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Neural Tensioner Exercise on Conditioned Pain Modulation

Primary Purpose

Neck Pain, Diffuse Noxious Inhibitory Control

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
manual therapy
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring pain measurement

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged 18-65 years.
  • neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head, trunk, and/or the upper limbs.
  • the ability to understand, write, and speak Spanish fluently

Exclusion Criteria:

  • development of systemic or degenerative diseases;
  • symptoms of depression according to Beck's questionnaire.
  • pain in any area between the lower back and the head in the last 9 months.
  • neck pain associated with whiplash injuries.
  • medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis). - neck pain with cervical radiculopathy.
  • neck pain associated with externalized cervical disc herniation.
  • fibromyalgia syndrome.
  • previous neck surgery.
  • neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches due to a traumatic event in the past 12 months.
  • and history of neck or face pain in the last 6 months.

Sites / Locations

  • Universidad Rey Juan Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

neural tensionner exercise

sham neural tensionner exercise

Arm Description

This group will receive a specific tensionner nerve exercise to provide mechanical stress across the median nerve. This technique have two positions, start and end. It consists on going from one to the other position constantly, controlling the speed of the technique to be constant. In the start position, the subject will be supine lying on a couch with the following parameters: contralateral cervical side bending, shoulder depression, shoulder abduction and external rotation to 90°, elbow flexion to 90º, and forearm supination. In the final position, the therapist will perform full elbow extension while maintaining all the joints previously situated as described above until the patients feel tension, then return to the start position.

The control group will receive a sham technique (ST) with minimal mechanical stress across the median nerve. Patients will be placed in neutral cervical spine position with no shoulder depression, shoulder abduction and external rotation to 45°, 45° of elbow extension, and forearm pronation.. This technique will be passively repeated from elbow flexion to extension in the same way than the NTE group

Outcomes

Primary Outcome Measures

Physiological parameter
Conditioned pain modulation: Diffusse noxious inhibitory control sistem will be measure with torniquete test

Secondary Outcome Measures

Visual analogue scale
Neck pain intensity measured by visual analogue scale (VAS)
physiological movement
Cervical range of motion measured with cervical range of motion device

Full Information

First Posted
June 9, 2016
Last Updated
March 8, 2017
Sponsor
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT02816060
Brief Title
Neural Tensioner Exercise on Conditioned Pain Modulation
Official Title
Effectiveness of Neural Tensioner Exercise on Conditioned Pain Modulation, Disability and Range of Motion in Patients With Chronic Neck Pain: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: There is evidence linking conditioned pain modulation (CPM) deficiency with musculoskeletal pain syndromes such as fibromyalgia, migraine, tension-type headaches and irritable bowel syndrome, as well as with temporomandibular disorders, idiopathic facial pain and chronic fatigue syndrome. Evidence shows that in pre-surgical situations of chronic pain there is no activation of CPM. Objectives: The purpose of this study is to measure the CPM response and determine whether neural tensioner exercise in patients with chronic neck pain is effective in the improvement of neck pain intensity, neck disability and cervical range of motion. Design: Double-blind, randomized placebo clinical trial. Methods: Patients with neck pain will be randomly allocated into two groups: the neural tensionner exercise group (NTE) or the sham technique (ST) group. Individuals will be included in the study if they meet the following inclusion criteria: aged 18-65 years, neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head. Neck pain intensity with a visual analogue scale (VAS), neck disability index (NDI), CPM, and cervical rang of motion will be measured pre and port intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Diffuse Noxious Inhibitory Control
Keywords
pain measurement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
neural tensionner exercise
Arm Type
Experimental
Arm Description
This group will receive a specific tensionner nerve exercise to provide mechanical stress across the median nerve. This technique have two positions, start and end. It consists on going from one to the other position constantly, controlling the speed of the technique to be constant. In the start position, the subject will be supine lying on a couch with the following parameters: contralateral cervical side bending, shoulder depression, shoulder abduction and external rotation to 90°, elbow flexion to 90º, and forearm supination. In the final position, the therapist will perform full elbow extension while maintaining all the joints previously situated as described above until the patients feel tension, then return to the start position.
Arm Title
sham neural tensionner exercise
Arm Type
Placebo Comparator
Arm Description
The control group will receive a sham technique (ST) with minimal mechanical stress across the median nerve. Patients will be placed in neutral cervical spine position with no shoulder depression, shoulder abduction and external rotation to 45°, 45° of elbow extension, and forearm pronation.. This technique will be passively repeated from elbow flexion to extension in the same way than the NTE group
Intervention Type
Procedure
Intervention Name(s)
manual therapy
Intervention Description
manual therapy with neural exercise will be applied on patients with neck pain
Primary Outcome Measure Information:
Title
Physiological parameter
Description
Conditioned pain modulation: Diffusse noxious inhibitory control sistem will be measure with torniquete test
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Visual analogue scale
Description
Neck pain intensity measured by visual analogue scale (VAS)
Time Frame
5 minutes
Title
physiological movement
Description
Cervical range of motion measured with cervical range of motion device
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 18-65 years. neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head, trunk, and/or the upper limbs. the ability to understand, write, and speak Spanish fluently Exclusion Criteria: development of systemic or degenerative diseases; symptoms of depression according to Beck's questionnaire. pain in any area between the lower back and the head in the last 9 months. neck pain associated with whiplash injuries. medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis). - neck pain with cervical radiculopathy. neck pain associated with externalized cervical disc herniation. fibromyalgia syndrome. previous neck surgery. neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches due to a traumatic event in the past 12 months. and history of neck or face pain in the last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josué Fernández-Carnero, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29945245
Citation
Fernandez-Carnero J, Sierra-Silvestre E, Beltran-Alacreu H, Gil-Martinez A, La Touche R. Neural Tension Technique Improves Immediate Conditioned Pain Modulation in Patients with Chronic Neck Pain: A Randomized Clinical Trial. Pain Med. 2019 Jun 1;20(6):1227-1235. doi: 10.1093/pm/pny115.
Results Reference
derived
Links:
URL
http://www.urjc.es
Description
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Neural Tensioner Exercise on Conditioned Pain Modulation

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