- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06271720
Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- -active myofascial trigger points in the upper trapezius muscle, and chronic Pain lasting more than 12 weeks
- BMI between 25 and 30 Kg/m².
Exclusion Criteria:
- a previous fracture in the cervical spine or shoulder surgery
- acute inflammatory condition.
- Malignant tumor.
- Multiple osteophytes.
- Cervical posture abnormalities.
- Osteoporosis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: visceral manipulation
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.
|
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 |
Active Comparator: integrated neuromuscular inhibition
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
pre treatment and after 4 weeks
|
pain pressure threshold
Time Frame: pre treatment and after 4 weeks
|
pressure threshold measured by pressure algometer
|
pre treatment and after 4 weeks
|
shoulder range of motion
Time Frame: pre treatment and after 4 weeks
|
shoulder flexion and abduction range of motion will be measured by inclinometer
|
pre treatment and after 4 weeks
|
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
|
pre treatment and after 4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- faculty of physical therapy (Cairo University)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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