Effects of IC With and Without MET on Upper Trapezius Trigger Points

April 6, 2023 updated by: University of Lahore

Effects of Ischemic Compression With and Without Muscle Energy Technique on Pain, Range of Motion and Functional Disability in Patients With Trigger Points in Upper Trapezius; A Randomized Clinical Trial

the aim of the study is to check the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius. In previous studies, Muscle Energy Technique and Ischemic Compression are compared with different conventional and combined therapy approaches, including most of the techniques used to treat Trigger Points in the upper trapezius. No study has evaluated the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius. The outcome measures are a Numeric pain rating scale, universal goniometer and neck disability index questionnaire.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Muhammad Haider Ullah Khan, MSPT(neuro)
  • Phone Number: 00923314127210
  • Email: haiderullah@live.com

Study Locations

  • Pakistan
    • Punjab
      • Sialkot, Punjab, Pakistan
        • University of Sialkot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both gender Aged 18 to 50 years (40)
  • Participants with active myofascial trigger points in the upper trapezius diagnosed by a senior physiotherapist on the basis of Travel and Simon criteria will be randomly allocated into two clinical groups.
  • Taut band having palpable nodule within upper trapezius muscle
  • Pain produced in a specific pattern which is radiating in character when firm pressure is applied on trigger points

Exclusion Criteria:

  • Trauma (whiplash injury)
  • Injury to Cervical Spine
  • Cervical Spine surgery
  • Cervical Myelopathy and Radiculopathy
  • Osteoporosis of the cervical spine
  • Cervical myeloma
  • Complex regional pain syndrome
  • Patients with the H/O any Neurological, Rheumatology and other serious medical illnesses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ischemic Compression
Ischemic Compression will be applied to the upper trapezius trigger points in patients recruited in group 1.
Other: Ischemic Compression
It includes conventional Physical therapy, hot packs (75°C) for 20 minutes, and active stretching exercises for the upper trapezius muscle (slow, 5 repetitions per session, 10-second hold, and 10-second relaxation between two repetitions) as a baseline treatment. For the Ischemic compression, the patient will be in the supine position with the cervical spine in opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were kept in a lengthened position physiotherapist will apply gradually increasing pressure to the Trigger points until the subject perceived the first noticeable pain. At that moment, the pressure will be maintained until the discomfort and/or pain eased by around 50% as perceived by the patient, at which time the pressure will be increased until the discomfort appears again. This process will be maintained for 90 seconds.
Experimental: Ischemic compression and Muscle Energy Technique
ischemic compression along with muscle energy technique will be applied to the upper trapezius trigger points in patients allocated to group 2.
Other: Ischemic compression with Muscle Energy Technique
The Participants will receive all the treatments given to the active comparator group and they will also receive the Muscle Energy Technique treatment in supine position and the practitioner will stabilize the shoulder of the affected side with one hand, while the ear/mastoid area of the affected side will be held by the opposite hand. The head and neck were then bent towards the contralateral side, flexed, and ipsilaterally rotated. The subjects will then shrug the stabilized shoulder towards the ear at a sub-maximal pain-free effort (20% of the available strength). The isometric contraction will be held for 7-10s. This position will be maintained for 30 seconds and repeated three to five times per treatment session. Treatment sessions will be given on alternate days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in pain on Numeric Pain Rating Scale at week 4
Time Frame: Baseline and week 4
on a scale of 1 to 10, o means no pain while 10 means worst pain
Baseline and week 4
Change from Baseline in Goniometer readings at week 4
Time Frame: Baseline and week 4
for flexion any value less than 90 degrees indicates limited range of motion, for extension any value less than 70 indicates limited range of motion, for lateral flexion values less than 20 and greater than 45 considered limited, for rotation value less than 90 is considered limited
Baseline and week 4
Change from baseline in Neck disability index questionnaire scores at week 4
Time Frame: Baseline and week 4
on a scale of 0 to 50, 0 indicates no disability and 50 indicates completely disabled
Baseline and week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain on Numeric Pain Rating Scale at week 2
Time Frame: week 2
on a scale of 1 to 10, o means no pain while 10 means worst pain
week 2
Goniometer readings at week 2
Time Frame: week 2
Using goniometer, neck ranges of motion will be measured. for flexion any value less than 90 degrees indicates limited range of motion, for extension any value less than 70 indicates limited range of motion, for lateral flexion values less than 20 and greater than 45 considered limited, for rotation value less than 90 is considered limited
week 2
Neck disability index questionnaire scores at week 2
Time Frame: week 2
on a scale of 0 to 50, 0 indicates no disability and 50 indicates completely disabled
week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Lahore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Syeda Khadija Kazmi, DPT, The University of Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 23, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-UOL-FAHS/890-II/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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