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Clinical Trials/NCT05331482
NCT05331482CompletedNot Applicable

Effectiveness of Two Exercise Programs on the Neck. Secondary Analysis of a Randomized Clinical Trial.

Universitat Internacional de Catalunya1 site in 1 country105 target enrollmentStarted: April 11, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
105
Locations
1
Primary Endpoint
Neck extensor muscle endurance Test

Study Overview

Brief Summary

The purpose of this study is to evaluate the clinical results in lower cervical range of motion, size deep muscles, endurance, craniovertebral angle and cervical propioception by a training protocol with the new device for cervical treatment (CDAT) and the conventional training protocol (CT) versus a control group (C) in subjects with cervical deep muscle strength deficit.

Detailed Description

Neck pain is one of the major public health problems, which has a great impact on people's lives, with high prevalence and recurrence rate. Cervical vertebral column is heavily dependent on the muscles for its physical support and activities. There are increasing evidences to support that cervical muscles may impair in patients with neck disorders. Training protocols can help to improve pain, cervical function, posture and cross-sectional area. However, there are no training protocols in subjects with strength deficit of deep cervical muscles, including deep neck extensor and flexor muscles. The cervical device treatment (CDAT) allows us to train the cervical flexor and extensor muscle in a simple and comfortable way.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Deep flexor strength deficit in craniocervical flexion test.
  • •Deep extensor strength deficit in neck extensor muscle endurance.
  • •≤ 14 score in Neck disability Index

Exclusion Criteria

  • •Have received cervical treatment during the last six month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination).
  • •Have received cervical manual therapy treatment during the last six month.
  • •A history of cervical trauma or surgery during the last year.
  • •Chronic neck pain occurring during the last six months (intensity, visual analogue scale >3/10, frequency > 2 days/week, duration >3 hours/day).

Arms & Interventions

Training protocol with the cervical device for treatment (CDAT).

Experimental

Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment.

Intervention: Training protocol with the cervical device for treatment (CDAT). (Other)

Conventional training protocol-

Active Comparator

Endurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol.

Intervention: Conventional training protocol (Other)

Control Group

No Intervention

Subject continues with activities of daily living. Does not receive deep cervical muscle training.

Outcomes

Primary Outcomes

Neck extensor muscle endurance Test

Time Frame: Baseline and 6 weeks, 10 weeks, 14 weeks

Mean change from baseline in neck extensor muscle endurance Test after 6 weeks, 10 weeks and 14 weeks. The examiners assess the endurance of deep cervical extensor muscle.

Measurement of Cervical Multifidus and Longus Colli Muscle size.

Time Frame: Baseline and 6 weeks, 10 weeks, 14 weeks

The examiners assess these deep muscles with ultrasound after 6 weeks, 10 weeks and 14 weeks.

Physical activity enjoyment Scale (PACES)

Time Frame: 6 weeks

The examiners assess participant satisfaction with cervical deep muscle training. This scale measures enjoyment during physical activity through 16 items, which are preceded by the phrase "When I am active..." This instrument measures enjoyment and bipolar enjoyment, through statements such as "I enjoy it", "I'm bored", "It's very exciting", and "I don't like it". The answers will be collected on a Likert scale from 1 (totally disagree) to 5 (totally agree).

Deep neck flexor endurance Test.

Time Frame: Baseline and 6 weeks, 10 weeks, 14 weeks

The Chin Tuck Neck Flexion Test is an assessment technique intended to determine the endurance of the deep cervical flexors.

Secondary Outcomes

  • Neck Disability Index(Baseline and 6 weeks, 10 weeks, 14 weeks)
  • Neck Pain(Baseline and 6 weeks, 10 weeks, 14 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pilar Pardos Aguilella

Colaborator Lecturer in Physiotherapy

Universitat Internacional de Catalunya

Study Sites (1)

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