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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06227637
Other study ID # local vibration vs MET in SIJD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 15, 2023
Est. completion date June 15, 2024

Study information

Verified date January 2024
Source Cairo University
Contact Asmaa A ali radwan, Bachelors
Phone 01020779243
Email asmaa.aboalmakarem2022@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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?


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 15, 2024
Est. primary completion date April 15, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Local Muscle Vibration compared to Muscle energy technique in SIJD
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.

Locations

Country Name City State
Egypt The faculty of physical therapy, Cairo university, and Gezira Youth Center Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
Primary 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. Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
Primary 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. Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
Primary 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). Assessment before treatment, then immediately after the intervention, then finally follow up after 2 weeks
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