Postural; DefectNCT05474443
Comparison of Instrument Assisted Soft Tissue Mobilization and Myofascial Gun in Upper Cross Syndrome
A study testing Myofascial gun with conventional therapy and Instrument Assisted Soft Tissue Mobilization with Conventional therapy in people with Postural; Defect, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of Instrument Assisted Soft Tissue Mobilization and Myofascial gun in Upper Cross Syndrome Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural; Defect
- What is being tested?
- Myofascial gun with conventional therapy and Instrument Assisted Soft Tissue Mobilization with Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Nov 2021to 10 Jul 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with forward head posture and upper crossed syndrome
Who cannot join
- Congenital anomalies of shoulder
- Malalignment/previous fracture of clavicle
- Malignancy and Tuberculosis of spine
- Pigeon and Barrel chest
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Railway General Hospital
Rawalpindi, Punjab Province, 46010
About this study
To compare the effects of Instrument Assisted Soft Tissue Mobilization and Myofascial gun in Upper Cross Syndrome
Read the 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,
- Conditions
- Postural; Defect
- Being tested
- Myofascial gun with conventional therapy, Instrument Assisted Soft Tissue Mobilization with Conventional therapy
- Keywords
- Upper Cross Syndrome, Instrument Assisted Soft Tissue Mobilization, Myofascial gun
- Medical subject headings
- Oculocerebral hypopigmentation syndrome type Preus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial gun with conventional therapyOther
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
Instrument Assisted Soft Tissue Mobilization with Conventional therapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Myofascial gun with Conventional therapy | Experimental | • 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. Receives: Other: Myofascial gun with conventional therapy |
| Instrument Assisted Soft Tissue Mobilization with Conventional therapy | Active comparator | 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 Receives: Other: Instrument Assisted Soft Tissue Mobilization with Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
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
Measured: 4th week
Tragus to wall distance test
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
Measured: 4th week
Neck Disability Index
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
Measured: 4th week
Inclinometer
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
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start25 Nov 2021
- Primary completion1 Jul 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural; DefectStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Model description
- 30 participants were recruited in study and divided into two groups. Group A was given intervention with Instrument Assisted Soft Tissue Mobilization and Group B with Myofascial gun
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Affan Iqbal, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474443
- Sponsor's protocol ID
- REC/01217 Hafsa
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Instrument Assisted Soft Tissue Mobilization and Myofascial Gun in Upper Cross Syndrome
- ClinicalTrials.gov ID
- NCT05474443
- Acronym / sponsor ID
- REC/01217 Hafsa
- Conditions
- Postural; Defect
- Keywords
- Upper Cross Syndrome, Instrument Assisted Soft Tissue Mobilization, Myofascial gun
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 26 Jul 2022 (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.
To compare the effects of Instrument Assisted Soft Tissue Mobilization and Myofascial gun in Upper Cross Syndrome
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 30 participants were recruited in study and divided into two groups. Group A was given intervention with Instrument Assisted Soft Tissue Mobilization and Group B with Myofascial gun
| Arm | Type | Receives |
|---|---|---|
| Myofascial gun with Conventional therapy | Experimental | Other: 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. |
| Instrument Assisted Soft Tissue Mobilization with Conventional therapy | Active comparator | Other: Instrument Assisted Soft Tissue Mobilization with Conventional therapyGraston'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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with forward head posture and upper crossed syndrome
Key exclusion criteria (4 listed)
- Congenital anomalies of shoulder
- Malalignment/previous fracture of clavicle
- Malignancy and Tuberculosis of spine
- Pigeon and Barrel chest
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 |
|---|---|---|
| Myofascial gun with conventional therapyMYofascial 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 | Other | Myofascial gun with Conventional therapy |
| Instrument Assisted Soft Tissue Mobilization with Conventional therapyGraston'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 | Other | Instrument Assisted Soft Tissue Mobilization with Conventional therapy |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Muhammad Affan Iqbal, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial gun with conventional therapy and Instrument Assisted Soft Tissue Mobilization with Conventional therapy in people with Postural; Defect, run by Riphah International University at 1 site in Pakistan.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numeric Pain Rating Scale (time frame: 4th week). 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?
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 26 Jul 2022.