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Effects of a Single Manual Therapy-Exercise Versus Exercise Session in Patients With Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise
Manual Therapy + Exercise
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring spine, manual therapy, exercise, chronic neck pain

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects diagnosed with chronic neck pain
  • More than 18 years old
  • Loss of mobility in one or more upper cervical spine segments found through manual assessment according to Zito et al. (2006) and Kaltenborn (2012).
  • A positive result in the Flexion rotation-test in the upper cervical spine (less than 32º or a difference of 10º or more between the two rotations.
  • Not being able to exceed 24 mmHg in the cranio-cervical flexion test.
  • Signing the informed consent.

Exclusion Criteria:

  • Contraindication to manual therapy or exercise (pathological changes due to neoplasm, inflammation infections, osteopenia, congenital collagenous compromise syndromes "Down´s, Ehlers-Danlos, Grisel, Morquio"
  • Marked degeneration of the cervical spine that may affect cervical spine ligament integrity.
  • History of trauma to cervical vessels.
  • Anticoagulant therapy or blood clotting disorders or to have participated in any program of exercises or manual therapy treatments designed to improve the performance of the cervical region in the previous 3 months.
  • Post-traumatic neck pain or red flags according to Rushton et al.
  • Inability to maintain the supine position, use of pacemakers, an inability to perform the flexion rotation-test
  • Language difficulties that hinder understanding of informed consent or completion of the questionnaires necessary for this study.
  • Subjects with litigation or lawsuits pending

Sites / Locations

  • Universitat Internacional de CatalunyaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Exercise Group

Exercise + Manual Therapy Group

Arm Description

20-minute session, composed of 2 blocks of 10 repetitions, holding each exercise for 10 seconds, a 40-second rest between each repetition and 2 minutes between blocks.

20-minute session. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise

Outcomes

Primary Outcome Measures

Active range of motion mobility in the inferior cervical region (º)
Mobility in the inferior cervical region will be evaluated in a sitting position with the back vertical and resting on the backrest of the chair with a CROM device (floating compass; Plastimo Airguide, Inc, Buffalo Groove,IL). Flexion, extension, right and left side-bending and right and left rotation will be measured. Three measurements will be made for each movement, and the result will be the mean of the three measurements.
Active range of motion mobility in the upper cervical region (º)
Flexion rotation-test will be used to measure the upper rotation, predominantly at C1-2. To perform this test, the subjects position themselves in the supine position and the evaluator passively will take the patients cervical spine to its maximum flexion and then will rotated the head to the right and left side with the occiput resting against the evaluator's abdomen. The movement will stopped at whichever situation occurs first, either the subject presents symptoms, or the evaluator reaches the end of the range of motion and finds a firm end feel. A CROM device will be used too, and three measurements will be performed for each movement, with the result being the mean of the three measurements
Pressure Pain Threshold (Kpa)
Cervical pressure pain threshold (PPT) will be measured using a digital algometer (Somedic AB Farsta, Somedic SenseLab AB, Sweden) with a round surface area of 1 cm2, and pressure will be applied at the rate of 1 kg/cm2/s perpendicular to the skin. With the subject supine, PPT will be assessed over 6 points bilaterally with a 10-second rest between each measurement: first metacarpal joint, upper trapezius muscle, elevator of scapula, C5-6 zygapophyseal joint, C2-3 zygapophyseal joint, and suboccipital muscles. Patients will be instructed to press the button of the digital algometer at the precise moment that pressure sensation changed to pain. The mean of 3 trials will be calculated over each point and used for analysis.

Secondary Outcome Measures

Pain Intensity (Visual analogue scale 0-100 mm)
Intensity of pain in the cervical region will be measured with VAS from 0 to 100 mm in length, with the extremes defined as "no pain" (0) and "the worst pain imaginable" (100) and without any intermediate points.

Full Information

First Posted
October 7, 2021
Last Updated
October 20, 2021
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT05085600
Brief Title
Effects of a Single Manual Therapy-Exercise Versus Exercise Session in Patients With Chronic Neck Pain
Official Title
Effects of a Single Manual Therapy-Exercise Versus Exercise Session in Patients With Chronic Neck Pain and Upper Cervical Spine Dysfunction. Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2021 (Anticipated)
Primary Completion Date
November 20, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

4. Oversight

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

5. Study Description

Brief Summary
Chronic neck pain is described as pain located between the occiput and the third thoracic vertebra that persists for more than 3 months. Chronic neck pain is one of the biggest musculoskeletal health problem in industrialized countries, representing 14.6% of all such problems today. 50% of the adult population will experience cervical pain at some point during the year. The objective of this study is to compare the effectiveness of a single exercise session with manual therapy techniques of the upper cervical spine against a single exercise session in patients with chronic neck pain and upper cervical spine dysfunction. The treatment will be applied by 1 therapist with orthopedic manual therapist (MT)-specialist training and more than 10 years of MT experience. The primary outcome measurements will be cervical mobility and cervical pressure pain threshold. Intensity of pain will be also used as secondary outcome measure. These measurements shall be taken before and immediately after the relevant intervention. Exercise Group After the baseline assessments, patients will performed the cervical stabilization exercise, and will taught to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine. In addition, progress will continued in the exercise of the contraction of deep neck flexor muscles in other positions. The progression of the exercises will be adapted to each patient, depending on their evolution. Firstly, exercises will undertaken in the supine and standing positions; once these positions will be mastered, the exercises progressed to asymmetric positions with cervical bending and/or rotation toward each patient's most symptomatic side. Also, no pain will be allowed in the positions. Exercises were always carried out without pain, because pain can be an inhibitor of muscle contraction. The Exercise (E) group will carried out one 20-minute session, composed of 2 blocks of 10 repetitions, holding each exercise for 10 seconds, a 40-second rest between each repetition and 2 minutes between blocks. Manual Therapy + Exercise Group The MT + E group will carried out 20-minute sessions led by an experienced physical therapist. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation (high velocity low amplitude) and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise. The MT techniques were applied depending on the clinical findings in each patient.
Detailed Description
Chronic neck pain is described as pain located between the occiput and the third thoracic vertebra that persists for more than 3 months. Chronic neck pain is one of the biggest musculoskeletal health problem in industrialized countries, representing 14.6% of all such problems today. 50% of the adult population will experience cervical pain at some point during the year. The objective of this study is to compare the effectiveness of a single exercise session with manual therapy techniques of the upper cervical spine against a single exercise session in patients with chronic neck pain and upper cervical spine dysfunction. The treatment will be applied by 1 therapist with orthopedic manual therapist (MT)-specialist training and more than 10 years of MT experience. The primary outcome measurements will be cervical mobility and cervical pressure pain threshold. Intensity of pain will be also used as secondary outcome measure. These measurements shall be taken before and immediately after the relevant intervention. Exercise Group After the baseline assessments, patients will performed the cervical stabilization exercise, and will taught to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine. In addition, progress will continued in the exercise of the contraction of deep neck flexor muscles in other positions. The progression of the exercises will be adapted to each patient, depending on their evolution. Firstly, exercises will undertaken in the supine and standing positions; once these positions will be mastered, the exercises progressed to asymmetric positions with cervical bending and/or rotation toward each patient's most symptomatic side. Also, no pain will be allowed in the positions. Exercises were always carried out without pain, because pain can be an inhibitor of muscle contraction. The Exercise (E) group will carried out one 20-minute session, composed of 2 blocks of 10 repetitions, holding each exercise for 10 seconds, a 40-second rest between each repetition and 2 minutes between blocks. Manual Therapy + Exercise Group The MT + E group will carried out 20-minute sessions led by an experienced physical therapist. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation (high velocity low amplitude) and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise. The MT techniques were applied depending on the clinical findings in each patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
spine, manual therapy, exercise, chronic neck pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
20-minute session, composed of 2 blocks of 10 repetitions, holding each exercise for 10 seconds, a 40-second rest between each repetition and 2 minutes between blocks.
Arm Title
Exercise + Manual Therapy Group
Arm Type
Experimental
Arm Description
20-minute session. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Patients will begin performing the cervical stabilization exercise, and will taught to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine. In addition, progress will continued in the exercise of the contraction of deep neck flexor muscles in other positions. The progression of the exercises will be adapted to each patient, depending on their evolution. Firstly, exercises will undertaken in the supine and standing positions; once these positions will mastered, the exercises progressed to asymmetric positions with cervical bending and/or rotation toward each patient's most symptomatic side.
Intervention Type
Other
Intervention Name(s)
Manual Therapy + Exercise
Intervention Description
20-minute session. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise
Primary Outcome Measure Information:
Title
Active range of motion mobility in the inferior cervical region (º)
Description
Mobility in the inferior cervical region will be evaluated in a sitting position with the back vertical and resting on the backrest of the chair with a CROM device (floating compass; Plastimo Airguide, Inc, Buffalo Groove,IL). Flexion, extension, right and left side-bending and right and left rotation will be measured. Three measurements will be made for each movement, and the result will be the mean of the three measurements.
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Active range of motion mobility in the upper cervical region (º)
Description
Flexion rotation-test will be used to measure the upper rotation, predominantly at C1-2. To perform this test, the subjects position themselves in the supine position and the evaluator passively will take the patients cervical spine to its maximum flexion and then will rotated the head to the right and left side with the occiput resting against the evaluator's abdomen. The movement will stopped at whichever situation occurs first, either the subject presents symptoms, or the evaluator reaches the end of the range of motion and finds a firm end feel. A CROM device will be used too, and three measurements will be performed for each movement, with the result being the mean of the three measurements
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Pressure Pain Threshold (Kpa)
Description
Cervical pressure pain threshold (PPT) will be measured using a digital algometer (Somedic AB Farsta, Somedic SenseLab AB, Sweden) with a round surface area of 1 cm2, and pressure will be applied at the rate of 1 kg/cm2/s perpendicular to the skin. With the subject supine, PPT will be assessed over 6 points bilaterally with a 10-second rest between each measurement: first metacarpal joint, upper trapezius muscle, elevator of scapula, C5-6 zygapophyseal joint, C2-3 zygapophyseal joint, and suboccipital muscles. Patients will be instructed to press the button of the digital algometer at the precise moment that pressure sensation changed to pain. The mean of 3 trials will be calculated over each point and used for analysis.
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary Outcome Measure Information:
Title
Pain Intensity (Visual analogue scale 0-100 mm)
Description
Intensity of pain in the cervical region will be measured with VAS from 0 to 100 mm in length, with the extremes defined as "no pain" (0) and "the worst pain imaginable" (100) and without any intermediate points.
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects diagnosed with chronic neck pain More than 18 years old Loss of mobility in one or more upper cervical spine segments found through manual assessment according to Zito et al. (2006) and Kaltenborn (2012). A positive result in the Flexion rotation-test in the upper cervical spine (less than 32º or a difference of 10º or more between the two rotations. Not being able to exceed 24 mmHg in the cranio-cervical flexion test. Signing the informed consent. Exclusion Criteria: Contraindication to manual therapy or exercise (pathological changes due to neoplasm, inflammation infections, osteopenia, congenital collagenous compromise syndromes "Down´s, Ehlers-Danlos, Grisel, Morquio" Marked degeneration of the cervical spine that may affect cervical spine ligament integrity. History of trauma to cervical vessels. Anticoagulant therapy or blood clotting disorders or to have participated in any program of exercises or manual therapy treatments designed to improve the performance of the cervical region in the previous 3 months. Post-traumatic neck pain or red flags according to Rushton et al. Inability to maintain the supine position, use of pacemakers, an inability to perform the flexion rotation-test Language difficulties that hinder understanding of informed consent or completion of the questionnaires necessary for this study. Subjects with litigation or lawsuits pending
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacobo Rodríguez-Sanz, PhD
Phone
+34636136789
Email
jrodriguezs@uic.es
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Effects of a Single Manual Therapy-Exercise Versus Exercise Session in Patients With Chronic Neck Pain

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