NCT05878821

Brief Summary

the aim of the study is to determine the effect of shockwave therapy on cervical myofascial pain syndrome in lactating women

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 25, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2023

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

May 18, 2023

Last Update Submit

March 7, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    4 weeks

  • 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).

    4 weeks

Study Arms (2)

Postural correction exercise

EXPERIMENTAL

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

EXPERIMENTAL

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

Interventions

ShockwaveDEVICE

Shockwave therapy session once a week for month 1000shock per session

Also known as: Postural correction exercise
Postural correction exerciseShockwave therapy

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Multipara two months after labor.
  • number of parity not more than 3.
  • age range 25\_35.BMI less than 35 Kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Giza, 12611, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups,one group will be treated by shockwave therapy and postural correction exercise and other group will be treated by postural correction exercise
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy Cairo university

Study Record Dates

First Submitted

May 18, 2023

First Posted

May 26, 2023

Study Start

August 25, 2023

Primary Completion

September 25, 2023

Study Completion

September 25, 2023

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations