Comparison of Somatosensory Versus Endurance-strength Exercise in Patients With Chronic Neck Pain

Neck Pain Clinical Trial

Official title:

Comparison of Somatosensory Exercise Versus Endurance-strength Exercise in Patients With Chronic Neck Pain: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05321537
• Other study ID #: CEIM/2022/1/001
• Status: Completed
• Phase: N/A
• Start date: March 19, 2022
• Est. completion date: May 8, 2023

Study information

• Verified date: May 2023
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. A total of 60 subjects with nonspecific chronic neck pain will be selected and randomly assigned into two intervention groups. The first group will perform a somatosensory exercise program and a second group will perform activation and endurance-strength exercises of the deep cervical flexors. The duration of the intervention will be 8 weeks, with 6 sessions of physical therapy and daily home exercise. The variables pain, pressure pain threshold, disability, endurance-strength, proprioception, quality of life, kinesiophobia, quality of sleep and depression will be analyzed. Measurements will be taken pre-treatment, post-treatment and a follow-up at 3 months.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Therapeutic exercises
A somatosensory training and an endurance-strength training protocol

Locations

Country	Name	City	State
Spain	University of Alcalá	Alcalá De Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Alexander Achalandabaso

Country where clinical trial is conducted

Spain, 

Outcome

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.