- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06366971
The Effect of Pelvic Proprioceptive Neuromuscular Facilitation Techniques in Patients With Sacroiliac Joint Dysfunction
April 14, 2024 updated by: Hikmet Ucgun, Biruni University
The sacroiliac joint dysfunction (SIJD) which has a widely heterogeneous etiology, may cause impairment of stability, mobility, posture and flexibility as well as pain due to adaptive or pathological biomechanical changes.
In 2020, the number of patients with low back pain (LBP) worldwide was more than half a billion and is expected to exceed 800 million by 2050.
Although SIJD has been shown to be related with LBP in more than 30% of patients with LBP, SIJD is still often overlooked as a cause of LBP.
Once the diagnosis of SIJD is confirmed by physical examination, the first treatment option consists of the use of a nonsteroidal anti-inflammatory drug or physiotherapy approaches.
The proprioceptive neuromuscular facilitation (PNF) is a neurophysiological model-based multifaceted exercise method which is widely used in rehabilitation practice.
However, despite the major role of SIJD among the causes of LBP, there are limited studies investigating the efficacy of PNF in SIJD and its effectiveness remains unclear.
Thus, the aim of this study was to investigate the effect of pelvic PNF techniques on pain, mobility, flexibility, lumbar range of motion, posture, and trunk muscle endurance in patients with SIJD.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kagıthane
-
Istanbul, Kagıthane, Turkey, 34408
- Istanbul Atlas University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Having a diagnosis of SIJD
- Being between the ages of 18 and 40
- Volunteering to participate in the study
Exclusion Criteria:
- Having a history of any neurological, psychiatric and/or orthopedic disease
- Being pregnant or having a suspicion of pregnancy
- Having one or more of disc herniations, spondylosis, spondylolisthesis and/or similar lumbar pathologies that may cause low back pain
- Having a history of previous spine/hip/lower extremity surgery
- Having a history of active malignancy and/or infection
- Having a history of any injection and/or surgical procedure for the sacroiliac joint within the last 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
The experimental group will receive exercise training consisting of pelvic PNF techniques in addition to patient education which consisting of basic lumbar stabilization exercises 3 days a week for 6-weeks.
|
The patient education will be given through a brochure and the content of the education included an exercise training consisting of simple exercises for lumbar stabilization (supine bridge, cat-camel, and lumbar stretching) and the participants will be asked to perform these exercises in 3 sets of 10 repetitions 3 days a week for 6-weeks.
The content of the pelvic proprioceptive neuromuscular facilitation techniques training will include the application of the anterior depression pattern with the rhythmic initiation technique and the application of the posterior elevation pattern with the contract-relax stretch technique.
All PNF techniques will be performed in 3 sets of 10 to 12 repetitions.
The pelvic proprioceptive neuromuscular facilitation techniques training will be delivered face to face 3 days a week for 6 weeks by an experienced and trained physiotherapist.
|
|
Active Comparator: Control Group
The control group will receive patient education consisting of basic lumbar stabilization exercises 3 days a week for 6-weeks.
|
The patient education will be given through a brochure and the content of the education included an exercise training consisting of simple exercises for lumbar stabilization (supine bridge, cat-camel, and lumbar stretching) and the participants will be asked to perform these exercises in 3 sets of 10 repetitions 3 days a week for 6-weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Level of Low Back Pain
Time Frame: 6 weeks
|
The intensity of low back pain will be rated subjectively on a 100-mm visual analog scale (VAS), where 0-mm indicated "no pain" and 100-mm indicated "worst possible pain"
|
6 weeks
|
|
Mobility
Time Frame: 6 weeks
|
The Modified Schober's test will be used to assess mobility of lower back.
|
6 weeks
|
|
Flexibility
Time Frame: 6 weeks
|
The sit-and-reach test will be used to assess flexibility of lower back.
|
6 weeks
|
|
Lumbar Range of Motion
Time Frame: 6 weeks
|
A long-arm universal goniometer will be used to measure the lumbar range of motion.
Flexion, extension, right and left lateral flexion, and right and left rotation will be assess.
|
6 weeks
|
|
Posture
Time Frame: 6 weeks
|
The postural alignment will be assessed by using the New York Posture Rating Chart.
Total score ranges between 13 and 65 points which higher scores indicate correct/normal postural alignment.
|
6 weeks
|
|
Trunk Muscle Endurance
Time Frame: 6 weeks
|
Trunk flexor and extensor muscle endurance will be assessed with the flexor endurance test and Biering-Sørensen test, respectively.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Actual)
March 31, 2024
Study Completion (Actual)
March 31, 2024
Study Registration Dates
First Submitted
April 5, 2024
First Submitted That Met QC Criteria
April 14, 2024
First Posted (Actual)
April 16, 2024
Study Record Updates
Last Update Posted (Actual)
April 16, 2024
Last Update Submitted That Met QC Criteria
April 14, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- auhucgun01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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