Neck Pain Clinical Trial
Official title:
Comparison of Somatosensory Exercise Versus Endurance-strength Exercise in Patients With Chronic Neck Pain: a Randomized Clinical Trial
Verified date | May 2023 |
Source | University of Jaén |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim: To compare the effects of somatosensory exercise vs endurance-strength exercise on the deep cervical flexor muscles on pain and perceived disability in patients with chronic neck pain. Study design: Protocol of a clinical trial, controlled, parallel and a blinded assessor. Population: Subjects aged 18 to 65 years with neck pain of 3 or more months of evolution.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 8, 2023 |
Est. primary completion date | December 14, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Subjects of age between 18 and 65 years - Neck pain of 3 or more months of evolution Exclusion Criteria: - Cervical Disability Index less than 15/50 - Infection - Oncological processes - Neck or arm surgery - Neck or arm trauma - Positive neurological signs - Rheumatic diseases |
Country | Name | City | State |
---|---|---|---|
Spain | University of Alcalá | Alcalá De Henares | Madrid |
Lead Sponsor | Collaborator |
---|---|
Alexander Achalandabaso |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain change | To assess pain, the Visual Analogue Scale will be used, which consists of a 10-centimeter horizontal line, at whose ends is the maximum expression of a symptom. | Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end. | |
Primary | Disability change | Disability will be assessed using the validated Spanish version of the Cervical Disability Index. Its range score is 0-50, higher values mean greater disability. | Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end. | |
Secondary | Pressure Pain Threshold change | To assess the Pressure Pain Threshold, a analog pressure algometer will be used. The pressure will be performed bilaterally on the levator scapulae, upper trapezius, splenius capitis and sternocleidomastoid. | Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end. | |
Secondary | Endurance of craniocervical flexion change | The isometric endurance of the deep flexor muscles of the neck will be measured with the Craniocervical Flexion Test, using a pressure biofeedback. | Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end. | |
Secondary | Proprioception change | The proprioception of the head and neck in space will be evaluated using the Cervical Joint Positioning Error Test. | Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end. | |
Secondary | Kinesiophobia change | The patients' level of fear of movement will be evaluated using the Tampa Scale for Kinesiophobia. Range score is 11-44, higher values mean greater fear of injury. | Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end. | |
Secondary | Sleep quality change | To assess sleep quality we will use the Pittsburgh Sleep Quality Index, using the Spanish version. Range score is 0-21, higher values mean worse outcome. | Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end. | |
Secondary | Quality of life change | Quality of life will be assessed with the 12-Item Short Form Survey, second version (SF-12v2), using its Spanish version. This questionnaire is made up of 12 items which measure both physical and mental items. Range score is PCS 24-56,6 and MCS 19-60,8, higher values mean higher quality of life. | Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end. | |
Secondary | Depression change | To assess depression, the Beck Depression Inventory in its second edition (BDI-II), in its Spanish version, will be used. Range score is 0-63, higher values mean worse outcome. | Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end. |
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