NCT05529602

Brief Summary

There is growing evidence on the effects of post isometric relaxation exercises and core stability exercises on pain and disability secondary to various disorders. However, very few studies have explored their effects in postpartum Sacroiliac joint dysfunction. The aim of this study will be to compare the effects of post isometric relaxation exercises and core stability exercises on pain in postpartum Sacroiliac joint dysfunction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

July 24, 2022

Last Update Submit

September 15, 2023

Conditions

Keywords

core stabilityCore strengtheningchronic low back paintherapeutic exercises

Outcome Measures

Primary Outcomes (1)

  • MODIFIED OSWESTRY DISABILITY INDEX (MODI)

    ODI is a reliable and valid to assess the functional disability related to low back pain, it has 10 questions, each question is answered via six choices, the first statement takes 0 and the sixth statement take 5, the patient was asked to selected the best chouce that prescribe her disability, then all scores collected and taken as a percentage from the total score the higher score indicate great disability, scores from 0-20% denote minimal disability, scores 40-60% denote moderate disability, while scores from 60-80% denote crippled disability , finally scores from 80-100% represent patient who are confined to bed. Changes from the baseline and 3rd week.

    3rd week

Secondary Outcomes (1)

  • Numeric Pain Rating Scale (NPRS)

    3rd week

Study Arms (2)

post isometric relaxation exercises and core stability

EXPERIMENTAL

for pain and disability secondary to SIJ dysfunction in postpartum females

Other: conventional physical therapy

conventional physical therapy

OTHER

for management of lower back pain

Other: relaxation exercise

Interventions

core stability exercises A total of 3 sessions per week were given for 15-20 minutes

post isometric relaxation exercises and core stability

the experimental group was given Post-isometric relaxation exercise along with core stability A total of 3 sessions per week were given for 15-20 minutes

conventional physical therapy

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Postpartum females with sacroiliac joint dysfunction
  • Diagnosed Patients with SIJ dysfunction
  • Females who will be physically active
  • Age between 20 to 35 years
  • Females having a post-partum period

You may not qualify if:

  • Post Spinal surgery/instrumentation
  • prolonged steroid use and bone tissue infection or malignancy)
  • Radiculopathy
  • Acute Traumatic injury of spine/lower extremity
  • Patient under anticoagulant therapy
  • Delivery with any complication
  • Females have any history of diabetes, hypertension, or any chronic illness
  • Any Pelvic or abdominal surgery in past
  • Disc herniation or spine fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syed Medical Complex.

Sialkot, Punjab Province, 51310, Pakistan

Location

Related Publications (6)

  • Ostgaard HC, Andersson GB, Wennergren M. The impact of low back and pelvic pain in pregnancy on the pregnancy outcome. Acta Obstet Gynecol Scand. 1991;70(1):21-4. doi: 10.3109/00016349109006172.

    PMID: 1830444BACKGROUND
  • To WW, Wong MW. Factors associated with back pain symptoms in pregnancy and the persistence of pain 2 years after pregnancy. Acta Obstet Gynecol Scand. 2003 Dec;82(12):1086-91. doi: 10.1046/j.1600-0412.2003.00235.x.

    PMID: 14616251BACKGROUND
  • Berg G, Hammar M, Moller-Nielsen J, Linden U, Thorblad J. Low back pain during pregnancy. Obstet Gynecol. 1988 Jan;71(1):71-5.

    PMID: 2962023BACKGROUND
  • Hayden JA, Ellis J, Ogilvie R, Malmivaara A, van Tulder MW. Exercise therapy for chronic low back pain. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD009790. doi: 10.1002/14651858.CD009790.pub2.

    PMID: 34580864BACKGROUND
  • Puntumetakul R, Saiklang P, Tapanya W, Chatprem T, Kanpittaya J, Arayawichanon P, Boucaut R. The Effects of Core Stabilization Exercise with the Abdominal Drawing-in Maneuver Technique versus General Strengthening Exercise on Lumbar Segmental Motion in Patients with Clinical Lumbar Instability: A Randomized Controlled Trial with 12-Month Follow-Up. Int J Environ Res Public Health. 2021 Jul 23;18(15):7811. doi: 10.3390/ijerph18157811.

    PMID: 34360103BACKGROUND
  • 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.

    PMID: 33988941BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Afifa Safdar, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2022

First Posted

September 7, 2022

Study Start

December 1, 2021

Primary Completion

August 30, 2022

Study Completion

August 30, 2022

Last Updated

September 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations