NCT02950909

Brief Summary

The primary aim of this study therefore is to investigate the effects on pain and disability of an emphasized exercise program targeting the deep neck extensor semispinalis cervicis and a general exercise program for all neck extensor muscles in patients with chronic neck pain. As a secondary aim , pain intensity (VAS), cervical ROM, pressure pain threshold (PPT), cervical and thoracic posture and self-perceived benefit of treatment (GROC) were measured. The investigators hypothesized that both exercise programs would have similar effects on pain alleviation and pain related disability, but that the emphasized exercise program for the deep semispinalis cervicis would improve its activation more compared to the general exercise program. The results of this study will be relevant for designing effective rehabilitation/training programs for patients with chronic neck pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 8, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

October 25, 2016

Last Update Submit

September 30, 2021

Conditions

Keywords

Therapeutic exerciseChronic painNeck extensors

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index

    Variation in the Neck Disability Index scale

    3 months

Secondary Outcomes (4)

  • Neck pain intensity (Visual Analogue Scale)

    6 months

  • Range of motion

    7 weeks

  • Pressure pain threshold

    7 weeks

  • Global Rating of Change scale

    7 weeks

Study Arms (2)

Emphasized exercise group

EXPERIMENTAL

Patients in the emphasized exercise group performed exercises emphasizing the deep cervical extensor muscles applying a resistance at the level of the vertebral arch of C4 either therapeutically with the therapist's fingers or as a home exercise with the aid of a towel or belt. These exercises were performed in sitting and standing in front of a table propped up on both forearms. In the latter position, a dynamic exercise was added moving the head from maximal flexion to maximal extension keeping the gaze fixed at an object lying between both elbows hoping to activate more the extensors in the lower cervical spine.

Procedure: Static exercise for emphasized neck extensorsProcedure: Dynamic exercise for emphasized neck extensors

General exercise group

EXPERIMENTAL

Patients in the general exercise group performed exercises targeting all cervical extensor muscles including the superficial ones applying resistance at the head pushing against a wall or the therapist's hand or as a home exercise with the aid of a towel. As in the other group, these exercises were performed in sitting and standing in front of a table propped up on both forearms. In the latter position, the same dynamic exercise was added as in the other group with the only difference that the gaze was fixed at an object lying between both hands hoping to activate all cervical extensors

Procedure: Static exercise for general neck extensorsProcedure: Dynamic exercise for general neck extensors

Interventions

Emphasized activation of the deep neck extensors was searched for applying a localized resistance with the thumb and index finger at the level of the vertebral arch of C4 while pushing into flexion in a ventral-cranial direction, approximately parallel to the surface of the zygapophyseal joint, asking the patient to resist maximally during 6 seconds in sitting position

Emphasized exercise group

The patient was asked to fix his gaze at an object lying between both elbows hoping to in order to emphasize extension in the lower cervical spine and consequently activation of the extensors in this region.

Emphasized exercise group

Emphasized activation of all neck extensors was searched for applying the resistance with the therapist's hand or a wall respectively a towel at the occiput in sitting position

General exercise group

. The patient was asked to fix his gaze at an object lying between both hands. Extension consequently occurred in the entire cervical spine.

General exercise group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mild to moderate pain intensity between 3 and 5 from 10 Visual Analogue Scale)to avoid exacerbation of pain with the neck exercises;.
  • Poor performance in the neck extensor resistance test as described by Lee et al. (Lee et al., 2005) and Parazza et al. (Parazza et al., 2014) of less than 250 seconds , which justify the application of an exercise program in the neck extensors.

You may not qualify if:

  • neurological signs in the upper limb
  • any contraindication for EMG like known risk of having infection following clinical needle insertion, coagulation disorders or medications affecting coagulation like aspirin
  • pregnancy
  • if they had participated in a neck exercise program in the past 12 months or had cervical spine surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Neck PainChronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Moises Giménez-Costa, Investigator

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

October 25, 2016

First Posted

November 1, 2016

Study Start

October 1, 2016

Primary Completion

June 28, 2017

Study Completion

December 1, 2017

Last Updated

October 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations