Cupping Therapy for Neck Pain in Cervical Spondylosis

Официальное название

Effectiveness of Cupping Therapy in Managing Neck Pain and Improving Cervical Mobility in Cervical Spondylosis Patients: A Randomized Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Dry cupping therapy
  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.
• Другое Electroacupuncture
  Electroacupuncture therapy will be performed five times a week for 2 weeks. The acupoints are the Huatuojiaji (EX-B2), A-shi, and Jianjing (GB21).

Первичные конечные точки

• The change of the Visual Analog Scale (VAS) [Срок оценки: Assessments were conducted before intervention and after each intervention week throughout the two weeks (Week 0, Week 1, Week 2)]

Вторичные конечные точки (2)

• Proportion of intervention-related adverse events [Срок оценки: Assessments were conducted after each intervention week throughout the two weeks.]
• Active range of motion of the cervical spine [Срок оценки: Assessments were conducted before intervention and after each intervention week throughout the two weeks (Week 0, Week 1, Week 2)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 30604505
• 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. PMID 30775093
• 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. PMID 29770333
• 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. PMID 2883835
• 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. PMID 24473589
• 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. PMID 27073404
• 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. PMID 30397006
• 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. PMID 20357682

Идентификаторы

NCT: NCT06893185 · 247/2024/HD-DHYD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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