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

Sponsor
Universidad de Extremadura (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05845346
Collaborator
(none)
100
1
3
4.9
20.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Electrotherapy-Transcutaneous Electrical Stimulation (TENS)
  • Other: Massage therapy
  • Other: Stretching exercises
  • Other: Ischaemic Compression Technique
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Efficacy of Two Physiotherapy Intervention Methods Applied in Subjects in the Social-healthcare Setting With Nonspecific Neck Pain
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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: Stretching exercises
Ten stretching exercise sessions.The stretching exercise modality performed consisted of passive static stretching with a sequence of 30s-10s-30s-10s.

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.

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

  1. Changes in Pain [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.

  2. Changes in Range of Motion [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

  3. Changes in Disability [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.

  4. General Health [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. Changes Pressure Pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
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:
  • 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 María de los Ángeles Cardero Durán Badajoz Spain 06006

Sponsors and Collaborators

  • Universidad de Extremadura

Investigators

  • Study Director: Luis Espejo Antunez, Universidad de Extremadura

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Mª Ángeles Cardero Durán, Principal Investigator, Universidad de Extremadura
ClinicalTrials.gov Identifier:
NCT05845346
Other Study ID Numbers:
  • 38/2014
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mª Ángeles Cardero Durán, Principal Investigator, Universidad de Extremadura
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023