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Effect of Shockwave Therapy on Cervical Myofascial Syndrome in Lactating Women

Primary Purpose

Cervical Myofascial Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Shockwave
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Myofascial Pain Syndrome

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of physical therapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Postural correction exercise

Shockwave therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Visual analogue scale
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.
Pressure Algometer
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).

Secondary Outcome Measures

Full Information

First Posted
May 18, 2023
Last Updated
August 24, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05878821
Brief Title
Effect of Shockwave Therapy on Cervical Myofascial Syndrome in Lactating Women
Official Title
Effect of Shockwave Therapy on Cervical Myofascial Pain Syndrome in Lactating Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Anticipated)
Primary Completion Date
September 25, 2023 (Anticipated)
Study Completion Date
September 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
the aim of the study is to determine the effect of shockwave therapy on cervical myofascial pain syndrome in lactating women
Detailed Description
Neck and shoulder pain was 73,1%,one fourth of which occurred after birth.the most common area was the superior part of the trapezius.the symptoms of patients are pain, stiffness and limited range of motion (ROM).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Myofascial Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups,one group will be treated by shockwave therapy and postural correction exercise and other group will be treated by postural correction exercise
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double masking
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Postural correction exercise
Arm Type
Experimental
Arm Description
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
Arm Title
Shockwave therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Shockwave
Other Intervention Name(s)
Postural correction exercise
Intervention Description
Shockwave therapy session once a week for month 1000shock per session
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
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.
Time Frame
4 weeks
Title
Pressure Algometer
Description
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).
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
H A Rezk, Master
Phone
01200012471
Email
dr.hebamonsef@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
H A Rezk
Phone
01010453449
Email
dr.hebamonsef@gmail.com
Facility Information:
Facility Name
Faculty of physical therapy
City
Giza
ZIP/Postal Code
12611
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H A Rezk, Master
Phone
0237617692
Ext
02460211198
Email
dr.hebamonsef@gmail.com
First Name & Middle Initial & Last Name & Degree
H A Rezk, Master
Phone
0237617691
Ext
0246011198
Email
dr.hebamonsef@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Effect of Shockwave Therapy on Cervical Myofascial Syndrome in Lactating Women

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