Neural Tensioner Exercise on Conditioned Pain Modulation

NCT02816060 | Completed DMC

• 1 other identifier: 14/2013
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; Diffuse Noxious Inhibitory Control

Keywords

pain measurement

Outcome Measures

Primary Outcomes (1)

• Physiological parameter

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

  5 minutes

Secondary Outcomes (2)

• Visual analogue scale

  5 minutes

• physiological movement

  5 minutes

Study Arms (2)

neural tensionner exercise

EXPERIMENTAL

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.

Procedure: manual therapy

sham neural tensionner exercise

PLACEBO COMPARATOR

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

Procedure: manual therapy

Interventions

manual therapy PROCEDURE

manual therapy with neural exercise will be applied on patients with neck pain

neural tensionner exercise; sham neural tensionner exercise

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (1)

• 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.

  PMID: 29945245 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Neck Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Josué Fernández-Carnero, PhD

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 28, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 9, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)