Effectiveness of Specific Strength Training Combined With Static Stretching of the Posterior Neck in Office Workers With Chronic Neck Pain: A Clinical Trial

June 7, 2024 updated by: María Santos, University of Alcala

Objective: To determine the effectiveness of strength training combined with stretching compared to specific strength training in office workers with chronic neck pain.

Methods: A single blind randomized clinical trial will be conducted. Participants will be adult of both sexes with sedentary office work and chronic neck pain.

The intervention will consist of a strength training program for the neck and shoulder muscles combined with static stretching of the neck, while the comparison group will only perform strength training. In addition, both groups will receive ergonomics guidelines.

Short-term, medium-term, and long-term evaluations will be performed using the Northwick Park Neck Pain Questionnaire (NPQ), Neck Disability Index (NDI), and Tampa Scale of Kinesiophobia (TSK).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

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.
40

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:

  • Adults aged between 18 and 70 years.
  • Workers from companies in the Community of Madrid.
  • Sedentary employees who work at least 20 hours in the office.
  • Subjects with nonspecific chronic neck pain.
  • All individuals who have decided to participate voluntarily after having read and signed the patient information sheet and the informed consent form.

Exclusion Criteria:

  • Arterial hypertension (systolic BP >160, diastolic BP >100) or cardiovascular diseases.
  • Diagnosed metabolic disorders.
  • Symptomatic disc herniation or severe cervical spine disorders.
  • Postoperative conditions.
  • History of severe trauma to the neck and shoulder region.
  • Pregnancy.
  • Subjects with a body mass index (BMI) greater than 29.9 kilograms per square meter (kg/m2).
  • Presence of physical or mental impairments that prevent the correct execution of the interventions and/or their corresponding evaluation.
  • Having undergone surgery in the previous six months.
  • Participating in parallel research studies.
  • Not having a permanent job position.
  • Using two monitors.
  • Using a laptop.

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: strength training and static stretching
The intervention will consist of a strength training program for the neck and shoulder muscles combined with static stretching of the neck.
Other: specific strength training with static neck stretching
The intervention will consist of specific strength training composed of 5 exercises performed with dumbbells: front raises, lateral raises, reverse flies, shoulder shrugs, and wrist extensions. In addition to the following static stretches: stretching towards lateral flexion of the upper part of the trapezius muscle, the scalene muscles, and the sternocleidomastoid muscle on both sides; extension of the extensor muscles; flexion of the flexor muscles; and contralateral flexion and rotation combined with scapular depression of the scalene muscles and elevation of the scapula on both sides, holding each stretch for 10 seconds. This sequence of stretches will constitute one set, with 6 sets performed with a 30-second rest between sets, lasting 8 minutes. Therefore, the intervention will have a total duration of 28 minutes per session, conducting 3 sessions per week.
Active Comparator: strength training
The comparison group will only perform strength training.
Other: Specific Strength Training
The intervention will consist of specific strength training comprised of 5 exercises using dumbbells: front raises, lateral raises, reverse flies, shoulder shrugs, and wrist extensions. Four sets will be performed, with a 1-minute rest between sets. Each exercise will be executed for 30 seconds, followed by a 25-second rest between exercises. Three 20-minute sessions will be conducted per week.

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
Time Frame: It will be measured 4 times: before the start of the intervention, short-term (4 weeks), medium-term (2 months), and long-term (1 year).
We will use the "Northwick Park Neck Pain Questionnaire", which consists of 9 questions with 5 statements of increasing difficulty. The minimum and maximum values are from 0 to 50 points. Higher scores indicate greater severity of neck pain.
It will be measured 4 times: before the start of the intervention, short-term (4 weeks), medium-term (2 months), and long-term (1 year).
Kinesiophobia
Time Frame: It will be measured 4 times: before the start of the intervention, short-term (4 weeks), medium-term (2 months), and long-term (1 year).
We will use the "Tampa Scale for Kinesiophobia," which consists of 11 questions with 4 numeric options, ranging from 1 (completely disagree) to 4 (completely agree). The minimum and maximum values range from 17 to 68 points; higher scores indicate higher levels of kinesiophobia.
It will be measured 4 times: before the start of the intervention, short-term (4 weeks), medium-term (2 months), and long-term (1 year).
Neck Disability
Time Frame: It will be measured 4 times: before the start of the intervention, short-term (4 weeks), medium-term (2 months), and long-term (1 year).
We will use the "Neck Disability Index," which consists of 10 questions with 6 statements of increasing difficulty. The values range from 0 to 50, where 0 indicates no disability and 50 indicates total disability.
It will be measured 4 times: before the start of the intervention, short-term (4 weeks), medium-term (2 months), and long-term (1 year).

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.
University of Alcala

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: María Santos, University of Alcalá

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 (Estimated)

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, 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.
December 31, 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.
December 31, 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).
June 3, 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.
June 7, 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.
June 11, 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.
June 11, 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.
June 7, 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.
June 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.
  • MSP-2024

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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