- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05878821
Effect of Shockwave Therapy on Cervical Myofascial Syndrome in Lactating Women
Effect of Shockwave Therapy on Cervical Myofascial Pain Syndrome in Lactating Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt, 12611
- Faculty of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Multipara two months after labor.
- number of parity not more than 3.
- age range 25_35.BMI less than 35 Kg/m2
Exclusion Criteria:
- Diabetic women
- Women with malignancy
- Neck pain from other conditions such as(spinal
- instability, spinal fracture, spinal cord compression,inflammatory disease, spinal infection, congenital postural deformity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Postural correction exercise
All women in both groups (A&B) will receive postural correction exercises which includes: A.mckenzie exercises: The exercise routine consists of seven types of movements,at static maximum strength, with 15_20 repetitions, holding each repetition for seven seconds.the subjects complete one 20-minutes set per day,three times a week for four weeks B.strengthening exercise targeted the periscapular muscles (Y to W,l to W), scapular retraction.strengthening exercises will be progressively performed for 3sets, with 10 to15 repetitions C.pectoralis flexibility on a foam roller.Hold for 5seconds and repeated 10 time s |
Shockwave therapy session once a week for month 1000shock per session
Other Names:
|
|
Experimental: Shockwave therapy
All women in group (B) will receive shockwave therapy once a week for the duration of the trial (4 weeks) The dosage used will be as the following: Energy flux Density (EFD)=0,25 ml/mm2 Number of shocks=1000 shocks(kamel et al.,2020). Time:2-5minutes per session. |
Shockwave therapy session once a week for month 1000shock per session
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogue scale
Time Frame: 4 weeks
|
Pain level will be assessed for both groups (A&B) before and after treatment program by using (VAS).
scores are based on self-reported measures of symptoms that are recorded with a single hand written mark placed at one point along the length of a10 cm line."0
cm" means no pain."10cm"
means maximum pain.
|
4 weeks
|
|
Pressure Algometer
Time Frame: 4 weeks
|
Pain threshold for each woman in both groups (A&B) will be measured before and after the treatment program by using "Pressure Algometer" .
The pressure pain threshold measurements for trapezius will be performed at mid-way between the seventh cervical vertebrae and acromial angle in limited area in the second and third quadrants (Barbero et al.' 2013).
|
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/012/1004409
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
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