NCT05845346

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 6, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 23, 2023

Last Update Submit

April 25, 2023

Conditions

Keywords

inespecif painphysicaltherapy

Outcome Measures

Primary Outcomes (5)

  • 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.

    5 weeks

  • 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

    5 weeks

  • 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.

    5 weeks

  • 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.

    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

Study Arms (3)

Group TENS

EXPERIMENTAL

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 therapyOther: Ischaemic Compression Technique

Group STRECHING

EXPERIMENTAL

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

Other: Massage therapyOther: Stretching exercisesOther: Ischaemic Compression Technique

Control Group

NO INTERVENTION

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

Interventions

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

Group TENS

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.

Group STRECHINGGroup TENS

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

Group STRECHING

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.

Group STRECHINGGroup TENS

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 (8)

  • 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.

    PMID: 19241653BACKGROUND
  • Torres Cueco R. La columna cervical: síndromes clínicos y su tratamiento manipulativo. Ed panamericana. 2008; 233-234.

    BACKGROUND
  • 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.

    PMID: 10872758BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 20651012BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

MassageMuscle Stretching Exercises

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationExercise TherapyAftercareContinuity of Patient CarePatient CareExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Luis Espejo Antunez

    Universidad de Extremadura

    STUDY DIRECTOR

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

February 23, 2023

First Posted

May 6, 2023

Study Start

February 1, 2023

Primary Completion

May 31, 2023

Study Completion

June 30, 2023

Last Updated

May 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations