Effect of MET With and Without MCTE in Mechanical Neck Pain

December 20, 2024 updated by: Riphah International University

Effects of Muscle Energy Techniques With and Without Motor Control Therapeutic Exercises on Pain, Range of Motion and Disability in Patients With Mechanical Neck Pain.

Work had to be done previously on METs and MCTE techniques, but no study has compared both techniques together to make it more comprehensible. The rationale of this will be to find out the combined effect of motor control therapeutic exercises and muscle energy technique for the treatment of pain, range of motion and disability associated with mechanical neck pain. This study will be effective for the clinicians to treat patients of mechanical neck pain.

Study Overview

Status

Status

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

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

Therapeutic exercises and manual therapy were shown to be useful in managing pain and lowering disability in patients with non-specific chronic neck pain (NCNP). However, little studies investigated the benefits of muscle energy technique and motor control therapeutics exercise on mechanical neck pain (MNP). The current research fulfill this gap by comparing the short and long term benefits of muscle energy technique with and without motor control therapeutic exercises (MCTE) with the grail of determining best approach for lowering pain and disability in mechanical neck pain patients.

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 (Estimated)

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.
50

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

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Study Locations

  • Pakistan
      • Lahore, Pakistan, 54660
        • Recruiting
        • Riphah college of rehabilitation and allied health sciences
        • Contact:
        • Principal Investigator:
          • Maham Javed, MS-OMPT
        • Sub-Investigator:
          • Dr.Ali Raza, phd

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Subjects were between 20 and 50 years old.

    • Pain in cervical or neck region with no radiating pain in one or both upper limbs.
    • Pain minimum of 3 months.
    • Neck disability index (NDI) score of should be at least 10%.
    • Forward head posture.

Exclusion Criteria:

  • • Neck pain associated with vertigo.

    • Irradiated neck pain.
    • Vertebral fracture.
    • Osteoporosis.
    • Previous neck injury.
    • Red flags (night pain, severe muscle loss, loss of involuntary control.
    • Subjects with difficulty in communication or understanding.

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: 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.
Active Comparator: METs
Hot pack along with Neck isometrics and muscle energy technique protocol
Other: METs
  • Hot pack for 10 minutes.
  • Neck isometrics with 10 second hold.
  • Each series of neck isometrics strengthening exercises had three movements including cervical flexion, cervical extension and cervical side flexion.
  • Muscle energy technique protocol: The individual was in a position of supine. The therapist was at the edge of bed, near the participants head. the therapist positioned the joint at the point of beginning range of motion resistance when performing a given movement. When the therapist felt restriction, positioned the cervical spine in that region and apply the resistive force. Patient was instructed to contract isometrically for five seconds without exceeding the therapist force. thereafter, therapist counterforce gradually reduced and patient was asked to relaxed. Therapist move the joint into new point of barrier and same protocol repeated three times.

Patient came thrice per week for a total of 4 weeks.
Experimental: MCTE along with METs
MCTE included cranio-cervical flexion, cranio-cervical extension, co-contraction of flexion and extension and synergistic exercise of neck flexor along with hot pack, neck isometrics and muscle energy technique protocol
Other: MCTE along with METs

▪ Hot pack for 10 minutes.

  • Neck isometrics with 10 second hold.
  • Each series of neck isometrics strengthening exercises had three movements including cervical flexion, cervical extension and cervical side flexion.
  • After it was treated with motor control therapeutic exercises together with muscle energy technique. Motor control therapeutic exercises included cranio-cervical flexor exercises, cranio-cervical extensor exercises, co contraction of flexor and extensor and synergy exercise for strengthening deep neck flexor. Exercises were performed in three sets with 10 repetitions with an approximate duration of 10 to 20 minutes. They were advised to perform at home once in a day, five times in a week for a duration of 4 weeks.

All exercises were performed three times per week for total of 4 weeks.

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
Numeric pain scale rating
Time Frame: 4th week
Changes from base line Pain intensity was assessed by Numeric Rating Scale (NRS). NRPS has fair to moderate reliability of test-retest in patients with Mechanical Neck Pain. The patient was required to indicate the number that represent his intensity of pain, in which 0 represents "no pain" and 10 represents "the worst pain imaginable". Numeric Pain Rating Scale is widely used subjective pain measure that has good test-retest reliability r = 0.79 - 0.96
4th week

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
Neck disability index
Time Frame: 4th week
Changes from base line NDI is self-assessment tool for the specific functional status of patients with neck pain, consisting of ten components pain, personal hygiene, obesity, reading, headache, focus, work, travelling, sleeping, and leisure, each part is scored on an index of 0 to 5, with 0 representing "painless" and 5 representing the "worst pain imaginable". These points earned are added to the total score. The questionnaire was determined in percentage. The NDI disability categories are: 0-8% without disability, 10-28% mild, 30-48% moderate, 50-64% serious, and 70-100% complete. NDI has fair to moderate reliability of test-retest in patients, with inter-class correlation coefficient ranging from 0.50-0.98.
4th week
ROM cervical spine (flexion)
Time Frame: 4th week
Changes from base line Universal Goniometer is used for measuring neck range of motion. Reliability of goniometer was found for all the measurements ranging from, interclass correlation coefficient for goniometer > 0.94. The concurrent validity of goniometer was good with ICC value of > 0.85. The goniometer will be used to measure flexion.
4th week
ROM cervical spine (Extension)
Time Frame: 4th week
Changes from base line Universal Goniometer is used for measuring neck range of motion. Reliability of goniometer was found for all the measurements ranging from, interclass correlation coefficient for goniometer > 0.94. The concurrent validity of goniometer was good with ICC value of > 0.85. The goniometer will be used to measure extension.
4th week
ROM cervical spine (Side flexion)
Time Frame: 4th week
Changes from base line Universal Goniometer is used for measuring neck range of motion. Reliability of goniometer was found for all the measurements ranging from, interclass correlation coefficient for goniometer > 0.94. The concurrent validity of goniometer was good with ICC value of > 0.85. The goniometer will be used to measure side flexion.
4th week

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

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: Saba Rafique, PhD, 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

Study record dates

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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.
July 4, 2024

Primary Completion (Estimated)

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.
January 7, 2025

Study Completion (Estimated)

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.
January 8, 2025

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 20, 2024

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 20, 2024

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.
March 25, 2025

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.
March 25, 2025

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 20, 2024

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.
December 1, 2024

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/RCR & AHS/24/0115

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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