- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06531746
Effect of Extracorporeal Shock Wave on Electrophysiological Changes and Pain in Patients With Lower Cross Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Group I (Study): will consist of 20 patients with lower cross syndrome and will receive extracorporeal shock wave in addition to conventional physical therapy program. For 12 sessions every other day, each session for 1 hour.
Group II (Control): will consist of 20 patients with lower cross syndrome and will receive sham extracorporeal shock wave in addition to conventional physical therapy program only same as group (I). For 12 sessions every other day, each session for 1 hour.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Menoufia
-
Sadat, Menoufia, Egypt
- Al Ryada University for Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Forty-four lower cross syndrome patients from both genders their ages ranged from 30-45 years old.
- All patients in present study will be ambulant independently.
- All patients will be medically stable.
- The body mass index (BMI) will be ranged from 20:25 Kg/m2.
Exclusion Criteria:
- Patients with musculoskeletal deformities and disorders.
- Patients with psychiatric disorders or seizures.
- Patients with visual and auditory impairment or tremors influencing balance.
- Patients with other neuromuscular disorders.
- Patients with BMI more than 25 kg/m2.
- Patients with cognitive impairment.
- Patients with lower limb or head and brain surgeries.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study group (I)
Will consist of 20 patients with lower cross syndrome and will receive extracorporeal shock wave in addition to conventional physical therapy program.
For 12 sessions every other day, each session for 1 hour.
|
Stretching and strengthening of Iliopoas muscle and Stretching and strengthening of Lower back muscles
Participants will receive (2.5 bars, 2000 pulses, 5 Hz, 7 min) rESWT with 1500 shock targeting the taut band of erector spinae, and 500 around the taut band, by using an EME S.r.l. via Degli Abeti 88/161122 Pesaro [serial number: EM12681015], Italy, shock wave generator. |
|
Experimental: Control group (II)
Will consist of 20 patients with lower cross syndrome and will receive sham extracorporeal shock wave in addition to conventional physical therapy program only same as group (I).
For 12 sessions every other day, each session for 1 hour.
|
Stretching and strengthening of Iliopoas muscle and Stretching and strengthening of Lower back muscles
Sham extracorporeal shock wave will be introduced without real shock wave impulses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: 4 weeks
|
Assess pain intensity
|
4 weeks
|
|
Electromyograph
Time Frame: 4 weeks
|
Assess activity of lower back muscles (Erector Spinae)
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005231
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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