Sacroiliac Joint DysfunctionSIJDNCT06227637
Local Muscle Vibration Versus Muscle Energy Technique In Sacroiliac Joint Dysfunction
A study testing Local Muscle Vibration compared to Muscle energy technique in SIJD in people with Sacroiliac Joint Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare the effect of Local Muscle Vibration versus Muscle energy technique on pain intensity, pain pressure threshold, functional disability, and innominate angle tilt in SIJD. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- Local Muscle Vibration compared to Muscle energy technique in SIJD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2023to 15 Jun 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- both male and female participants with ages between 20-40.
- Pain intensity is greater than 3 over the scale of VAS.
- Pain around SIJ (around PSIS and sacral sulcus).
- Participants with at least three positives out of six provocation and motion palpation tests that have been validated (distraction, compression, Gaenslen, posterior friction test, sacral thrust, and FABER tests).
Who cannot join
- Neurological impairments in the leg
- Sacroiliitis
- Spondylolisthesis
- pre-diagnosed central or peripheral nervous system disease
- The current pregnancy
- rheumatoid arthritis
- Major surgery of lower limbs and spine
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
The faculty of physical therapy, Cairo university, and Gezira Youth Center
Cairo
asmaa a ali radwan, Bachelors, 01020779243, asmaa.aboalmakarem2022@gmail.com
ahmed o abdelnaeem, Doctorate, 011407436820, ahmed.omar@pt.cu.edu.eg
About this study
The purpose of this study is to compare the effect of Local Muscle Vibration versus Muscle energy technique on pain intensity, pain pressure threshold, functional disability, and innominate angle tilt in SIJD.
This study will try to answer the following question:
What is the effect of Local Muscle Vibration compared to Muscle energy technique on pain intensity, pain pressure threshold, functional disability, and innominate angle tilt in SIJD?
Read the detailed description
Clinicians will attempt to identify the primary factors that contribute to the development of low back pain. These factors are related to specific areas of malfunction that may irritate the tissues and create pain, or cause pain through hypersensitivity of nociceptive pathways in the CNS. Joint dysfunction is one risk factor, which is defined as "loss of joint play movement that cannot be produced by voluntary muscles". Pain in the joint can result from joint dysfunction, in addition to joint dysfunction, muscle dysfunction is evaluated. History, inspection, palpation, and flexibility tests can all be used to determine this.
Muscle energy technique is based on the concepts of Autogenic Inhibition and Reciprocal Inhibition, to lengthen a shortened muscle, mobilize a stiff joint, strengthen a weak muscle, and reduce localized edema and passive congestion. Several studies approved that (MET) affects positively on SIJD cases.
Local Muscle Vibration is used to pain relief, stimulate edema absorption, improve blood flow, alleviate wound healing, and for its anti-inflammatory and ant-adhesion effects. In addition, pain relief effect have also been widely demonstrated. Vibration comprised of low-magnitude high-intensity stimuli which represents a suitable technique to securely transmit appropriate mechanical signals to patients who are unable to exercise to increase musculoskeletal strength. According to a narrative literature review contain about 35 study descuss effects of local vibration therapy on various performance parameters, LMV have apositive effect on muscle activation, strengh, power and joint range of motion.
According to Iodice et al (2011), local administration of high-frequency VT resulted in significant increase in muscle function after several weeks however, some hormonal alterations and moderate performance gains were observed after a single session. This study will try to investigate the effect of Local Muscle Vibration versus Muscle energy technique, which is more effective in reducing low back pain and disability in cases of SIJD. Up to the authors knowledge no previous study discussed the difference between (LMV) and (MET) on SIJD.
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- Local Muscle Vibration compared to Muscle energy technique in SIJD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Muscle Vibration compared to Muscle energy technique in SIJDOther
Apply Local Muscle Vibration compared to Muscle energy technique on patients with sacroiliac joint dysfunction and note the effect on pain intensity, pain pressure threshold, functional disability, and innominate angle tilt in SIJD.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) (Muscle Energy Techniques ) | Active comparator | Muscle Energy Techniques Receives: Other: Local Muscle Vibration compared to Muscle energy technique in SIJD |
| Group( B) (Local Muscle Vibration) | Active comparator | Local Muscle Vibration Receives: Other: Local Muscle Vibration compared to Muscle energy technique in SIJD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
VAS in the simple model, which will be used as a self-reported method of pain intensity measurement, the patient will be asked to put a mark point at the scale range (from 0 to 10 cm). This assessment procedure will be applied before and after treatment procedure.
Measured: Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
Pain pressure threshold
PPT should be measured on both sides at the level of right and left posterior inferior iliac spines (PIIS). With the patient is a prone position, two algometer measurements will be taken before and after treatment at the level of (PIIS). All measurements will be recorded at intervals of 30 second. The patient will be instructed to report when the sensation beginning of pain.
Measured: Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
Back functional disability
This questionnaire is Self-reported pain and disability method (Arabic model). The therapist will ask the patient ten questions covering pain severity, personal care, lifting, walking, sitting, standing, sleeping, social life, travelling, and changing degrees of pain. Each part has six statements, each with a score ranging from 0 (showing no disability) to 5 (representing maximum disability). The final score was calculated as a percentage out of 50, representing perceived disability at the time. The validated Arabic version of ODI will be used in this study.
Measured: Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
The innominate angle tilt
The patient will be instructed to march 10 steps in place before standing in a fully erect posture without bending ankles, knees, or hips, feet in front 30.5 cm apart, and arms across the chest. The therapist will stand beside the patient and mark the anterior and posterior superior iliac spines (ASIS and PSIS).
Measured: Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start15 Oct 2023
- Primary completion15 Apr 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sacroiliac Joint DysfunctionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- The sample will be randomly subdivided into 2 Groups: Group (A)- Muscle Energy Techniques and Group (B)- Local Muscle Vibration.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abou Almakarem Ali Radwan, Cairo University
- Investigators
- Mona M ibrahim, Doctorate, Study chair, Cairo UniversityEnas F youssef, Doctorate, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227637
- Sponsor's protocol ID
- local vibration vs MET in SIJD
- Acronym
- SIJD
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Germann D, El Bouse A, Shnier J, Abdelkader N, Kazemi M. Effects of local vibration therapy on various performance parameters: a narrative literature review. J Can Chiropr Assoc. 2018 Dec;62(3):170-181.
PubMed 30662072Konrad A, Glashuttner C, Reiner MM, Bernsteiner D, Tilp M. The Acute Effects of a Percussive Massage Treatment with a Hypervolt Device on Plantar Flexor Muscles' Range of Motion and Performance. J Sports Sci Med. 2020 Nov 19;19(4):690-694. eCollection 2020 Dec.
PubMed 33239942
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Muscle Vibration Versus Muscle Energy Technique In Sacroiliac Joint Dysfunction
- ClinicalTrials.gov ID
- NCT06227637
- Acronym / sponsor ID
- SIJD / local vibration vs MET in SIJD
- Conditions
- Sacroiliac Joint Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 29 Jan 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 purpose of this study is to compare the effect of Local Muscle Vibration versus Muscle energy technique on pain intensity, pain pressure threshold, functional disability, and innominate angle tilt in SIJD.
This study will try to answer the following question:
What is the effect of Local Muscle Vibration compared to Muscle energy technique on pain intensity, pain pressure threshold, functional disability, and innominate angle tilt in SIJD?
Detailed description
Clinicians will attempt to identify the primary factors that contribute to the development of low back pain. These factors are related to specific areas of malfunction that may irritate the tissues and create pain, or cause pain through hypersensitivity of nociceptive pathways in the CNS. Joint dysfunction is one risk factor, which is defined as "loss of joint play movement that cannot be produced by voluntary muscles". Pain in the joint can result from joint dysfunction, in addition to joint dysfunction, muscle dysfunction is evaluated. History, inspection, palpation, and flexibility tests can all be used to determine this.
Muscle energy technique is based on the concepts of Autogenic Inhibition and Reciprocal Inhibition, to lengthen a shortened muscle, mobilize a stiff joint, strengthen a weak muscle, and reduce localized edema and passive congestion. Several studies approved that (MET) affects positively on SIJD cases.
Local Muscle Vibration is used to pain relief, stimulate edema absorption, improve blood flow, alleviate wound healing, and for its anti-inflammatory and ant-adhesion effects. In addition, pain relief effect have also been widely demonstrated. Vibration comprised of low-magnitude high-intensity stimuli which represents a suitable technique to securely transmit appropriate mechanical signals to patients who are unable to exercise to increase musculoskeletal strength. According to a narrative literature review contain about 35 study descuss effects of local vibration therapy on various performance parameters, LMV have apositive effect on muscle activation, strengh, power and joint range of motion.
According to Iodice et al (2011), local administration of high-frequency VT resulted in significant increase in muscle function after several weeks however, some hormonal alterations and moderate performance gains were observed after a single session. This study will try to investigate the effect of Local Muscle Vibration versus Muscle energy technique, which is more effective in reducing low back pain and disability in cases of SIJD. Up to the authors knowledge no previous study discussed the difference between (LMV) and (MET) on SIJD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The sample will be randomly subdivided into 2 Groups: Group (A)- Muscle Energy Techniques and Group (B)- Local Muscle Vibration.
| Arm | Type | Receives |
|---|---|---|
| Group (A) (Muscle Energy Techniques ) | Active comparator | Other: Local Muscle Vibration compared to Muscle energy technique in SIJDMuscle Energy Techniques |
| Group( B) (Local Muscle Vibration) | Active comparator | Other: Local Muscle Vibration compared to Muscle energy technique in SIJDLocal Muscle Vibration |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- both male and female participants with ages between 20-40.
- Pain intensity is greater than 3 over the scale of VAS.
- Pain around SIJ (around PSIS and sacral sulcus).
- Participants with at least three positives out of six provocation and motion palpation tests that have been validated (distraction, compression, Gaenslen, posterior friction test, sacral thrust, and FABER tests).
Key exclusion criteria (7 listed)
- Neurological impairments in the leg
- Sacroiliitis
- Spondylolisthesis
- pre-diagnosed central or peripheral nervous system disease
- The current pregnancy
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 |
|---|---|---|
| Local Muscle Vibration compared to Muscle energy technique in SIJDApply Local Muscle Vibration compared to Muscle energy technique on patients with sacroiliac joint dysfunction and note the effect on pain intensity, pain pressure threshold, functional disability, and innominate angle tilt in SIJD. | Other | Group (A) (Muscle Energy Techniques ), Group( B) (Local Muscle Vibration) |
Primary outcome
Pain intensity
Time frame: Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
VAS in the simple model, which will be used as a self-reported method of pain intensity measurement, the patient will be asked to put a mark point at the scale range (from 0 to 10 cm). This assessment procedure will be applied before and after treatment procedure.
Pain pressure threshold
Time frame: Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
PPT should be measured on both sides at the level of right and left posterior inferior iliac spines (PIIS). With the patient is a prone position, two algometer measurements will be taken before and after treatment at the level of (PIIS). All measurements will be recorded at intervals of 30 second. The patient will be instructed to report when the sensation beginning of pain.
Back functional disability
Time frame: Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
This questionnaire is Self-reported pain and disability method (Arabic model). The therapist will ask the patient ten questions covering pain severity, personal care, lifting, walking, sitting, standing, sleeping, social life, travelling, and changing degrees of pain. Each part has six statements, each with a score ranging from 0 (showing no disability) to 5 (representing maximum disability). The final score was calculated as a percentage out of 50, representing perceived disability at the time. The validated Arabic version of ODI will be used in this study.
The innominate angle tilt
Time frame: Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
The patient will be instructed to march 10 steps in place before standing in a fully erect posture without bending ankles, knees, or hips, feet in front 30.5 cm apart, and arms across the chest. The therapist will stand beside the patient and mark the anterior and posterior superior iliac spines (ASIS and PSIS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Background: PubMed 30662072Germann D, El Bouse A, Shnier J, Abdelkader N, Kazemi M. Effects of local vibration therapy on various performance parameters: a narrative literature review. J Can Chiropr Assoc. 2018 Dec;62(3):170-181.
- Background: PubMed 33239942Konrad A, Glashuttner C, Reiner MM, Bernsteiner D, Tilp M. The Acute Effects of a Percussive Massage Treatment with a Hypervolt Device on Plantar Flexor Muscles' Range of Motion and Performance. J Sports Sci Med. 2020 Nov 19;19(4):690-694. eCollection 2020 Dec.
- Alkady, S. M. E., Kamel, R. M., AbuTaleb, E., Lasheen, Y., \& Alshaarawy, F. A. (2019). Effect of Muscle Energy Technique in Chronic Sacroiliac Joint Dysfunction. South Valley University International Journal of Physical Therapy and Sciences, 1(1), 8-19.Link provided by the sponsor.
- Salvador Coloma, P., \& Sánchez-Zuriaga, D. (2019). Effects of myofascial release in erector spinae myoelectric activity and lumbar spine kinematics in non-specific chronic low back pain: Randomized controlled trial. Clinical Biomechanics, 63(1), 27-33.Link provided by the sponsor.
- Azevedo, D. C., Santos, H., Carneiro, R. L., \& Andrade, G. T. (2014). Reliability of sagittal pelvic position assessments in standing, sitting and during hip flexion using palpation meter. Journal of Bodywork and Movement Therapies, 18(2), 210-214.Link provided by the sponsor.
- Posterior , Lateral , and Anterior Hip Pain Due to Musculoskeletal Origin : A Narrative Literature Review of History , Physical Examination , and Diagnostic Imaging. Journal of Chiropractic Medicine, 15(4), 281-293.Link provided by the sponsor.
- Changes in Pain and Disability Secondary to Shoe Lift Intervention in Subjects With Limb Length Inequality and Chronic Low Back Pain: A Preliminary Report. Journal of Orthopaedic and Sports Physical Therapy, 37(7), 380-388Link provided by the sponsor.
- Chan, M. E., Uzer, G., \& Rubin, C. T. (2013). The potential benefits and inherent risks of vibration as a non-drug therapy for the prevention and treatment of osteoporosis. Current Osteoporosis Reports, 11(1), 36-44.Link provided by the sponsor.
- 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.
Mona M ibrahim, Doctorate study chair
Cairo University
Enas F youssef, Doctorate study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Muscle Vibration compared to Muscle energy technique in SIJD in people with Sacroiliac Joint Dysfunction, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Jan 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa A ali radwan, Bachelors (01020779243, asmaa.aboalmakarem2022@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06227637, which also lists 2 linked publications.
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 29 Jan 2024.