NCT02225873

Brief Summary

This study will verify whether the cranio-cervical flexion coordination (motor control) and muscle strength training protocol is more effective in improving muscle than the proprioception and muscle strength protocol in patients with chronic neck pain. Hypothesis: The craniocervical flexion (motor control) and muscle strength training protocol will improve muscle function more than the proprioception and muscle strength protocol in patients with chronic cervical pain. Objective: To find out if applying the strength therapeutic exercise protocol and the craniocervical flexion coordination (motor control) training is more effective than the strength and articular repositioning protocol when carrying out the craniocervical flexion test in patients with chronic cervical pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

2 months

First QC Date

August 24, 2014

Last Update Submit

November 30, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Craniocervical Flexion Test

    This test measures the activation and resistance of the neck flexor muscles in 5 steps, with isometric contractions on the patient every 2 mmHg, increasing pressure sequentially from 20 mmHg up to 30 mmHg. Once carried out the test, performance will be measured by the pressure level achieved and the number of times pressure can be maintained by the patient with the correct cranioflexion movement in each level.

    up to six months after treatment

Study Arms (2)

strength-endurance exercises

EXPERIMENTAL

Group 1 (experimental) will carry out motor control exercises through cranio-cervical flexion training and strength-endurance exercises.

Other: motor control exercises

strength-endurance and proprioception

PLACEBO COMPARATOR

Group 2 (control) will carry out exercises to improve muscle strength-endurance and proprioception.

Other: muscle strength-endurance and proprioception

Interventions

Will carry out intermuscular coordination exercises through cranio-cervical training, following Jull et al. and exercises to increase strength-endurance on the neck flexor muscles

strength-endurance exercises

Will carry out proprioception exercises through articular repositioning training and exercises to increase strength-endurance on the neck flexor muscles. They will be performed in the same way as the experimental group protocol.

strength-endurance and proprioception

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • History of cervical pain of at least 3 months.
  • Between 18 and 55 years old.
  • Altered movement and/or loss of cervical control.
  • Pain after palpation of the muscles to be treated.

You may not qualify if:

  • Previous history of central neurological condition.
  • Previous surgery of the cervical, cranial, scapular waist, upper limb or jaw.
  • Having received specific treatment or therapy of the cervical region in the 6 months prior to the study.
  • Neck pain or headache with no musculo-skeletal causes.
  • Any other disorder that prevents physical activity.
  • Having received psychological treatment due to neck pain.
  • Patients with fibromyalgia, rheumatoid arthritis, vascular diseases, neoplasm or vestibular system pathologies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcalá University

Alcalá de Henares, Madrid, 28871, Spain

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Proprioception

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological PhenomenaPhysiological PhenomenaSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tomas Gallego-Izquierdo, Dr

    Alcala University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 24, 2014

First Posted

August 26, 2014

Study Start

September 1, 2014

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations