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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06045182
Other study ID # FUI/CTR/2023/16
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 30, 2023
Est. completion date February 1, 2024

Study information

Verified date September 2023
Source Foundation University Islamabad
Contact Anum Sadiq, DPT,MS-MSKPT*
Phone +923095628050
Email anumsadiq1995@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sacroiliac joint (SIJ) dysfunction is known as an important contributing factor in lower back pain. Pain and stiffness experienced from the sacroiliac joint in the SI region (hips/groins or may spread to lower extremity) is referred as SIJ dysfunction.Physiotherapists have a wide range of options in managing SIJD including Manipulation, Kinesiotaping, Muscle Energy Technique (MET), McKenzie, Maitland's mobilization, and Mulligan's mobilization. So far studies have shown the efficacy of different treatment tools in combination or in isolation. Likewise, researchers have also studied the effect of piriformis stretch in combination with other exercises on sacroiliac joint pain. However, there is very limited literature available on the cumulative effect of piriformis stretch along with mobilization maneuvers on pain and disability in patient with SIJ dysfunction.Since piriformis is one of the most important muscles involved in stabilization of SI joint and a major source of SI dysfunction, hence the current study is designed to investigate the additional effects of piriformis stretch with manual therapy in the management of sacroiliac joint dysfunction.


Description:

SIJ dysfunction is a prominent source of pain in low back pain patients. It is reported that 10-30% of individuals suffering from lower back pain is due to SIJ dysfunction.There are different risk factors for developing SIJ dysfunction including leg length discrepancies, a history of lumbar fusion, scoliosis, sustained athletic activity, pregnancy, spondyloarthropathies, or gait abnormalities.Muscles that are commonly found to be shortened (or tightened) in SIJ dysfunction include the rectus femoris, tensor fascia Lata, hip adductors, quadratus lumborum, piriformis, obturator internus, and latissimus dorsi. Particular attentions should be directed to the piriformis muscle. t alters the SIJ motion by rotating the sacrum to the opposite side.Continued inflexibility of this muscle is often thought to be part of the source of recurrent pain Over time several treatment aporaches have been developd to treat SIJ dysfunction.Clinicians also use different electrotherapy modalities, biomechanical correction techniques, and exercises for addressing SI joint pain. Many therapeutic exercises including piriformis stretch, muscle activation exercises and exercise therapy have the potential of improving sacroiliac joint dysfunction , however evidence is deficient. This research presents additional effects of piriformis stretch in the management of sacroiliac joint dysfunction.It will expand current understanding of effects of piriformis stretch on disability and pain in patients with SIJ dysfunction and help in providig treatment protocols for improving pain in patients with sacroiliac joint dysfunction. Main objective of thi study is to determine and compare the effect of piriformis stretch along with mobilization as compared to SIJ mobilization alone on pain and disability in patients with SIJ dysfunction. The participants meeting the eligibility citeria will be recruited, followed by random allocation to 2 groups. Both groups will recive standard treatment protocol which consists of Hot pack TENs, mobalization.Three sessions will be provided on alternative days. Pre and Post assessment of pain and disability will be noted


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date February 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Adults (both male and female) aged 18-45 years experiencing sacroiliac joint pain - Patients fulfilling the diagnostic criteria, recommended by the International Association for the Study of Pain (IASP).(13) - Those with > 4 score on Numeric pain rating scale for the sacroiliac pain - Using no other pain killers or non steroidal anti-inflammatory drugs during the therapy Exclusion Criteria: - Individuals suffering from pain due to other conditions (low back pain, hip pathology, hip osteoarthritis, cognitive disorders, radicular pain, ankylosing spondylitis, coccydynia) - Patients with piriformis syndrome. - SIJ pain due to other causes such as fractures, tumors and trauma. - Pregnant females - Those patients who have received any surgical treatment for SIJ dysfunction

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Maitland mobilization
Participants in this group will be first given hot pack and TENS for 10 min. Then they will be given Maitland Mobilizations (10 oscillations total of 3 sets )with 10 sec rest in between. Mobilization will be Unilateral or central based on the patient condition and Intensity of Mobilizations increases as per patient tolerance in 2nd and 3rd session.
Piriformis stretch
Piriformis stretch will be given to this group. In first session piriformis stretch will be given for 10 sec with 10-second resting time in between with, 7 rep total of 1 set. For the 2nd and 3rd session repetitions will be increase to 8 and 10 respectively.
Electrotherapy
Hot pack and TENS for 10 min

Locations

Country Name City State
Pakistan Foundation University College of Physical Therapy Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity Pain will be measured using the Numeric Pain Rating Scale, which is an 11-item scale 1 week
Primary Disability level of participant Disability will be assessed using Oswestry low back disability Index. A higher score indicates more disability 1 week
See also
  Status Clinical Trial Phase
Completed NCT02652611 - Sacroiliac (SI) Screws: The Effect of SI Screw Removal on Patient-Reported Pain and Functional Outcomes N/A