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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05015413
Other study ID # 012/003237
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 25, 2021
Est. completion date December 29, 2021

Study information

Verified date November 2021
Source Cairo University
Contact Manal Ahmed El shafei, Doctoral
Phone 201220664518
Email Manalpt1989@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sacroiliac joint pain is the most causes of back pain In pregnancy caused ligament laxity in sacroiliac joint so cause pain and this pain continue after natal Shock wave is new conservative treatment used in physical therapy Shock wave is most effective for sacroiliac joint pain Low level laser is a most effective pain relive and effective on sacroiliac joint pain


Description:

The study is to determine if there is any difference between the effect of shockwave and low level laser therapy on sacroiliac joint pain in postnatal women This study will be randomly distributed into two equal group Group A consisted of 25 postpartum women complaining from sacroiliac joint pain . They will receive shockwave therapy 2 session per week for 6 weeks Group B consisted of 25 postpartum women complaining from sacroiliac joint pain . They will receive low level laser therapy 2 session per week for 6 weeks Evaluation procedures History taking recording in recording data sheet Weight and height measurement by calculate BMI Disability assessment by OWDI Pain assessment by VAS scale Assessment of pressure of pain threshold by pressure algometry


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 29, 2021
Est. primary completion date December 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 40 Years
Eligibility Inclusion Criteria: - postnatal women suffering from sacroiliac joint pain for at least 3 months. - They should have moderate to severe pain . - They should have positive findings in at least 3 of 5 provocation sacroiliac joint tests Exclusion Criteria: - lumber or hip joint pathology - Acute pelvic bacterial or viral infection . - Receiving corticosteroid injections within the previous 6 weeks

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Shockwave
Shock wave master 500 Germany

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Samar Mimi Mohamed Okby

Outcome

Type Measure Description Time frame Safety issue
Primary Sacroiliac joint pain •Pain intensity: it will by measure by VAS it's presented as 10 cm horizontal line on which the patient pain intensity is point between no pain at zero score to extreme pain at 10 score . About two months
Primary Functional disability •Functional disability :it will be measure by oswestry disability index it is 10 point Patient reported outcome questionnaire which the higher score mean its the worst and the low score mean its the better outcome. About 2 month
Primary Pain pressure threshold •Pain pressure threshold : it will be measure by a device Called pressure algometry About 2 month
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