NCT06271720

Brief 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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

January 19, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

January 19, 2024

Last Update Submit

February 15, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

    pre treatment and after 4 weeks

  • pain pressure threshold

    pressure threshold measured by pressure algometer

    pre treatment and after 4 weeks

  • shoulder range of motion

    shoulder flexion and abduction range of motion will be measured by inclinometer

    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

    pre treatment and after 4 weeks

Study Arms (2)

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.

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.

Other: integrated neuromuscular inhibition

Interventions

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

visceral manipulation

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

integrated neuromuscular inhibition

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • active myofascial trigger points in the upper trapezius muscle, and chronic Pain lasting more than 12 weeks
  • BMI between 25 and 30 Kg/m².

You may not qualify if:

  • a previous fracture in the cervical spine or shoulder surgery
  • acute inflammatory condition.
  • Malignant tumor.
  • Multiple osteophytes.
  • Cervical posture abnormalities.
  • Osteoporosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 19, 2024

First Posted

February 22, 2024

Study Start

March 1, 2024

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

February 22, 2024

Record last verified: 2024-02