Effectiveness of NMES on Neck Pain

March 16, 2024 updated by: Aybike Senel, Istanbul University - Cerrahpasa (IUC)

The Effectiveness of Neuromuscular Electrical Stimulation Applied Simultaneously to Exercise on Pain, Range of Motion, Muscle Endurance, Fear of Movement and Disability in Chronic Neck Pain

The aim of this randomized-controlled study was to determine the effectiveness of neuromuscular electrical stimulation (NMES) applied simultaneously to exercise on pain, static endurance of cervical deep flexor muscles, fear of movement and disability in chronic neck pain. The participants were randomly assigned to one group which in only five clinical pilates exercises were performed (Group I) or the other group which NMES was applied on lower trapezius and serratus anterior muscles while the same exercises were performing (Group II).

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

The aim of randomized-controlled study was to determine the effectiveness of neuromuscular electrical stimulation (NMES) applied simultaneously to exercise on pain, static endurance of cervical deep flexor muscles, fear of movement and disability in chronic neck pain. This study, including adults with chronic neck pain aged between 18-65 years, was conducted in laboratory of xxx University from March 2021 to May 2021. The participants were randomly assigned to one group which in only five clinical pilates exercises were performed (Group I) or the other group which NMES was applied on lower trapezius and serratus anterior muscles while the same exercises were performing (Group II). Both groups received 20 minutes of treatment session two days a week for the 8 weeks. The pain intensity, range of motion (ROM), static endurance of cervical deep flexor muscles, fear of movement, and neck disability were assessed with Visual Analogue (VAS), universal goniometer, The Deep Neck Flexor (DNF) Endurance Test, Tampa Scale of Kinesiophobia (TSK) and Neck Disability Index (NDI), respectively. All the assessments were performed twice as before and end of the treatment.

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

  • Turkey
      • İstanbul, Turkey
        • Istanbul Aydın 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) being aged from 18 to 65 years old,
  • (2) having neck pain shows mechanical nature longer than 3 months, and
  • (3) getting a score of at least 10 from Neck Disability Index.

Exclusion Criteria:

  • (1) having a surgery on neck and shoulder regions,
  • (2) having a neurological symptom, and
  • (3) did not complete the process of the assessment and intervention of this study.

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.
Experimental: Group II
Other: Exercise
the patients were performed following five exercises for 20 minutes of treatment session two days a week for the 8 weeks.: (1) the swan-dive vol. I, (2) the swan-dive vol II., (3) breast stroke preparation vol. I, (4) breast stroke preparation vol. II, and (5) swimming vol. II. All the exercises were repeated for the 10 times in a session. Before the exercises, patients were taught and instructed about the five key elements (lateral expansion, centralization, positioning the chest, the shoulder girdle, and the head) of clinical pilates that they should pay attention to while performing the exercises. In addition, verbal and tactile feedbacks were given to patients during all the treatment sessions to maintain the good posture and to perform exercises properly.
Other: Electrotherapy
Two channels of four-channelled Compex SP Fit-3 (MediCompex SA in Geneva, Switzerland) was used to apply NMES (120 mA, 400 μs, 150 Hz) on lower trapezius and serratus anterior muscles for 20 minutes during exercise.
Active Comparator: Group I
Other: Exercise
the patients were performed following five exercises for 20 minutes of treatment session two days a week for the 8 weeks.: (1) the swan-dive vol. I, (2) the swan-dive vol II., (3) breast stroke preparation vol. I, (4) breast stroke preparation vol. II, and (5) swimming vol. II. All the exercises were repeated for the 10 times in a session. Before the exercises, patients were taught and instructed about the five key elements (lateral expansion, centralization, positioning the chest, the shoulder girdle, and the head) of clinical pilates that they should pay attention to while performing the exercises. In addition, verbal and tactile feedbacks were given to patients during all the treatment sessions to maintain the good posture and to perform exercises properly.

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
Neck disability
Time Frame: baseline (first assessment)
The Neck Disability Index consisted 10 questions investigating the pain intensity and difficulty in lifting, reading, concentration, working, sleeping and recreational activities. Each question is scoring from 0 to 5 and higher score means greater disability.
baseline (first assessment)
Neck disability
Time Frame: at the end of the invervention program (8 weeks after from baseline)
The Neck Disability Index consisted 10 questions investigating the pain intensity and difficulty in lifting, reading, concentration, working, sleeping and recreational activities. Each question is scoring from 0 to 5 and higher score means greater disability.
at the end of the invervention program (8 weeks after from baseline)

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 intensity
Time Frame: baseline (first assessment)
The neck pain intensity of the participants were assessed with VAS which is a widely used pain assessments in the musculoskeletal disorders. The participants were asked to rate their pain intensity with a mark on a 10 cm line, which starts with "0-no pain" and ends with "10-unbearable pain". The distance of the mark to the 0 point was measured with a ruler and the pain intensity was recorded as cm.
baseline (first assessment)
Pain intensity
Time Frame: at the end of the invervention program (8 weeks after from baseline)
The neck pain intensity of the participants were assessed with VAS which is a widely used pain assessments in the musculoskeletal disorders. The participants were asked to rate their pain intensity with a mark on a 10 cm line, which starts with "0-no pain" and ends with "10-unbearable pain". The distance of the mark to the 0 point was measured with a ruler and the pain intensity was recorded as cm.
at the end of the invervention program (8 weeks after from baseline)
Range of Motion
Time Frame: baseline (first assessment)
Cervical ROM in all six directions (flexion-extension, lateral flexion, and rotation) were assessed with universal goniometer. Universal goniometer were shown to have good to excellent intra-rater and inter-rater reliability to assess ROM of cervical spine (10.1093/ptj/71.2.98). The measurement were performed as described in (https://doi.org/10.21315/mjms2021.28.2.9). The measurement of each six directions were repeated three times and means were recorded as degree.
baseline (first assessment)
Range of Motion
Time Frame: at the end of the invervention program (8 weeks after from baseline)
Cervical ROM in all six directions (flexion-extension, lateral flexion, and rotation) were assessed with universal goniometer. Universal goniometer were shown to have good to excellent intra-rater and inter-rater reliability to assess ROM of cervical spine (10.1093/ptj/71.2.98). The measurement were performed as described in (https://doi.org/10.21315/mjms2021.28.2.9). The measurement of each six directions were repeated three times and means were recorded as degree.
at the end of the invervention program (8 weeks after from baseline)
Static endurance of cervical deep flexor muscles
Time Frame: baseline (first assessment)
Deep Neck Flexor ((longus capitis, longus colli, rectus capitis anterior and lateralis) Endurance Test was used to static endurance of cervical deep flexor muscles. The subjects began in a supine, hook-lying position, with the hands resting on the abdomen. Upon request, with the chin in maximally tucked position and maintained isometrically, the subject lifted the head and neck approximately 2.5 cm from resting position The duration of holding the head position properly was timed, and static endurance of the DNF was recorded as second.
baseline (first assessment)
Static endurance of cervical deep flexor muscles
Time Frame: at the end of the invervention program (8 weeks after from baseline)
Deep Neck Flexor ((longus capitis, longus colli, rectus capitis anterior and lateralis) Endurance Test was used to static endurance of cervical deep flexor muscles. The subjects began in a supine, hook-lying position, with the hands resting on the abdomen. Upon request, with the chin in maximally tucked position and maintained isometrically, the subject lifted the head and neck approximately 2.5 cm from resting position The duration of holding the head position properly was timed, and static endurance of the DNF was recorded as second.
at the end of the invervention program (8 weeks after from baseline)
Fear of the movement
Time Frame: baseline (first assessment)
Tampa Scale of Kinesiophobia is a Likert type questionnaire consisted of 17 questions scoring from "1-strongly disagree" to "4-strongly agree". Scoring of questions 4, 8, 12, and 16 are reversed. The higher score means greater fear of movement.
baseline (first assessment)
Fear of the movement
Time Frame: at the end of the invervention program (8 weeks after from baseline)
Tampa Scale of Kinesiophobia is a Likert type questionnaire consisted of 17 questions scoring from "1-strongly disagree" to "4-strongly agree". Scoring of questions 4, 8, 12, and 16 are reversed. The higher score means greater fear of movement.
at the end of the invervention program (8 weeks after from baseline)

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.
Istanbul University - Cerrahpasa (IUC)

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.
March 15, 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 15, 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.
September 15, 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).
March 9, 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.
March 16, 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 20, 2024

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 20, 2024

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.
March 16, 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.
March 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.
  • 07032024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be shared on request.

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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