CClinicalTrials.gg
Status unknownNCT05845346Updated May 6, 2023

Efficacy of Two Physiotherapy Intervention Methods Applied in Subjects in the Social-healthcare Setting With Nonspecific Neck Pain.

An interventional study of Electrotherapy-Transcutaneous Electrical Stimulation (TENS) and Massage therapy in Neck Pain, sponsored by Universidad de Extremadura. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by Universidad de Extremadura · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The overall objective of this study is to compare the effectiveness of two physiotherapy treatments, one based on the application of massage most current analgesic TENS compared to a second massage treatment based on more specific stretching techniques in subject in th social-health care setting with non-specific neck pain.

Read the detailed description

The subjects included in the sample will be evaluated according to the above-mentioned parameters by researchers trained and assigned for this purpose.

The data collection of the different variables will be carried out before and after the completion of the programs designed for the study. The programs designed for the experimental groups have a duration of 10 sessions, twice a week.

02

Conditions studied

  • Neck Pain

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Keywords

  • inespecif pain
  • physicaltherapy
03

In context

Neck Pain

1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.

This study's planned enrollment of 100 is above the median of 52 across 1,004 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Universidad de Extremadura is the lead sponsor of 38 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Group TENS

    Experimental group 1 will undergo a physiotherapy treatment based on TENS-type analgesic currents and application of massage therapy for neck pain.

    Other: Electrotherapy-Transcutaneous Electrical Stimulation (TENS) · Other: Massage therapy · Other: Ischaemic Compression Technique

  • Experimental
    Group STRECHING

    Experimental group 2 will undergo a physiotherapy treatment based on stretching and the application of massage therapy therapy for neck pain.

    Other: Massage therapy · Other: Stretching exercises · Other: Ischaemic Compression Technique

  • No intervention
    Control Group

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

Interventions

  • OtherElectrotherapy-Transcutaneous Electrical Stimulation (TENS)

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

  • OtherMassage therapy

    Ten massage therapy sessions lasting 20 minutes each were carried out. Techniques such as superficial rubbing, deep rubbing, kneading and gliding pressure were performed on the cervical region.

  • OtherStretching exercises

    Ten stretching exercise sessions.The stretching exercise modality performed consisted of passive static stretching with a sequence of 30s-10s-30s-10s.

  • OtherIschaemic Compression Technique

    Ten Ischaemic Compression Technique sessions. The execution of the technique is described as follows: after locating a painful point (trigger point), pressure is applied until pain is generated, then a position is sought where the pain disappears, the position of maximum comfort, which is maintained for 90 seconds (sec), after which time the patient is returned to the starting position in a passive manner.

06

What researchers measure

Primary outcomes

  1. Changes in Pain

    A visual analog scale (VAS). The scale is represented by a 10 centimeter line on whose extremes have two adjectives, absence of pain and pain unbearable.

    Time frame: 5 weeks

  2. Changes in Range of Motion

    Measurement of joint amplitude with goniometry. The ROM exploration was performed with the subjects in sitting in order to stabilize the pelvis and the thoracic-lumbar spine. From this position, the degrees of maximum position reached by the subjects in each of the 6 movements of space. Unit of measurement in degrees of articulation

    Time frame: 5 weeks

  3. Changes in Disability

    Neck Disability Index 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 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.

    Time frame: 5 weeks

  4. General Health

    The SF-12 contains 12 questions distributed in each of the 8 dimensions. The higher the score, the better the state of health.

    Time frame: 5 weeks

  5. 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.

    Time frame: 5 weeks

07

Study locations

1 site
  • María de los Ángeles Cardero Durán
    Badajoz, 06006, Spain
08

References and documents

Publications

  • Covarrubias-Gomez A, Guevara-Lopez U, Lara-Solares A, Tamayo-Valenzuela AC, Salinas-Cruz J, Torres-Gonzalez R. [Clinical pattern of patients cared for at pain clinic by first time]. Rev Med Inst Mex Seguro Soc. 2008 Sep-Oct;46(5):467-72. Spanish. PubMed 19241653 ↗
  • Torres Cueco R. La columna cervical: síndromes clínicos y su tratamiento manipulativo. Ed panamericana. 2008; 233-234.
  • Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003. PubMed 10872758 ↗
  • Amer- Cuenca J.J. Programación y aplicación de la estimulación nerviosa eléctrica transcutanea (TENS): guía de práctica clínica basada en la evidencia. Fisioterapia 2010; 32(6):271-278.
  • Fuentes JP, Armijo Olivo S, Magee DJ, Gross DP. Effectiveness of interferential current therapy in the management of musculoskeletal pain: a systematic review and meta-analysis. Phys Ther. 2010 Sep;90(9):1219-38. doi: 10.2522/ptj.20090335. Epub 2010 Jul 22. PubMed 20651012 ↗
  • Jonhoson MI, Tabasam G. A double blind placebo controlled investigation into the analgesic effects of inferential currents (IFC) and transcutaneous electrical nerve stimulation (TENS) on cold-induced pain in healthy subjects. Physiother Theory Pract 1999; 15: 217-33
  • Calle Fuentes P, Muñoz- Cruzado y Barba M, Catalán Matamoros D, Fuentes Hervías M.T. Los efectos de los estiramientos musculares: ¿que sabemos realmente? Rev Iberoam Fisioter Kinesol 2006; 9(1):36-44.
  • Meseguer-Henarejos, B, Medina-I-Mirapeix, F, Canovas-Gascón J.J, Esteban-Argente, I, Torres-Vaquero A.I, Alcántara F. Prevalencia, consecuencias y factores de riesgo de la cervicalgia. Fisioterapia. 2000; 22 (monográfico 2): 13-32

Study documents

  • Informed consent form · Apr 23, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05845346
Lead sponsor
Universidad de Extremadura
Responsible party
Mª Ángeles Cardero Durán (Principal Investigator, Universidad de Extremadura) — Principal investigator
First posted
May 6, 2023
Start date
Feb 1, 2023
Primary completion
May 31, 2023 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
May 6, 2023

Study contacts

Luis Espejo Antunez
study director · Universidad de Extremadura

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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