Clinical trial NCT04193423: The Effects of Exercise Therapy for Flexor and Extensor Cervical Muscles on Non-specific Neck Pain.
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
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Chronic Pain
Keywords: neck pain
exercise
training
endurance
intervention
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a randomized controlled clinical trial with parallel groups.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Pain related disability
timeFrame: Baseline, 1 month (primary timepoint) and 6 months after intervention.
Secondary outcomes:
measure: Change in Neck pain
timeFrame: Baseline, 1 month (primary timepoint) and 6 months after intervention.
measure: Change in Health-related quality of life (HRQoL)
timeFrame: Baseline, 1 month (primary timepoint) and 6 months after intervention.
measure: Change in Neck muscles endurance
timeFrame: Baseline and 1 month (primary timepoint).
measure: Change in Active Range of cervical Motion (AROM)
timeFrame: Baseline and 1 month (primary timepoint).
measure: Change in Joint Position Sense (JPS)
timeFrame: Baseline and 1 month (primary timepoint).
measure: Change in Frequency of use of drugs
timeFrame: Baseline, 1 month (primary timepoint) and 6 months after intervention.
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Recoletas Burgos Hospital
Study officials:
affiliation: University of Jaén
name: Achalandabaso
role: STUDY_DIRECTOR
References: