Chronic Pelvic PainNCT04436445
Effect of Neurogenic Acupoint CUPPING ON WOMEN WITH CHRONIC PELVIC PAIN
A study testing dry cupping and Life style modification in people with Chronic Pelvic Pain, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Chronic Pelvic Pain
- What is being tested?
- dry cupping and Life style modification
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2018to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
They will be selected from 6th District Family Medicine Unit, Giza.
Giza, 00202
rehab tareq tareq mohamad, 00201111287279, rehabtareqmohamad@gmail.com
About this study
Official title: Effect of Neurogenic Acupoint Cupping on Hs-CRP and Pain Perception in Women With Chronic Pevic Pain
PURPOSE:
The purpose of this study is to determine the effect of dry cupping on women with chronic pelvic pain.
Read more
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.
Read the 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
- Being tested
- dry cupping, Life style modification
- Keywords
- chronic pelvic pain, dry cupping, neurogenic acupoint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry cuppingCombination 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 modificationOther
Life style modification
| Study group | Role | What they receive |
|---|---|---|
| dry cupping | Active comparator | 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 Receives: Combination Product: dry cupping |
| Life style modification | Active comparator | 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. Receives: Other: Life style modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
High sensitive C - reactive protein (Hs-CRP)
Measured: 8 weeks
Short-Form McGill Pain Questionnaire (SF-MPQ)
It is a reliable and valid instrument that is easier and quicker to use in clinical research than the McGill pain questionnaire (MPQ). It will be used to evaluate pain intensity for each woman in both groups before and after the end of treatment program. It consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Measured: 8 weeks
Pelvic Pain Impact Questionnaire (PPIQ)
a questionnaire that assesses the impact of pelvic pain on women, that has high utility, sound psychometric performance, easy scoring, and high reliability, 10-item questionnaire consisted of 8 Likert questions and 2 supplemental, nonscored questions, the questionnaire targeted the pelvic pain population well, had appropriate Likert categories, constituted a unidimensional scale, and showed internal consistency. Test-retest reliability was highPelvic Pain Impact Questionnaire assesses the life impact of pelvic pain. It uses patient-generated language, is easily administered and scored, has very strong psychometric properties, and it is suitable for research and clinical settings across primary, secondary, and tertiary care
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start15 Jul 2018
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- women's with chronic pelvic pain
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health and Population, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rehab Tareq Mohamad, Ministry of Health and Population, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436445
- Sponsor's protocol ID
- NO:P.T.REC/012/002019
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neurogenic Acupoint Cupping on Hs-CRP and Pain Perception in Women With Chronic Pevic Pain
- ClinicalTrials.gov ID
- NCT04436445
- Acronym / sponsor ID
- NO:P.T.REC/012/002019
- Conditions
- Chronic Pelvic Pain
- Keywords
- chronic pelvic pain, dry cupping, neurogenic acupoint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ministry of Health and Population, EgyptOther government
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- women's with chronic pelvic pain
| Arm | Type | Receives |
|---|---|---|
| dry cupping | Active comparator | Combination Product: dry cuppingDry 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 |
| Life style modification | Active comparator | Other: Life style modificationlifestyle 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. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry cuppingrepresents 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. | Combination product | dry cupping |
| Life style modificationLife style modification | Other | Life style modification |
Primary outcome
High sensitive C - reactive protein (Hs-CRP)
Time frame: 8 weeks
Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 8 weeks
It is a reliable and valid instrument that is easier and quicker to use in clinical research than the McGill pain questionnaire (MPQ). It will be used to evaluate pain intensity for each woman in both groups before and after the end of treatment program. It consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Pelvic Pain Impact Questionnaire (PPIQ)
Time frame: 8 weeks
a questionnaire that assesses the impact of pelvic pain on women, that has high utility, sound psychometric performance, easy scoring, and high reliability, 10-item questionnaire consisted of 8 Likert questions and 2 supplemental, nonscored questions, the questionnaire targeted the pelvic pain population well, had appropriate Likert categories, constituted a unidimensional scale, and showed internal consistency. Test-retest reliability was highPelvic Pain Impact Questionnaire assesses the life impact of pelvic pain. It uses patient-generated language, is easily administered and scored, has very strong psychometric properties, and it is suitable for research and clinical settings across primary, secondary, and tertiary care
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
They will be selected from 6th District Family Medicine Unit, Giza.
Giza, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dry cupping and Life style modification in people with Chronic Pelvic Pain, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High sensitive C - reactive protein (Hs-CRP) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.