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

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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: Therapeutic exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcalá De Henares, Madrid, Spain, 28801
      • University of Alcala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Somatosensory training; It consists of head relocation exercises, eye tracking, gaze stability and eye-head coordination. It requires the use of special material, the pupillary glasses allow the gaze to be fixed by restricting peripheral vision and the laser pointer provides visual feedback on the positioning of the head.	Other: Therapeutic exercises; A somatosensory training and an endurance-strength training protocol
Experimental: Endurance-strength training; It consists of low-load training of the craniocervical flexor muscles. This exercise is specific for the deep cervical flexor muscles, while seeking minimal activation of the superficial flexor muscles. This training consists of 5 phases, starting with a pressure of 20 mmHg, progressively increasing 2 mmHg in each phase.	Other: Therapeutic exercises; A somatosensory training and an endurance-strength training protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Alexander Achalandabaso

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2022
• Primary Completion (Actual): December 14, 2022
• Study Completion (Actual): May 8, 2023

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: chronic pain; neck pain; proprioception; motor control; therapeutic exercise
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: CEIM/2022/1/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No