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Clinical Trials/NCT04193423
NCT04193423
Completed
Not Applicable

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

University of Jaén1 site in 1 country54 target enrollmentDecember 2, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neck Pain
Sponsor
University of Jaén
Enrollment
54
Locations
1
Primary Endpoint
Change in Pain related disability
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2, 2019
End Date
May 6, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Jaén
Responsible Party
Principal Investigator
Principal Investigator

Alexander Achalandabaso

Principal investigator

University of Jaén

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,

Outcomes

Primary Outcomes

Change in Pain related disability

Time Frame: Baseline, 1 month (primary timepoint) and 6 months after intervention.

using the Neck Disability Index (NDI) Questionnaire

Secondary Outcomes

  • Change in Joint Position Sense (JPS)(Baseline and 1 month (primary timepoint).)
  • Change in Neck pain(Baseline, 1 month (primary timepoint) and 6 months after intervention.)
  • Change in Health-related quality of life (HRQoL)(Baseline, 1 month (primary timepoint) and 6 months after intervention.)
  • Change in Neck muscles endurance(Baseline and 1 month (primary timepoint).)
  • Change in Frequency of use of drugs(Baseline, 1 month (primary timepoint) and 6 months after intervention.)
  • Change in Active Range of cervical Motion (AROM)(Baseline and 1 month (primary timepoint).)

Study Sites (1)

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