Neck PainNCT04402463
Effects of Global Postural Exercises Versus Specific Therapeutic Neck Exercises in Chronic Non-specific Neck Pain
A study testing Global Postural Reeducation and Exercise Therapeutic in people with Neck Pain and Chronic Pain, run by University of Salamanca at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Neck Pain, Chronic Pain
- What is being tested?
- Global Postural Reeducation and Exercise Therapeutic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2020to 14 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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))
- Conditions
- Neck Pain, Chronic Pain
- Being tested
- Global Postural Reeducation, Exercise Therapeutic
- Keywords
- Postural Global Reeducation, Exercise, Chronic neck pain, Disability, Postural Control, Cervical muscles
- Medical subject headings
- Neck Pain, Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Postural ReeducationOther
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"
Exercise TherapeuticOther
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).
| Study group | Role | What they receive |
|---|---|---|
| GPR Group | Experimental | Global Postural Reeducation with 2 parts in each session:
1. 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.
2. st: Standing posture - integration under gravity load (10 minutes): With the participant standing the physiotherapist makes final corrections for postural integration. Receives: Other: Global Postural Reeducation |
| Exercise Group | Experimental | 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. Receives: Other: Exercise Therapeutic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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)
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
Measured: 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 outcomes (6)
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 Jun 2020
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Politécnico da Guarda
- Responsible party
- Principal investigator, Roberto Méndez Sánchez, University of Salamanca
- Investigators
- Roberto Méndez-Sánchez, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402463
- Sponsor's protocol ID
- 458-2019 USalamanca
- Status last verified
- Oct 2021
- First submitted
- 19 May 2020
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34682453
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04402463
- Acronym / sponsor ID
- 458-2019 USalamanca
- Conditions
- Neck Pain, Chronic Pain
- Keywords
- Postural Global Reeducation, Exercise, Chronic neck pain, Disability, Postural Control, Cervical muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Collaborators
- Instituto Politécnico da Guarda
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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))
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GPR Group | Experimental | Other: Global Postural ReeducationGlobal Postural Reeducation with 2 parts in each session: 1. 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. 2. st: Standing posture - integration under gravity load (10 minutes): With the participant standing the physiotherapist makes final corrections for postural integration. |
| Exercise Group | Experimental | Other: Exercise TherapeuticTherapeutic 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global Postural ReeducationThe 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" | Other | GPR Group |
| Exercise TherapeuticThe 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). | Other | Exercise Group |
Primary outcome
Changes in neck pain intensity before, during and after the intervention
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)
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
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)
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
6 secondary outcomes
Changes in Cervical Range of Motion (CROM) before, during and after the intervention
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)
Changes in Pressure Pain Threshold (PPTs) before, during and after the intervention
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)
Changes in Pain Catastrophizing Scale (PCS) before, during and after the intervention
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)
Changes in Tampa Scale for kinesiophobia (TSK-13) before, during and after the intervention
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)
Changes in Static postural stability before, during and after the
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)
Changes in Electromyography parameters of cervical flexor muscles before, during and after the
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Derived from this study: PubMed 34682453Mendes-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Méndez-Sánchez, PhD principal investigator
University of Salamanca
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global Postural Reeducation and Exercise Therapeutic in people with Neck Pain and Chronic Pain, run by University of Salamanca at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in neck pain intensity before, during and after the intervention (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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04402463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.