Positional Release Technique in Patients With Unilateral Subacute Trapezitis

May 31, 2022 updated by: Riphah International University

Effects of Positional Release Technique on Pain, Range of Motion and Function in Patients With Unilateral Subacute Trapezitis

To assess the effects of positional release technique to improve the cervical range of motion, relieve pain and function in the patient with unilateral subacute trapezitis.

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.

Detailed Description

Trapezius pain is the most common muscular pain due to increased stress which results in trapezitis. The trapezius muscle is postural muscle diamond shape highly susceptible to overuse. It helps in extension, neck rotation, and side bending. Trapezitis is frequently caused by bad posture, watching TV or working on computer for a long and use of thick pillo. Passive ROM may be painful and restricted due to protective spasm in muscle. This study will be a Randomized controlled study and will be conducted in Met Life Rehablitation center Lahore. The study will be completed within the time duration of six months . Consecutive sampling technique will be used to collect the data. The sample size of 44 patients will be taken in this study to find the effect of positional release technique in subacute unilateral trapezitis. Patient will be divided into two groups. Mayoficial release therapy and ultrasound will be given to both groups as a baseline treatment. (Group A will be treated with positional release technique, mayofascial release technique and ultrasound while Group B will be treated with mayofascial release technique and ultrasound). All measurements will be taken at baseline and at the end of 2nd week.Each group will be given 3 sessions per week for 2 weeks. Neck disability index will be used to measure function, Numeric pain rating scale will be used to measure pain intensity and goniometer will be used to measure cervical lateral flexion and extension and rotation range of motion. Data will be analyzed on SPSS 25.

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.
44

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 Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 38000
        • Met Life Rehab center

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

25 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pain with less than 3 months duration
  • Subjects of sub- acute trapezitis with trigger points
  • Taut band palpable in upper trapezius muscle
  • Excruciating spot tenderness at one point along the length of the taut band of the upper trapezius muscle
  • Restriction in cervical lateral flexion when measured
  • Pain increased by elongating (stretching) the trapezius muscle.

Exclusion Criteria:

  • Traumatic Neck Injury
  • Fracture of cervical vertebras
  • Cervical Spinal Cord Compromise
  • Cervical Radiculopathy
  • Spondylolisthesis of the cervical spine
  • A history of heart disease or the presence of a pacemaker

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
  • Masking: SINGLE

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.
EXPERIMENTAL: Positional release technique
Positional release technique, Mayofascial release technique and ultrasound
Other: Positional release technique

Positional Release Technique The subject lies supine with therapist standing on the affected side; tender points are located along the upper fibres of the trapezius. Pressure will applied by pinching the muscle between the thumb and fingers. The subject's head is laterally flexed toward the side of tender point, then therapist grasps the subject's forearm and abducts shoulder to approximately 90° a slight flexion or extension is added to obtain fine-tune. The ideal position of comfort achieved is held for a period of 90 seconds and followed by a passive return of the body part to an anatomically neutral position continued for 5 minutes.

Mayofascial Release Technique Therapeutic Ultrasound

Other: Myofascial release technique & Ultrasound

Myofascial Release Technique

  • Position of the patient - sitting comfortably with supported back, elbow flexed with forearm placed on a pillow. A low load, long duration stretch is applied along the lines of maximal fascial restrictions. The fascia is palpated and the pressure is applied directly to the skin, into the direction of restriction just until resistance (tissue barrier) is felt. The pressure will be applied for 90 to120 seconds. This procedure will carried out without sliding over the skin or forcing the tissue until the fascia complex starts to yield and a sensation of softening is achieved.
  • Therapeutic ultrasound with the frequency of 3Mhz , with continuous mode and an intensity of 0.1-1.5 W/cm2 for a duration of 5 min will given with the patient position back rest.
ACTIVE_COMPARATOR: Mayofascial release technique and ultrasound
Other: Myofascial release technique & Ultrasound

Myofascial Release Technique

  • Position of the patient - sitting comfortably with supported back, elbow flexed with forearm placed on a pillow. A low load, long duration stretch is applied along the lines of maximal fascial restrictions. The fascia is palpated and the pressure is applied directly to the skin, into the direction of restriction just until resistance (tissue barrier) is felt. The pressure will be applied for 90 to120 seconds. This procedure will carried out without sliding over the skin or forcing the tissue until the fascia complex starts to yield and a sensation of softening is achieved.
  • Therapeutic ultrasound with the frequency of 3Mhz , with continuous mode and an intensity of 0.1-1.5 W/cm2 for a duration of 5 min will given with the patient position back rest.

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
UNIVERSAL GONIOMETER
Time Frame: 2 weeks
UG is a reliable device to evaluate cervical ROM. The UG is cheap, easy to use, popular instrument and requires minimum training. Intra-rater reliability is observed for both raters measuring ACROM using UG, with ICC (2,1) ranging from 0.83 to 0.98.
2 weeks
NUMERIC PAIN RATING SCALE
Time Frame: 2 weeks
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.
2 weeks
NECK DISABILITY INDEX
Time Frame: 2 weeks
Methods of assessment for such disability, especially those targeted at activities of daily living which are most affected by neck pain, questionnaire 10-item scaled entitled the Neck Disability Index (NDI). Face validity was ensured through peer-review and patient feedback sessions. Test-retest reliability was conducted (Pearson's r = 0.89, p ≤ . 05)
2 weeks

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.
Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Parab AA, Pattanshetty R. Effect of myofascial release versus muscle energy technique on trapezius spasm in head and neck cancer patients: A randomized clinical trial. Indian Journal of Physical Therapy and Research. 2019;1(2):114.
  • Chaudhary ES, Shah N, Vyas N, Khuman R, Chavda D, Nambi G. Comparative study of myofascial release and cold pack in upper trapezius spasm. International Journal of Health Sciences & Research. 2013;3(12):20-7.
  • Mishra D, Prakash RH, Mehta J, Dhaduk A. Comparative Study of Active Release Technique and Myofascial Release Technique in Treatment of Patients with Upper Trapezius Spasm. Journal of Clinical & Diagnostic Research. 2018;12(11).
  • Karthick K. A Study on the Effectiveness of Positional Release Therapy in the Management of Trapezitis. Research & Reviews: Journal of Computational Biology. 2018;6(2):19-25.

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.
January 25, 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.
May 25, 2021

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.
July 25, 2021

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).
January 19, 2021

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.
January 19, 2021

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.
January 20, 2021

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.
June 2, 2022

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.
May 31, 2022

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.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • REC/LHR/20/1039 Sana Naz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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