Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02011477
Other study ID # CSEULS-PI-001/2013
Secondary ID
Status Completed
Phase Phase 0
First received December 2, 2013
Last updated December 9, 2013
Start date March 2013
Est. completion date November 2013

Study information

Verified date December 2013
Source Universidad Rey Juan Carlos
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the immediate mechanical hypoalgesic effect of neural mobilization in asymptomatic subjects. We also compared neural gliding versus neural stretching to see which produced greater hypoalgesic effects in asymptomatic subjects.


Description:

Asymptomatic subjects will be randomly allocated into three groups: the neural glide group; the neural stretch group; and the placebo group. Each subject will receive one treatment session. Outcome measures included bilateral pressure pain threshold measured at the trigeminal, cervical, and tibialis anterior points, which will assess pre-treatment and immediately post-treatment by a blinded assessor. Three-way repeated measures analysis of variance was used to evaluate changes in pressure pain threshold, with group (experimental or control) as the between-subjects variable and time (pre-, post-treatment) or side (dominant, nondominant) as the within-subjects variable.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date November 2013
Est. primary completion date October 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- Asymptomatic subjects who met the inclusion criterion of being between 18 and 30 years old.

Exclusion Criteria:

- rheumatologic diseases or any type of cancer, cervical surgery in the past, whiplash trauma and undergoing any type of treatment like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture during the last three months. All patients recruited for the study complained of pain localized in the neck and/or head region. Initial screening was accomplished by telephone and eligible persons attended a evaluation appointment.

- development of systemic or degenerative diseases

- subjects with symptoms of depression according Beck's questionnaire

- pain in any area between the lower back and head in the last 9 months

- traumatic event in the past 12 months

- history of neck or face pain in the last 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Neural Glide
This technique involves two movements, throughout several joints to glide the nerves. The subject sit on a couch with the right lower limb extended and the left lower limb flexed. The therapist will take the subject's head by putting his hands on the suboccipital and front region. In the initial movement, performe craniocervical flexion in the subject, while he helped with his right elbow to rectify the dorsal spine of the subject; at the same time, the subject performed dorsiflexion of the right ankle. In the final movement, the subject must increase thoracic kyphosis at the same time as performing plantarflexion in the right ankle; also, the therapist performed craniocervical extension in the subject
Neural stretching
In the start position, the subject was supine on a couch, with knees bent with the right leg above the left, and supported with the popliteal zone. Both hands were crossed over the chest. The therapist was on the subject´s side, with his knee below the subject's head, bringing stability. One hand was placed on the occipital, and the other hand was placed over the crossed hands of the subject

Locations

Country Name City State
Spain Centro superior de Estudios Universitarios La Salle Madrid Aravaca

Sponsors (2)

Lead Sponsor Collaborator
Josue Fernandez Carnero Universidad Autonoma de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pressure pain threshold assessment The pressure pain threshold (PPT) is defined as the amount of pressure at which the sense of pressure first changes to pain. A digital algometer (FDX 25, Wagner Instruments, CT, USA) consisting of a rubber head (1 cm2) attached to a pressure gauge was used to measure PPTs. Force was measured in kilograms (kg); therefore, thresholds were expressed in kg/cm2. The protocol will use a sequence of three measurements, with an interval of 30 seconds between them. PPT will assess over bilateral masseter points 1 and 2, the temporalis muscles, the suboccipital muscle, the upper trapezius muscle (midway between C7 and the acromion), and the tibialis anterior muscle (upper third of the muscle belly) by an assessor blinded to the subject's condition. 5 minutes No
See also
  Status Clinical Trial Phase
Completed NCT01301079 - Evaluation of the Effect of Ketamine on Remifentanil-induced Hyperalgesia Phase 3
Completed NCT00833755 - Effect of Ketamine on Opioid-Induced Hyperalgesia N/A
Completed NCT00279032 - GW406381 In Patients With Peripheral Nerve Injury Phase 1
Completed NCT03793790 - The Role of Learning in Nocebo Hyperalgesia N/A
Completed NCT03985995 - Pain Response to Cannabidiol in Induced Acute Nociceptive Pain, Allodynia and Hyperalgesia By Using a Model Mimicking Acute Pain in Healthy Adults N/A
Completed NCT04199858 - Electrophysiological Correlates of Nocebo Effects on Pain N/A
Not yet recruiting NCT02934763 - Opioid Induced Hyperalgesia (OIH) Modulation With Propranolol Phase 4
Completed NCT02938455 - DNA Methylation and Perioperative Pain Treatment
Completed NCT02653703 - L-menthol as a Topical Counter-irritant to TRPA1-induced Neurogenic Inflammation and Pain N/A
Completed NCT02253966 - Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty Phase 2
Completed NCT01702389 - Opioid-induced Hyperalgesia After Remifentanil Infusion Phase 4
Terminated NCT01615510 - Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models Phase 1
Completed NCT00218374 - Dextromethorphan, Gabapentin, and Oxycodone to Treat Opioid-Induced Hyperalgesia N/A
Completed NCT00387413 - A Study Of GSK189254 And Duloxetine In The Electrical Hyperalgesia Model Of Healthy Volunteers Phase 1
Completed NCT04197154 - Pain-related Fear as a Facilitator of Nocebo Hyperalgesia N/A
Completed NCT02976337 - Effect of High-dose Naloxone Following Third Molar Extraction Phase 2
Completed NCT03354624 - Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity N/A
Completed NCT02596360 - Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers Phase 1
Recruiting NCT01480765 - Preventing Pain After Heart Surgery Phase 4
Recruiting NCT01015482 - The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun) Phase 4