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| Name | Class |
|---|---|
| Instituto Politécnico da Guarda | OTHER |
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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))
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GPR Group | Experimental | Global Postural Reeducation with 2 parts in each session:
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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" |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Méndez-Sánchez, PhD | University of Salamanca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Politécnico da Guarda | Guarda | 6300-559 | Portugal | |||
| University of Salamanca |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34682453 | Derived | 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. |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D059350 | Chronic Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| 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). |
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| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Salamanca |
| 37007 |
| Spain |
| D001519 | Behavior |