Back to resultsManual Therapy Versus Manual Therapy and Exercise and Education in Chronic Neck Pain
Primary Purpose
Neck Pains, Posterior Cervical Pains, Posterior Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manual Therapy and Education
Manual Therapy
Manual therapy, Education and Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pains focused on measuring Manual therapy, Exercise, Education
Eligibility Criteria
Inclusion Criteria:
- The subjects for the study were selected if they fulfilled the following inclusion criteria: Aged between 18 to 60 years old, head and/or neck pain for at least 12 weeks and having the willing to undergo the treatment.
Exclusion Criteria:
- if they had appearance of "red flags", 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Manual therapy, education and Exercise
Manual Therapy and Education
Manual Therapy
Arm Description
The protocol for this group is identical to the previous group with the sole difference that is added an exercise protocol : In the fifth session we explained the patients to perform : Five sets of isometric contraction of the deep neck flexors for 8-10 seconds. Five sets of isometric contraction of the neck extensors for 6-8 seconds Neural self-mobilization and stretching held for 10 - 12 seconds for the levator scapulae and the trapezius muscle. In the sixth session the patient repeat all the exercises from the previous session and also with the help of a theraband made : • Isotonic contraction of the head, performing 3-4 sets of 8-10 repetitions.
The protocol used for therapeutic education consisted of two approaches: Manual therapy will consist on Traction oscillatory,craniocervical region, Mobilization of upper cervical region in flexion, Side glide roll, Mobilization upper cervical anteroposterior with Wedge, Sliding lateral techniques and High-velocity technique in dorsal region. And Education of the physiology of pain and Education about cognitive behavioral perspective.
Manual therapy will consist on Traction oscillatory, Mobilization of upper cervical region in flexion, Side glide roll, Mobilization upper cervical anteroposterior with Wedge, Sliding lateral C1- C2 ( 2 minutes) , C2 -C3, and C5 -C6 and High-velocity technique in dorsal region.
Outcomes
Primary Outcome Measures
visual analogue scale
This scale comprises of a 100-mm horizontal line with pain descriptors marked "no pain" at left side and "the worst pain imagine" at the right side, and is used to measure the pain intensity. It was recorded at the beginning of the physical assessment and the patient was asked what their pain intensity was at the time by marking the VAS with a perpendicular line. This is a valid method to measure the pain level37 and psychometric properties of the VAS have been reported widely. The minimal important difference of the VAS is based on detecting an 8.6 mm (based in previous study for a score < 40mm with a pain onset more than 12 weeks) of difference immediately after treatment.
Pressure Pain threshold
Pressure pain threshold (PPT) is defined as the amount of pressure where the sense of pressure first changes to pain. A digital algometer (FDX 25, Wagner Instruments, CT, USA), will be used. Pressure pain threshold was assessed over right side of masseter 1 and 2, the temporalis muscle 1 and 2, suboccipital muscle, spinous process of C2, vertebral joint process of C5 y C6, upper trapezius muscle (midway between C7 and acromion), epicondyle, scaphoid bone and tibialis anterior muscle (upper one-third of the muscle belly) by an assessor blinded to the subject's condition.
Cervical Range of Motion
Cervical spine mobility was measured with Cervical Range of Motion (CROM) device (Performance Attainment Associates, MN). The CROM is an instrument that assesses the active range of motion of the cervical segment. It´s 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. The patients were measured while sitting with the back against a chair. 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).
Neck disability index
It is a well-validated 10-item questionnaire. The Neck Disability Index (NDI) has sufficient support in the literature, to be the most commonly used to report neck pain. It was used a spanish validation of the index. Scores of <4 indicate no disability, 5-14 mild disability, 15-25 moderate disability, 25-34 severe disability and >35 complete disability
Secondary Outcome Measures
Kinesiophobia
The Tampa Scale for Kinesiophobia, developed by Miller was used to assess fear of movement and injury. We used a 11-items version.
Catastrophizing
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.
Fear Avoidance Belief Questionnaire (FABQ)
The FABQ assesses patient beliefs with regard to the effect of physical activity and work on their pain. It consists of 16 items and patients rate their agreement with each statement on a 7- point Likert scale (0 = completely disagree, 6 = completely agree).
Full Information
NCT ID
NCT02033460
First Posted
January 9, 2014
Last Updated
January 10, 2014
Sponsor
Josue Fernandez Carnero
Collaborators
Universidad Autonoma de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02033460
Brief Title
Manual Therapy Versus Manual Therapy and Exercise and Education in Chronic Neck Pain
Official Title
Manual Therapy vs Manual Therapy and Exercise vs Manual Therapy and Exercise and Education in Patients With Chronic Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Josue Fernandez Carnero
Collaborators
Universidad Autonoma de Madrid
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to know which combination of treatments are the most effective in patients with non-specific neck pain. Study design: This is a single-blind randomized controlled trial. (outcomes assessor). Study population: Men and women aged 18 to 60 years old with neck pain for at least 12 weeks. Interventions: 3 groups will be treated for a period of 4 weeks (8 sessions total; 2 per week).
Detailed Description
Nonspecific chronic neck pain has a high prevalence and is very common in clinical practice.
Manual therapy (MT) studies of techniques like mobilization, manipulation, and therapeutic exercise, has been demonstrated effectiveness for the treatment of pain and disability in the neck. These investigations have thought of this treatments as individual interventions. Thus, multimodal ways of treatment to improve patients with nonspecific chronic neck pain are necessary.
The aim of this study is to evaluate the effectiveness of a multimodal treatment protocol compared to a unimodal treatment protocol in the medium-term, on patients with chronic non-specific neck pain.
Subjects are randomly allocated into three groups: MT group; MT+Educational therapy (ET) group; and MT+ET+Exercise group. Each subject receive a 4 weeks period treatment (8 sessions). Outcome measures include physical, somatosensory, and psychosocial characteristics; which are measure at 0, 4, 8, 16 weeks by a blinded assessor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pains, Posterior Cervical Pains, Posterior Neck Pain, Cervicalgia
Keywords
Manual therapy, Exercise, Education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual therapy, education and Exercise
Arm Type
Experimental
Arm Description
The protocol for this group is identical to the previous group with the sole difference that is added an exercise protocol :
In the fifth session we explained the patients to perform :
Five sets of isometric contraction of the deep neck flexors for 8-10 seconds.
Five sets of isometric contraction of the neck extensors for 6-8 seconds
Neural self-mobilization and stretching held for 10 - 12 seconds for the levator scapulae and the trapezius muscle.
In the sixth session the patient repeat all the exercises from the previous session and also with the help of a theraband made :
• Isotonic contraction of the head, performing 3-4 sets of 8-10 repetitions.
Arm Title
Manual Therapy and Education
Arm Type
Active Comparator
Arm Description
The protocol used for therapeutic education consisted of two approaches:
Manual therapy will consist on Traction oscillatory,craniocervical region, Mobilization of upper cervical region in flexion, Side glide roll, Mobilization upper cervical anteroposterior with Wedge, Sliding lateral techniques and High-velocity technique in dorsal region. And Education of the physiology of pain and Education about cognitive behavioral perspective.
Arm Title
Manual Therapy
Arm Type
Active Comparator
Arm Description
Manual therapy will consist on Traction oscillatory, Mobilization of upper cervical region in flexion, Side glide roll, Mobilization upper cervical anteroposterior with Wedge, Sliding lateral C1- C2 ( 2 minutes) , C2 -C3, and C5 -C6 and High-velocity technique in dorsal region.
Intervention Type
Other
Intervention Name(s)
Manual Therapy and Education
Intervention Description
Manual therapy will consist on Traction oscillatory,craniocervical region, Mobilization of upper cervical region in flexion, Side glide roll, Mobilization upper cervical anteroposterior with Wedge, Sliding lateral techniques and High-velocity technique in dorsal region. And Education of the physiology of pain and Education about cognitive behavioral perspective will add to manual therapy treatment.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
Manual therapy will consist on Traction oscillatory, Maintained traction in the craniocervical region, Mobilization of upper cervical region in flexion, Side glide roll, Mobilization upper cervical anteroposterior with Wedge, Sliding lateral C1- C2 ( 2 minutes) , C2 -C3, and C5 -C6 and High-velocity technique in dorsal region.
Intervention Type
Other
Intervention Name(s)
Manual therapy, Education and Exercise
Intervention Description
Manual therapy will consist on Traction oscillatory,craniocervical region, Mobilization of upper cervical region in flexion, Side glide roll, Mobilization upper cervical anteroposterior with Wedge, Sliding lateral techniques and High-velocity technique in dorsal region. And Education of the physiology of pain and Education about cognitive behavioral perspective and Craniocervical exercise will add to this arm.
Primary Outcome Measure Information:
Title
visual analogue scale
Description
This scale comprises of a 100-mm horizontal line with pain descriptors marked "no pain" at left side and "the worst pain imagine" at the right side, and is used to measure the pain intensity. It was recorded at the beginning of the physical assessment and the patient was asked what their pain intensity was at the time by marking the VAS with a perpendicular line. This is a valid method to measure the pain level37 and psychometric properties of the VAS have been reported widely. The minimal important difference of the VAS is based on detecting an 8.6 mm (based in previous study for a score < 40mm with a pain onset more than 12 weeks) of difference immediately after treatment.
Time Frame
pre-treatment, 4, 8, 16 weeks
Title
Pressure Pain threshold
Description
Pressure pain threshold (PPT) is defined as the amount of pressure where the sense of pressure first changes to pain. A digital algometer (FDX 25, Wagner Instruments, CT, USA), will be used. Pressure pain threshold was assessed over right side of masseter 1 and 2, the temporalis muscle 1 and 2, suboccipital muscle, spinous process of C2, vertebral joint process of C5 y C6, upper trapezius muscle (midway between C7 and acromion), epicondyle, scaphoid bone and tibialis anterior muscle (upper one-third of the muscle belly) by an assessor blinded to the subject's condition.
Time Frame
pre-treatment, 4, 8, 16 weeks
Title
Cervical Range of Motion
Description
Cervical spine mobility was measured with Cervical Range of Motion (CROM) device (Performance Attainment Associates, MN). The CROM is an instrument that assesses the active range of motion of the cervical segment. It´s 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. The patients were measured while sitting with the back against a chair. 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).
Time Frame
pre-treatment, 4, 8, 16 weeks
Title
Neck disability index
Description
It is a well-validated 10-item questionnaire. The Neck Disability Index (NDI) has sufficient support in the literature, to be the most commonly used to report neck pain. It was used a spanish validation of the index. Scores of <4 indicate no disability, 5-14 mild disability, 15-25 moderate disability, 25-34 severe disability and >35 complete disability
Time Frame
pre-treatment, 4, 8, 16 weeks
Secondary Outcome Measure Information:
Title
Kinesiophobia
Description
The Tampa Scale for Kinesiophobia, developed by Miller was used to assess fear of movement and injury. We used a 11-items version.
Time Frame
Pre-treatment, 4, 8, 16 weeks
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, 4, 8, 16 weeks
Title
Fear Avoidance Belief Questionnaire (FABQ)
Description
The FABQ assesses patient beliefs with regard to the effect of physical activity and work on their pain. It consists of 16 items and patients rate their agreement with each statement on a 7- point Likert scale (0 = completely disagree, 6 = completely agree).
Time Frame
Pre-treatment, 4, 8, 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The subjects for the study were selected if they fulfilled the following inclusion criteria: Aged between 18 to 60 years old, head and/or neck pain for at least 12 weeks and having the willing to undergo the treatment.
Exclusion Criteria:
if they had appearance of "red flags", 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josue Fernandez-Carnero, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
25888653
Citation
Beltran-Alacreu H, Lopez-de-Uralde-Villanueva I, Fernandez-Carnero J, La Touche R. Manual Therapy, Therapeutic Patient Education, and Therapeutic Exercise, an Effective Multimodal Treatment of Nonspecific Chronic Neck Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2015 Oct;94(10 Suppl 1):887-97. doi: 10.1097/PHM.0000000000000293.
Results Reference
derived
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Manual Therapy Versus Manual Therapy and Exercise and Education in Chronic Neck Pain
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