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Effectiveness of Manual Therapy and Exercise vs Exercise in Subjects With Chronic Cervical Pain and Upper Cervical Spine Dysfunction

Primary Purpose

Neck Pain, Cervical Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy and Exercise
Exercise
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring manual therapy, exercise, physiotherapy, chronic cervical pain, upper cervical spain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years old and over
  • Medical diagnosis of chronic cervical pain (more than 3 months of cervical pain evolution)
  • Positive flexion rotation test

Exclusion Criteria:

  • Recent spine, head or mouth surgery.
  • Diabetes mellitus
  • Recent infection and/or inflammatory arthritis, and cervical and/or brain traumatism records.
  • Contraindication for manual therapy or cervical training

Sites / Locations

  • Faculty of Health Sciences of University of Zaragoza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual Therapy and Exercise Group

Exercise Group

Arm Description

Combination of manual therapy and exercises for chronic cervical pain

Only exercises for chronic cervical pain

Outcomes

Primary Outcome Measures

Change in Neck Disability Index (NDI) Questionnaire
The NDI is a modification of the Oswestry Low Back Pain Disability Index . It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain
Change in Flexion Rotation Test (FRT)
This test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32º

Secondary Outcome Measures

Change in Pressure Pain Threshold
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom. This force is applied by a portable and digital machine. This machine has a push button so the patient can press at the moment in which the applied force begins to be slightly painful. When the patient presses the button, the evaluator registers the number that appears on the screen.
Change in Cervical Range of Movement
Change in Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) is a one-dimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.
Change in Ultrasound
To measure the thickness of the longus colli muscle

Full Information

First Posted
September 6, 2018
Last Updated
February 13, 2020
Sponsor
Universidad de Zaragoza
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1. Study Identification

Unique Protocol Identification Number
NCT03670719
Brief Title
Effectiveness of Manual Therapy and Exercise vs Exercise in Subjects With Chronic Cervical Pain and Upper Cervical Spine Dysfunction
Official Title
Effectiveness of Manual Therapy and Exercise vs Exercise in Subjects With Chronic Cervical Pain and Upper Cervical Spine Dysfunction: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
There is a lot of scientific evidence about the effectiveness of manual therapy and exercise / training in subjects with cervical pain. Most of the high quality systematic reviews agree on the need to combine manual therapy and exercise for the treatment of chronic cervical pain. However, articles that focus on manual therapy in the treatment of the upper cervical spine are not as common, being that the most commonly prescribed exercises are those of craniocervical flexion, (flexion of the upper cervical spine). The investigators believe that participants who are going to benefit more from the integration of manual therapy and exercise will be those who have a real restriction of the upper cervical spine, and for these, is indispensable, the application of manual therapy techniques before the integration of the active exercise to obtain optimal results. This project is going to try to define participants with chronic cervical pain and upper cervical spine restriction that may benefit more from the combination of manual therapy and exercise than the rest. The investigators are going to study changes in different variables about function, pain, ultrasound, muscle tone, joints... Strengthen the importance of specificity in physiotherapy interventions and increase the evidence on the importance of manual therapy in a subgroup of participants with chronic cervical pain, improve knowledge about the involvement of the upper cervical spine in cervical pathology and check the effectiveness of a self-treatment program for participants with chronic cervical pain. The objective of this trial is to compare the effectiveness of an integrative approach of manual therapy associated with exercise versus exercise in participants with chronic cervical pain and upper cervical spine dysfunction. For this purpose, the investigators conduct a randomized controlled trial, simple-blind (Only is possible to blind the evaluator). The Sample size is 52 participants (2 groups of 26 participants). One of the groups will receive 4 training sessions with exercises for the cervical spine between 30 and 45 minutes duration per session and the other group will receive 4 sessions of a combination of manual therapy and training exercises also between 30 and 45 minutes each session. In addition, all participants will receive self-treatment techniques for self-management of their dysfunction. Cervical exercises will consist of a set of training techniques to improve the function and symptomatology that the participant has. These exercises have been widely evidenced and do not suppose any health risk. The techniques of manual therapy can be the manipulation technique in resting position, vertebral mobilization and / or musculature (massage and / or stretching). All the treatments applied follow the safety recommendations of the International Federation of Orthopedic Manual Therapists (IFOMPT). If participants need clarification, they can talk to the principal investigator (Jacobo Rodríguez Sanz) at any time. One physiotherapist will perform the physical examination, and a different one will apply the treatment. Physical therapists doing the screening will not know which group has been assigned to them, so the participant will be asked not to provide the evaluators any information about the assignment of his group to improve the quality of the study. The examination will consist of tests to assess whether the participant is a candidate to participate in the study, the measurement of pain, the exhaustive assessment of all cervical musculature with different measuring instruments and the measurement of joint mobility. The first day theparticipant be given information about his pain, his daily habits and activities that he usually does. The assessment of his problem will consist in the measurement of the amount of movement he can makes in the cervical area without pain, the ability to orient himself in certain movements with his eyes closed, the intensity of his pain, the evaluation of the state of his muscles. stabilizing as a mobilizer through ultrasound, muscle test and palpation. The functionality of his cervical vertebrae will also be evaluated and he will be asked different questionnaires about the functionality, pain and condition of his cervical pain, headache (in case of suffering) and kinesiophobia. Both the evaluation and the treatment will be without pain. In addition, he will be given a series of personalized exercises to improve his problem, which must be done every day during the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Cervical Pain
Keywords
manual therapy, exercise, physiotherapy, chronic cervical pain, upper cervical spain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Only the evaluator is blinded
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy and Exercise Group
Arm Type
Experimental
Arm Description
Combination of manual therapy and exercises for chronic cervical pain
Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
Only exercises for chronic cervical pain
Intervention Type
Other
Intervention Name(s)
Manual Therapy and Exercise
Intervention Description
Combination of physiotherapy (manual therapy) techniques and exercises for the cervical spine
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Exercises for the cervical spine
Primary Outcome Measure Information:
Title
Change in Neck Disability Index (NDI) Questionnaire
Description
The NDI is a modification of the Oswestry Low Back Pain Disability Index . It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain
Time Frame
Change between baseline (immediately before intervention) and post intervention (1 month), after 3 months
Title
Change in Flexion Rotation Test (FRT)
Description
This test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32º
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention), and post intervention (1 month) after 3 months
Secondary Outcome Measure Information:
Title
Change in Pressure Pain Threshold
Description
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom. This force is applied by a portable and digital machine. This machine has a push button so the patient can press at the moment in which the applied force begins to be slightly painful. When the patient presses the button, the evaluator registers the number that appears on the screen.
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention), and post intervention (1 month) after 3 months
Title
Change in Cervical Range of Movement
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention), and post intervention (1 month), after 3 months
Title
Change in Numeric Pain Rating Scale (NPRS)
Description
The Numeric Pain Rating Scale (NPRS) is a one-dimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention), and post intervention (1 month), after 3 months
Title
Change in Ultrasound
Description
To measure the thickness of the longus colli muscle
Time Frame
Change between baseline(immediately before intervention) and post intervention (1 month), after 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old and over Medical diagnosis of chronic cervical pain (more than 3 months of cervical pain evolution) Positive flexion rotation test Exclusion Criteria: Recent spine, head or mouth surgery. Diabetes mellitus Recent infection and/or inflammatory arthritis, and cervical and/or brain traumatism records. Contraindication for manual therapy or cervical training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacobo Rodríguez-Sanz, Pt
Organizational Affiliation
Physiotherapy Research Unit, University of Zaragoza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences of University of Zaragoza
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

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Effectiveness of Manual Therapy and Exercise vs Exercise in Subjects With Chronic Cervical Pain and Upper Cervical Spine Dysfunction

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