- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06227637
Local Muscle Vibration Versus Muscle Energy Technique In Sacroiliac Joint Dysfunction (SIJD)
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?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed O Abdelnaeem, Doctorate
- Phone Number: 01140736820
- Email: ahmed.omar@pt.cu.edu.eg
Study Contact Backup
- Name: asmaa a ali radwan, Bachelors
- Phone Number: 01020779243
- Email: asmaa.aboalmakarem2022@gmail.com
Study Locations
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Cairo, Egypt
- Recruiting
- The faculty of physical therapy, Cairo university, and Gezira Youth Center
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Contact:
- asmaa a ali radwan, Bachelors
- Phone Number: 01020779243
- Email: asmaa.aboalmakarem2022@gmail.com
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Contact:
- ahmed o abdelnaeem, Doctorate
- Phone Number: 011407436820
- Email: ahmed.omar@pt.cu.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Group (A) (Muscle Energy Techniques )
Muscle Energy Techniques
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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.
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Active Comparator: Group( B) (Local Muscle Vibration)
Local Muscle Vibration
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
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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.
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Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
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Pain pressure threshold
Time Frame: Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
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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.
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Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
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Back functional disability
Time Frame: Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
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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.
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Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
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The innominate angle tilt
Time Frame: Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
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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).
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Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mona M ibrahim, Doctorate, Cairo University
- Study Chair: Enas F youssef, Doctorate, Cairo University
Publications and helpful links
General Publications
- Konrad 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.
- 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.
Helpful Links
- 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.
- 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.
- 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.
- Barbosa, A. C., Martins, F. L. M., Barbosa, M. C. S. A., & Dos Santos, R. T. (2013). Manipulation and selective exercises decrease pelvic anteversion and low-back pain: A pilot study. Journal of Back and Musculoskeletal Rehabilitation, 26(1), 33-36.
- 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.
- Guidolin, D., & Stecco, C. (2021). Pilot study of sacroiliac joint dysfunction treated with a single session of fascial manipulation method: Clinical implications for effective pain reduction. Medicina (Lithuania), 57(7), 1-11.
- 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.
- Chou, L. H., Slipman, C. W., Bhagia, S. M., Tsaur, L., Bhat, A. L., Isaac, Z., Gilchrist, R., El Abd, O. H., & Lenrow, D. A. (2004). Inciting events initiating injection-proven sacroiliac joint syndrome. Pain Medicine, 5(1), 26-32.
- Cohen, S. P. (2005). Sacroiliac Joint Pain : A Comprehensive Review of Anatomy , Diagnosis , and Treatment. Anesthesia & Analgesia, 101(5), 1440-1453.
- De Gail, P., Lance, J. W., & Neilson, P. D. (1966). Differential effects on tonic and phasic reflex mechanisms produced by vibration of muscles in man. Journal of Neurology, Neurosurgery, and Psychiatry, 29(1), 1-11.
- Dueñas, L., Zamora, T., Lluch, E., Artacho-Ramírez, M. A., Mayoral, O., Balasch, S., & Balasch-Bernat, M. (2020). The effect of vibration therapy on neck myofascial trigger points: A randomized controlled pilot study. Clinical Biomechanics, 78(May 2019),
- Increase in paravertebral muscle activity in lumbar kyphosis patients by surface electromyography compared with lumbar spinal canal stenosis patients and healthy volunteers. The Spine Journal, 13(11), 1711.
- Feeney, D. F., Capobianco, R. A., Montgomery, J. R., Morreale, J., Grabowski, A. M., & Enoka, R. M. (2018). Individuals with sacroiliac joint dysfunction display asymmetrical gait and a depressed synergy between muscles providing sacroiliac joint force
- Fritton, S. P., J. McLeod, K., & Rubin, C. T. (2000). Quantifying the strain history of bone: Spatial uniformity and self-similarity of low-magnitude strains. Journal of Biomechanics, 33(3), 317-325.
- Fryer, G., & Pearce, A. J. (2013). The effect of muscle energy technique on corticospinal and spinal reflex excitability in asymptomatic participants. Journal of Bodywork and Movement Therapies, 17(4), 440-447.
- Gartenberg, A., Nessim, A., & Cho, W. (2021). Sacroiliac joint dysfunction : pathophysiology , diagnosis , and treatment. European Spine Journal, 30(10), 2936-2943.
- Goebel, R. T., Kleinöder, H., Yue, Z., Gosh, R., & Mester, J. (2015). Effect of Segment-Body Vibration on Strength Parameters. Sports medicine - open, 1(1), 14.
- Harkins&, I, D. D. P., Bush, F. M., Long, S., S. W. (1993). A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain, 56(2), 21-226.
- Holey, L. (1996). Muscle Energy Techniques. Physiotherapy, 82(8), 493.
- Hussein, Y. I., Hassan, K. A., & EL-Nahass, B. G. E. (2022). Strain-counterstrain versus muscle energy technique in sacroiliac joint dysfunction. International Journal of Health Sciences, 6(July), 8738-8754.
- Iodice, P., Bellomo, R. G., Gialluca, G., Fanò, G., & Saggini, R. (2011). Acute and cumulative effects of focused high-frequency vibrations on the endocrine system and muscle strength. European Journal of Applied Physiology, 111(6), 897-904.
- Ivanov, A. A., Kiapour, A., Ebraheim, N. A., & Goel, V. (2009). Lumbar Fusion Leads to Increases in Angular Motion and Stress Across Sacroiliac Joint A Finite Element Study. Spine, 34(5), 162-169.
- Kiapour, A. L. I., Joukar, A., Elgafy, H., & Erbulut, D. U. (2020). Biomechanics of the Sacroiliac Joint : Anatomy , Function , Biomechanics , Sexual Dimorphism , and Causes of Pain. Journal of Pain Research, 14(1), 3135-3143.
- Diagnosing painful sacroiliac joints : A validity study of a McKenzie evaluation and sacroiliac provocation tests. Australian Journal of Physiotherapy, 49(2), 89-97.
- Delayed iliacus compartment syndrome following femoral artery puncture: case report and literature review. Journal of Surgical Case Reports, 16(6), 102.
- The acute effects of local muscle vibration frequency on peak torque, rate of torque development, and EMG activity. Official Journal of the International Society of Electrophysiological Kinesiology. 24(6), 888-894.
- Paris, S. V. (1979). Mobilization of the spine. Physical Therapy, 59(8), 988-995.
- "Effectiveness of Manipulation and Muscle Energy Techniques in Subjects with SI Joint Dysfunction." nternational Journal of Pharmaceutical Science and Health Care 4(5): 16-29.
- Effects of local vibrations on skeletal muscle trophism in elderly people: mechanical, cellular, and molecular events. International journal of molecular medicine, 24(4), 503-512.
- Deformation of the innominate bone and mobility of the pubic symphysis during asymmetric moment application to the pelvis. Manual Therapy, 17(1), 66-70.
- Prather, H., Bonnette, M., & Hunt, D. (2020). Nonoperative Treatment Options for Patients With Sacroiliac Joint Pain. International Journal of Spine Surgery, 14, 35-40.
- Prather, H., & Hunt, D. (2004). Sacroiliac Joint Pain. Disease-a-Month, 50(12), 670-683.
- Ramzy, R. (2008). Validation of the Arabic Version of the Oswestry Disability Index Developed in Tunisia for low back pain patients in the UAE.
- Effects of Muscle Energy Technique versus Mobilization on Pain and Disability in Post-Partum Females with Sacroiliac Joint Dysfunction. In Indian Journal of Health Sciences and Care, 5(1), 11.
- A randomized clinical trial of manual versus mechanical force manipulation in the treatment of sacroiliac joint syndrome. Journal of Manipulative and Physiological Therapeutics, 28(7), 493-501.
- Effect of Sacroiliac Joint Mobilization on the Level of Soft Tissue Pain Threshold in Asymptomatic Women. Journal of Manipulative and Physiological Therapeutics, 41(3), 258-264.
- New concepts and hypotheses Transfer of lumbosacral load to iliac bones and legs Part 1 : Biomechanics of self-bracing of the sacroiliac joints and its significance for treatment and exercise. Clinical Biomechanics, 8(6), 285-294.
- Szadek, K. M., Wurff, P. Van Der, Tulder, M. W. Van, Zuurmond, W. W., & Perez, R. S. G. M. (2009). Diagnostic Validity of Criteria for Sacroiliac Joint Pain : The Journal of Pain, 10(4), 354-368.
- Effect of the single-leg, lateral oblique, decline squat exercise on sacroiliac joint pain with knee pain. Journal of Physical Therapy Science, 28(9), 2688-2689.
- Zunzunwala, S., Phansopkar, P., & Lakhwani, M. (2022). Effect of theragun on calf muscle tightness in asymptomatic individuals. Journal of Medical Pharmaceutical and Allied Sciences, 11(3), 4863-4866.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- local vibration vs MET in SIJD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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