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

NCT05321537 | Completed

• 1 other identifier: CEIM/2022/1/001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

neck pain; chronic pain; therapeutic exercise; proprioception; motor control

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Pressure Pain Threshold change

  Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

• Endurance of craniocervical flexion change

  Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

• Proprioception change

  Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

• Kinesiophobia change

  Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

• Sleep quality change

  Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

Study Arms (2)

Somatosensory training

EXPERIMENTAL

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

Endurance-strength training

EXPERIMENTAL

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

Interventions

Therapeutic exercises OTHER

A somatosensory training and an endurance-strength training protocol

Endurance-strength training; Somatosensory training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of age between 18 and 65 years
• Neck pain of 3 or more months of evolution

You may not qualify if:

• Cervical Disability Index less than 15/50
• Infection
• Oncological processes
• Neck or arm surgery
• Neck or arm trauma
• Positive neurological signs
• Rheumatic diseases

Sponsors & Collaborators

• Alexander Achalandabaso: lead

Study Sites (1)

University of Alcalá

Alcalá de Henares, Madrid, 28801, Spain

Location

MeSH Terms

Conditions

Neck Pain; Chronic Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator will not know to which treatment group each belongs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor

Model Details: A single center, parallel, randomized, blinded rater, controlled clinical trial will be conducted. The 25 requirements proposed by the CONSORT declaration will be followed.

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 11, 2022
• Study Start: March 19, 2022
• Primary Completion: December 14, 2022
• Study Completion: May 8, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)