Studies
| Study First Submitted Date | 2021-03-24 |
| Study First Posted Date | 2021-03-26 |
| Last Update Posted Date | 2021-04-14 |
| Start Month Year | August 18, 2019 |
| Primary Completion Month Year | June 27, 2020 |
| Verification Month Year | April 2021 |
| Verification Date | 2021-04-30 |
| Last Update Posted Date | 2021-04-14 |
Detailed Descriptions
| Sequence: | 20802351 |
| Description | Pelvic-girdle pain is a mechanical disorder growing rapidly as a consequence of changing delivery pattern and changing lifestyle. Medication with synthetic drugs not only has been unable to effectively curtail the spread of this disease conditions but also is most of the times linked with co-occurring side-effects. The exercise and manual therapy-based approach could lead in reducing the functional limitations and morbidity rate in females with the postpartum pain. This research could also help in spreading the awareness globally, to Prenatal and Postnatal Hospital Caregivers. |
Facilities
| Sequence: | 200790041 |
| Name | Riphah Rehabilitation Center |
| City | Lahore |
| State | Punjab |
| Zip | 54000 |
| Country | Pakistan |
Conditions
| Sequence: | 52376950 |
| Name | Pelvic Girdle Pain |
| Downcase Name | pelvic girdle pain |
Id Information
| Sequence: | 40305331 |
| Id Source | org_study_id |
| Id Value | IRB-UOL-FAHS/659 Anam Naz |
Countries
| Sequence: | 42727845 |
| Name | Pakistan |
| Removed | False |
Design Groups
| Sequence: | 55822048 | Sequence: | 55822049 |
| Group Type | Active Comparator | Group Type | Experimental |
| Title | Routine physical therapy treatment with the Stabilization exercises | Title | Routine physical therapy treatment + High-velocity thrust manipulation |
| Description | Stabilization exercises | Description | High-velocity thrust manipulation |
Interventions
| Sequence: | 52687190 | Sequence: | 52687191 |
| Intervention Type | Other | Intervention Type | Other |
| Name | Routine physical therapy treatment with the Stabilization exercises | Name | Routine physical therapy treatment + High-velocity thrust manipulation |
| Description | The program was based on specific training of the transversely oriented abdominal muscles with coactivation of the lumbar multifidus at the lumbosacral region, training of the gluteus maximus, the latissimus dorsi, the oblique abdominal muscles, the erector spinae, the quadratus lumborum, and the hip adductors and abductors. Initially, we focused on the specific contraction of the transversely oriented abdominal muscles. After approximately 2 weeks, loading was progressively increased throughout the intervention period. The women were required to exercise for 30 to 60 minutes, 3 days a week, for 3-4 weeks. | Description | : For high-velocity thrust technique, a modified Chicago technique was used. For this procedure, the lumbopelvic region was targeted. The side to be treated was chosen, based on the subject's report of her most symptomatic side. The physical therapist, performed passively side bend the subject toward the painful side, rotate the upper body in the direction opposite to the side bending, and then deliver a quick posterior and inferior thrust at a grade V including a small-amplitude/high-velocity therapeutic movement. A maximum of 2 attempts per side was permitted if no pop was heard following the first attempt. If the subject showed improvement of 50% or less after the first treatment, the intervention was categorized as a failure, the examination and intervention were repeated, and the subjects were asked to return 2 to 4 days later. If the subject showed greater than 50% improvement, the intervention was categorized as a success, and study participation was concluded. |
Design Outcomes
| Sequence: | 178139014 | Sequence: | 178139015 |
| Outcome Type | primary | Outcome Type | primary |
| Measure | Visual analog scale | Measure | Oswestry disability index |
| Time Frame | 2 months | Time Frame | 2 months |
| Description | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." | Description | The ODI score (index) is calculated as: If all 10 sections are completed the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32% If one section is missed (or not applicable) the score is calculated: If 16 (total scored) / 45 (total possible score) x 100 = 35.5% |
Browse Conditions
| Sequence: | 194269369 | Sequence: | 194269370 | Sequence: | 194269371 | Sequence: | 194269372 | Sequence: | 194269373 |
| Mesh Term | Pelvic Girdle Pain | Mesh Term | Musculoskeletal Pain | Mesh Term | Pain | Mesh Term | Neurologic Manifestations | Mesh Term | Pelvic Pain |
| Downcase Mesh Term | pelvic girdle pain | Downcase Mesh Term | musculoskeletal pain | Downcase Mesh Term | pain | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | pelvic pain |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48511383 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Riphah International University |
Overall Officials
| Sequence: | 29393596 |
| Role | Principal Investigator |
| Name | Maryam Shabbir, PhD* |
| Affiliation | Riphah International University |
Design Group Interventions
| Sequence: | 68428825 | Sequence: | 68428826 |
| Design Group Id | 55822048 | Design Group Id | 55822049 |
| Intervention Id | 52687190 | Intervention Id | 52687191 |
Eligibilities
| Sequence: | 30884378 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | 45 Years |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: • Post-partum females with the normal vaginal delivery present with pelvic girdle pain before the next conception. Aged between 18 and 45 Posterior pelvic girdle pain located distal and/or lateral to the L5-S1 Pain onset during pregnancy or within 3 weeks after delivery, most recent delivery within 6 to 16 weeks Positive posterior pelvic pain provocation (P4) test Exclusion Criteria: Patients presenting with the history of: Back pain indicating radiculopathy Mechanical back pain Back pain due to disc herniation Rheumatological diseases Neurological illness or recent surgery Women who have gone through C-section |
| Adult | True |
| Child | False |
| Older Adult | False |
Calculated Values
| Sequence: | 254075020 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2021 |
| Actual Duration | 10 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Maximum Age Num | 45 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 2 |
Designs
| Sequence: | 30630144 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | Double |
| Subject Masked | True |
| Outcomes Assessor Masked | True |
Responsible Parties
| Sequence: | 28996722 |
| Responsible Party Type | Sponsor |
Study References
| Sequence: | 52285283 | Sequence: | 52285284 | Sequence: | 52285285 | Sequence: | 52285286 | Sequence: | 52285287 | Sequence: | 52285288 |
| Pmid | 15866079 | Pmid | 26885363 | Pmid | 19863747 | Pmid | 16532908 | Pmid | 28915804 | Pmid | 22282770 |
| Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
| Citation | Bastiaanssen JM, de Bie RA, Bastiaenen CH, Essed GG, van den Brandt PA. A historical perspective on pregnancy-related low back and/or pelvic girdle pain. Eur J Obstet Gynecol Reprod Biol. 2005 May 1;120(1):3-14. doi: 10.1016/j.ejogrb.2004.11.021. | Citation | Bergstrom C, Persson M, Mogren I. Sick leave and healthcare utilisation in women reporting pregnancy related low back pain and/or pelvic girdle pain at 14 months postpartum. Chiropr Man Therap. 2016 Feb 15;24:7. doi: 10.1186/s12998-016-0088-9. eCollection 2016. | Citation | Vermani E, Mittal R, Weeks A. Pelvic girdle pain and low back pain in pregnancy: a review. Pain Pract. 2010 Jan-Feb;10(1):60-71. doi: 10.1111/j.1533-2500.2009.00327.x. Epub 2010 Oct 26. | Citation | Robinson HS, Eskild A, Heiberg E, Eberhard-Gran M. Pelvic girdle pain in pregnancy: the impact on function. Acta Obstet Gynecol Scand. 2006;85(2):160-4. doi: 10.1080/00016340500410024. | Citation | Bergstrom C, Persson M, Nergard KA, Mogren I. Prevalence and predictors of persistent pelvic girdle pain 12 years postpartum. BMC Musculoskelet Disord. 2017 Sep 16;18(1):399. doi: 10.1186/s12891-017-1760-5. | Citation | Eggen MH, Stuge B, Mowinckel P, Jensen KS, Hagen KB. Can supervised group exercises including ergonomic advice reduce the prevalence and severity of low back pain and pelvic girdle pain in pregnancy? A randomized controlled trial. Phys Ther. 2012 Jun;92(6):781-90. doi: 10.2522/ptj.20110119. Epub 2012 Jan 26. |