Effect of Diaphragmatic Breathing Exercise on Pain and Sleep Quality in Individuals With Non-specific Chronic Neck Pain: A Randomized Control Trial

NCT06379763 | Completed Phase 2

• 1 other identifier: 170/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This research focuses on adding diaphragmatic breathing to conventional physiotherapy sessions, particularly for patients suffering from chronic neck pain aged between 20-40 years in Jordan. Chronic neck pain is recognized as one of the most prevalent musculoskeletal pain disorders, significantly impacting physical, social, and psychological aspects of life. This issue leads to a decline in functional performance and work productivity, negatively affecting both individual and societal levels. Several factors, such as poor posture and prolonged use of smartphones, contribute to the exacerbation of non-specific chronic neck pain. These problems also affect respiratory muscles, particularly the diaphragm responsible for primary respiration, resulting in a shift from abdominal to chest breathing. This alteration increases the use of neck muscles, subsequently intensifying neck pain and negatively impacting sleep quality in these individuals. The primary objective of this therapeutic study is to investigate the role of adding diaphragmatic breathing to physiotherapy sessions in alleviating pain and improving sleep quality. RCT study will investigate the effect of adding the diaphragmatic breathing to conventional physiotherapy treatment on pain and sleep quality over one month.

Conditions

Non-specific Chronic Neck Pain; Diaphragmatic Breathing Exercise

Keywords

diaphragmatic breathing; sleep Quality; pain; physiotherapy

Outcome Measures

Primary Outcomes (2)

• neck pain

  assessed by visual analogue scale. from 0 to 10 therefor 0 mean no pain where as 10 mean extremely pain

  assessed before and after 4 weeks

• neck pain

  assessed by neck disability index. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. The test can be interpreted as a raw score from 0 to 50, with a maximum score of 50, or as a percentage , therefor 0 mean no pain where as 50 mean extremely pain .

  assessed before and after 4 weeks

Secondary Outcomes (1)

• sleep quality

  assessed before and after 4 weeks

Study Arms (2)

group one

EXPERIMENTAL

diaphragmatic breathing exercise in addition to conventional physiotherapy such as ROM, stretching exercises for superficial neck muscles

Other: diaphragmatic breathing exercise; Other: conventional physiotherapy exercise

group two

ACTIVE COMPARATOR

conventional physiotherapy exercise such as ROM, stretching exercises for superficial neck muscles

Other: conventional physiotherapy exercise

Interventions

diaphragmatic breathing exercise OTHER

15-minute diaphragmatic breathing exercise from a semi-Fowler's position. Patients will be instructed to position one hand on the chest and the other on the belly, gradually inhaling deeply through the nose, moving from functional residual capacity to total lung capacity, and holding the breath for three seconds. Patients will be advised to relax their shoulders, maintain quiet upper chest movement, and allow the abdomen to slightly rise. Subsequently, patients will exhale slowly through the mouth for up to five seconds. Diaphragmatic breathing exercises will be organized into three sets lasting 15 minutes, with 3 minutes of active exercise and a 2-minute rest period between sets. During rest intervals, patients will be instructed to breathe normally. If individuals experience dizziness or discomfort, the session will stop.

Also known as: abdominal breathing exercise

group one

conventional physiotherapy exercise OTHER

conventional physiotherapy exercise such as ROM, stretching exercises for superficial neck muscles

group one; group two

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants aged between 20 and 40
• experienced neck pain for more than 3 months

You may not qualify if:

• Individuals with neurological or cardiorespiratory problems
• Individuals with cancer
• Individuals with officially diagnosed sleep disturbances
• Individuals with experiencing neck pain for less than 3 months
• Individuals with psychological diseases

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

The university of Jordan

Amman, 11942, Jordan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the participants will not know which of exercises that will be giving for them more better in experimental or control group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized clinical trial (RCT) Participants will be randomly allocated into two groups using the block randomization method. The following groups will be formed: experimental group A (diaphragmatic breathing plus conservative physiotherapy intervention, cervical neck ROM, neck stretching exercises), and group B,

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 23, 2024
• Study Start: March 1, 2024
• Primary Completion: May 30, 2024
• Study Completion: June 23, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)