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The Effects of Exercise Therapy for Flexor and Extensor Cervical Muscles on Non-specific Neck Pain. (CCF)

Primary Purpose

Neck Pain, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neck extensors training versus deep cervical flexors training, compared to a control group.
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, exercise, training, endurance, intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • non-specific neck pain (NSNP) for at least 3 months prior intervention commencement,
  • age between 18 and 65 years,
  • sedentary lifestyle,
  • score > 5/50 on the Neck Disability Index (NDI) or score > 2 on the Numeric Rating Scale (NPRS) whose symptoms are not increased performing the exercises proposed in the study,
  • limitation in the Active Range of cervical Motion (AROM) in flexion, extension, lateral inclination and/or rotation.

Exclusion Criteria:

  • previous neck surgery,
  • neck pain associated with whiplash injuries,
  • subjects who ave received physical therapy 3 months prior intervention commencement,
  • dizziness in the quadruped position, supine position, sitting or performing neck movements,
  • pain in other parts od the body that prevents the performance of the exercises proposed in the study,
  • neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or pain accompanied by non-cervicogenic headaches,
  • neck pain with cervical radiculopathy and/or externalized cervical disc herniation,
  • red flags: fracture, tumor or cervical infection or diagnosis of osteoporosis, metabolic diseases or rheumatoid arthritis,
  • myopathy, ankylosing spondylitis or fibromyalgia,
  • central nervous system involvement,
  • pregnant women,
  • severe psychiatric oe psychological disorders,
  • subjects with pending legal action,
  • not understand, write and speak spanish fluently.

Sites / Locations

  • Recoletas Burgos Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

A-Group: craniocervical and cervicothoracic extension training

B-Group: craniocervical flexion training

C-Group: control group

Arm Description

No intervention will be performed due to the fact that they will be still on the waiting list.

Outcomes

Primary Outcome Measures

Change in Pain related disability
using the Neck Disability Index (NDI) Questionnaire

Secondary Outcome Measures

Change in Neck pain
Using a Numeric Rating Scale (NPRS) from 0 to 10
Change in Health-related quality of life (HRQoL)
using the SF-36 quality of life questionnaire.
Change in Neck muscles endurance
Using the modified Neck Extensor Endurance test (NEE test) proposed by Lee el al. (2005) or the Neck Flexor Muscle Endurance Test (NFME test) with a chronometer and a BDI
Change in Active Range of cervical Motion (AROM)
Using a digital inclinometer
Change in Joint Position Sense (JPS)
Using a target and a rule
Change in Frequency of use of drugs
Using a shelf-completed drug registration document

Full Information

First Posted
December 5, 2019
Last Updated
May 6, 2022
Sponsor
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT04193423
Brief Title
The Effects of Exercise Therapy for Flexor and Extensor Cervical Muscles on Non-specific Neck Pain.
Acronym
CCF
Official Title
Deep Cervical Flexors or Cervical Extensors Strengthening Program in Patients With Chronic Neck Pain, Does it Matter Which One to Choose?: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
May 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective: To compare the effects craniocervical and cervicothoracic extension training versus deep cervical flexor training, both combined with conventional treatment, on disability, perceived pain, Health-related quality of life (HRQoL), endurance, active range of motion (AROM) of the cervical spine, joint position sense (JPS) and intake of drugs in subjects with non-specific chronic neck pain, referenced by the control group. Methods: The research will be done from December 2019 to August 2020 at the Recoletas Burgos Hospital. Fifty-four volunteers with non-specific chronic neck pain, recruited at the hospital, will be randomly assigned, using sealed envelopes, to 1 of the three groups. The first two experimental groups will be named Group A and Group B and each of them will go to the Rehabilitation Service for 4 weeks to perform the exercises under the supervision of the physiotherapist. This process will occur along with the conventional treatment (infrared heat, massage and transcutaneous electrical nerve stimulation). These groups will differ between them in the muscles they will mainly train through training. The group A will perform a neck extensor muscles training and group B a deep cervical flexor muscles training. After these 4 weeks, these exercises will be performed by them on a daily routine which will be prescribed for 6 months at home. On the control group (group C), no intervention will be performed due to the fact that they will be still on the waiting list. Disability, pain, HRQoL and drug intake will be measured in pre-treatment, at 4 weeks (post-treatment) and at 6 months follow-up; endurance, AROM and JPS will be measured in pre-treatment and at 4 weeks (post-treatment); while demographic variables (height, weight and age) will only be measured at the baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Chronic Pain
Keywords
neck pain, exercise, training, endurance, intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a randomized controlled clinical trial with parallel groups.
Masking
Participant
Masking Description
It is a single-blind study: only the investigator performing the measurements will be blinded.
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-Group: craniocervical and cervicothoracic extension training
Arm Type
Experimental
Arm Title
B-Group: craniocervical flexion training
Arm Type
Experimental
Arm Title
C-Group: control group
Arm Type
Active Comparator
Arm Description
No intervention will be performed due to the fact that they will be still on the waiting list.
Intervention Type
Other
Intervention Name(s)
Neck extensors training versus deep cervical flexors training, compared to a control group.
Intervention Description
During the first month, the participants of the experimental groups will come at Rehabilitation Service to do the exercises individually and supervised by the physiotherapist and to received the conventional treatment (10 minutes of infrared heat, 10 minutes of massage and 15 minutes of TENS). The last six months, they will perform daily home exercises. A-group: the degrees respect to the floor in wich each participant can hold the craniocervical extension and the cervicothoracic extension during 5 seconds will bo measured with the BDI. B-group: Using an air-filled pressure sensor placed behind the neck, the physiotherapist will identify the target level that the patient can hold steadily a craniocervical flexion (CCF) for 5 seconds in a controlled manner. They will train following the protocol described by Jull et al. Of each of this exercises, they will perform 10 isometric contractions, at the corresponding degrees or target level, of 10 seconds with a rest of 3-5 seconds.
Primary Outcome Measure Information:
Title
Change in Pain related disability
Description
using the Neck Disability Index (NDI) Questionnaire
Time Frame
Baseline, 1 month (primary timepoint) and 6 months after intervention.
Secondary Outcome Measure Information:
Title
Change in Neck pain
Description
Using a Numeric Rating Scale (NPRS) from 0 to 10
Time Frame
Baseline, 1 month (primary timepoint) and 6 months after intervention.
Title
Change in Health-related quality of life (HRQoL)
Description
using the SF-36 quality of life questionnaire.
Time Frame
Baseline, 1 month (primary timepoint) and 6 months after intervention.
Title
Change in Neck muscles endurance
Description
Using the modified Neck Extensor Endurance test (NEE test) proposed by Lee el al. (2005) or the Neck Flexor Muscle Endurance Test (NFME test) with a chronometer and a BDI
Time Frame
Baseline and 1 month (primary timepoint).
Title
Change in Active Range of cervical Motion (AROM)
Description
Using a digital inclinometer
Time Frame
Baseline and 1 month (primary timepoint).
Title
Change in Joint Position Sense (JPS)
Description
Using a target and a rule
Time Frame
Baseline and 1 month (primary timepoint).
Title
Change in Frequency of use of drugs
Description
Using a shelf-completed drug registration document
Time Frame
Baseline, 1 month (primary timepoint) and 6 months after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: non-specific neck pain (NSNP) for at least 3 months prior intervention commencement, age between 18 and 65 years, sedentary lifestyle, score > 5/50 on the Neck Disability Index (NDI) or score > 2 on the Numeric Rating Scale (NPRS) whose symptoms are not increased performing the exercises proposed in the study, limitation in the Active Range of cervical Motion (AROM) in flexion, extension, lateral inclination and/or rotation. Exclusion Criteria: previous neck surgery, neck pain associated with whiplash injuries, subjects who ave received physical therapy 3 months prior intervention commencement, dizziness in the quadruped position, supine position, sitting or performing neck movements, pain in other parts od the body that prevents the performance of the exercises proposed in the study, neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or pain accompanied by non-cervicogenic headaches, neck pain with cervical radiculopathy and/or externalized cervical disc herniation, red flags: fracture, tumor or cervical infection or diagnosis of osteoporosis, metabolic diseases or rheumatoid arthritis, myopathy, ankylosing spondylitis or fibromyalgia, central nervous system involvement, pregnant women, severe psychiatric oe psychological disorders, subjects with pending legal action, not understand, write and speak spanish fluently.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Achalandabaso
Organizational Affiliation
University of Jaén
Official's Role
Study Director
Facility Information:
Facility Name
Recoletas Burgos Hospital
City
Burgos
ZIP/Postal Code
09006
Country
Spain

12. IPD Sharing Statement

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The Effects of Exercise Therapy for Flexor and Extensor Cervical Muscles on Non-specific Neck Pain.

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