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

NCT05229393 | Completed

• 1 other identifier: UWestAttica300921
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Neck Pain

Keywords

neck pain,diaphragm manual, manual therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  change from baseline up to 4 weeks and up to 3 months

• Pain Intensity VAS

  Visual Analog Scale: Minimum value = 0 (Best outcome); Maximum value = 100 (Worst Outcome)

  change from baseline up to 4 weeks and up to 3 months

Secondary Outcomes (11)

• Change in Range of motion (ROM)

  change from baseline up to 4 weeks and up to 3 months

• Craniovertebral Angle

  change from baseline up to 4 weeks and up to 3 months

• Nijmegen Questionnaire (NQ)

  change from baseline up to 4 weeks and up to 3 months

• Hi-Lo test

  change from baseline up to 4 weeks and up to 3 months

• Single Breath Count (SBC)

  change from baseline up to 4 weeks and up to 3 months

Study Arms (3)

Diaphragmatic Manual Therapy Group A

EXPERIMENTAL

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.

Other: Cervical plus Diaphragmatic Manual Therapy plus Breathing Reeducation Exercises

Cervical Manual Therapy Group B

SHAM COMPARATOR

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.

Other: Cervical Manual Therapy plus sham Diaphragmatic Manual Therapy

Conventional Physiotherapy Program Group C

ACTIVE COMPARATOR

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.

Other: Conventional Physiotherapy Program

Interventions

Cervical plus Diaphragmatic Manual Therapy plus Breathing Reeducation Exercises OTHER

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

Diaphragmatic Manual Therapy Group A

Cervical Manual Therapy plus sham Diaphragmatic Manual Therapy OTHER

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 -

Cervical Manual Therapy Group B

Conventional Physiotherapy Program OTHER

Conventional Physiotherapy Program consists of TENS for 15min, Microwave pulsed Diathermy for 10min, soft tissue techniques for 15min

Conventional Physiotherapy Program Group C

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of West Attica: lead

Study Sites (1)

Tatsios Petros

Glyfada, Athens, 16561, Greece

Location

Related Publications (9)

• 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.

  PMID: 33992285 RESULT

• 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.

  PMID: 25435700 RESULT

• 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.

  PMID: 28602744 RESULT

• 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.

  PMID: 33275908 RESULT

• 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.

  PMID: 30774207 RESULT

• 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.

  PMID: 33464539 RESULT

• 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.

  PMID: 24835338 RESULT

• 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.

  PMID: 17959320 RESULT

• 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.

  PMID: 25640070 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the outcome assessor will be blind only for those outcomes that are not self-reported
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd cand., MSc, MSc, OMPT, CMP, Clinical Instructor Manual Therapy

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 8, 2022
• Study Start: October 31, 2022
• Primary Completion: November 21, 2023
• Study Completion: November 21, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately following publication
• Access Criteria: Anyone who wishes to access the data.

Locations

GR (1)