Shoulder ImpingementNCT06271720
Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome
A study testing visceral manipulation and integrated neuromuscular inhibition in people with Shoulder Impingement, run by Noha Elserty.
Trial summary
This study will be conducted To evaluate the effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Shoulder Impingement
- What is being tested?
- visceral manipulation and integrated neuromuscular inhibition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to May 2024
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -active myofascial trigger points in the upper trapezius muscle, and chronic Pain lasting more than 12 weeks
- BMI between 25 and 30 Kg/m².
Who cannot join
- a previous fracture in the cervical spine or shoulder surgery
- acute inflammatory condition.
- Malignant tumor.
- Multiple osteophytes.
- Cervical posture abnormalities.
- Osteoporosis.
About this study
This study will be conducted To evaluate the effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome
Read the detailed description
HYPOTHESES
It will be hypothesized that:
- There will be no statistically significant effect of Visceral Manipulation on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, or function in shoulder impingement syndrome
- There will be no statistically significant effect of the Integrated Neuromuscular Inhibition Technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, or function in shoulder impingement syndrome.
- There will be no statistically significant difference in the effect of visceral manipulation versus the integrated neuromuscular inhibition technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome.
This study will be conducted to answer the following questions:
Is there an effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome?
- Conditions
- Shoulder Impingement
- Being tested
- visceral manipulation, integrated neuromuscular inhibition
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visceral manipulationOther
visceral manipulation: A palpation technique will be applied till the barrier is felt and it will be applied until release is felt.
integrated neuromuscular inhibition: ischemic compression will be applied to trigger point of upper trapezius
integrated neuromuscular inhibitionOther
It involves applying direct sustained digital pressure to the TrP with sufficient force over dedicated time duration, to slow down the blood supply and relieve the tension within the involved muscle. The pressure is gradually applied, maintained and the gradually released
| Study group | Role | What they receive |
|---|---|---|
| visceral manipulation | Active comparator | Palpation will be applied and the pressure will directly to the skin, into the direction of restriction just until resistance (tissue barrier) is felt. Once found, the collagenous barrier will be engaged for 90 to 120 seconds for each technique without sliding over the skin or forcing the tissue until the fascia complex starts to yield and a sensation of softening is achieved. Receives: Other: visceral manipulation |
| integrated neuromuscular inhibition | Active comparator | The practitioner first identifies TrPs to be treated within the upper trapezius muscle. The subjects will be placed in a supine position. Their arm will be positioned in slight shoulder abduction with the elbow bent and their hand resting on their stomach. Using a pincer grasp, the practitioner will move throughout the fibers of the upper trapezius and make note of any active TrPs. Once the TrPs were identified, treatment began. The first technique applied will be ischemic compression. The therapist again utilized a pincer grasp, placing the thumb and index finger over the active TrP. Slow, increasing levels of pressure will be applied until the tissue resistance barrier is identified. The pressure will be maintained until a release of the tissue barrier is felt. At that time, pressure will again be applied until a new barrier is felt. This process will be repeated until tension or tenderness is unable to be identified or 90 seconds have elapsed. Receives: Other: integrated neuromuscular inhibition |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
pain intensity will be measured by a visual analog scale, the scale is marked from 0 to 10 while 0 represents no pain and 10 represents intolerable pain
Measured: pre treatment and after 4 weeks
pain pressure threshold
pressure threshold measured by pressure algometer
Measured: pre treatment and after 4 weeks
shoulder range of motion
shoulder flexion and abduction range of motion will be measured by inclinometer
Measured: pre treatment and after 4 weeks
shoulder functional level
The functional level of the shoulder will be measured by shoulder pain and disability index. the index consists of subscales that measure how much shoulder pain interferes with the functional activity of daily living
Measured: pre treatment and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder ImpingementStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noha Elserty
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noha Elserty, Egyptian Chinese University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271720
- Sponsor's protocol ID
- faculty of physical therapy
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elserty NS, Shokry DO, Altoury SA, Kentiba E, Mohamed RR. Effect of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome. Physiother Res Int. 2026 Jul;31(3):e70253. doi: 10.1002/pri.70253.
PubMed 42287703
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT06271720
- Acronym / sponsor ID
- faculty of physical therapy
- Conditions
- Shoulder Impingement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Noha ElsertyUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 22 Feb 2024 (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.
This study will be conducted To evaluate the effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome
Detailed description
HYPOTHESES
It will be hypothesized that:
- There will be no statistically significant effect of Visceral Manipulation on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, or function in shoulder impingement syndrome
- There will be no statistically significant effect of the Integrated Neuromuscular Inhibition Technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, or function in shoulder impingement syndrome.
- There will be no statistically significant difference in the effect of visceral manipulation versus the integrated neuromuscular inhibition technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome.
This study will be conducted to answer the following questions:
Is there an effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| visceral manipulation | Active comparator | Other: visceral manipulationPalpation will be applied and the pressure will directly to the skin, into the direction of restriction just until resistance (tissue barrier) is felt. Once found, the collagenous barrier will be engaged for 90 to 120 seconds for each technique without sliding over the skin or forcing the tissue until the fascia complex starts to yield and a sensation of softening is achieved. |
| integrated neuromuscular inhibition | Active comparator | Other: integrated neuromuscular inhibitionThe practitioner first identifies TrPs to be treated within the upper trapezius muscle. The subjects will be placed in a supine position. Their arm will be positioned in slight shoulder abduction with the elbow bent and their hand resting on their stomach. Using a pincer grasp, the practitioner will move throughout the fibers of the upper trapezius and make note of any active TrPs. Once the TrPs were identified, treatment began. The first technique applied will be ischemic compression. The therapist again utilized a pincer grasp, placing the thumb and index finger over the active TrP. Slow, increasing levels of pressure will be applied until the tissue resistance barrier is identified. The pressure will be maintained until a release of the tissue barrier is felt. At that time, pressure will again be applied until a new barrier is felt. This process will be repeated until tension or tenderness is unable to be identified or 90 seconds have elapsed. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- -active myofascial trigger points in the upper trapezius muscle, and chronic Pain lasting more than 12 weeks
- BMI between 25 and 30 Kg/m².
Key exclusion criteria (6 listed)
- a previous fracture in the cervical spine or shoulder surgery
- acute inflammatory condition.
- Malignant tumor.
- Multiple osteophytes.
- Cervical posture abnormalities.
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 |
|---|---|---|
| visceral manipulationvisceral manipulation: A palpation technique will be applied till the barrier is felt and it will be applied until release is felt. integrated neuromuscular inhibition: ischemic compression will be applied to trigger point of upper trapezius | Other | visceral manipulation |
| integrated neuromuscular inhibitionIt involves applying direct sustained digital pressure to the TrP with sufficient force over dedicated time duration, to slow down the blood supply and relieve the tension within the involved muscle. The pressure is gradually applied, maintained and the gradually released | Other | integrated neuromuscular inhibition |
Primary outcome
pain intensity
Time frame: pre treatment and after 4 weeks
pain intensity will be measured by a visual analog scale, the scale is marked from 0 to 10 while 0 represents no pain and 10 represents intolerable pain
pain pressure threshold
Time frame: pre treatment and after 4 weeks
pressure threshold measured by pressure algometer
shoulder range of motion
Time frame: pre treatment and after 4 weeks
shoulder flexion and abduction range of motion will be measured by inclinometer
shoulder functional level
Time frame: pre treatment and after 4 weeks
The functional level of the shoulder will be measured by shoulder pain and disability index. the index consists of subscales that measure how much shoulder pain interferes with the functional activity of daily living
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Derived from this study: PubMed 42287703Elserty NS, Shokry DO, Altoury SA, Kentiba E, Mohamed RR. Effect of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome. Physiother Res Int. 2026 Jul;31(3):e70253. doi: 10.1002/pri.70253.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing visceral manipulation and integrated neuromuscular inhibition in people with Shoulder Impingement, run by Noha Elserty.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
pain intensity (time frame: pre treatment and after 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06271720, which also lists 1 linked publication.
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 22 Feb 2024.