NCT06346249

Brief Summary

The overall objective of this study is to determine the efficacy of a physical therapy intervention based on manual therapy, therapeutic exercise and application of electrotherapy in healthcare workers with non-specific neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

May 1, 2025

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

March 12, 2024

Last Update Submit

April 30, 2025

Conditions

Keywords

non specific painphysiotherapymanual therapyelectrical stimulation therapytherapeutic exercise

Outcome Measures

Primary Outcomes (3)

  • Changes in Pain

    A visual analog scale (VAS). The scale is represented by a 10-centimeter line at the ends of which there are two adjectives whose ends there are two adjectives, absence of pain (0) and unbearable pain (10). The higher the score, the greater the pain.

    5 weeks

  • Changes Pressure Pain

    Pressure Pain with Algometry. To assess the mechanosensitivity of the trigger points , the pain threshold was measured at the pressure. Unit of measure Kg/cm2.

    5 weeks

  • Changes in Disability

    Neck Disability Index ( NDI) through which will give us the degree of disability neck pain.The NDI consists of 10 sections, 4 of them are related to subjective symptoms (pain intensity, headache, head, ability to concentrate and quality of sleep) and the other 6 are related to basic activities of daily living (ABVD) (personal care, ability to lift weights, reading, work, driving, leisure activities and free time). Each of the sections presents 6 possible answers, scoring these from 0 to 5 according to the progression of functional disability.

    5 weeks

Secondary Outcomes (2)

  • Changes in Range of Motion

    5 weeks

  • General Health.

    5 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

The overall objective of this study is to determine the efficacy of a physical therapy intervention based on manual therapy, therapeutic exercise and application of electrical stimulation therapy in healthcare workers with non-specific neck pain.

Other: Electrical Stimulation TherapyOther: Manual TherapyOther: Exercise Therapeutic

Control Group

NO INTERVENTION

The control group will not undergo any physiotherapy treatment therapy for neck pain.

Interventions

Ten Electrical Stimulation Therapy sessions lasting 30 minutes were carried out. Analgesic currents of the TENS type, placed in the cervical region.

Experimental Group

Manual Therapy consistin of soft tissue mobilization and release techniques over the neck and craniocervical regions. Ten sessions.

Experimental Group

The exercise therapeutic program consisting of neck movement control and stretching exercise. Ten sessions.

Experimental Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age range between 18-60 years.
  • Cervical pain of non-specific origin or Cervicalgia type I and II according to the Quebec - Task Force on Spinal Disorders.
  • Be willing to participate in the study and sign the informed consent form.
  • Have at least one year of seniority in the company exercising the current professional activity within the team of socio-health personnel.

You may not qualify if:

  • Cervicalgia with neurological involvement or caused by pathologies such as: inflammatory disease, neurological disease, rheumatic disease, severe osteoporosis, fracture, dislocation, vertebro-basilar insufficiency, neoplasia or infection.
  • Spine surgery.
  • Present metallic implants at the spinal column level.
  • Have received physiotherapy or alternative treatment in the last 6 months before starting the study.
  • To present any type of inconvenience to the application of electrotherapy (score ≥45 points in EAPP).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

María de los Ángeles Cardero Durán

Badajoz, 06006, Spain

Location

Related Publications (9)

  • Guzman J, Hurwitz EL, Carroll LJ, Haldeman S, Cote P, Carragee EJ, Peloso PM, van der Velde G, Holm LW, Hogg-Johnson S, Nordin M, Cassidy JD; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. A new conceptual model of neck pain: linking onset, course, and care: the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S14-23. doi: 10.1097/BRS.0b013e3181643efb.

    PMID: 18204387BACKGROUND
  • de Campos TF, Maher CG, Steffens D, Fuller JT, Hancock MJ. Exercise programs may be effective in preventing a new episode of neck pain: a systematic review and meta-analysis. J Physiother. 2018 Jul;64(3):159-165. doi: 10.1016/j.jphys.2018.05.003. Epub 2018 Jun 19.

    PMID: 29908853BACKGROUND
  • Nyman T, Grooten WJ, Wiktorin C, Liwing J, Norrman L. Sickness absence and concurrent low back and neck-shoulder pain: results from the MUSIC-Norrtalje study. Eur Spine J. 2007 May;16(5):631-8. doi: 10.1007/s00586-006-0152-6. Epub 2006 Jun 2.

    PMID: 16741741BACKGROUND
  • Heintz MM, Hegedus EJ. Multimodal management of mechanical neck pain using a treatment based classification system. J Man Manip Ther. 2008;16(4):217-24. doi: 10.1179/106698108790818260.

    PMID: 19771194BACKGROUND
  • Carroll LJ, Hogg-Johnson S, Cote P, van der Velde G, Holm LW, Carragee EJ, Hurwitz EL, Peloso PM, Cassidy JD, Guzman J, Nordin M, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Course and prognostic factors for neck pain in workers: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S93-100. doi: 10.1097/BRS.0b013e31816445d4.

    PMID: 18204406BACKGROUND
  • Driessen MT, Proper KI, van Tulder MW, Anema JR, Bongers PM, van der Beek AJ. The effectiveness of physical and organisational ergonomic interventions on low back pain and neck pain: a systematic review. Occup Environ Med. 2010 Apr;67(4):277-85. doi: 10.1136/oem.2009.047548.

    PMID: 20360197BACKGROUND
  • Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.

    PMID: 28826164BACKGROUND
  • Llamas-Ramos R, Pecos-Martin D, Gallego-Izquierdo T, Llamas-Ramos I, Plaza-Manzano G, Ortega-Santiago R, Cleland J, Fernandez-de-Las-Penas C. Comparison of the short-term outcomes between trigger point dry needling and trigger point manual therapy for the management of chronic mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Nov;44(11):852-61. doi: 10.2519/jospt.2014.5229. Epub 2014 Sep 30.

    PMID: 25269764BACKGROUND
  • Cardero Duran MLA, Espejo Antunez L, Fernandez Morales C, Albornoz Cabello M, Rodriguez Mansilla J. Workplace-Based Physiotherapy of Elderly Care Workers With Nonspecific Chronic Neck Pain: A Randomized Controlled Trial. J Occup Environ Med. 2026 Feb 1;68(2):e172-e181. doi: 10.1097/JOM.0000000000003566. Epub 2025 Oct 3.

MeSH Terms

Conditions

Neck Pain

Interventions

Electric Stimulation TherapyMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitationComplementary Therapies

Study Officials

  • María de los Ángeles Cardero Durán, Doctor

    Universidad de Extremadura

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2024

First Posted

April 4, 2024

Study Start

March 4, 2024

Primary Completion

May 30, 2024

Study Completion

May 31, 2024

Last Updated

May 1, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations