Clinical trial NCT05529602: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lower Back Pain
Keywords: core stability
Core strengthening
chronic low back pain
therapeutic exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 54
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: MODIFIED OSWESTRY DISABILITY INDEX (MODI)
timeFrame: 3rd week
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 3rd week
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Syed Medical Complex.
state: Punjab
Study officials:
affiliation: Riphah International University
name: Afifa Safdar, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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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.