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

April 25, 2023 updated by: Mª Ángeles Cardero Durán, Universidad de Extremadura

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain, 06006
        • María de los Ángeles Cardero Durán

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Ten electrotherapy sessions lasting 30 minutes were carried out. Analgesic currents of the TENS type, placed in the cervical region.
Other: 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.
Other: 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.
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
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.
Other: 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.
Other: Stretching exercises
Ten stretching exercise sessions.The stretching exercise modality performed consisted of passive static stretching with a sequence of 30s-10s-30s-10s.
No Intervention: Control Group
The control group will not undergo any physiotherapy treatment therapy for neck pain.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Pain
Time Frame: 5 weeks
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
Time Frame: 5 weeks

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
Time Frame: 5 weeks
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
Time Frame: 5 weeks
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
Time Frame: 5 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Extremadura

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Luis Espejo Antúnez, Universidad de Extremadura

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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