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Clinical Trials/NCT04402463
NCT04402463
Completed
N/A

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

University of Salamanca2 sites in 2 countries52 target enrollmentJune 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neck Pain
Sponsor
University of Salamanca
Enrollment
52
Locations
2
Primary Endpoint
Changes in neck pain intensity before, during and after the intervention
Status
Completed
Last Updated
4 years ago

Overview

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))

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
October 14, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roberto Méndez Sánchez

Professor

University of Salamanca

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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 Electromyography parameters of cervical flexor muscles 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))
  • 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 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))
  • 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 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))

Study Sites (2)

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