Effect of Shockwave Versus LLL Therapy on Sacroiliac Joint Pain in Postnatal Women
Primary Purpose
Sacroiliac Joint Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shockwave
Sponsored by
About this trial
This is an interventional treatment trial for Sacroiliac Joint Pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
shock wave group
low level laser group
Arm Description
Group A will receive shockwave therapy 2 session per week for 6 weeks
Group B will receive low level laser therapy 2 session per week for 6 weeks
Outcomes
Primary Outcome Measures
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 .
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.
Pain pressure threshold
•Pain pressure threshold : it will be measure by a device Called pressure algometry
Secondary Outcome Measures
Full Information
NCT ID
NCT05015413
First Posted
July 14, 2021
Last Updated
November 20, 2021
Sponsor
Samar Mimi Mohamed Okby
1. Study Identification
Unique Protocol Identification Number
NCT05015413
Brief Title
Effect of Shockwave Versus LLL Therapy on Sacroiliac Joint Pain in Postnatal Women
Official Title
Effect of Shockwave Versus Low Level Laser Therapy on Sacroiliac Joint Pain in Postnatal Women
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 25, 2021 (Anticipated)
Primary Completion Date
December 3, 2021 (Anticipated)
Study Completion Date
December 29, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Samar Mimi Mohamed Okby
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A will receive shock wave therapy Group B will receive low level laser therapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
shock wave group
Arm Type
Experimental
Arm Description
Group A will receive shockwave therapy 2 session per week for 6 weeks
Arm Title
low level laser group
Arm Type
Experimental
Arm Description
Group B will receive low level laser therapy 2 session per week for 6 weeks
Intervention Type
Device
Intervention Name(s)
Shockwave
Intervention Description
Shock wave master 500 Germany
Primary Outcome Measure Information:
Title
Sacroiliac joint pain
Description
•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 .
Time Frame
About two months
Title
Functional disability
Description
•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.
Time Frame
About 2 month
Title
Pain pressure threshold
Description
•Pain pressure threshold : it will be measure by a device Called pressure algometry
Time Frame
About 2 month
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postnatal women
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manal Ahmed El shafei, Doctoral
Phone
201220664518
Email
Manalpt1989@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effect of Shockwave Versus LLL Therapy on Sacroiliac Joint Pain in Postnatal Women
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