Efficacy of Adding LLL Therapy to Postural Correction Exercises on Postnatal SIJ Pain

Efficacy of Adding Low Level Laser Therapy to Postural Correction Exercises on Postnatal Sacroiliac Joint Pain

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.

Study Overview

• Status: Completed
• Conditions: Sacroiliac Joint Pain
• Intervention / Treatment: Other: LLL therapy , postural correction ex

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 .

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Manal Ahmed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 33 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LLL therapy and postural correction ex (study group); study group will be treated by low level laser therapy and postural correction exercises	Other: LLL therapy , postural correction ex; 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.
Experimental: postural correction ex (control group); control group will be treated by postural correction exercises only	Other: LLL therapy , postural correction ex; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 2 months
pain pressure threshold	pressure algometer will be used to assess pain pressure threshold for both groups before and at the end of the study	up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 2 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia
• Other Study ID Numbers: P.T.REC/012/003492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No