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Clinical Trials/NCT02011477
NCT02011477CompletedEarly Phase 1

Comparison of Hypoalgesic Effects of Neural Stretching Versus Neural Gliding: a Randomized Clinical Trial

Josue Fernandez Carnero2 sites in 1 country45 target enrollmentStarted: March 2013Last updated:
Conditions

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Sponsor
Enrollment
45
Locations
2
Primary Endpoint
Pressure pain threshold assessment

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Pressure pain threshold assessment

Time Frame: 5 minutes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Josue Fernandez Carnero
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Josue Fernandez Carnero

Associate Professor

Universidad Rey Juan Carlos

Study Sites (2)

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