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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Neck Pain
• Intervention / Treatment: Other: Neck extensors training versus deep cervical flexors training, compared to a control group.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Burgos, Spain, 09006
    • Recoletas Burgos Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A-Group: craniocervical and cervicothoracic extension training	Other: Neck extensors training versus deep cervical flexors training, compared to a control group.; 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.
Experimental: B-Group: craniocervical flexion training	Other: Neck extensors training versus deep cervical flexors training, compared to a control group.; 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.
Active Comparator: C-Group: control group; No intervention will be performed due to the fact that they will be still on the waiting list.	Other: Neck extensors training versus deep cervical flexors training, compared to a control group.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain related disability	using the Neck Disability Index (NDI) Questionnaire	Baseline, 1 month (primary timepoint) and 6 months after intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Neck pain	Using a Numeric Rating Scale (NPRS) from 0 to 10	Baseline, 1 month (primary timepoint) and 6 months after intervention.
Change in Health-related quality of life (HRQoL)	using the SF-36 quality of life questionnaire.	Baseline, 1 month (primary timepoint) and 6 months after intervention.
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	Baseline and 1 month (primary timepoint).
Change in Active Range of cervical Motion (AROM)	Using a digital inclinometer	Baseline and 1 month (primary timepoint).
Change in Joint Position Sense (JPS)	Using a target and a rule	Baseline and 1 month (primary timepoint).
Change in Frequency of use of drugs	Using a shelf-completed drug registration document	Baseline, 1 month (primary timepoint) and 6 months after intervention.

Collaborators and Investigators

• Sponsor: University of Jaen
• Investigators: Study Director: Achalandabaso, University of Jaén

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Actual): November 2, 2021
• Study Completion (Actual): May 6, 2022

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 7, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: exercise; neck pain; intervention; training; endurance
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Neck Pain
• Other Study ID Numbers: CEIM/HU/2019/28; U1111-1241-3966 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No