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

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic exercises
Sponsored by
Alexander Achalandabaso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, chronic pain, therapeutic exercise, proprioception, motor control

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alcalá

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Somatosensory training

Endurance-strength training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Proprioception change
The proprioception of the head and neck in space will be evaluated using the Cervical Joint Positioning Error Test.
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.
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.
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.
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.

Full Information

First Posted
March 23, 2022
Last Updated
May 8, 2023
Sponsor
Alexander Achalandabaso
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1. Study Identification

Unique Protocol Identification Number
NCT05321537
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 19, 2022 (Actual)
Primary Completion Date
December 14, 2022 (Actual)
Study Completion Date
May 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alexander Achalandabaso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
neck pain, chronic pain, therapeutic exercise, proprioception, motor control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The evaluator will not know to which treatment group each belongs.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Somatosensory training
Arm Type
Experimental
Arm Description
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.
Arm Title
Endurance-strength training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Therapeutic exercises
Intervention Description
A somatosensory training and an endurance-strength training protocol
Primary Outcome Measure Information:
Title
Pain change
Description
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.
Time Frame
Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Title
Disability change
Description
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.
Time Frame
Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Secondary Outcome Measure Information:
Title
Pressure Pain Threshold change
Description
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.
Time Frame
Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Title
Endurance of craniocervical flexion change
Description
The isometric endurance of the deep flexor muscles of the neck will be measured with the Craniocervical Flexion Test, using a pressure biofeedback.
Time Frame
Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Title
Proprioception change
Description
The proprioception of the head and neck in space will be evaluated using the Cervical Joint Positioning Error Test.
Time Frame
Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Title
Kinesiophobia change
Description
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.
Time Frame
Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Title
Sleep quality change
Description
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.
Time Frame
Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Title
Quality of life change
Description
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.
Time Frame
Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.
Title
Depression change
Description
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.
Time Frame
Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alcalá
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28801
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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