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

NCT ID: NCT05321537

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-19
• Study Completion Date: 2023-05-08

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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Therapeutic exercises

Intervention Type: OTHER

A somatosensory training and an endurance-strength training protocol

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.

Group Type: EXPERIMENTAL

Therapeutic exercises

Intervention Type: OTHER

A somatosensory training and an endurance-strength training protocol

Interventions

Therapeutic exercises

A somatosensory training and an endurance-strength training protocol

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexander Achalandabaso

OTHER

Sponsor Role: lead

Responsible Party

Alexander Achalandabaso

Clinical professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Alcalá

Alcalá de Henares, Madrid, Spain

Countries

Spain

Other Identifiers

CEIM/2022/1/001

Identifier Type: -

Identifier Source: org_study_id