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

NCT04193423 | Completed

• 2 other identifiers: CEIM/HU/2019/28U1111-1241-3966
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; Chronic Pain

Keywords

neck pain; exercise; training; endurance; intervention

Outcome Measures

Primary Outcomes (1)

• Change in Pain related disability

  using the Neck Disability Index (NDI) Questionnaire

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

Secondary Outcomes (6)

• 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 Active Range of cervical Motion (AROM)

  Baseline and 1 month (primary timepoint).

• Change in Joint Position Sense (JPS)

  Baseline and 1 month (primary timepoint).

Study Arms (3)

A-Group: craniocervical and cervicothoracic extension training

EXPERIMENTAL

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

B-Group: craniocervical flexion training

EXPERIMENTAL

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

C-Group: control group

ACTIVE COMPARATOR

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.

Interventions

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.

A-Group: craniocervical and cervicothoracic extension training; B-Group: craniocervical flexion training; C-Group: control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Recoletas Burgos Hospital

Burgos, 09006, Spain

Location

MeSH Terms

Conditions

Neck Pain; Chronic Pain; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Achalandabaso

  University of Jaén

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It is a single-blind study: only the investigator performing the measurements will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: It is a randomized controlled clinical trial with parallel groups.

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 10, 2019
• Study Start: December 2, 2019
• Primary Completion: November 2, 2021
• Study Completion: May 6, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

ES (1)