
- Kolenkiewicz M, Wlodarczyk A, Wojtkiewicz J. Diagnosis and Incidence of Spondylosis and Cervical Disc Disorders in the University Clinical Hospital in Olsztyn, in Years 2011-2015. Biomed Res Int. 2018 Mar 25;2018:5643839. doi: 10.1155/2018/5643839. eCollection 2018.
- Peng AT, Behar S, Yue SJ. Long-term therapeutic effects of electro-acupuncture for chronic neck and shoulder pain--a double blind study. Acupunct Electrother Res. 1987;12(1):37-44. doi: 10.3727/036012987816358922.
- Zhang SP, Chiu TT, Chiu SN. Long-term efficacy of electroacupuncture for chronic neck pain: a randomised controlled trial. Hong Kong Med J. 2013 Dec;19 Suppl 9:36-9.
- Chi LM, Lin LM, Chen CL, Wang SF, Lai HL, Peng TC. The Effectiveness of Cupping Therapy on Relieving Chronic Neck and Shoulder Pain: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2016;2016:7358918. doi: 10.1155/2016/7358918. Epub 2016 Mar 17.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 247/2024/HD-DHYD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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