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Effect of Shockwave Therapy on Cervical Myofascial Syndrome in Lactating Women

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05878821
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
2
Anticipated Duration (Months)
15
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Shockwave
 N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 exerciseTwo groups,one group will be treated by shockwave therapy and postural correction exercise and other group will be treated by postural correction exercise
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Double masking
Primary Purpose:
Treatment
Official Title:
Effect of Shockwave Therapy on Cervical Myofascial Pain Syndrome in Lactating Women
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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

Device: Shockwave
Shockwave therapy session once a week for month 1000shock per session
Other Names:
  • Postural correction exercise

    		•
    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.

    Device: Shockwave
    Shockwave therapy session once a week for month 1000shock per session
    Other Names:
  • Postural correction exercise

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual analogue scale [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.

    2. Pressure Algometer [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of physical therapy Giza Egypt 12611

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elham Shahat Hassan Baiuomy Ramadan, Elham shahat Hassan, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05878821
    Other Study ID Numbers:
    • P.T.REC/012/1004409
    First Posted:
    May 26, 2023
    Last Update Posted:
    May 26, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Myofascial Pain Syndromes
    Fibromyalgia
    Syndrome

    Study Results

    No Results Posted as of May 26, 2023