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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05845346
Other study ID # 38/2014
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date June 30, 2023

Study information

Verified date February 2023
Source Universidad de Extremadura
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date June 30, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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: - 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Electrotherapy-Transcutaneous Electrical Stimulation (TENS)
Ten electrotherapy sessions lasting 30 minutes were carried out. Analgesic currents of the TENS type, placed in the cervical region.
Massage 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.
Stretching exercises
Ten stretching exercise sessions.The stretching exercise modality performed consisted of passive static stretching with a sequence of 30s-10s-30s-10s.
Ischaemic 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.

Locations

Country Name City State
Spain María de los Ángeles Cardero Durán Badajoz

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Extremadura

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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.

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.

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. — View Citation

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. — View Citation

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

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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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