Back to resultsEfficacy of Two Physiotherapy Intervention Methods Applied in Subjects in the Social-healthcare Setting With Nonspecific Neck Pain.
Primary Purpose
Neck Pain
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Electrotherapy-Transcutaneous Electrical Stimulation (TENS)
Massage therapy
Stretching exercises
Ischaemic Compression Technique
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring inespecif pain, physicaltherapy
Eligibility Criteria
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).
Sites / Locations
- María de los Ángeles Cardero Durán
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Group TENS
Group STRECHING
Control Group
Arm Description
Experimental group 1 will undergo a physiotherapy treatment based on TENS-type analgesic currents and application of massage therapy for neck pain.
Experimental group 2 will undergo a physiotherapy treatment based on stretching and the application of massage therapy therapy for neck pain.
The control group will not undergo any physiotherapy treatment therapy for neck pain.
Outcomes
Primary Outcome Measures
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.
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
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05845346
First Posted
February 23, 2023
Last Updated
April 25, 2023
Sponsor
Universidad de Extremadura
1. Study Identification
Unique Protocol Identification Number
NCT05845346
Brief Title
Efficacy of Two Physiotherapy Intervention Methods Applied in Subjects in the Social-healthcare Setting With Nonspecific Neck Pain.
Official Title
Efficacy of Two Physiotherapy Intervention Methods Applied in Subjects in the Social-healthcare Setting With Nonspecific Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Extremadura
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
inespecif pain, physicaltherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group TENS
Arm Type
Experimental
Arm Description
Experimental group 1 will undergo a physiotherapy treatment based on TENS-type analgesic currents and application of massage therapy for neck pain.
Arm Title
Group STRECHING
Arm Type
Experimental
Arm Description
Experimental group 2 will undergo a physiotherapy treatment based on stretching and the application of massage therapy therapy for neck pain.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will not undergo any physiotherapy treatment therapy for neck pain.
Intervention Type
Other
Intervention Name(s)
Electrotherapy-Transcutaneous Electrical Stimulation (TENS)
Intervention Description
Ten electrotherapy sessions lasting 30 minutes were carried out. Analgesic currents of the TENS type, placed in the cervical region.
Intervention Type
Other
Intervention Name(s)
Massage therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stretching exercises
Intervention Description
Ten stretching exercise sessions.The stretching exercise modality performed consisted of passive static stretching with a sequence of 30s-10s-30s-10s.
Intervention Type
Other
Intervention Name(s)
Ischaemic Compression Technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Pain
Description
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
Title
Changes in Range of Motion
Description
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
Title
Changes in Disability
Description
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
Title
General Health
Description
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
Title
Changes Pressure Pain
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Espejo Antunez
Organizational Affiliation
Universidad de Extremadura
Official's Role
Study Director
Facility Information:
Facility Name
María de los Ángeles Cardero Durán
City
Badajoz
ZIP/Postal Code
06006
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19241653
Citation
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.
Results Reference
background
Citation
Torres Cueco R. La columna cervical: síndromes clínicos y su tratamiento manipulativo. Ed panamericana. 2008; 233-234.
Results Reference
background
PubMed Identifier
10872758
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
20651012
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.
Results Reference
background
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
Results Reference
background
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
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Efficacy of Two Physiotherapy Intervention Methods Applied in Subjects in the Social-healthcare Setting With Nonspecific Neck Pain.
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