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Additional Effects of Piriformis Stretch in the Management of Sacroiliac Joint Dysfunction

Primary Purpose

Sacroiliac Joint

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Maitland mobilization
Piriformis stretch
Electrotherapy
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacroiliac Joint

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foundation University College of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A (Maitland mobalizations )

Group B (Maitland Moblizations along with piriformis stretch)

Arm Description

Patients in this group will receive Maitland mobilizations along with hot pack and TENS for pain and disability. A total of 3 sessions would be conducted over a period of 1 week.

Patients will receive Maitland mobilizations along with hot pack and TENs and additional stretch of piriformis muscle is given. A total of 3 sessions would be conducted over a period of 1 week.

Outcomes

Primary Outcome Measures

Pain intensity
Pain will be measured using the Numeric Pain Rating Scale, which is an 11-item scale
Disability level of participant
Disability will be assessed using Oswestry low back disability Index. A higher score indicates more disability

Secondary Outcome Measures

Full Information

First Posted
September 13, 2023
Last Updated
September 13, 2023
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT06045182
Brief Title
Additional Effects of Piriformis Stretch in the Management of Sacroiliac Joint Dysfunction
Official Title
Additional Effects of Piriformis Stretch in the Management of Sacroiliac Joint Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

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
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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized controlled trial having two groups. One group will receive maitland mobalizations and the second will receive maitland mobalization along with piriformis stretch. Both groups will be recruited concurrently.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Maitland mobalizations )
Arm Type
Active Comparator
Arm Description
Patients in this group will receive Maitland mobilizations along with hot pack and TENS for pain and disability. A total of 3 sessions would be conducted over a period of 1 week.
Arm Title
Group B (Maitland Moblizations along with piriformis stretch)
Arm Type
Experimental
Arm Description
Patients will receive Maitland mobilizations along with hot pack and TENs and additional stretch of piriformis muscle is given. A total of 3 sessions would be conducted over a period of 1 week.
Intervention Type
Procedure
Intervention Name(s)
Maitland mobilization
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Piriformis stretch
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Electrotherapy
Intervention Description
Hot pack and TENS for 10 min
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain will be measured using the Numeric Pain Rating Scale, which is an 11-item scale
Time Frame
1 week
Title
Disability level of participant
Description
Disability will be assessed using Oswestry low back disability Index. A higher score indicates more disability
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anum Sadiq, DPT,MS-MSKPT*
Phone
+923095628050
Email
anumsadiq1995@gmail.com
Facility Information:
Facility Name
Foundation University College of Physical Therapy
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zara Khalid, MS-CPPT,PHD*
Phone
+923335415822
Email
zara.khalid@fui.edu.pk

12. IPD Sharing Statement

Learn more about this trial

Additional Effects of Piriformis Stretch in the Management of Sacroiliac Joint Dysfunction

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