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

Chronic Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193423
• Other study ID #: CEIM/HU/2019/28
• Secondary ID: U1111-1241-3966
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: May 6, 2022

Study information

• Verified date: May 2022
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 6, 2022
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Neck Pain

Intervention

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.

Locations

Country	Name	City	State
Spain	Recoletas Burgos Hospital	Burgos

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain related disability	using the Neck Disability Index (NDI) Questionnaire	Baseline, 1 month (primary timepoint) and 6 months after intervention.
Secondary	Change in Neck pain	Using a Numeric Rating Scale (NPRS) from 0 to 10	Baseline, 1 month (primary timepoint) and 6 months after intervention.
Secondary	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.
Secondary	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).
Secondary	Change in Active Range of cervical Motion (AROM)	Using a digital inclinometer	Baseline and 1 month (primary timepoint).
Secondary	Change in Joint Position Sense (JPS)	Using a target and a rule	Baseline and 1 month (primary timepoint).
Secondary	Change in Frequency of use of drugs	Using a shelf-completed drug registration document	Baseline, 1 month (primary timepoint) and 6 months after intervention.