Back to resultsEfficacy of Adding LLL Therapy to Postural Correction Exercises on Postnatal SIJ Pain
Primary Purpose
Sacroiliac Joint Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
LLL therapy , postural correction ex
Sponsored by
About this trial
This is an interventional treatment trial for Sacroiliac Joint Pain
Eligibility Criteria
Inclusion Criteria:
- Post natal women suffering from sacroiliac joint pain for at least 3 months.
- They should have moderate to severe pain in the sacroiliac joint region (visual analogue scale ≥ 4).
- They should have positive findings in at least three of five provocation sacroiliac joint tests (i.e., Patrick's sign, Gaenslen test, compression test, thigh thrust test and distraction test).
- Their age will range from 25 to 40 years old.
- Their Body mass index (BMI) will be ranged from 25 to 30 Kg /m2.
- They should not have any musculoskeletal disorders.
Exclusion Criteria:
- Lumber or hip joint pathology.
- Acute pelvic bacterial or viral infections or tumour.
- Taking nonsteroidal anti-inflammatory drugs, or hormonal treatments.
- Having positive straight leg raising test.
Sites / Locations
- Manal Ahmed
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
LLL therapy and postural correction ex (study group)
postural correction ex (control group)
Arm Description
study group will be treated by low level laser therapy and postural correction exercises
control group will be treated by postural correction exercises only
Outcomes
Primary Outcome Measures
pain intensity
The pain intensity will be assessed through visual analogue scale (VAS) for both groups before and after the end of treatment program. Each woman will be asked to mark a point on the line between the extremes that related to her pain intensity.
pain pressure threshold
pressure algometer will be used to assess pain pressure threshold for both groups before and at the end of the study
Secondary Outcome Measures
functional disability
oswestery disability index will be used to assess level of functional disability for both groups before and at the end of the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05306236
Brief Title
Efficacy of Adding LLL Therapy to Postural Correction Exercises on Postnatal SIJ Pain
Official Title
Efficacy of Adding Low Level Laser Therapy to Postural Correction Exercises on Postnatal Sacroiliac Joint Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
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
the purpose of the study will be to to examine the effect of low level laser therapy on pain and function disability in postnatal women with sacroiliac joint pain.
Detailed Description
Women are more susceptible to sacroiliac joint pain than men because the physiological changes associated with childbearing (e.g. pregnancy associated with weight gain, exaggerated lumber lordosis, hormone-induced ligamentous laxity and the mechanical trauma associated with childbirth) may result in sacroiliac joint pathology .
Low level laser is effective for treatment of various musculoskeletal pain disorders. It releases local neurotransmitters such as serotonin and endorphins. Additionally, the analgesic effect of LLLT is thought to be related to its anti-inflammatory action. Laser irradiations also relieve pain by alleviating and removing swelling and by increasing oxygenation of the tissues, thus results in reduction of the pain .
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
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LLL therapy and postural correction ex (study group)
Arm Type
Experimental
Arm Description
study group will be treated by low level laser therapy and postural correction exercises
Arm Title
postural correction ex (control group)
Arm Type
Experimental
Arm Description
control group will be treated by postural correction exercises only
Intervention Type
Other
Intervention Name(s)
LLL therapy , postural correction ex
Intervention Description
study group: will receive low level laser therapy 2 sessions per week for 6 weeks in addition to posture correction exercises.
control group: will be treated by posture correction ex only.
Primary Outcome Measure Information:
Title
pain intensity
Description
The pain intensity will be assessed through visual analogue scale (VAS) for both groups before and after the end of treatment program. Each woman will be asked to mark a point on the line between the extremes that related to her pain intensity.
Time Frame
up to 2 months
Title
pain pressure threshold
Description
pressure algometer will be used to assess pain pressure threshold for both groups before and at the end of the study
Time Frame
up to 2 months
Secondary Outcome Measure Information:
Title
functional disability
Description
oswestery disability index will be used to assess level of functional disability for both groups before and at the end of the study
Time Frame
up to 2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Post natal women suffering from sacroiliac joint pain for at least 3 months.
They should have moderate to severe pain in the sacroiliac joint region (visual analogue scale ≥ 4).
They should have positive findings in at least three of five provocation sacroiliac joint tests (i.e., Patrick's sign, Gaenslen test, compression test, thigh thrust test and distraction test).
Their age will range from 25 to 40 years old.
Their Body mass index (BMI) will be ranged from 25 to 30 Kg /m2.
They should not have any musculoskeletal disorders.
Exclusion Criteria:
Lumber or hip joint pathology.
Acute pelvic bacterial or viral infections or tumour.
Taking nonsteroidal anti-inflammatory drugs, or hormonal treatments.
Having positive straight leg raising test.
Facility Information:
Facility Name
Manal Ahmed
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Efficacy of Adding LLL Therapy to Postural Correction Exercises on Postnatal SIJ Pain
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