NONSPECIFIC NECK PAIN

December 8, 2022 updated by: Mohamed Elsayed, Helwan University

GRASTON VERSUS MUSCLE ENERGY TECHNIQUE IN NONSPECIFIC NECK PAIN

The goal of this a randomized control trial is to carried out to examine Graston technique (GT) and muscle energy method (MET) impact on nonspecific neck pain compared to traditional physiotherapy treatment (TPT), This study aims to contrast between the outcomes of GT and MET on both pain intensity and functional disability in patients. Each participant was assigned a unique number, and then those numbers were randomly divided into three groups. Three groups were formed from a random selection of participants: GT Group (A): received 12 sessions of GT and (TPT) over the course of four weeks (three sessions per week). MET Group (B): received 12 sessions of MET treatment and (TPT) over a period of four weeks (three sessions per week). Control Group (C): received 12 sessions of traditional physiotherapy (TPT) over a period of four weeks (three sessions per week).

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

Pain intensity (VAS) It was utilized to evaluate the degree of pain both before and after treatment. Subjects were asked to rate their pain on a scale from 0 (no pain) to 10 (extreme pain). Specifically, a line representing 10 centimeters was used as the scale's visual representation. Distance from zero to the respondent's mark was then used to approximate the sufferer's level of discomfort.

Functional Disability (NDI) The Neck Disability Index (NDI) is a 10-item questionnaire used to assess the functional impairment caused by neck pain. The questionnaire covers a wide range of topics related to one's everyday life, including but not limited to: personal care, heavy lifting, work, driving, sleeping, playing, recreational, pain level, concentration, and headache. Scores range from 0 (no disability) to 5 (severe disability) for each question, with the total score out of 100 determined by adding and doubling the scores for each question. If a patient has a high NDI score, they report being more disabled as a result of their neck pain. Patients have identified a 5-10% improvement as the "minimally clinically meaningful change." This study excluded any patient with: Symptoms or signs of upper motor neuron disease, vestibulobasilar insufficiency, and amyotrophic lateral sclerosis. Cervical spine fracture, Cases of disc prolapse that have been diagnosed (27), prior cervical or thoracic spine surgery.

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.
42

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

  • Egypt
      • Cairo, Egypt, 11795
        • Helwan 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

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • non specific neck pain

Exclusion Criteria:

  • Symptoms or signs of upper motor neuron disease, vestibulobasilar insufficiency, and amyotrophic lateral sclerosis.

Cervical spine fracture. Cases of disc prolapse that have been diagnosed. prior cervical or thoracic spine surgery, (28).

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • 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: Graston
Graston technique and traditional physical treatment (control)
Other: graston and muscle energy technique

Graston technique (Gt) is a technique of mobilization of soft tissue using instruments which consider myofascial release instrument that has been reported to relieve pain, improve overall function, and increase range of motion.

Muscle energy technique (MET) is a term composed of various types of active muscular relaxation and stretching procedures. The two cornerstone forms of MET are reciprocal inhibition and post isometric relaxation. In theory, reciprocal inhibition takes advantage of the neurological phenomena of muscular contraction, which results in an inhibitory effect on the antagonistic muscles.
Experimental: Muscle energy technique
Muscle energy technique and traditional physical treatment
Other: graston and muscle energy technique

Graston technique (Gt) is a technique of mobilization of soft tissue using instruments which consider myofascial release instrument that has been reported to relieve pain, improve overall function, and increase range of motion.

Muscle energy technique (MET) is a term composed of various types of active muscular relaxation and stretching procedures. The two cornerstone forms of MET are reciprocal inhibition and post isometric relaxation. In theory, reciprocal inhibition takes advantage of the neurological phenomena of muscular contraction, which results in an inhibitory effect on the antagonistic muscles.
Active Comparator: Traditional physical therapy
Traditional physical therapy treatment as heat application
Other: graston and muscle energy technique

Graston technique (Gt) is a technique of mobilization of soft tissue using instruments which consider myofascial release instrument that has been reported to relieve pain, improve overall function, and increase range of motion.

Muscle energy technique (MET) is a term composed of various types of active muscular relaxation and stretching procedures. The two cornerstone forms of MET are reciprocal inhibition and post isometric relaxation. In theory, reciprocal inhibition takes advantage of the neurological phenomena of muscular contraction, which results in an inhibitory effect on the antagonistic muscles.

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
Pain intensity (VAS)
Time Frame: 1 month
Pain intensity (VAS) It was utilized to evaluate the degree of pain both before and after treatment. Subjects were asked to rate their pain on a scale from 0 (no pain) to 10 (extreme pain). Specifically, a line representing 10 centimeters was used as the scale's visual representation. Distance from zero to the respondent's mark was then used to approximate the sufferer's level of discomfort
1 month

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
Functional Disability (NDI)
Time Frame: 1 month
Functional Disability (NDI) The Neck Disability Index (NDI) is a 10-item questionnaire used to assess the functional impairment caused by neck pain. The questionnaire covers a wide range of topics related to one's everyday life, including but not limited to: personal care, heavy lifting, work, driving, sleeping, playing, recreational, pain level, concentration, and headache. Scores range from 0 (no disability) to 5 (severe disability) for each question, with the total score out of 100 determined by adding and doubling the scores for each question. If a patient has a high NDI score, they report being more disabled as a result of their neck pain. Patients have identified a 5-10% improvement as the "minimally clinically meaningful change."
1 month

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.
Helwan 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

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.
April 1, 2022

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.
October 1, 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.
November 1, 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).
December 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.
December 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.
December 16, 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.
December 16, 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.
December 8, 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.
November 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.
  • HelwanU

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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