Neck PainNCT06988241
Efficacy of Positional Release Muscles for Neck Pain During Lactation
A study testing positional release and Posture correction in people with Neck Pain, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Purpose of the study: To determine the efficacy of neck muscles positional release for Neck Pain during lactation.Methods:Fifty patient with postpartum neck pain will be recruited. Patients will be randomly assigned into two groups, group A and group B . Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Neck Pain
- What is being tested?
- positional release and Posture correction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 23 May 2025to 25 Nov 2025
- 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
- lactating mothers.
- Age between 25-35 years old.
- six weeks to one year after childbirth.
- at least a moderate level of education.
Who cannot join
- Mothers were excluded if they had facet joint, neurological, or cardio vascular and respiratory conditions.
- History of breast cancer.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of physical therapy kafr Elsheikh university
KafrElSheikh, kafrElsheikh, 33516
About this study
Purpose of the study: To determine the efficacy of neck muscles positional release for Neck Pain during lactation.Methods:Fifty patient with postpartum neck pain will be recruited. Patients will be randomly assigned into two groups, group A and group B . Patients in both groups will receive posture correction advices during lactation and posture correction exercises but group A will receive additional positional release for upper trapezius. All patients will be evaluated for Pressure pain threshold (PPT) of upper trapezius by algometry, neck disability using Arabic version of neck disability index, pain intensity using 11-numerical rating scale.
Read the detailed description
Treatment procedure Both groups will receive posture education advices during lactation and Posture correction exercise program which will include Strengthening Exercise Program and Spinal Stretches.Spinal stretches were also included .In the intervention program mothers who underwent normal delivery were advised to start home based exercise program after 5 weeks and the caesarean mothers after 2 months of delivery Group (A): will receive Positional release of neck muscles in addition to Posture correction.Positional release technique For deactivation of Trigger Points (TrPs) and decrease spasm Manual approaches. [PRT] was developed by Lawrence H. PRT is a method in which muscles are placed in a position of greatest comfort, and this causes normalization of muscle hypertonicity and fascial tension. Also, it decreases joint hypomobility, increases circulation, followed by a reduction in swelling, decreased pain, and increase muscle strength. The practical section of the study will be undertaken in 4 weeks (3 sessions a week). Measurement will be taken before the start of treatment program then after the end of 4 weeks treatment program.
- Conditions
- Neck Pain
- Being tested
- positional release, Posture correction
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positional releaseOther
Also called strain counter strain
All participants in group (A) will receive the same program of group B added to positional release . In order to make the positional release , the therapist will pick up the trigger points by palpation in the upper trapezius muscle by pincer palpation method and distinguished with dots on the skin. Participants will be made supine lying and relaxed by maintaining the cervical spine in a neutral position. Lateral flexion of subject's head toward the side of a tender point, the therapist grasps the subject's forearm and abducts shoulder to approximately 90° and adds slight flexion or extension to fine-tune.The most comfortable position achieved will be held for 90 seconds and after that passive return of the body part to an anatomically neutral position will be maintained for 5 minutes. All participants will be treated three times per week for 4 consecutive weeks and will be instructed to maintain their normal activities while avoiding any undue stress to the neck.
Posture correctionOther
Posture correction advices during lactation + posture correction exercises
| Study group | Role | What they receive |
|---|---|---|
| Positional Release | Experimental | Positional Release For upper trapezius + Posture correction advices during lactation + posture correction exercises Receives: Other: positional release; Other: Posture correction |
| Posture correction | Other | Posture correction advices during lactation + posture correction exercises Receives: Other: Posture correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of neck pain
Neck pain intensity will be measured by 11- numerical rating scale.Primary outcome updated to pain intensity to better reflect the study objective.
Measured: baseline and four weeks
Secondary outcomes (2)
Pressure pain threshold (PPT)
Pressure pain threshold (PPT) of upper trapezius will be measured by digital pressure algometer.
Measured: baseline and four weeks
functional status related to neck disability
Functional status related to neck disability will be measured by Arabic version of Neck
Measured: baseline and four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start23 May 2025
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan Hassan Elsayed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988241
- Sponsor's protocol ID
- KFSIRB200-439
- Status last verified
- Dec 2025
- First submitted
- 17 May 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Positional Release Muscles for Neck Pain During Lactation
- ClinicalTrials.gov ID
- NCT06988241
- Acronym / sponsor ID
- KFSIRB200-439
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 23 May 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 23 May 2025 (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.
Purpose of the study: To determine the efficacy of neck muscles positional release for Neck Pain during lactation.Methods:Fifty patient with postpartum neck pain will be recruited. Patients will be randomly assigned into two groups, group A and group B . Patients in both groups will receive posture correction advices during lactation and posture correction exercises but group A will receive additional positional release for upper trapezius. All patients will be evaluated for Pressure pain threshold (PPT) of upper trapezius by algometry, neck disability using Arabic version of neck disability index, pain intensity using 11-numerical rating scale.
Detailed description
Treatment procedure Both groups will receive posture education advices during lactation and Posture correction exercise program which will include Strengthening Exercise Program and Spinal Stretches.Spinal stretches were also included .In the intervention program mothers who underwent normal delivery were advised to start home based exercise program after 5 weeks and the caesarean mothers after 2 months of delivery Group (A): will receive Positional release of neck muscles in addition to Posture correction.Positional release technique For deactivation of Trigger Points (TrPs) and decrease spasm Manual approaches. [PRT] was developed by Lawrence H. PRT is a method in which muscles are placed in a position of greatest comfort, and this causes normalization of muscle hypertonicity and fascial tension. Also, it decreases joint hypomobility, increases circulation, followed by a reduction in swelling, decreased pain, and increase muscle strength. The practical section of the study will be undertaken in 4 weeks (3 sessions a week). Measurement will be taken before the start of treatment program then after the end of 4 weeks treatment program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positional Release | Experimental | Other: positional release, Other: Posture correctionPositional Release For upper trapezius + Posture correction advices during lactation + posture correction exercises |
| Posture correction | Other | Other: Posture correctionPosture correction advices during lactation + posture correction exercises |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- lactating mothers.
- Age between 25-35 years old.
- six weeks to one year after childbirth.
- at least a moderate level of education.
Key exclusion criteria (2 listed)
- Mothers were excluded if they had facet joint, neurological, or cardio vascular and respiratory conditions.
- History of breast cancer.
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 |
|---|---|---|
| positional releaseAlso: strain counter strainAll participants in group (A) will receive the same program of group B added to positional release . In order to make the positional release , the therapist will pick up the trigger points by palpation in the upper trapezius muscle by pincer palpation method and distinguished with dots on the skin. Participants will be made supine lying and relaxed by maintaining the cervical spine in a neutral position. Lateral flexion of subject's head toward the side of a tender point, the therapist grasps the subject's forearm and abducts shoulder to approximately 90° and adds slight flexion or extension to fine-tune.The most comfortable position achieved will be held for 90 seconds and after that passive return of the body part to an anatomically neutral position will be maintained for 5 minutes. All participants will be treated three times per week for 4 consecutive weeks and will be instructed to maintain their normal activities while avoiding any undue stress to the neck. | Other | Positional Release |
| Posture correctionPosture correction advices during lactation + posture correction exercises | Other | Positional Release, Posture correction |
Primary outcome
Intensity of neck pain
Time frame: baseline and four weeks
Neck pain intensity will be measured by 11- numerical rating scale.Primary outcome updated to pain intensity to better reflect the study objective.
2 secondary outcomes
Pressure pain threshold (PPT)
Time frame: baseline and four weeks
functional status related to neck disability
Time frame: baseline and four weeks
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 12 Dec 2025.
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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 positional release and Posture correction in people with Neck Pain, run by Kafrelsheikh 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 4 inclusion and 2 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 12 Dec 2025. 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?
Intensity of neck pain (time frame: baseline and four weeks). 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 12 Dec 2025.