Cervicothoracic Junction Mobilization Versus Eccentric Muscle Energy Technique in Mechanical Cervical Pain

June 7, 2022 updated by: Riphah International University

Effects of Cervicothoracic Junction Mobilization Versus Eccentric Muscle Energy Technique in the Treatment of Mechanical Cervical Pain

  1. To compare the effectiveness of the cervicothoracic junction mobilization and eccentric muscle energy technique on mechanical cervical pain.
  2. To compare the effectiveness of the cervicothoracic junction mobilization and eccentric muscle energy technique on cervical disability.
  3. To compare the effectiveness of the cervicothoracic junction mobilization and eccentric muscle energy technique on cervical ROM.

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.
36

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
    • ICT
      • Islamabad, ICT, Pakistan, 44000
        • Riphah International University

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 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Participants falling in this category would be recruited into the study.

    1. Females
    2. Age between 18-45 years.
    3. Diagnosed with mechanical cervical pain.

Exclusion Criteria:

  • Participant failing to fall in this category would be excluded of the study.

    1. Pregnant Females
    2. Any previous history of trauma or surgery
    3. Diagnosed with mechanical cervical pain due to disc herniation, radiculopathy or any other cervical malignancy.

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: Cervicothoracic Junction Mobilization Technique

It is a part of manual therapy technique. Maitland mobilization to the C7- T1 level, according to their primary movement restriction (for flexion-extension restriction- central PA glide, for rotation restrictions unilateral PA glide) is given.For central PA glide, a central pressure angled towards the participant's head was given with overlapping thumbs of the therapist placed on the spinous process of C7.

Dosage:

Glide would be given according to the nature, intensity and severity of the patient's pain. 30 sec bouts with 3 sets & 2 reps. Total 2-3 min duration. 2 sessions per week for 3 weeks.
Other: Cervicothoracic Junction Mobilization Technique
It is a part of manual therapy technique. Patient would be in prone position with his forehead in the palm of the therapist. Maitland mobilization to the C7- T1 level, according to their primary movement restriction (for flexion-extension restriction- central PA glide, for rotation restrictions unilateral PA glide) is given. For central PA glide, a central pressure angled towards the participant's head was given with overlapping thumbs of the therapist placed on the spinous process of C7. The therapist's thumbs were placed on the posterior surface of the articular process to be mobilized (C7 on the side of restriction), and anteriorly directed oscillatory pressure was applied for unilateral PA mobilization.
EXPERIMENTAL: Eccentric Muscle Energy Technique

Eccentric muscle energy technique would be applied to the patient's cervical spine. The cervical spine would be brought to the barrier of motion in each plane i.e. flexion/extension, lateral bending and rotation. Then patient would be asked to push their heads into the direction opposite that of the barrier.

Dosage:

The therapist provided isometric resistance for 3- 5 seconds, after which the subjects relaxed their muscles completely and the therapist applied stretch. This is applied for generalized cervical movements in each plane like Flexion, Extension, Side Bending

& Rotation. 3-5 repetitions with 2-3 sets were performed. Total duration: 3-5 min 2 sessions per week for 3 weeks.
Other: Eccentric Muscle Energy Technique
Eccentric muscle energy technique would be applied to the patient's cervical spine. The cervical spine would be brought to the barrier of motion in each plane i.e. flexion/extension, lateral bending and rotation. Then patient would be asked to push their heads into the direction opposite that of the barrier.

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
Visual Analogue Scale
Time Frame: 3 Weeks
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. It is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best). Test-retest reliability has been shown to be good, but higher among literate (r= 0.94)
3 Weeks
Neck Disability Index (NDI)
Time Frame: 3 Weeks
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. Patient-completed, condition-specific, functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each section is scored on a 0 to 5 rating scale, in which zero means "no pain" and 5 means "Worst imaginable pain". It has highest score of 50.
3 Weeks
Cervical Goniometer
Time Frame: 3 Weeks
A goniometer is an instrument which measures the available range of motion atjoint. Goniometer have different types; the most use is the universal standard goniometer, which is either made with plastic or metal tool. It consists of a stationary arm, a movable arm and a fulcrum.
3 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

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.
September 1, 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, 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.
May 25, 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 4, 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 7, 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 8, 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.
June 8, 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.
June 7, 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.
June 1, 2022

More Information

Terms related to this study

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.
  • Ayesha Sadiq

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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