Back to resultsEfficacy of Manual Therapy and Sacroiliac Joint Injection in Sacroiliac Joint Dysfunction
Primary Purpose
Sacroiliac Joint Somatic Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manuel therapy
Sacroiliac joint injection
Sponsored by
About this trial
This is an interventional treatment trial for Sacroiliac Joint Somatic Dysfunction focused on measuring Sacroiliac joint dysfunction, Manuel therapy, Sacroiliac joint injection
Eligibility Criteria
Inclusion Criteria:
- Low back and/or gluteal pain and/or groin pain without radicular extension below the L4 level for more than 3 months
- Pain score greater than 3 according to NRS
- Unresponsiveness to conservative treatment (such as exercise, NSAID)
- At least 3 of the five sacroiliac provocation tests (FABER (Patrick), thigh thrust, Gaenslen, sacroiliac compression, and sacroiliac distraction tests) are positive
Exclusion Criteria:
- Refusing to participate in the study
- Pregnancy
- History of inflammatory disease (ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, etc.)
- Infective sacroiliitis
- Malignancy
- Osteoporosis
- Mechanical lumbosacral pathologies (spondylolisthesis, scoliosis, stenosis, etc.)
- Neurological finding in the lower extremity
- Pain spreading below the knee
- History of spinal surgery
- History of allergy to drugs to be injected (local anesthetic, contrast material, steroid allergy)
Sites / Locations
- SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Manuel therapy and exercise group
Sacroiliac injection and exercise group
Arm Description
Patients in the manual therapy group will receive 5 sessions of sacroiliac joint manipulation once a week. And home exercises will be given and told. Each patient will do exercise 4 days a week for 4 weeks.
To patients in the injection group corticosteroid (1 ml 40 mg methylprednisolone) and local anesthetic (1 ml 1% lidocaine)will be injected into the sacroiliac joint using a 22 G spinal needle, guided by fluoroscopy (C-arm fluoroscopy). And home exercises will be given and told. Each patient will do exercise 4 days a week for 4 weeks.
Outcomes
Primary Outcome Measures
Numeric Rating Scale, NRS
NRS is an 11-grade scale that evaluates the severity of pain in adults .NRS is one of the most commonly used scales in the assessment of pain severity. Possible scores ranges from 0( no pain) to 10 ( worst pain)
Secondary Outcome Measures
Oswestry Disability index
The Oswestry disability index will be used to evaluate how much the patients' low back pain limits their activities in daily life. This index was first created in 1980 . The questionnaire consists of 10 sections, each assessing limitations in different daily activities and functions. Each section is scored from 0 to 5. A score of 0 indicates that there is no restriction while doing that activity, while a score of 5 represents the highest level of restriction in that activity. The maximum score is 50. As the total score increases, the disability level of the individual increases. In 2004, Turkish validity study was carried out by Yakut et al.
Full Information
NCT ID
NCT05181579
First Posted
December 3, 2021
Last Updated
July 12, 2023
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05181579
Brief Title
Efficacy of Manual Therapy and Sacroiliac Joint Injection in Sacroiliac Joint Dysfunction
Official Title
Efficacy of Manual Therapy and Sacroiliac Joint Injection in the Treatment of Patients With Sacroiliac Joint Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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
The purpose of this study is to compare the efficacy of manual therapy and sacroiliac joint injections in patients with sacroiliac joint dysfunction
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Somatic Dysfunction
Keywords
Sacroiliac joint dysfunction, Manuel therapy, Sacroiliac joint injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manuel therapy and exercise group
Arm Type
Experimental
Arm Description
Patients in the manual therapy group will receive 5 sessions of sacroiliac joint manipulation once a week. And home exercises will be given and told. Each patient will do exercise 4 days a week for 4 weeks.
Arm Title
Sacroiliac injection and exercise group
Arm Type
Experimental
Arm Description
To patients in the injection group corticosteroid (1 ml 40 mg methylprednisolone) and local anesthetic (1 ml 1% lidocaine)will be injected into the sacroiliac joint using a 22 G spinal needle, guided by fluoroscopy (C-arm fluoroscopy).
And home exercises will be given and told. Each patient will do exercise 4 days a week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Manuel therapy
Intervention Description
Some sacroiliac manipulation and mobilization techniques will be applied to patients by an experienced physiatrist. Patients in the manual therapy group will receive 5 sessions of sacroiliac joint manipulation once a week.
Intervention Type
Other
Intervention Name(s)
Sacroiliac joint injection
Intervention Description
Corticosteroid (1 ml 40 mg methylprednisolone) and local anesthetic (1 ml 1% lidocaine) will be injected into the sacroiliac joint using a 22 G spinal needle, guided by fluoroscopy (C-arm fluoroscopy) by an experienced physiatrist. It will be applied just one time.
Primary Outcome Measure Information:
Title
Numeric Rating Scale, NRS
Description
NRS is an 11-grade scale that evaluates the severity of pain in adults .NRS is one of the most commonly used scales in the assessment of pain severity. Possible scores ranges from 0( no pain) to 10 ( worst pain)
Time Frame
Change from baseline NRS at 3 months
Secondary Outcome Measure Information:
Title
Oswestry Disability index
Description
The Oswestry disability index will be used to evaluate how much the patients' low back pain limits their activities in daily life. This index was first created in 1980 . The questionnaire consists of 10 sections, each assessing limitations in different daily activities and functions. Each section is scored from 0 to 5. A score of 0 indicates that there is no restriction while doing that activity, while a score of 5 represents the highest level of restriction in that activity. The maximum score is 50. As the total score increases, the disability level of the individual increases. In 2004, Turkish validity study was carried out by Yakut et al.
Time Frame
Baseline, Month 1, Month 3, Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Low back and/or gluteal pain and/or groin pain without radicular extension below the L4 level for more than 3 months
Pain score greater than 3 according to NRS
Unresponsiveness to conservative treatment (such as exercise, NSAID)
At least 3 of the five sacroiliac provocation tests (FABER (Patrick), thigh thrust, Gaenslen, sacroiliac compression, and sacroiliac distraction tests) are positive
Exclusion Criteria:
Refusing to participate in the study
Pregnancy
History of inflammatory disease (ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, etc.)
Infective sacroiliitis
Malignancy
Osteoporosis
Mechanical lumbosacral pathologies (spondylolisthesis, scoliosis, stenosis, etc.)
Neurological finding in the lower extremity
Pain spreading below the knee
History of spinal surgery
History of allergy to drugs to be injected (local anesthetic, contrast material, steroid allergy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umut Guzelkucuk, MD
Organizational Affiliation
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06800
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Manual Therapy and Sacroiliac Joint Injection in Sacroiliac Joint Dysfunction
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