Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1241-3966 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-Group: craniocervical and cervicothoracic extension training | Experimental |
| |
| B-Group: craniocervical flexion training | Experimental |
| |
| C-Group: control group | Active Comparator | No intervention will be performed due to the fact that they will be still on the waiting list. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.
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. |
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Achalandabaso | University of JaƩn | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recoletas Burgos Hospital | Burgos | 09006 | Spain |
Not provided
| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D059350 | Chronic Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
It is a randomized controlled clinical trial with parallel groups.
Not provided
Not provided
It is a single-blind study: only the investigator performing the measurements will be blinded.
|
| 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. |
| D001519 | Behavior |