Clinical trial NCT05212753: The Effect of Breathing Exercise and Stabilization Exercise With Chronic Low Back Pain
Official title: The Effect of Sleep Hygiene, Breathing and Stabilization Exercises on Pain, Sleep Quality and Anxiety Level in Patients With Chronic Non-Specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Sleep Hygiene
Anxiety
Keywords: Nonspecific Chronic Low Back Pain
Sleep Quality
Breathing Exercises
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effect of sleep hygiene, breathing exercises, and stabilization exercises on pain, sleep quality, and anxiety level in patients with non-specific chronic low back pain.

Detailed description: Addressing sleep problems in patients with chronic non-specific low back pain (LBP) can reduce chronic pain, the risk of developing depressive illness and improve pain-related quality of life.

Sleep is a concept that has physiological, psychological, and social dimensions. Sleep is one of the essential and indispensable daily life activities that affect individuals' quality of life and well-being. Decreasing pain is expected and likely to improve sleep quality. Still, it is unknown what will happen due to improving sleep quality to resolve the pain of unknown origin.

Education about sleep hygiene with physiotherapy has not been assessed before on individuals with nonspecific LBP. Since this training will require a lifestyle change, individuals should be warned not once but several times in a certain time, and this training should be reinforced. This will be an advantage for the patients receiving physiotherapy, and their therapists will support them in applying this training during the physiotherapy sessions.

In our study, individuals with nonspecific chronic low back pain will be divided into three groups using the blinding method as part of a randomized controlled trial.

The first group, as the conventional physical therapy group, will receive a hot pack and TENS only.

The second group, as the stabilization group, will receive lumbar stabilization exercises and the conventional physical therapy program.

The third group, as the breathing exercise group, will receive breathing exercises, including sleep hygiene and stabilization group program.

Eligibility criteria: Inclusion Criteria:

* individuals between the ages of 18-65
* Having low back pain for at least the last 3 months
* Pain at 4 out of 10 according to VAS (Visual Analogue Scale)

Exclusion Criteria:

* Radiculopathies
* Body mass index \> 35
* Neurological, orthopedic, or cardiopulmonary diseases that will contraindicate exercise
* Treatment for pain in the last 3 months who have received
* individuals who can't cooperate and those who have problems adapting to exercises

Primary outcomes:
measure: Change from Baseline in Pain at 3 weeks and 8 weeks
timeFrame: Baseline, 3 weeks, 8 weeks
measure: Change from Baseline in Form of Pain at 3 weeks and 8 weeks
timeFrame: Baseline, 3 weeks, 8 weeks
measure: Change from Baseline in Sleep Quality at 3 weeks and 8 weeks
timeFrame: Baseline, 3 weeks, 8 weeks
measure: Change from Baseline in Anxiety at 3 weeks and 8 weeks
timeFrame: Baseline, 3 weeks, 8 weeks
measure: Change from Baseline in Fatigue at 3 weeks and 8 weeks
timeFrame: Baseline, 3 weeks, 8 weeks
Secondary outcomes:
measure: Obstructive Sleep Apnea Risk Screening İn İndividuals With Chronic Non-Specific Low Back Pain
timeFrame: Baseline
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: İslahiye İlçe Hast.
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur Tuncer, PhD
role: STUDY_DIRECTOR
References: