Effectiveness of a Training Protocol With the Cervical Device in Subjects With Deep Cervical Muscle Strength Deficit.

NCT05288712 | Completed

• 1 other identifier: C.P. - C.I. PI21/357
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the clinical results produced 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 and mild neck disability.

Conditions

Muscle Weakness; Cervical Disability

Keywords

neck pain; exercise therapy; muscle weakness; telerehabilitation; neck muscles

Outcome Measures

Primary Outcomes (4)

• Neck Disability Index

  Mean change from baseline in Neck Disability Index (NDI) (Neck Function) after 6 weeks , 10 weeks and 14 weeks. The examiners assess the self-perceived disability from neck pain using the NDI. The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items concerning pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation. The measure is designed to be given to the patient to complete. Item scores range from 0 (no disability) to 5 (total disability), with the minimum score is 0 (no disability) and maximum score of 50 (complete disability).

  Baseline and 6 weeks, 10 weeks, 14 weeks

• Cervical Spine range of motion

  Mean change from baseline in Lower and Upper Cervical Spine Range of Movement (ROM) after 6 weeks , 10 weeks and 14 weeks. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Cervical flexion, extension, right/left sidebending, right/left rotation will be evaluated. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Upper cervical flexion, upper cervical extension and flexion rotation test will be evaluated. Flexion rotation test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32.

  Baseline and 6 weeks, 10 weeks, 14 weeks

• Craniocervical flexion test

  The examiners assess the strength of deep cervical flexors with craniocervical flexion test.

  Baseline and 6 weeks, 10 weeks, 14 weeks

• GLOBAL RATING OF CHANGE SCALE (GROC)

  The examiners assess self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores after 6 weeks, 10 weeks and 14 weeks. The GROC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter. Item scores range from - 7 (A very great deal worse) to + 7 A very great deal better.

  Baseline and 6 weeks, 10 weeks, 14 weeks

Study Arms (3)

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

EXPERIMENTAL

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

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

Conventional training protocol:

ACTIVE COMPARATOR

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

Other: Conventional training protocol

Control Group

NO INTERVENTION

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

Interventions

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

Training protocol with the cervical device for treatment (CDAT)

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

Conventional training protocol OTHER

Conventional training protocol

Conventional training protocol:

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Élite Fisioterapia, María Montessori 2.

Zaragoza, Zaragoza, 50018, Spain

Location

MeSH Terms

Conditions

Muscle Weakness; Neck Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Pilar Pardos-Aguilella, teacher

  UicCatalunya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collaborating Teacher

Model Details: This will be a randomized controlled trial with 3 different groups

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 21, 2022
• Study Start: March 11, 2022
• Primary Completion: September 11, 2022
• Study Completion: October 11, 2022
• Last Updated: June 22, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)