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Different Types of Manual Therapy Techniques in Patients With Chronic Neck Pain (CNP)

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manipulation
Mobilization
Mobilization with movement
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Posterior Neck Pain, Cervical spine pain, Manual therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical Diagnosis of Chronic neck pain

Exclusion Criteria:

  • 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.

Sites / Locations

  • Universidad Rey Juan Carlos

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Manipulation group

Mobilisation

Mobilization with movement

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Neck disability
The Neck Disability Index (NDI) is an assessment tool used to record the perceived disability in patients with neck pain .It was developed by Howard Vernon from the well-known and validated Oswestry scale for low back pain. The NDI is a self-administered questionnaire with 10 sections. 7 related to activities of daily living, 2 related to pain and 1 with concentration. Each of the sections is scored from 0 to 5, and the total score is expressed as a percentage relative to the maximum possible. The Spanish version was used in this study. This scale offer a high levels of validity and reliability (infraclass correlation coefficient, ICC: 0.88), is stable against different cultural levels and is consistent and reliable. The minimum detectable change is 5 points out of 50, while it is recommended t 7 points as the minimum difference clinically important.
Active Cervical Range of Motion
The ACROM is an instrument that assesses the active range of motion of the cervical segment and has been used in numerous studies to evaluate the results in manual therapy. Furthermore, it has proven to be a reliable method of measuring, providing a range of intra-meter reliability from 0.7 to 0.9 and a range of inter-meter reliability from 0.8 to 0.87. It consists of an inclinometers system. Gravitational inclinometers for flexion-extension and lateral flexion, and magnetic inclinometers for rotation. The patient, sitting in a chair with the goniometer placed over his head, is asked to perform analytical neck movements (flexion, extension, right lateral flexion, left lateral flexion, right rotation and left rotation) to the point of beginning of pain symptoms or, otherwise, to the fullest extent of mobility. Each movement is recorded three times to take the average.
Pressure Pain thresholds (PPTs)
Pressure pain threshold (PPT) was used in this study for measure the mechanical hyperalgesia. A digital algometer (FDX 25, Wagner Instruments, Greenwich, CT, USA) comprised of a rubber head (1 cm2) attached to a pressure gauge, was used to measure PPTs. Force was measured in kilograms/f (kgf). The measures were taken 3 times at the cervical spine (C2 spinous process), with an interval of 30 seconds between each of the measurements. An average of the 3 measurements was calculated to obtain a single value for each of the measured points in each of the assessments. The assessor localized the spinous process of C2.

Full Information

First Posted
February 12, 2013
Last Updated
October 21, 2013
Sponsor
Universidad Rey Juan Carlos
Collaborators
Universidad Europea de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT01792895
Brief Title
Different Types of Manual Therapy Techniques in Patients With Chronic Neck Pain
Acronym
CNP
Official Title
Is Better the One Type of Manual Therapy Than Others for to Treat the Patients With Chronic Neck Pain? : A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
Collaborators
Universidad Europea de Madrid

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The randomized controlled trial included patients with mechanically reproducible CNP, ≥ age 18-years who are randomized into three groups of treatment. The main outcome measures were the Visual Analogue scale (VAS), and, with secondary measures of Neck Disability Index (NDI), Global Rating Of Change (GROC), Cervical Range Of Motion (CROM), Pressure Pain Threshold (PPT), State Trait Anxiety Inventory (STAI-T), Beck depression Inventory (BDI-II), Tampa Scale for Kinesiophobia, Pain Catastrophizing Scale (PCS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Posterior Neck Pain, Cervical spine pain, Manual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manipulation group
Arm Type
Active Comparator
Arm Description
This Technique will be applied over four sessions, during two weeks
Arm Title
Mobilisation
Arm Type
Active Comparator
Arm Description
This treatment will be applied on cervical spine during four sessions, over two weeks
Arm Title
Mobilization with movement
Arm Type
Active Comparator
Arm Description
This Technique will be applied over four sessions, during two weeks
Intervention Type
Procedure
Intervention Name(s)
Manipulation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mobilization
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mobilization with movement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
The Patients will be followed for 12 weeks after treatment
Secondary Outcome Measure Information:
Title
Neck disability
Description
The Neck Disability Index (NDI) is an assessment tool used to record the perceived disability in patients with neck pain .It was developed by Howard Vernon from the well-known and validated Oswestry scale for low back pain. The NDI is a self-administered questionnaire with 10 sections. 7 related to activities of daily living, 2 related to pain and 1 with concentration. Each of the sections is scored from 0 to 5, and the total score is expressed as a percentage relative to the maximum possible. The Spanish version was used in this study. This scale offer a high levels of validity and reliability (infraclass correlation coefficient, ICC: 0.88), is stable against different cultural levels and is consistent and reliable. The minimum detectable change is 5 points out of 50, while it is recommended t 7 points as the minimum difference clinically important.
Time Frame
The Patients will be followed for 12 weeks after treatment
Title
Active Cervical Range of Motion
Description
The ACROM is an instrument that assesses the active range of motion of the cervical segment and has been used in numerous studies to evaluate the results in manual therapy. Furthermore, it has proven to be a reliable method of measuring, providing a range of intra-meter reliability from 0.7 to 0.9 and a range of inter-meter reliability from 0.8 to 0.87. It consists of an inclinometers system. Gravitational inclinometers for flexion-extension and lateral flexion, and magnetic inclinometers for rotation. The patient, sitting in a chair with the goniometer placed over his head, is asked to perform analytical neck movements (flexion, extension, right lateral flexion, left lateral flexion, right rotation and left rotation) to the point of beginning of pain symptoms or, otherwise, to the fullest extent of mobility. Each movement is recorded three times to take the average.
Time Frame
The Patients will be followed for 12 weeks after treatment
Title
Pressure Pain thresholds (PPTs)
Description
Pressure pain threshold (PPT) was used in this study for measure the mechanical hyperalgesia. A digital algometer (FDX 25, Wagner Instruments, Greenwich, CT, USA) comprised of a rubber head (1 cm2) attached to a pressure gauge, was used to measure PPTs. Force was measured in kilograms/f (kgf). The measures were taken 3 times at the cervical spine (C2 spinous process), with an interval of 30 seconds between each of the measurements. An average of the 3 measurements was calculated to obtain a single value for each of the measured points in each of the assessments. The assessor localized the spinous process of C2.
Time Frame
pre-treatment and post-treatment
Other Pre-specified Outcome Measures:
Title
Satisfaction
Description
The Global Rating Of Change Scale - GROC is also a commonly used scale in clinical research, particularly in patients with neck pain. It is designed to quantify the improvements or deterioration over time, and allows the patient to choose the aspects of life that he considers important. There is variability in the design of the scales, a systematic review in Cochrane quoted seven different designs in the eight studies using a scale of GROC. This scale goes from -7 (much worse) to +7 (much better) with 0 being the midpoint (equally).
Time Frame
The Patients will be followed for 12 weeks after treatment
Title
Anxiety
Description
All participants completed Spanish version 47 of trait subscale of State Trait Anxiety Inventory (STAI-T. The STAI-T has been found to possess adequate reliability (alpha coefficients of 0.93, test-retest reliability of 0.80) and validity.
Time Frame
pre-treatment
Title
Depression
Description
The level of depressive symptomatology was measured by the Spanish version50 of Beck depression Inventory (BDI-II), a self-report measure which assess affective, cognitive, and somatic symptoms of depression. The BDI has shown good internal consistency both in original sample (alpha coefficient 0.90) and in Spanish population (alpha coefficient 0.92). In addition, both versions has an adequate validity
Time Frame
pre-treatment
Title
Kinesiophobia
Description
The Tampa Scale for Kinesiophobia, developed by Miller was used to assess fear of movement and injury. We used the original 17-items version, which has showed good psychometric guarantees.
Time Frame
Pre-treatment
Title
Catastrophizing
Description
To evaluate the subject's propensity to catastrophize about pain we used the Spanish version of Pain Catastrophizing Scale (PCS). This scale is a 13-item questionnaire designed to measure the three components of catastrophizing: rumination, magnification and helplessness, resulting this evaluation in a unique score
Time Frame
Pre-Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical Diagnosis of Chronic neck pain Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josue Fernandez-Carnero, PhD
Organizational Affiliation
Universidad Europea de Madrid/Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.urjc.es
Description
web site of the University

Learn more about this trial

Different Types of Manual Therapy Techniques in Patients With Chronic Neck Pain

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