Sacroiliac Joint DysfunctionNCT06366971
The Effect of Pelvic Proprioceptive Neuromuscular Facilitation Techniques in Patients With Sacroiliac Joint Dysfunction
A study testing The Patient Education and The Pelvic Proprioceptive Neuromuscular Facilitation Techniques Training in people with Sacroiliac Joint Dysfunction, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- The Patient Education and The Pelvic Proprioceptive Neuromuscular Facilitation Techniques Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having a diagnosis of SIJD
- Being between the ages of 18 and 40
- Volunteering to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Atlas University
Istanbul, Kagıthane, 34408
About this study
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.
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- The Patient Education, The Pelvic Proprioceptive Neuromuscular Facilitation Techniques Training
- Keywords
- flexibility, mobility, pain, proprioceptive neuromuscular facilitation, sacroiliac joint dysfunction
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Patient EducationOther
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 Pelvic Proprioceptive Neuromuscular Facilitation Techniques TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Other: The Patient Education; Other: The Pelvic Proprioceptive Neuromuscular Facilitation Techniques Training |
| Control Group | Active comparator | The control group will receive patient education consisting of basic lumbar stabilization exercises 3 days a week for 6-weeks. Receives: Other: The Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Level of Low Back Pain
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"
Measured: 6 weeks
Mobility
The Modified Schober's test will be used to assess mobility of lower back.
Measured: 6 weeks
Flexibility
The sit-and-reach test will be used to assess flexibility of lower back.
Measured: 6 weeks
Lumbar Range of Motion
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.
Measured: 6 weeks
Posture
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.
Measured: 6 weeks
Trunk Muscle Endurance
Trunk flexor and extensor muscle endurance will be assessed with the flexor endurance test and Biering-Sørensen test, respectively.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Dec 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hikmet Ucgun, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366971
- Sponsor's protocol ID
- auhucgun01
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Proprioceptive Neuromuscular Facilitation Techniques in Patients With Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT06366971
- Acronym / sponsor ID
- auhucgun01
- Conditions
- Sacroiliac Joint Dysfunction
- Keywords
- flexibility, mobility, pain, proprioceptive neuromuscular facilitation, sacroiliac joint dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: The Patient Education, Other: The Pelvic Proprioceptive Neuromuscular Facilitation Techniques TrainingThe 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. |
| Control Group | Active comparator | Other: The Patient EducationThe control group will receive patient education consisting of basic lumbar stabilization exercises 3 days a week for 6-weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having a diagnosis of SIJD
- Being between the ages of 18 and 40
- Volunteering to participate in the study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Patient EducationThe 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. | Other | Control Group, Experimental Group |
| The Pelvic Proprioceptive Neuromuscular Facilitation Techniques TrainingThe 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. | Other | Experimental Group |
Primary outcome
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"
Mobility
Time frame: 6 weeks
The Modified Schober's test will be used to assess mobility of lower back.
Flexibility
Time frame: 6 weeks
The sit-and-reach test will be used to assess flexibility of lower back.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Patient Education and The Pelvic Proprioceptive Neuromuscular Facilitation Techniques Training in people with Sacroiliac Joint Dysfunction, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Level of Low Back Pain (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.