- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05474443
Comparison of Instrument Assisted Soft Tissue Mobilization and Myofascial Gun in Upper Cross Syndrome
Study Overview
Status
Conditions
Detailed Description
Upper Cross Syndrome is a very common postural abnormality developed due to prolong slouched postures in desk jobs and also in students. Janda explained it that it is simultaneous presence of Forward Head Posture and protracted shoulders.
This includes weakness of lower and middle trapezius, deep neck flexors, rhomboids and serratus anterior. It also includes tightness of upper trapezius, Sternocleidomastoid, Pectoralis major and minor. The simultaneous occurrence of FHP and rounded shoulder is nothing but upper crossed syndrome.
Upper Trapezius is the primary muscle that is involved in Upper Cross Syndrome. Instrument Assisted Soft Tissue Mobilization is applied over the tight muscles to improve muscle length to its normal length. It is applied from origin to insertion with some pressure to apply compression on the muscle.
Myofascial gun is a recent technology that can be applied by the clinician and also by the affected person for self mobilization. They provide varying amount of frequencies through various shaped heads according to the area they are used,
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46010
- Pakistan Railway General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Patients with forward head posture and upper crossed syndrome
Exclusion Criteria:
- Congenital anomalies of shoulder
- Malalignment/previous fracture of clavicle
- Malignancy and Tuberculosis of spine
- Pigeon and Barrel chest
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Myofascial gun with Conventional therapy
• Myofascial gun was applied over the Upper Trapezius muscle for 5 minutes.
In the first two sessions frequency was set to 1-2 then increased to next two sessions 3-4 and so on.
|
MYofascial gun was applied for the duration of 5 minutes over upper trapezius muscle. every week, on first two sessions frequency was set to 1-2 then for next two 3-4 and so on conventional therapy Hot Pack applied at the beginning of session for 10 minutes Muscle stretching of Upper Trapezius, Levator Scapulae and Pectoralis Major applied with holding time 20 seconds and 4 repetitions. Cold pack was applied at the end of the session for few minutes |
|
ACTIVE_COMPARATOR: Instrument Assisted Soft Tissue Mobilization with Conventional therapy
Graston's tool moved over the skin on upper trapezius muscle from its origin to insertion at 45 degree.
conventional therapy applied with Thermotherapy, upper trapezius, levator scapulae and pectoralis major stretching and cryotherapy at the end
|
Graston's tool was applied over upper trapezius muscle from its origin to insertion kept at the angle of 45 Conventional Therapy Hot pack 10mins Upper Trapezius, Levator scapule and Pectoralis major muscle stretching(20s hold and 4 reps) Cold pack for few minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale
Time Frame: 4th week
|
Changes from baseline Numeric pain Rating Scale is used to objectively assess musculoskeletal pain as marked by the patient.
It is a 10 point scale from 0 to 10. 0 depicts no pain at all and 10 shows worst pain ever felt.
It was measured at baseline and after 4 weeks of the intervention
|
4th week
|
|
Tragus to wall distance test
Time Frame: 4th week
|
Changes from baseline Tragus to wall distance test is used to measure Forward Head Posture.
The subject stands 10cm away from wall and then with the help of a ruler the distance from tragus of ear to wall is measured.
If the distance was more than 9.5 cm then it was considered as forward head posture.
it was measured at baseline and after 4 weeks of intervention
|
4th week
|
|
Neck Disability Index
Time Frame: 4th week
|
Changes from baseline NDI is the most widely used instrument for assessing self-rated disability in patients with neck pain.
The NDI is a self-report questionnaire with 10-items.
The response to each item is rated on a 6-point scale from 0 (no disability) to 5 (complete disability).
The numeric responses for each item are summed for a total score ranging between 0 and 50.
Most of the subjects did not know how to drive so their total score was taken from 45.
The questionnaire was filled by the subjects at basline and after 4 weeks of the intervention
|
4th week
|
|
Inclinometer
Time Frame: 4th week
|
Changes from baseline Bubble inclinometers are portable, lightweight, inexpensive and require training.
With the movement of neck the ink in the inclinometer moves and the level of ink gives the measure of the range of motion.
For flexion, extension and lateral flexion of cervical Range of motion in sitting position and inclinometer was positioned at the top of head in sagittal plane.
For rotations the subject was in supine position and inclinometer was placed over the forehead.
Cervical ranges of motions were measured at baseline and then after 4 weeks of intervention
|
4th week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REC/01217 Hafsa
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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