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Effects of Global Postural Exercises Versus Specific Therapeutic Neck Exercises in Chronic Non-specific Neck Pain

Primary Purpose

Neck Pain, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Global Postural Reeducation
Exercise Therapeutic
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Postural Global Reeducation, Exercise, Chronic neck pain, Disability, Postural Control, Cervical muscles

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Non-specific chronic neck pain (neck or upper shoulder pain that is not related to a known pathology or injury, with an evolution of at least 12 weeks)

Exclusion Criteria:

  • Specific cause of cervical pain (systemic, traumatic, rheumatic pathology, discal pathology,...)
  • Central or peripheral neurological signs
  • Cognitive impairment to follow instructions during the evaluations or interventions
  • History of cervical surgery
  • Treatment of physical therapy in the last 3 months
  • Pharmacologic treatment during the study

Sites / Locations

  • Instituto Politécnico da Guarda
  • University of Salamanca

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GPR Group

Exercise Group

Arm Description

Global Postural Reeducation with 2 parts in each session: st: 2 postures in lying position - without gravity load (15 minutes each posture): The aim of these postures is to achieve and maintain postural balance and to stretch the posterior muscle chain. In order to achieve this, specific exercises in the lying position are used. That exercises involve a precise use of contractions, stretch reflexes, light and controlled manual tractions and sustained elongations. The maintenance of alignment during posture will be achieved by verbal commands and manual contact of the therapist, guaranteeing the active engagement of patient to reach the correct posture. st: Standing posture - integration under gravity load (10 minutes): With the participant standing the physiotherapist makes final corrections for postural integration.

Therapeutic exercises. That they will be divided into 3 phases: The exercises in these phases will consist in active exercises of the cervical spine and shoulder girdle, motor control exercises, and finally strength and endurance of the cervical flexors and extensors and of the musculature of the shoulder girdle.

Outcomes

Primary Outcome Measures

Changes in neck pain intensity before, during and after the intervention
Numerical Pain Rating Scale (NPRS) will be used. It is a scale used to quantify the patient's pain level on an 11-point numerical scale 0-10 with 0 being "no pain" and 10 being the "worst possible pain."
Changes in disability before, during and after the intervention
The Neck Disability Index (NDI) will be used. It is a modification of the Oswestry Low Back Pain Disability Index. It is a scale used to measure disability associated with cervical pain due to acute or chronic conditions. He has 10 items: 7 related to activities of daily living, 2 related to pain and 1 related to concentration. The test can be interpreted with a maximum score of 50. 0 - 4 = no disability 5 - 14 = mild 15 - 24 = moderate 25 - 34 = severe above 34 = complete

Secondary Outcome Measures

Changes in Cervical Range of Motion (CROM) before, during and after the intervention
The Cervical Range of Motion (CROM) device (Performance Attainment Associates, USA) will be used to measure the cervical range of motion, including flexion, extension, lateral flexion and rotation.
Changes in Pressure Pain Threshold (PPTs) before, during and after the intervention
Pressure algometry measurements will be performed with a digital algometer to assess pressure pain thresholds on the trapezius muscles and the spinous process of the 2nd and 6th cervical vertebrae.
Changes in Pain Catastrophizing Scale (PCS) before, during and after the intervention
Pain Catastrophizing Scale (PCS) will be used. People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52).
Changes in Tampa Scale for kinesiophobia (TSK-13) before, during and after the intervention
The Tampa Scale for kinesiophobia (TSK-13) will be used. It is a patient-reported outcome measure designed to help identify kinesiophobia. This version is a 13-item questionnaire aimed at the assessment of fear of movement/re-injury. Each item is provided with a 4-points Likert scale with scoring alternatives ranging from "strongly disagree" [0] to "strongly agree" [4] . This gives a possible total raw score range from 0 to 52.
Changes in Static postural stability before, during and after the
Postural assessment will be examined with the subjects standing on a force platform to evaluate the stabilometry parameters of Center of Pressure (COP) excursions (displacements, velocities, areas and pressures) in different conditions.
Changes in Electromyography parameters of cervical flexor muscles before, during and after the
Surface electromyographic signals will be acquired with electrodes from sternocleidomastoid and anterior scalene muscles.

Full Information

First Posted
May 19, 2020
Last Updated
October 31, 2021
Sponsor
University of Salamanca
Collaborators
Instituto Politécnico da Guarda
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1. Study Identification

Unique Protocol Identification Number
NCT04402463
Brief Title
Effects of Global Postural Exercises Versus Specific Therapeutic Neck Exercises in Chronic Non-specific Neck Pain
Official Title
Effects of Global Postural Exercises Versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women With Chronic Nonspecific Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
October 14, 2021 (Actual)
Study Completion Date
October 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca
Collaborators
Instituto Politécnico da Guarda

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
This study is a randomized, parallel, blinded, clinical trial of treatments. The general objective of this study is to analyze and compare the short-term results, during a 4-week follow-up, of two different treatments in patients with chronic nonspecific neck pain. The treatments to be applied are Global Postural Reeducation (GPR) and specific therapeutic exercise, applied during 8 treatment sessions in 4 weeks. These treatments will be applied by a physiotherapist with clinical experience in the treatment of cervical pain. During the study, 4 evaluations will be carried out to assess the effects of the interventions on pain, disability, standing postural control and neuromuscular behavior of the cervical muscles ((1) Baseline (pre-intervention); 2) Second pre-intervention (1 week later); 3) 1st post-intervention after four sessions (1+2 weeks later); 4) Final, 2nd post-intervention (1+4 weeks later))

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Chronic Pain
Keywords
Postural Global Reeducation, Exercise, Chronic neck pain, Disability, Postural Control, Cervical muscles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
the evaluator (investigator who will carry out the measurements) and the results analysis consultant will be masked. After second pre-intervention assessment, the physiotherapist who will apply the interventions will carry out the allocation. Randomization will be done using a computerized randomization system (randomized.com), and concealment of allocation will be ensured by sequentially numbered, opaque, sealed envelopes.
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GPR Group
Arm Type
Experimental
Arm Description
Global Postural Reeducation with 2 parts in each session: st: 2 postures in lying position - without gravity load (15 minutes each posture): The aim of these postures is to achieve and maintain postural balance and to stretch the posterior muscle chain. In order to achieve this, specific exercises in the lying position are used. That exercises involve a precise use of contractions, stretch reflexes, light and controlled manual tractions and sustained elongations. The maintenance of alignment during posture will be achieved by verbal commands and manual contact of the therapist, guaranteeing the active engagement of patient to reach the correct posture. st: Standing posture - integration under gravity load (10 minutes): With the participant standing the physiotherapist makes final corrections for postural integration.
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
Therapeutic exercises. That they will be divided into 3 phases: The exercises in these phases will consist in active exercises of the cervical spine and shoulder girdle, motor control exercises, and finally strength and endurance of the cervical flexors and extensors and of the musculature of the shoulder girdle.
Intervention Type
Other
Intervention Name(s)
Global Postural Reeducation
Intervention Description
The participants will receive treatment along 4 weeks, 2 sessions per week, and 40-45 minutes each session. In the treatment 3 of the therapeutic postures of GPR method to will carry out following Souchard's principles of "Global Postural Reeducation"
Intervention Type
Other
Intervention Name(s)
Exercise Therapeutic
Intervention Description
The participants will receive treatment along 4 weeks, 2 sessions per week, and 40-45 minutes each session. The treatment will be divided into 3 phases, where it initially starts with phase 1 (3 treatments) and progresses to phase 2 (3 treatments) until reaching stage 3 (2 treatments).
Primary Outcome Measure Information:
Title
Changes in neck pain intensity before, during and after the intervention
Description
Numerical Pain Rating Scale (NPRS) will be used. It is a scale used to quantify the patient's pain level on an 11-point numerical scale 0-10 with 0 being "no pain" and 10 being the "worst possible pain."
Time Frame
5 weeks. 4 time points: 1) Baseline (pre-intervention); 2) Second pre-intervention (1 week later); 3) 1st post-intervention after four sessions (1+2 weeks later); 4) Final, 2nd post-intervention (1+4 weeks later)
Title
Changes in disability before, during and after the intervention
Description
The Neck Disability Index (NDI) will be used. It is a modification of the Oswestry Low Back Pain Disability Index. It is a scale used to measure disability associated with cervical pain due to acute or chronic conditions. He has 10 items: 7 related to activities of daily living, 2 related to pain and 1 related to concentration. The test can be interpreted with a maximum score of 50. 0 - 4 = no disability 5 - 14 = mild 15 - 24 = moderate 25 - 34 = severe above 34 = complete
Time Frame
5 weeks. 3 time points: 1) Baseline (pre-intervention); 2) Second pre-intervention (1 week later); 3) Final, 2nd post-intervention (1+4 weeks later)
Secondary Outcome Measure Information:
Title
Changes in Cervical Range of Motion (CROM) before, during and after the intervention
Description
The Cervical Range of Motion (CROM) device (Performance Attainment Associates, USA) will be used to measure the cervical range of motion, including flexion, extension, lateral flexion and rotation.
Time Frame
5 weeks. 4 time points: 1) Baseline (pre-intervention); 2) Second pre-intervention (1 week later); 3) 1st post-intervention after four sessions (1+2 weeks later); 4) Final, 2nd post-intervention (1+4 weeks later)
Title
Changes in Pressure Pain Threshold (PPTs) before, during and after the intervention
Description
Pressure algometry measurements will be performed with a digital algometer to assess pressure pain thresholds on the trapezius muscles and the spinous process of the 2nd and 6th cervical vertebrae.
Time Frame
5 weeks. 4 time points: 1) Baseline (pre-intervention); 2) Second pre-intervention (1 week later); 3) 1st post-intervention after four sessions (1+2 weeks later); 4) Final, 2nd post-intervention (1+4 weeks later)
Title
Changes in Pain Catastrophizing Scale (PCS) before, during and after the intervention
Description
Pain Catastrophizing Scale (PCS) will be used. People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52).
Time Frame
5 weeks. 3 time points: 1) Baseline (pre-intervention); 2) Second pre-intervention (1 week later); 3) Final, 2nd post-intervention (1+4 weeks later)
Title
Changes in Tampa Scale for kinesiophobia (TSK-13) before, during and after the intervention
Description
The Tampa Scale for kinesiophobia (TSK-13) will be used. It is a patient-reported outcome measure designed to help identify kinesiophobia. This version is a 13-item questionnaire aimed at the assessment of fear of movement/re-injury. Each item is provided with a 4-points Likert scale with scoring alternatives ranging from "strongly disagree" [0] to "strongly agree" [4] . This gives a possible total raw score range from 0 to 52.
Time Frame
5 weeks. 3 time points: 1) Baseline (pre-intervention); 2) Second pre-intervention (1 week later); 3) Final, 2nd post-intervention (1+4 weeks later)
Title
Changes in Static postural stability before, during and after the
Description
Postural assessment will be examined with the subjects standing on a force platform to evaluate the stabilometry parameters of Center of Pressure (COP) excursions (displacements, velocities, areas and pressures) in different conditions.
Time Frame
5 weeks. 3 time points: 1) Baseline (pre-intervention); 2) Second pre-intervention (1 week later); 3) Final, 2nd post-intervention (1+4 weeks later)
Title
Changes in Electromyography parameters of cervical flexor muscles before, during and after the
Description
Surface electromyographic signals will be acquired with electrodes from sternocleidomastoid and anterior scalene muscles.
Time Frame
5 weeks. 3 time points: 1) Baseline (pre-intervention); 2) Second pre-intervention (1 week later); 3) Final, 2nd post-intervention (1+4 weeks later)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-specific chronic neck pain (neck or upper shoulder pain that is not related to a known pathology or injury, with an evolution of at least 12 weeks) Exclusion Criteria: Specific cause of cervical pain (systemic, traumatic, rheumatic pathology, discal pathology,...) Central or peripheral neurological signs Cognitive impairment to follow instructions during the evaluations or interventions History of cervical surgery Treatment of physical therapy in the last 3 months Pharmacologic treatment during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Méndez-Sánchez, PhD
Organizational Affiliation
University of Salamanca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Politécnico da Guarda
City
Guarda
ZIP/Postal Code
6300-559
Country
Portugal
Facility Name
University of Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34682453
Citation
Mendes-Fernandes T, Puente-Gonzalez AS, Marquez-Vera MA, Vila-Cha C, Mendez-Sanchez R. Effects of Global Postural Reeducation versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women with Chronic Nonspecific Neck Pain: Study Protocol for a Randomized, Parallel, Clinical Trial. Int J Environ Res Public Health. 2021 Oct 12;18(20):10704. doi: 10.3390/ijerph182010704.
Results Reference
derived

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Effects of Global Postural Exercises Versus Specific Therapeutic Neck Exercises in Chronic Non-specific Neck Pain

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