NCT06451107

Brief Summary

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

June 3, 2024

Last Update Submit

June 7, 2024

Conditions

Keywords

randomized controlled trialNeck painexerciseOccupational Health

Outcome Measures

Primary Outcomes (3)

  • Pain intensity

    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

    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

    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).

Study Arms (2)

strength training and static stretching

EXPERIMENTAL

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

strength training

ACTIVE COMPARATOR

The comparison group will only perform strength training.

Other: Specific Strength Training

Interventions

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.

strength training and static stretching

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.

strength training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck PainMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • María Santos

    University of Alcala

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The design will consist of a single-blind, randomized controlled trial, corresponding to an experimental longitudinal analytical study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 11, 2024

Study Start

September 1, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share