NCT06227637

Brief 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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 11, 2024

Last Update Submit

January 25, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Group (A) (Muscle Energy Techniques )

ACTIVE COMPARATOR

Muscle Energy Techniques

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

Group( B) (Local Muscle Vibration)

ACTIVE COMPARATOR

Local Muscle Vibration

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

Interventions

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.

Group (A) (Muscle Energy Techniques )Group( B) (Local Muscle Vibration)

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The faculty of physical therapy, Cairo university, and Gezira Youth Center

Cairo, Egypt

RECRUITING

Related 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.

    PMID: 30662072BACKGROUND
  • 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.

    PMID: 33239942BACKGROUND

Related Links

Study Officials

  • Mona M ibrahim, Doctorate

    Cairo University

    STUDY CHAIR
  • Enas F youssef, Doctorate

    Cairo University

    STUDY CHAIR

Central Study Contacts

Asmaa A ali radwan, Bachelors

CONTACT

Ahmed O Abdelnaeem, Doctorate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be blinded to the treatment they will receive, and the statistics doctor will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The sample will be randomly subdivided into 2 Groups: Group (A)- Muscle Energy Techniques and Group (B)- Local Muscle Vibration.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 11, 2024

First Posted

January 29, 2024

Study Start

October 15, 2023

Primary Completion

April 15, 2024

Study Completion

June 15, 2024

Last Updated

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations