Manual Therapy Techniques on Cervical Spine and Psychological Interaction

Neck Pain Clinical Trial

Official title:

Hypoalgesic Effects of Three Different Manual Therapy Techniques on Cervical Spine and Psychological Interaction: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782585
• Other study ID #: Psychological interaction
• Status: Completed
• Phase: N/A
• First received: May 17, 2016
• Last updated: May 20, 2016
• Start date: July 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2016
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Manual therapy (MT) techniques applied over cervical region have over both local (neck) and distant regions (elbow) in both asymptomatic and symptomatic populations. Neurophysiological mechanisms are hypothesized to explain the underlying effects, with effects originating from peripheral mechanisms, spinal cord and supraspinal mechanisms.

There is also an increasing interest in the study of the role of psychological variables in the treatment success in neck pain. Psychological variables, like anxiety catastrophizing or kinesiophobia are related to poor prognosis in the development of pain outcomes and disability in neck pain, being the Fear-Avoidance Model of pain one of the most tested models in this field.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Neck pain

Exclusion Criteria:

• myelopathy

• fracture

• infection

• dystonia

• tumor

• inflammatory disease

• fibromyalgia

• or osteoporosis

Study Design

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Cervical manipulation
The therapist cradled the subject´s head with the other hand. Gentle ipsilateral side flexion and contralateral rotation to the targeted side were introduced until slight tension was perceived in the tissues at the contact point. The High velocity, low amplitude (HVLA) manipulation was directed upward and medially in the direction of the subject´s contralateral eye. The therapist monitored for cavitation or 'popping sound' accompanying the manipulations. If an audible popping sound was not heard during the first manipulative attempt, the procedure was repeated in the second time.
• Cervical lateral glide
The upper limb of the right side of subjects was maintained in rest, with the arm along the trunk and the hand over the abdominal wall. The right hand of the treating therapist was positioned over scapula region, to depress the scapula while left hand cradled the occiput and neck above C5-C6 and left hand produced a passive lateral movement of the occipital and neck region.
• Cervical mobilisation
The patients received a passive cervical mobilization that involved a grade III oscillatory unilateral posteroanterior mobilization to the right articular pillar of C5/C6 segment as described Maitland at a frequency of 2Hz. All the subjects were positioned in prone position as the protocol described by Sterling et al. for 3 sets of 2 minutes with 1 minute rest between sets.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Pressure Pain Thresholds (PPT) at 24 hours	PPT will be assessed bilaterally over the C7 zygapophyseal joint, epicondyle region, and trapezious muscle by an assessor blinded to the subjects condition.	24 hours, 5 minutes after the treatment	Yes
Primary	Change from State-Trait Anxiety Inventory subscale (STAI-E) at 24 hours	Will be used to measure anxiety status	24 hours, 5 minutes after the treatment	Yes
Secondary	Beck depression Inventory (BDI-II)	Will be used to measure depression status	24 hours, 5 minutes after the treatment	Yes
Secondary	Tampa Scale for Kinesiophobia	Will be used to measure Kinesiophobia status	24 hours, 5 minutes after the treatment	Yes