Acupuncture as another treatment option for women who have Pain in the belly foot and Muscle Pain in the belly that did not improve with the Injection of Anesthetic at the pain site

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-4y8vd2
• Date of registration: 19/06/2017
• Prospective Registration: No
• Primary sponsor: Faculdade de Medicina de Ribeirão Preto / Universidade de São Paulo - FMRP/USP
• Public title: Acupuncture as another treatment option for women who have Pain in the belly foot and Muscle Pain in the belly that did not improve with the Injection of Anesthetic at the pain site
• Scientific title: Acupuncture as an alternative method for the treatment of women with Chronic Pelvic Pain and Myofascial Syndrome not-responsive to Topical Injectable Treatment
• Date of first enrolment: 11/07/2014
• Recruitment status: Data analysis completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-4y8vd2
• Study type: Intervention
• Study design: A double-blind, parallel, double-blind, randomized, controlled clinical trial
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Andréia Moreira de Souza Mitidieri
• Affiliation: Faculdade de Medicina de Ribeirão Preto / Universidade de São Paulo - FMRP/USP

• Name: Andréia Moreira de Souza Mitidieri
• Affiliation: Faculdade de Medicina de Ribeirão Preto / Universidade de São Paulo - FMRP/USP

Key inclusion & exclusion criteria

Inclusion criteria: Women with diagnostic criteria for chronic pelvic pain secondary to abdominal myofascial syndrome; Presence of only one active trigger point on the abdominal wall, have not undergone previous treatment with topical injectable block or acupuncture, age above 18 years and premenopausal, visual analogue scale with a value above 4.4 (moderate pain)
Exclusion criteria: Women with anticoagulation or hemorrhagic disorders, local or systemic infections; Allergy to anesthetics, acute muscle trauma, extreme fear of needles; History of complaints of chronic musculoskeletal pain such as fibromyalgia, chronic fatigue or diabetes; Aspirin intake within 3 days after injection; All patients with suspected endometriosis, interstitial cystitis, irritable bowel syndrome, or other disease that warrants or contributes to chronic pelvic pain; Endometrioma or hernia evidenced by ultrasound of the abdominal wall, infections of the abdominal wall, lack after the beginning of the treatment

Age minimum: 18Y
Age maximum: 50Y
Gender: F

Health Condition(s) or Problem(s) studied

Myofascial pain syndromes, pelvic pain

C05.651.550

C23.888.592.612.944

Intervention(s)

Other

Procedure/surgery

D27.505.696.277.100

Experiential group: 16 women with abdominal muscle pain received acupuncture ashi treatment (acupuncture technique at pain points), was applied once a week for 10 consecutive weeks by an acupuncturist while in the active control group an injection of anesthesia medication (2ml with 1% of an anesthetic called lidocaine) at the point of pain in 19 women with abdominal pain syndrome was performed once a week for 4 consecutive weeks by physicians. The treatments were randomized (lottery) among the participants of this study.

E02.190.044

Primary Outcome(s)

Primary outcome: decreased pain perception through the Visual Analogue Scale, Numerical Categorical Scale, McGill Pain and Algometry Questionnaire with a pressure manometer based on a significance level of 5% in pre and 1 week, 1 month , 3 months and 6 months after the interventions.

There was a reduction in the perception of pain in the participants of this study through analysis of the visual analog scale, numerical categorical scale and McGill questionnaire, and there was a correlation between these analyzed variables. At the algometry examination there was no reduction in the perception of statistically significant pain.

Secondary Outcome(s)

There was no statistically significant change in the aspects related to quality of life or risk for anxiety and depression in the study participants for both groups.

Secondary outcome: quality of life measurement using the SF-36 questionnaire and anxiety and depression risk assessment using the hospital scale of anxiety and depression (HAD), based on a 5% level of significance in the pre and 1 measurements Week, 1 month, 3 months and 6 months after the interventions.

Source(s) of Monetary Support

Comissão de Aperfeiçoamento de Pessoal do Nível Superior

Secondary Sponsor(s)

Faculdade de Medicina de Ribeirão Preto / Universidade de São Paulo - FMRP/USP