NCT06104761

Brief Summary

This study will be a randomized controlled trial conducted to investigate the effect of myofascial release with IASTM on pain intensity level, cervical ROM, chest expansion, craniovertebral angle and kyphotic angle in upper crossed syndrome patients. A sample size of 52 will be randomly allocated to two group ,(26 participants in each group), by using computer-generated random number list Control group will recieve conventional physical therapy in form of stretching and strengthening and experimental group will recieve firstly myofascial release with IASTM then applying the same conventional physical therapy of control group . Both groups will recieve 3 sessions per week for 4 weeks .

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
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Status
unknown

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

October 23, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 23, 2023

Last Update Submit

October 23, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Cervical range of motion

    The ROM of the cervical spine was measured using CROM device and CROM measurements had established validity which contains sagittal plane inclinometer, frontal plane inclinometer and transverse plane inclinometer Total active cervical flexion range in upright sitting , Total active cervical rotation ROM (right and left) in upright sitting , Total active cervical extension in upright sitting., Total active side pending ROM (right and left) in upright sitting .

    up to 4 weeks

  • Chest Expansion

    Tape measurement to measure chest expansion For the upper thoracic excursion, the tape measure placed at the level of the fifth thoracic spinous process and the third intercostal space at the midclavicular line For the lower thoracic excursion, the tape measure placed at the level of the 10th thoracic spinous process and the tip of the xiphoid process .

    up to 4 weeks

  • Cranio verteberal angle

    Digitized camera will be used it wiil be taken from lateral view photograph of the subject in his\\her usual standing posture and taken again to minimize image distortion, and therapist placed a circular spirit level at the base of the camera to ensure that the camera is perpendicular to the horizontal level. Next, the tragus of the subject's ear will be marked and a plastic pointer will be attached to the skin overlying the C7 vertebra. Once the photograph is obtained, the therapist will use image to measure FHP, quantified by the cranio-vertbral angle (CVA) (the angle between the horizontal lines passing through C7and a line extending from the tragus of the ear to C7 notably). Lesser CVA indicates greater FHP

    up to 4 weeks

  • Thoracic Kyphosis

    Flexicurve ruler will be used to measure kyphosis The subject will be instructed to stand up straight and as tall as possible, and the flexicurve ruler will be aligned to the anterior-posterior curves of the spine from C7 to T12. The ruler will then placed flat on paper and its outline will be traced. A straight line was then drawn from the ruler position of C7 to T12 that corresponded to the length of thoracic kyphosis (l) and will be measured in cm. The height of the thoracic kyphosis (h) in cm will be determined by drawing a perpendicular line from the highest point in the thoracic curve to the point at which it will intersect the straight line drawn from C7 to T12. The index of kyphosis was calculated by applying the formula: (h/l ) x 100.

    up to 4 weeks

  • pain Intenisty level

    Numeric Pain Rating Scale (NPRS) will be used to measure pain intensity level To assess pain intensity it is the most widely used tool for estimating both severity of pain and to judge the extent of pain relief. Patient will asked to select a point on a line drawn between two ends to express how intense he/she perceives pain. It composed of 10 cm long, anchored by two verbal descriptors (i.e., "no pain" and "worst imaginable pain". Patients are asked to rate "current" pain intensity or pain intensity "in the last 24 hours"

    up to 4 weeks

Study Arms (2)

Release Group

EXPERIMENTAL

Release of tight muscles in upper crossed syndrome

Other: Release groupOther: strength exercises and stretching for upper crossed syndrome

Control group

OTHER

strength exercises and stretching for upper crossed syndrome

Other: strength exercises and stretching for upper crossed syndrome

Interventions

i will make release for these muscles ( upper trapizius , levator scapulae , strenomastoid ) in addition to sub occipital fascia , then I will apply conventional physical therapy in form of stretching exercises (Trapezius (upper fibers) muscle , Levator scapulae muscle , Pectoralis major and Sternocleidomastoid muscles) and strengthening exercises for these muscles (Deep neck flexors, Trapezius (middle and lower fibers), Rhomboids and Serratus anterior muscles).

Release Group

I will apply conventional physical therapy in form of stretching exercises (Trapezius (upper fibers) muscle , Levator scapulae muscle , Pectoralis major and Sternocleidomastoid muscles) and strengthening exercises for these muscles (Deep neck flexors, Trapezius (middle and lower fibers), Rhomboids and Serratus anterior muscles).

Control groupRelease Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 1-Age ranged from 18 to 45 years . 2- All participants had intensity of neck pain on VAS (4-8) (moderate cases) . 3 - All participants had mechanical neck pain and FHP (craniovertebral angle CVA \< 49) CVA of \< 49) ..
  • All participants had kyphosis angle ≥45°.

You may not qualify if:

  • Malignancy. 2- Fractures of the cervical spine. 3- Cervical radiculopathy or myelopathy. 4- Vascular syndromes such as vertebrobasilar insufficiency. 5- Rheumatoid arthritis. 6- Neck or upper back surgery. 7- Taking anticoagulants. 8- Local infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Oculocerebral hypopigmentation syndrome type Preus

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double ( participant , Outcomes Assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Effect of instrument assisted sopf tissue mobilization on upper cross syndrome
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physical therapist

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 27, 2023

Study Start

November 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

October 27, 2023

Record last verified: 2023-10