- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07440849
Effects of Core Stability and Pelvic Clock Exercises in Sacroiliac Joint Dysfunction
Combine Effects of Core Stability and Pelvic Clock Exercises on Pain, Disability and Quality of Life in Postpartum Females With Sacroiliac Joint Dysfunction
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: imran amjad
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Sargodha, Punjab Province, Pakistan, 6400
- Recruiting
- Al-Khidmat Hospital
-
Contact:
- adeela arif, t-DPT
- Phone Number: 03320845723
- Email: adeela.arif@riphah.edu.pk
-
Sub-Investigator:
- ayesha arshad, MSPT(WH)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Vaginal delivery
- Primiparous women
- Pain intensity greater than 6 on the Numerical Pain Rating Scale (NPRS)
- Positive responses to at least three physical provocation tests suggestive of sacroiliac joint dysfunction
Exclusion Criteria:
- Participants were excluded from the study if they had any of the following conditions:
- Previous history of trauma
- Musculoskeletal disorders (e.g., coccydynia, impingement syndrome)
- Postpartum depression
- Disc bulge or degeneration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: core stability exercises
Core stability exercises were performed in modified or low-impact forms suitable for the postpartum phase to ensure safety for participants with sacroiliac joint dysfunction. Each exercise session included two sets of core stability exercises with ten repetitions per set, performed two to three times per week for a total duration of eight weeks. |
Core stability exercises were performed in modified or low-impact forms suitable for the postpartum phase to ensure safety for participants with sacroiliac joint dysfunction. Each exercise session included two sets of core stability exercises with ten repetitions per set, performed two to three times per week for a total duration of eight weeks.
Pelvic clock exercises were performed in a hook-lying position to promote spinal alignment and minimize lumbar lordosis.
These exercises were designed to improve pelvic awareness, control, and mobility.Pelvic clock exercises were performed for two to three minutes, three times per week, for a duration of eight weeks
|
|
Active Comparator: pelvic clock exercises
Pelvic clock exercises were performed in a hook-lying position to promote spinal alignment and minimize lumbar lordosis.
These exercises were designed to improve pelvic awareness, control, and mobility.Pelvic clock exercises were performed for two to three minutes, three times per week, for a duration of eight weeks
|
Core stability exercises were performed in modified or low-impact forms suitable for the postpartum phase to ensure safety for participants with sacroiliac joint dysfunction. Each exercise session included two sets of core stability exercises with ten repetitions per set, performed two to three times per week for a total duration of eight weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 8th week
|
The Numeric Pain Rating Scale (NPRS) is a segmented numeric version of the Visual Analog Scale (VAS), which asked respondents to choose a number ranging from 0-10 that represented their current pain intensity.
The scale used a horizontal line with anchors describing the highest and lowest levels of pain intensity.
|
8th week
|
|
Oswestry Disability Index (ODI)
Time Frame: 8th week
|
Another common tool utilized to examine the degree to which the participant was affected due to back pain is the Oswestry Disability Index.The ODI had 10 items, each exploring a particular dimension within the patient's life.
Scoring was from 0 to 5. Higher scores reflected increasing levels of disability.
Self-administering the inventory took approximately five minutes to answer the items.
|
8th week
|
|
WHOQOL-BREF
Time Frame: 8th week
|
The WHOQOL-BREF is a standardized scale developed by WHO to determine the perception of quality of life of an individual.
It is a brief version of another scale known as WHOQOL-100 and has 26 questions related to four domains: Physical Health, Psychological Well-being, Social Relations, and Environment.
|
8th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: adeela arif, t-DPT, Riphah International University
Publications and helpful links
General Publications
- Javadov A, Ketenci A, Aksoy C. The Efficiency of Manual Therapy and Sacroiliac and Lumbar Exercises in Patients with Sacroiliac Joint Dysfunction Syndrome. Pain Physician. 2021 May;24(3):223-233.
- Zaidi F, Ahmed I. Effectiveness of muscle energy technique as compared to Maitland mobilisation for the treatment of chronic sacroiliac joint dysfunction. J Pak Med Assoc. 2020 Oct;70(10):1693-1697. doi: 10.5455/JPMA.43722.
- Kiapour A, Joukar A, Elgafy H, Erbulut DU, Agarwal AK, Goel VK. Biomechanics of the Sacroiliac Joint: Anatomy, Function, Biomechanics, Sexual Dimorphism, and Causes of Pain. Int J Spine Surg. 2020 Feb 10;14(Suppl 1):3-13. doi: 10.14444/6077. eCollection 2020 Feb.
- Fiani B, Sekhon M, Doan T, Bowers B, Covarrubias C, Barthelmass M, De Stefano F, Kondilis A. Sacroiliac Joint and Pelvic Dysfunction Due to Symphysiolysis in Postpartum Women. Cureus. 2021 Oct 9;13(10):e18619. doi: 10.7759/cureus.18619. eCollection 2021 Oct.
- Li C, Xiao Z, Chen L, Pan S. Efficacy and safety of extracorporeal shock wave on low back pain: A systematic review and meta-analysis. Medicine (Baltimore). 2022 Dec 30;101(52):e32053. doi: 10.1097/MD.0000000000032053.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/RCR&AHS/24/0537
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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