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Manual Therapy to the Cervical Spine and Diaphragm Combined With Breathing Reeducation Exercises, in nsCNP Patients

Primary Purpose

Chronic Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Cervical plus Diaphragmatic Manual Therapy plus Breathing Reeducation Exercises
Cervical Manual Therapy plus sham Diaphragmatic Manual Therapy
Conventional Physiotherapy Program
Sponsored by
University of West Attica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring neck pain,diaphragm manual, manual therapy

Eligibility Criteria

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

Inclusion Criteria:

  • Individuals who have pain for at least 3 months with non-specific mechanical neck pain
  • Individuals voluntarily participating in the study
  • Patients will also be selected on the basis of demonstrating DB in at least one of a series of tests conducted to assess the extent of their Dysfunctional Breathing (biomechanical, biochemical, psychological)

Exclusion Criteria:

  • Pregnancy

    • Contraindications for manual therapy or inability to complete the treatment
    • Patients who received physiotherapy or osteopathic treatment during the last 3 months
    • Individuals with bronchial asthma, chronic bronchitis, emphysema, bronchiectasis and malignancy
    • Medical diagnosis of rheumatologic disease
    • Medical diagnosis of respiratory disease (COPD, asthma)
    • Spine surgery (cervical, spinal, thoracic or abdominal region)
    • Medical diagnosis of cancer (past or present)
    • Whiplash injuries
    • Previous cervical fracture
    • Cervical anatomical changes
    • Thrombotic events, Anaemia or Diabetes
    • Body temperature greater than 37 degrees in the previous 48 hours
    • Obesity (BMI greater than 40)
    • Scoliosis or other diseases that cause spine and chest deformity
    • Positive cervical region instability and positive vertebral artery test
    • Individuals with neurological deficits or with motor loss
    • Individuals who have whiplash injuries, osteoporosis, or rheumatoid disease (such as rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome)

Sites / Locations

  • Tatsios PetrosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

Diaphragmatic Manual Therapy Group A

Cervical Manual Therapy Group B

Conventional Physiotherapy Program Group C

Arm Description

Experimental: Diaphragmatic Manual Therapy plus Cervical Manual Therapy plus Breathing Reeducation Exercises group. Cervical manual therapy will be the same as for the Manual Control Group (20 minutes). Diaphragmatic Manual Therapy (10 minutes) and Breathing Reeducation Exercises (10 minutes). The program will be carried out three times per week lasting four weeks in total. Each session will last about 40 minutes.

Sham Comparator: Sham Treatment group or Manual Control Group Patients included in this group will receive Cervical Manual Therapy (25 minutes) plus sham Diaphragmatic Manual techniques (15 minutes). The program will be carried out three times per week lasting four weeks in total. Each session will last about 40 minutes.

Active Comparator: Conventional Treatment group Patients included in this group will receive a conventional physiotherapy program with Transcutaneous Electrical Nerve Stimulation-TENS (15 minutes) plus Microwave pulsed Diathermy (10 minutes), and soft tissue techniques (15 minutes). The program will be carried out three sessions per week during the four weeks. Each session will last about 40 minutes.

Outcomes

Primary Outcome Measures

Change in Neck Disability Index (NDI)
The NDI consists of 10 sections. Each section is scored on a 0 (no pain) to 5 (worst imaginable pain) rating scale. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.
Pain Intensity VAS
Visual Analog Scale: Minimum value = 0 (Best outcome); Maximum value = 100 (Worst Outcome)

Secondary Outcome Measures

Change in Range of motion (ROM)
A smartphone-based application and KFORCE SENS electronic goniometer, KINVENT, France will be used to accurately measure ROM during neck movements of Flexion-Extension, Left-Right Side Flexion, and Left-Right Rotation.
Craniovertebral Angle
Lateral Photography- examination of the FHP through lateral photographs can provide very reliable estimates. The reliability remained high in both the sitting and standing position.
Nijmegen Questionnaire (NQ)
Screening tool used to detect patients with hyperventilation complaints and DB patterns. Scores>20 are used as the cut-score to identify DB in patients with various conditions. NQ values in healthy individuals range from 10 to 12 ± 7 and values do tend to decrease towards these levels after breathing retraining.
Hi-Lo test
A test that assesses breathing dysfunction. Instructions will be given to the examiners for how to perform and record the Hi-Lo: ''Examiner at the front and slightly to the side of the person have to place one hand on the sternum of the patient and the other hand on their upper abdomen. The examiner has to determine whether thoracic or abdominal motion is dominant during breathing and to what extent this is so. Also, has to check for paradoxical breathing. The extent of thoracic or abdominal breathing rate using a score between 1 and 3.
Single Breath Count (SBC)
A test that assesses breathing dysfunction. To perform, ask the patient to count out loud after maximal inspiration. The ability to reach 50 indicates normal respiratory function.
End Tidal CO2 (ETCO2) and Respiratory Rate (RR)
Measured by Capnography. ETCO2 less than 35 mmHg, RR of 16 breaths/min or more, will be considered as signs of respiratory pattern abnormality.
Breath Holding Time
A test that assesses DB. This test is an indicator of a person's respiratory response to biochemical, biomechanical, and psychological fac-tors, and it seems that abnormally, shortened, BHT may indicate abnormalities in the respiratory function that are closely related to DB. Participants will be instructed to assume a comfortable sitting position and breath usually and gently in and out and at the end of a normal exhalation, they will be asked to pinch their nose and hold their breath. The instruction is to hold their breath until they cannot hold their breath any longer and require breathing in again. According to Kiesel (2020) [30], a BHT <25 secs is con-sidered as a sign of DB.
Chest Expansion
The difference between the values obtained during deep inspiration and expiration will be determined by tape ruler (cm), high degrees represent better outcome, low degrees represent worse outcome
Hospital and Anxiety Depression Scale (HADS) (Greek version 2007)
Assesses the level of anxiety and depression experienced by patients in a hospital outpatient clinic. A subscale score >8 denotes anxiety or depression.
Tampa Scale for Kinesiophobia (TSK) (Greek version 2005)
Kinesiophobia is one of the most frequently employed measures for assessing pain-related fear in pain patients through a 17-item questionnaire.
Adverse events
Through an interview, potential adverse effects are evaluated during and after the physiotherapy treatment.

Full Information

First Posted
January 27, 2022
Last Updated
November 22, 2022
Sponsor
University of West Attica
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1. Study Identification

Unique Protocol Identification Number
NCT05229393
Brief Title
Manual Therapy to the Cervical Spine and Diaphragm Combined With Breathing Reeducation Exercises, in nsCNP Patients
Official Title
The Effectiveness of Manual Therapy to the Cervical Spine and Diaphragm,Combined With Breathing Reeducation Exercises, in Patients With Non-specific Chronic Neck Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of West Attica

4. Oversight

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

5. Study Description

Brief Summary
Chronic neck pain (CNP) is reported to be one of the most common musculoskeletal pain syndromes. Studies showed that patients with chronic neck pain compensated with changes in Pain, Function, Musculoskeletal and Respiratory outcomes. The diaphragm is a primary respiratory muscle contributing to postural stability and spinal control. Many studies showed that manual therapy and exercise improve clinical and respiratory outcomes in CNP patients. Few studies highlight the importance of diaphragm manual therapy and Reeducation Breathing Exercises in musculoskeletal diseases and in CNP patients. However, the exact mechanism is still unclear. This study aims to examine the hypothesis that: "Diaphragm Manual Therapy and Breathing Reeducation Exercises combined with cervical manual therapy - improve clinical and respiratory outcomes more than cervical manual therapy intervention only or conventional physiotherapy
Detailed Description
Chronic neck pain (CNP) may affect the physical, social, and psychological aspects of the individual, contributing to the increase in costs in society and business. Neck pain is a major cause of morbidity and disability in everyday life and at the workplace, in many different countries and populations, but its basic pathology and pathophysiology are still unclear. CNP patients present respiratory dysfunction and pain presence is accompanied by a varying amount of decrements in several clinical outcomes affecting the neuromusculoskeletal system like disability, range of motion restriction, and decreased proprioception as well as neuromuscular control. However, the quality of life and psychology of patients with CNP are affected in parallel. The diaphragm is the most important respiratory muscle also contributing to postural stability and spinal control. Several studies have shown that diaphragm manual therapy and breathing retraining exercises can improve respiratory, as well as pain, function, and musculoskeletal outcomes in chronic low back pain. However, the effectiveness in patients with chronic neck pain has not been definitively determined in relation to other physical therapy interventions. The primary purpose of the present study is to determine further the effectiveness of Diaphragmatic Manual Therapy and Breathing Reeducation Exercises in CNP patients. The secondary purpose is to investigate the relationship between CNP, breathing dysfunction, pain, disability, and musculoskeletal clinical outcomes. The present study is expected to recruit 90 patients with CNP. Patients with CNP will be randomly assigned to (1) Diaphragmatic Manual Therapy plus Cervical Manual Therapy plus Breathing Reeducation Exercises (2) Cervical Manual Therapy plus sham Diaphragmatic Manual Therapy and (3) Conventional Physiotherapy. Each participant will receive a particular intervention program depending on their group allocation. All participants will receive two evaluation sessions before and after the intervention.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
the outcome assessor will be blind only for those outcomes that are not self-reported
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diaphragmatic Manual Therapy Group A
Arm Type
Experimental
Arm Description
Experimental: Diaphragmatic Manual Therapy plus Cervical Manual Therapy plus Breathing Reeducation Exercises group. Cervical manual therapy will be the same as for the Manual Control Group (20 minutes). Diaphragmatic Manual Therapy (10 minutes) and Breathing Reeducation Exercises (10 minutes). The program will be carried out three times per week lasting four weeks in total. Each session will last about 40 minutes.
Arm Title
Cervical Manual Therapy Group B
Arm Type
Sham Comparator
Arm Description
Sham Comparator: Sham Treatment group or Manual Control Group Patients included in this group will receive Cervical Manual Therapy (25 minutes) plus sham Diaphragmatic Manual techniques (15 minutes). The program will be carried out three times per week lasting four weeks in total. Each session will last about 40 minutes.
Arm Title
Conventional Physiotherapy Program Group C
Arm Type
Active Comparator
Arm Description
Active Comparator: Conventional Treatment group Patients included in this group will receive a conventional physiotherapy program with Transcutaneous Electrical Nerve Stimulation-TENS (15 minutes) plus Microwave pulsed Diathermy (10 minutes), and soft tissue techniques (15 minutes). The program will be carried out three sessions per week during the four weeks. Each session will last about 40 minutes.
Intervention Type
Other
Intervention Name(s)
Cervical plus Diaphragmatic Manual Therapy plus Breathing Reeducation Exercises
Intervention Description
Diaphragmatic Manual Therapy consists of techniques intended to indirectly stretch and mobilize the diaphragmatic muscle fibers. This will help to improve muscle contraction and decrease tension. The experimental maneuvers include the Doming Diaphragmatic Technique as described by Leon Chaitow, Lewit, and the Manual Diaphragmatic Release Technique as described by Leon Chaitow. Both maneuvers are performed in two sets of 10 repetitions, within a 1-minute interval. Cervical Manual Therapy consists of vertebral mobilization techniques according to the Mulligan technique. Breathing Reeducation Exercises consist of i) recognition of the abnormal breathing pattern, ii) relaxation techniques for all the primary and accessory respiratory muscles, iii) diaphragm breathing reeducation iv) pursed lips exercise v) reeducation of the normal breathing rate
Intervention Type
Other
Intervention Name(s)
Cervical Manual Therapy plus sham Diaphragmatic Manual Therapy
Intervention Description
Ultrasound sham as Diaphragmatic Manual techniques. Disconnected ultrasound will be applied in the same position as for the experimental group for 15 min as a placebo treatment. Cervical Manual Therapy: will consist of vertebral mobilization techniques according to Mulligan -
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy Program
Intervention Description
Conventional Physiotherapy Program consists of TENS for 15min, Microwave pulsed Diathermy for 10min, soft tissue techniques for 15min
Primary Outcome Measure Information:
Title
Change in Neck Disability Index (NDI)
Description
The NDI consists of 10 sections. Each section is scored on a 0 (no pain) to 5 (worst imaginable pain) rating scale. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.
Time Frame
change from baseline up to 4 weeks and up to 3 months
Title
Pain Intensity VAS
Description
Visual Analog Scale: Minimum value = 0 (Best outcome); Maximum value = 100 (Worst Outcome)
Time Frame
change from baseline up to 4 weeks and up to 3 months
Secondary Outcome Measure Information:
Title
Change in Range of motion (ROM)
Description
A smartphone-based application and KFORCE SENS electronic goniometer, KINVENT, France will be used to accurately measure ROM during neck movements of Flexion-Extension, Left-Right Side Flexion, and Left-Right Rotation.
Time Frame
change from baseline up to 4 weeks and up to 3 months
Title
Craniovertebral Angle
Description
Lateral Photography- examination of the FHP through lateral photographs can provide very reliable estimates. The reliability remained high in both the sitting and standing position.
Time Frame
change from baseline up to 4 weeks and up to 3 months
Title
Nijmegen Questionnaire (NQ)
Description
Screening tool used to detect patients with hyperventilation complaints and DB patterns. Scores>20 are used as the cut-score to identify DB in patients with various conditions. NQ values in healthy individuals range from 10 to 12 ± 7 and values do tend to decrease towards these levels after breathing retraining.
Time Frame
change from baseline up to 4 weeks and up to 3 months
Title
Hi-Lo test
Description
A test that assesses breathing dysfunction. Instructions will be given to the examiners for how to perform and record the Hi-Lo: ''Examiner at the front and slightly to the side of the person have to place one hand on the sternum of the patient and the other hand on their upper abdomen. The examiner has to determine whether thoracic or abdominal motion is dominant during breathing and to what extent this is so. Also, has to check for paradoxical breathing. The extent of thoracic or abdominal breathing rate using a score between 1 and 3.
Time Frame
change from baseline up to 4 weeks and up to 3 months
Title
Single Breath Count (SBC)
Description
A test that assesses breathing dysfunction. To perform, ask the patient to count out loud after maximal inspiration. The ability to reach 50 indicates normal respiratory function.
Time Frame
change from baseline up to 4 weeks and up to 3 months
Title
End Tidal CO2 (ETCO2) and Respiratory Rate (RR)
Description
Measured by Capnography. ETCO2 less than 35 mmHg, RR of 16 breaths/min or more, will be considered as signs of respiratory pattern abnormality.
Time Frame
change from baseline up to 4 weeks and up to 3 months
Title
Breath Holding Time
Description
A test that assesses DB. This test is an indicator of a person's respiratory response to biochemical, biomechanical, and psychological fac-tors, and it seems that abnormally, shortened, BHT may indicate abnormalities in the respiratory function that are closely related to DB. Participants will be instructed to assume a comfortable sitting position and breath usually and gently in and out and at the end of a normal exhalation, they will be asked to pinch their nose and hold their breath. The instruction is to hold their breath until they cannot hold their breath any longer and require breathing in again. According to Kiesel (2020) [30], a BHT <25 secs is con-sidered as a sign of DB.
Time Frame
change from baseline up to 4 weeks and up to 3 months
Title
Chest Expansion
Description
The difference between the values obtained during deep inspiration and expiration will be determined by tape ruler (cm), high degrees represent better outcome, low degrees represent worse outcome
Time Frame
change from baseline up to 4 weeks and up to 3 months
Title
Hospital and Anxiety Depression Scale (HADS) (Greek version 2007)
Description
Assesses the level of anxiety and depression experienced by patients in a hospital outpatient clinic. A subscale score >8 denotes anxiety or depression.
Time Frame
change from baseline up to 4 weeks and up to 3 months
Title
Tampa Scale for Kinesiophobia (TSK) (Greek version 2005)
Description
Kinesiophobia is one of the most frequently employed measures for assessing pain-related fear in pain patients through a 17-item questionnaire.
Time Frame
change from baseline up to 4 weeks and up to 3 months
Title
Adverse events
Description
Through an interview, potential adverse effects are evaluated during and after the physiotherapy treatment.
Time Frame
change from baseline up to 4 weeks and up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals who have pain for at least 3 months with non-specific mechanical neck pain Individuals voluntarily participating in the study Patients will also be selected on the basis of demonstrating DB in at least one of a series of tests conducted to assess the extent of their Dysfunctional Breathing (biomechanical, biochemical, psychological) Exclusion Criteria: Pregnancy Contraindications for manual therapy or inability to complete the treatment Patients who received physiotherapy or osteopathic treatment during the last 3 months Individuals with bronchial asthma, chronic bronchitis, emphysema, bronchiectasis and malignancy Medical diagnosis of rheumatologic disease Medical diagnosis of respiratory disease (COPD, asthma) Spine surgery (cervical, spinal, thoracic or abdominal region) Medical diagnosis of cancer (past or present) Whiplash injuries Previous cervical fracture Cervical anatomical changes Thrombotic events, Anaemia or Diabetes Body temperature greater than 37 degrees in the previous 48 hours Obesity (BMI greater than 40) Scoliosis or other diseases that cause spine and chest deformity Positive cervical region instability and positive vertebral artery test Individuals with neurological deficits or with motor loss Individuals who have whiplash injuries, osteoporosis, or rheumatoid disease (such as rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PETROS TATSIOS, MSc, MSc, PhD cand
Phone
00306972886149
Email
petrostatsios@hotmail.gr
First Name & Middle Initial & Last Name or Official Title & Degree
University of West Attica
Facility Information:
Facility Name
Tatsios Petros
City
Glyfada
State/Province
Athens
ZIP/Postal Code
16561
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PETROS TATSIOS
Phone
+30 6972886149
Email
petrostatsios@hotmail.gr
First Name & Middle Initial & Last Name & Degree
GEORGIOS KOUMANTAKIS
Phone
+306974377707
Email
gkoumantakis@uniwa.gr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Immediately following publication
IPD Sharing Access Criteria
Anyone who wishes to access the data.
Citations:
PubMed Identifier
33992285
Citation
Simoni G, Bozzolan M, Bonnini S, Grassi A, Zucchini A, Mazzanti C, Oliva D, Caterino F, Gallo A, Da Roit M. Effectiveness of standard cervical physiotherapy plus diaphragm manual therapy on pain in patients with chronic neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:481-491. doi: 10.1016/j.jbmt.2020.12.032. Epub 2021 Feb 16.
Results Reference
result
PubMed Identifier
25435700
Citation
Hwangbo PN, Hwangbo G, Park J, Lee S. The Effect of Thoracic Joint Mobilization and Self-stretching Exercise on Pulmonary Functions of Patients with Chronic Neck Pain. J Phys Ther Sci. 2014 Nov;26(11):1783-6. doi: 10.1589/jpts.26.1783. Epub 2014 Nov 13.
Results Reference
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PubMed Identifier
28602744
Citation
Genebra CVDS, Maciel NM, Bento TPF, Simeao SFAP, Vitta A. Prevalence and factors associated with neck pain: a population-based study. Braz J Phys Ther. 2017 Jul-Aug;21(4):274-280. doi: 10.1016/j.bjpt.2017.05.005. Epub 2017 May 20.
Results Reference
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PubMed Identifier
33275908
Citation
Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1. Erratum In: Lancet. 2020 Dec 4;:
Results Reference
result
PubMed Identifier
30774207
Citation
Koseki T, Kakizaki F, Hayashi S, Nishida N, Itoh M. Effect of forward head posture on thoracic shape and respiratory function. J Phys Ther Sci. 2019 Jan;31(1):63-68. doi: 10.1589/jpts.31.63. Epub 2019 Jan 10.
Results Reference
result
PubMed Identifier
33464539
Citation
Peng B, Yang L, Li Y, Liu T, Liu Y. Cervical Proprioception Impairment in Neck Pain-Pathophysiology, Clinical Evaluation, and Management: A Narrative Review. Pain Ther. 2021 Jun;10(1):143-164. doi: 10.1007/s40122-020-00230-z. Epub 2021 Jan 12.
Results Reference
result
PubMed Identifier
24835338
Citation
Wirth B, Amstalden M, Perk M, Boutellier U, Humphreys BK. Respiratory dysfunction in patients with chronic neck pain - influence of thoracic spine and chest mobility. Man Ther. 2014 Oct;19(5):440-4. doi: 10.1016/j.math.2014.04.011. Epub 2014 Apr 30.
Results Reference
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PubMed Identifier
17959320
Citation
Kapreli E, Vourazanis E, Strimpakos N. Neck pain causes respiratory dysfunction. Med Hypotheses. 2008;70(5):1009-13. doi: 10.1016/j.mehy.2007.07.050. Epub 2007 Oct 23.
Results Reference
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PubMed Identifier
25640070
Citation
Dimitriadis Z, Podogyros G, Polyviou D, Tasopoulos I, Passa K. The Reliability of Lateral Photography for the Assessment of the Forward Head Posture Through Four Different Angle-Based Analysis Methods in Healthy Individuals. Musculoskeletal Care. 2015 Sep;13(3):179-186. doi: 10.1002/msc.1095. Epub 2015 Jan 30. No abstract available.
Results Reference
result

Learn more about this trial

Manual Therapy to the Cervical Spine and Diaphragm Combined With Breathing Reeducation Exercises, in nsCNP Patients

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