Cervical Myofascial Pain SyndromeNCT05878821
Effect of Shockwave Therapy on Cervical Myofascial Syndrome in Lactating Women
A study testing Shockwave in people with Cervical Myofascial Pain Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of the study is to determine the effect of shockwave therapy on cervical myofascial pain syndrome in lactating women Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Cervical Myofascial Pain Syndrome
- What is being tested?
- Shockwave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2023to 25 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Multipara two months after labor.
- number of parity not more than 3.
- age range 25_35.BMI less than 35 Kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Shockwave Therapy on Cervical Myofascial Pain Syndrome in Lactating Women
the aim of the study is to determine the effect of shockwave therapy on cervical myofascial pain syndrome in lactating women
Read the 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).
- Conditions
- Cervical Myofascial Pain Syndrome
- Being tested
- Shockwave
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShockwaveDevice
Also called Postural correction exercise
Shockwave therapy session once a week for month 1000shock per session
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Shockwave |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start25 Aug 2023
- Primary completion25 Sep 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Myofascial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elham Shahat Hassan Baiuomy Ramadan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878821
- Sponsor's protocol ID
- P.T.REC/012/1004409
- Status last verified
- Mar 2024
- First submitted
- 18 May 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shockwave Therapy on Cervical Myofascial Pain Syndrome in Lactating Women
- ClinicalTrials.gov ID
- NCT05878821
- Acronym / sponsor ID
- P.T.REC/012/1004409
- Conditions
- Cervical Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Postural correction exercise | Experimental | Device: ShockwaveAll 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 | Experimental | Device: ShockwaveAll 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. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Multipara two months after labor.
- number of parity not more than 3.
- age range 25_35.BMI less than 35 Kg/m2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShockwaveAlso: Postural correction exerciseShockwave therapy session once a week for month 1000shock per session | Device | Postural correction exercise, Shockwave therapy |
Primary outcome
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave in people with Cervical Myofascial Pain Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.