NCT01792895

Brief Summary

The purpose of this study was to investigate the comparative effectiveness of high velocity and low amplitude (HVLA)vs Mobilization (Mob) vs Mobilization with movement technique (MWMT) in sample of patients with chronic neck pain (CNP). Secondly to evaluate the immediate effects in range of motion and pain thresholds, and the interaction between psychological factors and the outcomes of these three types of manual therapy. The hypothesis is that all manual therapies techniques will produce similar effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
Last Updated

October 22, 2013

Status Verified

October 1, 2013

Enrollment Period

1.4 years

First QC Date

February 12, 2013

Last Update Submit

October 21, 2013

Conditions

Keywords

Posterior Neck PainCervical spine painManual therapy

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    visual analogue scale (VAS). Despite being a subjective evaluation, it has been documented in previous studies its reliability and validity and its sensitivity to the clinical changes. For this reason, this scale has been used in numerous clinical trials on neck pains to evaluate the results. The patient places a vertical mark on a flat horizontal line of 10 cm. One extreme is 0 (no pain) and the other extreme is 10 (maximum pain) and it must be a difference of 2 points in the evaluation range to produce minimal improvement which is clinically significant.

    The Patients will be followed for 12 weeks after treatment

Secondary Outcomes (3)

  • Neck disability

    The Patients will be followed for 12 weeks after treatment

  • Active Cervical Range of Motion

    The Patients will be followed for 12 weeks after treatment

  • Pressure Pain thresholds (PPTs)

    pre-treatment and post-treatment

Other Outcomes (5)

  • Satisfaction

    The Patients will be followed for 12 weeks after treatment

  • Anxiety

    pre-treatment

  • Depression

    pre-treatment

  • +2 more other outcomes

Study Arms (3)

Manipulation group

ACTIVE COMPARATOR

This Technique will be applied over four sessions, during two weeks

Procedure: MobilizationProcedure: Mobilization with movement

Mobilisation

ACTIVE COMPARATOR

This treatment will be applied on cervical spine during four sessions, over two weeks

Procedure: ManipulationProcedure: Mobilization with movement

Mobilization with movement

ACTIVE COMPARATOR

This Technique will be applied over four sessions, during two weeks

Procedure: ManipulationProcedure: Mobilization

Interventions

ManipulationPROCEDURE

The Cervical Spine Manipulation is a manual therapy technique directed at the hypomobile and painful vertebral level. The subject was supine with the cervical spine in a neutral position. The index finger of the therapist applies contact over the posterolateral aspect of the zygapophyseal joint of the hypomobile vertebra. The therapist performs the technique taking account the most limited movement; lateral or rotational. A maximum of 2 attempts will performed on each subject regardless audible cavitation.

MobilisationMobilization with movement
MobilizationPROCEDURE

The mobilization is a passive oscillatory technique, applied over cervical region in the hypomobile cervical level, the patient will be in prone and the therapist standing at the head of the patients with his thumbs in opposition placed at the level of the facet of the hypomobile cervical vertebra. A posteroanterior(PA) oscillatory pressure is applied, through the thumbs, over the process of the hypomobile vertebra. This oscillatory mobilization, is performed at a frequency of 2Hz (with metronome control/steps) for 2 minutes and repeated 3 times. The rest time between each mobilization was 1 minute.

Manipulation groupMobilization with movement

This is a manual therapy technique that consist of applied a sustain pressure over cervical hypomobile symptomatic level and request to patient a pain free movement. For performs it, the therapist placed his thumbs on the articular process of that level. The patient sitting. Then, the subject had to perform actively the painful motion while the therapist guides the movement of that vertebra and resists it while returning to neutral. The strength applied was parallel to the plane of the joint, and the procedure was performed in 3 sets of 10 repetitions.

Manipulation groupMobilisation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical Diagnosis of Chronic neck pain

You may not qualify if:

  • Neck pain is associated with whiplash injuries.
  • Resting blood pressure greater than 140/90 mmHg.
  • Cervical radiculopathy.
  • Cervical disc herniation.
  • Fibromyalgia syndrome.
  • Previous neck surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Related Links

MeSH Terms

Conditions

Neck Pain

Interventions

Movement

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Josue Fernandez-Carnero, PhD

    Universidad Europea de Madrid/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
PhD and Physical Therapist

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 15, 2013

Study Start

January 1, 2011

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

October 22, 2013

Record last verified: 2013-10

Locations