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Post Isometric Relaxation and Core Stability Exercises in Sacroiliac Joint Dysfunction

Primary Purpose

Lower Back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
conventional physical therapy
relaxation exercise
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain focused on measuring core stability, Core strengthening, chronic low back pain, therapeutic exercises

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Syed Medical Complex.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

post isometric relaxation exercises and core stability

conventional physical therapy

Arm Description

for pain and disability secondary to SIJ dysfunction in postpartum females

for management of lower back pain

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Numeric Pain Rating Scale (NPRS)
Changes from baseline the Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). Changes from the baseline and 3rd week.

Full Information

First Posted
July 24, 2022
Last Updated
September 15, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05529602
Brief Title
Post Isometric Relaxation and Core Stability Exercises in Sacroiliac Joint Dysfunction
Official Title
Comparison of Post Isometric Relaxation and Core Stability Exercises on Pain and Disability in Postpartum Females With Sacroiliac Joint Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
A previous study conducted by Farhadi et al. assessed that the prevalence of sacroiliac joint pain has been reported between 13-30% in postpartum females aged between 40-and 45 years. Specifically, 13% of the individuals with low back pain have the origin of their pain from the sacroiliac joint. It has been found that 33.6% of pregnant women have pelvic girdle pain, and 18.9% of post-partum women have "serious" pelvic girdle pain. In most women with pregnancy-related sacroiliac, joint pain resolves with time after pregnancy, but in some females, the pain lingers on. Patients with Sacroiliac dysfunction generally complain of pain in their back, and buttock or may radiate to the knee. On examination, there is pain and local tenderness. The symptoms increase on position change such as getting up from a sitting or lying position or while ascending and descending stairs. Sacroiliac pain is localized to the posterior pelvis and is described as stabbing pain deep. Terzi and Clinton et al., (2019) found thirty women diagnosed with post-partum SIJ pain, their age ranged from (25-35)years, their BMI ranged from (25-to 30)kg/m², and their number of parity ranged(from 2-to 4)times were selected randomly from the outpatient clinic of Al-Ahrar teaching hospital. Women were divided randomly into two equal groups, Group A (Control group): 15 patients, they were treated by TENS for 4 weeks 30 min\session, 3 sessions \week. Group B(Study group):15 patient, were treated with core stability exercises for 4 weeks, 30 min\session, 5 sessions \week plus TENS as for group A. All participant was evaluated by VAS, Oswestry disability index (ODI), serum cortisol levels before and after treatment. The results revealed that there was a statistically significant decrease in the mean value of VAS in the group (B) when compared with its corresponding value in group (A). In spite of there being no statistically significant difference in plasma cortisol level, there was a clinical difference and high percent of improvement in favor of group B (8.83%) over group A (2.66%). Also, there was a statistically significant decrease in the mean value of ODI in the group (B) when compared with its corresponding value in group (A). It was concluded that core stability exercises could be used as a complementary treatment in reducing post-partum SIJ pain. Also, it could be considered a useful treatment to increase flexibility and range of motion. Shamsi et al., in 2014, found that reduced pain and increased function are outcomes when core stability exercises are used in the early stages of interventions. Also, Huxel et al., found that core exercises resulted in better outcomes measures than general exercise in the first 3 months of interventions for LBP, as they found clinical improvements in pain perception and functional disability levels when the patients with LBP engaged in core-specific exercise. One study was done by Noelle M.Selkow et al., (2017) supports the findings of our study by concluding that MET is effective in decreasing pain in patients with acute low back pain. Another study was done by Roberts BL where he described two techniques of soft tissue manipulation viz neuromuscular technique and MET and found that MET can reduce Pain, muscle rigidity, and lengthen muscle fibers. The effect of MET on disability is supported by Fenech et al., (2015) determined that LBP is one of the most common musculoskeletal problems that affects about 60-80% of the population throughout their life expectancy. The lifetime prevalence of low back pain is reported to be 84% with 11-12% of the population being disabled by this condition. In 2010 Global Burden of Disease conducted a study on low back pain and estimated the global age-standardized point prevalence to be 9.4%. Low back pain is a self-limiting condition that can commonly be found in middle age ranging from 35 to 65 years and 90% of the people can be cured within 3-4 months without any treatment protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain
Keywords
core stability, Core strengthening, chronic low back pain, therapeutic exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
post isometric relaxation exercises and core stability
Arm Type
Experimental
Arm Description
for pain and disability secondary to SIJ dysfunction in postpartum females
Arm Title
conventional physical therapy
Arm Type
Other
Arm Description
for management of lower back pain
Intervention Type
Other
Intervention Name(s)
conventional physical therapy
Intervention Description
core stability exercises A total of 3 sessions per week were given for 15-20 minutes
Intervention Type
Other
Intervention Name(s)
relaxation exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
MODIFIED OSWESTRY DISABILITY INDEX (MODI)
Description
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.
Time Frame
3rd week
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
Changes from baseline the Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). Changes from the baseline and 3rd week.
Time Frame
3rd week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afifa Safdar, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syed Medical Complex.
City
Sialkot
State/Province
Punjab
ZIP/Postal Code
51310
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1830444
Citation
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.
Results Reference
background
PubMed Identifier
14616251
Citation
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.
Results Reference
background
PubMed Identifier
2962023
Citation
Berg G, Hammar M, Moller-Nielsen J, Linden U, Thorblad J. Low back pain during pregnancy. Obstet Gynecol. 1988 Jan;71(1):71-5.
Results Reference
background
PubMed Identifier
34580864
Citation
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.
Results Reference
background
PubMed Identifier
34360103
Citation
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.
Results Reference
background
PubMed Identifier
33988941
Citation
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.
Results Reference
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Post Isometric Relaxation and Core Stability Exercises in Sacroiliac Joint Dysfunction

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