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Completed

NCT Number: NCT04193423

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

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.

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Key information

Conditions

Neck Pain Behavior Chronic Pain Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recoletas Burgos Hospital

Burgos, 09006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neck extensors training versus deep cervical flexors training, compared to a control group.

Other

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 outcomes

  1. 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

  1. Change in Neck pain

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

    Using a Numeric Rating Scale (NPRS) from 0 to 10

  2. Change in Health-related quality of life (HRQoL)

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

    using the SF-36 quality of life questionnaire.

  3. Change in Neck muscles endurance

    Time frame: Baseline and 1 month (primary timepoint).

    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

  4. Change in Active Range of cervical Motion (AROM)

    Time frame: Baseline and 1 month (primary timepoint).

    Using a digital inclinometer

  5. Change in Joint Position Sense (JPS)

    Time frame: Baseline and 1 month (primary timepoint).

    Using a target and a rule

  6. Change in Frequency of use of drugs

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

    Using a shelf-completed drug registration document

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Official study 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

Acronym: CCF

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 10, 2019
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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