Neural Tensioner Exercise on Conditioned Pain Modulation

Not Applicable

Completed

• Conditions: Diffuse Noxious Inhibitory Control; Neck Pain
• Interventions: Procedure: manual therapy

• Registration Number: NCT02816060
• Lead Sponsor: Universidad Rey Juan Carlos

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
neural tensionner exercise	manual therapy	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.
sham neural tensionner exercise	manual therapy	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

Primary Outcome Measures

Name	Time	Method
Physiological parameter	5 minutes	Conditioned pain modulation: Diffusse noxious inhibitory control sistem will be measure with torniquete test

Secondary Outcome Measures

Name	Time	Method
physiological movement	5 minutes	Cervical range of motion measured with cervical range of motion device
Visual analogue scale	5 minutes	Neck pain intensity measured by visual analogue scale (VAS)

Trial Locations

Locations (1)

Universidad Rey Juan Carlos; 🇪🇸 Alcorcon, Madrid, Spain