Clinical trial NCT05321537: Comparison of Somatosensory Versus Endurance-strength Exercise in Patients With Chronic Neck Pain
Official title: Comparison of Somatosensory Exercise Versus Endurance-strength Exercise in Patients With Chronic Neck Pain: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: neck pain
chronic pain
therapeutic exercise
proprioception
motor control
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single center, parallel, randomized, blinded rater, controlled clinical trial will be conducted. The 25 requirements proposed by the CONSORT declaration will be followed.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain change
timeFrame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
measure: Disability change
timeFrame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Secondary outcomes:
measure: Pressure Pain Threshold change
timeFrame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
measure: Endurance of craniocervical flexion change
timeFrame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
measure: Proprioception change
timeFrame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
measure: Kinesiophobia change
timeFrame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
measure: Sleep quality change
timeFrame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
measure: Quality of life change
timeFrame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
measure: Depression change
timeFrame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: University of Alcalá
state: Madrid
Study officials:
References: