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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04402463
• Other study ID #: 458-2019 USalamanca
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: October 14, 2021

Study information

• Verified date: October 2021
• Source: University of Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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))

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 14, 2021
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Neck Pain

Intervention

Other:
• Global Postural Reeducation
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 Therapeutic
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).

Locations

Country	Name	City	State
Portugal	Instituto Politécnico da Guarda	Guarda
Spain	University of Salamanca	Salamanca

Sponsors (2)

Lead Sponsor	Collaborator
University of Salamanca	Instituto Politécnico da Guarda

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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."	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)
Primary	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	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	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.	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)
Secondary	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.	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)
Secondary	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).	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	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.	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	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.	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	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.	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)