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

NCT04402463 | Completed

• 1 other identifier: 458-2019 USalamanca
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 2

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))

Conditions

Neck Pain; Chronic Pain

Keywords

Postural Global Reeducation; Exercise; Chronic neck pain; Disability; Postural Control; Cervical muscles

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (6)

• Changes in Cervical Range of Motion (CROM) before, during and after the intervention

  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

  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

  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

  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

  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)

Study Arms (2)

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.

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.

Other: Exercise Therapeutic

Interventions

Global Postural Reeducation OTHER

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"

GPR Group

Exercise Therapeutic OTHER

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).

Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salamanca: lead
• Instituto Politécnico da Guarda: collaborator

Study Sites (2)

Instituto Politécnico da Guarda

Guarda, 6300-559, Portugal

Location

University of Salamanca

Salamanca, 37007, Spain

Location

Related Publications (1)

• 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.

  PMID: 34682453 DERIVED

MeSH Terms

Conditions

Neck Pain; Chronic Pain; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Roberto Méndez-Sánchez, PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 26, 2020
• Study Start: June 1, 2020
• Primary Completion: October 14, 2021
• Study Completion: October 14, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1); ES (1)