Effect of Neurogenic Acupoint CUPPING ON WOMEN WITH CHRONIC PELVIC PAIN

NCT ID: NCT04436445

Last Updated: 2020-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-15
• Study Completion Date: 2020-09-01

Brief Summary

PURPOSE:

The purpose of this study is to determine the effect of dry cupping on women with chronic pelvic pain.

BACKGROUND:

Recent studies have examined the efficacy of dry cupping on acupoints for various pain-related conditions. They showed good result . However, no studies up to date has been evaluated the effect of dry cupping in treating Chronic pelvic pain. Therefore, this study is the first one which aims to investigate the effect of dry cupping on women suffering from Chronic pelvic pain. This study may expand the role of physiotherapy in woman's health.

HYPOTHESE:

There is no effect of bioptron light therapy on postmenopausal osteoporosis.

RESEARCH QUESTION:

There is no effect of dry cupping on chronic pelvic pain.

Detailed Description

Chronic pelvic pain is a highly prevalent debilitating disease with negative impact on the quality of life and productivity of women. The estimated prevalence of CPP is 3.8% among women aged 15-73 years, ranging from 14% to 24% among women of reproductive age, with a direct impact on their marital, social and professional life .

A specific diagnosis for CPP is often difficult; no diagnosis is made in 60% of patients . Treatment of these patients remains a challenge due to the diverse clinical signs and phenotypes. Several non-surgical as well as surgical strategies exist. However, many of the therapy approaches seem to have only limited effect in managing CPP . Additionally, many of the recommended medical and surgical interventions have a potential for harm in a proportion of women . Accordingly, an alternative therapeutic approach is desirable.

Dry cupping is considered to be a noninvasive and inexpensive technique, used worldwide to treating patients with pain syndromes . It is in fact a type of physical therapy which is applied by the specialists of acupuncture or other individuals. It improves the subcutaneous blood flow and, as a result, stimulates the autonomic nervous system and reduces the pain . The application of suction on selected acupoints produces hyperemia or hemostasis, which may result in a therapeutic effect .When compared to acupuncture, cupping therapy is a non-invasive therapy with relatively shorter treatment duration and less treatment cost .

Recent studies have examined the efficacy of dry cupping on acupoints for various pain-related conditions. They showed good results . However, no studies up to date has been evaluated the effect of dry cupping in treating CPP. Therefore, this study is the first one which aims to investigate the effect of dry cupping on women suffering from CPP. This study may expand the role of physiotherapy in woman's health

Conditions

Chronic Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

dry cupping

Dry cupping is considered to be a noninvasive and inexpensive technique, used worldwide to treating patients with pain syndromes It is in fact a type of physical therapy which is applied by the specialists of acupuncture or other individuals. It improves the subcutaneous blood flow and, as a result, stimulates the autonomic nervous system and reduces the pai

Group Type: ACTIVE_COMPARATOR

dry cupping

Intervention Type: COMBINATION_PRODUCT

represents the location and clinical importance of each acupoint. First, the position of the patient will be supine lying for SP6, SP9, KI6, GB34 and CV6 acupoints and it will be prone lying for B23 acupoint. Second, the skin will be cleaned by alcohol then cups will be placed on the acupoints. Dry cupping for SP6, SP9, KI6 and GB34 acupoints will be applied using small cups while dry cupping for CV6 and B23 will be applied using large cups. Third, a negative pressure will be applied with a manual handle. Finally, the cups will be removed after 5 to 15 minutes by pressing one side of the skin with a finger to release the vacuum slowly.

Life style modification

lifestyle modifications in the form of dietary recommendations, exercises and sleep quality improvement for 8 weeks.The life style modification followed in the treatment: Avoid consumption of all kinds of alcohol beverages. Avoid consumption of spicy foods, pepper, chili and coffee Follow a correct diet assuming each day 50% carbohydrates,30% fats and 20% proteins Increase your intake of fruits, vegetables and foods rich of natural fibers (dark bred, vegetables, spinaches).

8 hour sleep at night 40 minutes of walking 3time per week.

Group Type: ACTIVE_COMPARATOR

Life style modification

Intervention Type: OTHER

Life style modification

Interventions

dry cupping

represents the location and clinical importance of each acupoint. First, the position of the patient will be supine lying for SP6, SP9, KI6, GB34 and CV6 acupoints and it will be prone lying for B23 acupoint. Second, the skin will be cleaned by alcohol then cups will be placed on the acupoints. Dry cupping for SP6, SP9, KI6 and GB34 acupoints will be applied using small cups while dry cupping for CV6 and B23 will be applied using large cups. Third, a negative pressure will be applied with a manual handle. Finally, the cups will be removed after 5 to 15 minutes by pressing one side of the skin with a finger to release the vacuum slowly.

Intervention Type: COMBINATION_PRODUCT

Life style modification

Life style modification

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• thirty married women suffering from chronic pelvic pain
• Their age will range from 25 to 40 years old.
• Their BMI will be ≤ 30 kg/m2.
• They should be non-smokers.
• They should have sedentary life style without participation at any exercise training program during this study.
• Maximum parity number is three.
• Their score is less than 6 on The Interstitial Cystitis Symptom Index and Problem Index" (The O'Leary-Sant), to exclude Interstitial Cystitis.
• Their score on visual analog scale above 5.
• Their muscle strength is good in hip abductor, adductor, external rotator and internal rotator muscles .
• Their pelvic floor muscle strength is good.

Exclusion Criteria

• Women having any serious physical disorders such as vertebral fractures, disk hernia, acute inflammation and deep venous thrombosis.
• Women having any problems in the acupoints such as fractures, ulcers, varicose veins, skin disease or inflammation.
• Women having history of cancer or congenital anomaly.
• Use of any kind of analgesic medications or contraceptive pills.
• Diabetic or hypertensive patient.
• Have any auto immune disease (rheumatoid, lupus), chest disease and cardiac disease.
• HS-CRP test exclusion patient during menses, patient suffering any medical condition increase inflammation ex cough, sneezing.
• Patient suffering from chronic pelvic pain due to another cause except PID.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health and Population, Egypt

OTHER_GOV

Sponsor Role: lead

Responsible Party

Rehab Tareq Mohamad

physiotherapist in Ministry of Health and Population, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

They will be selected from 6th District Family Medicine Unit, Giza.

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

rehab tareq tareq mohamad

Role: primary

rehabtareqmohamad@gmail.com

00201111287279

Other Identifiers

NO:P.T.REC/012/002019

Identifier Type: -

Identifier Source: org_study_id