Clinical trial NCT04402463: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Chronic Pain
Keywords: Postural Global Reeducation
Exercise
Chronic neck pain
Disability
Postural Control
Cervical muscles
Lead sponsor: University of Salamanca
Sponsor class: OTHER
Collaborators: name: Instituto Politécnico da Guarda
First posted: 2020-05-26
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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))


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

Primary outcomes:
measure: Changes in neck pain intensity before, during and after the intervention
timeFrame: 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)
measure: Changes in disability before, during and after the intervention
timeFrame: 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:
measure: Changes in Cervical Range of Motion (CROM) before, during and after the intervention
timeFrame: 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)
measure: Changes in Pressure Pain Threshold (PPTs) before, during and after the intervention
timeFrame: 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)
measure: Changes in Pain Catastrophizing Scale (PCS) before, during and after the intervention
timeFrame: 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)
measure: Changes in Tampa Scale for kinesiophobia (TSK-13) before, during and after the intervention
timeFrame: 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)
measure: Changes in Static postural stability before, during and after the
timeFrame: 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)
measure: Changes in Electromyography parameters of cervical flexor muscles before, during and after the
timeFrame: 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)
Other outcomes:
Locations:
city: Guarda
country: Portugal
facility: Instituto Politécnico da Guarda
city: Salamanca
country: Spain
facility: University of Salamanca
Study officials:
affiliation: University of Salamanca
name: Roberto Méndez-Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.