The Effect of Breathing Exercise and Stabilization Exercise With Chronic Low Back Pain

NCT ID: NCT05212753

Last Updated: 2023-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-08-30

Brief Summary

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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

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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.

Conditions

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Low Back Pain Sleep Hygiene Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional Physical Therapy Group

The conventional physical therapy group will receive Transcutaneous Electrical Nerve Stimulation (TENS) and hot pack application.

Group Type ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type DEVICE

Hot packs or hot water bags are superficial warming agents that will be used to heat muscle tissue, reduce muscle spasms and pain sensation. TENS is a pain reliever application.

Stabilization Group

The stabilization group will receive lumbar stabilization exercises and the conventional physical therapy program. That program includes lumbar stabilization exercises including activation of the transverses abdominals (TA) and multifidi muscles.

Group Type ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type DEVICE

Hot packs or hot water bags are superficial warming agents that will be used to heat muscle tissue, reduce muscle spasms and pain sensation. TENS is a pain reliever application.

Lumbar stabilization exercises

Intervention Type OTHER

Training about the concepts of stabilization and abdominal bracing is given before starting the study. The motor control tests for local muscles transversus abdominus and multifidi are performed after the training. The abdominal bracing test is performed in the quadruped position, in prone, and in hook lying position with the patient's spine supine with hips and knees flexed and knees in contact with the surface. The second stage consists of closed-chain segmental control exercises. It is a series of weight-bearing exercises are performed on stable and unstable surfaces. The last stage of the stabilization program is an open kinetic chain exercise to promote distal stability.

Breathing Exercise Group

The breathing exercise group will receive breathing exercises including sleep hygiene, and the stabilization group program. Breathing exercises include diaphragmatic breathing and pursed-lip.

Group Type ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type DEVICE

Hot packs or hot water bags are superficial warming agents that will be used to heat muscle tissue, reduce muscle spasms and pain sensation. TENS is a pain reliever application.

Lumbar stabilization exercises

Intervention Type OTHER

Training about the concepts of stabilization and abdominal bracing is given before starting the study. The motor control tests for local muscles transversus abdominus and multifidi are performed after the training. The abdominal bracing test is performed in the quadruped position, in prone, and in hook lying position with the patient's spine supine with hips and knees flexed and knees in contact with the surface. The second stage consists of closed-chain segmental control exercises. It is a series of weight-bearing exercises are performed on stable and unstable surfaces. The last stage of the stabilization program is an open kinetic chain exercise to promote distal stability.

Breathing exercises

Intervention Type OTHER

Breathing exercises consist of the techniques of diaphragmatic and pursed-lip breathing. During diaphragmatic breathing, attention is focused on the correct abdominal breathing. The pursed-lip breathing is one step further to the diaphragmatic breathing and a technique designed to have control time and volume over-breathing. This intervention also includes Sleep Hygiene education to the subjects,

Interventions

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Conventional physical therapy

Hot packs or hot water bags are superficial warming agents that will be used to heat muscle tissue, reduce muscle spasms and pain sensation. TENS is a pain reliever application.

Intervention Type DEVICE

Lumbar stabilization exercises

Training about the concepts of stabilization and abdominal bracing is given before starting the study. The motor control tests for local muscles transversus abdominus and multifidi are performed after the training. The abdominal bracing test is performed in the quadruped position, in prone, and in hook lying position with the patient's spine supine with hips and knees flexed and knees in contact with the surface. The second stage consists of closed-chain segmental control exercises. It is a series of weight-bearing exercises are performed on stable and unstable surfaces. The last stage of the stabilization program is an open kinetic chain exercise to promote distal stability.

Intervention Type OTHER

Breathing exercises

Breathing exercises consist of the techniques of diaphragmatic and pursed-lip breathing. During diaphragmatic breathing, attention is focused on the correct abdominal breathing. The pursed-lip breathing is one step further to the diaphragmatic breathing and a technique designed to have control time and volume over-breathing. This intervention also includes Sleep Hygiene education to the subjects,

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hasan Kalyoncu University

OTHER

Sponsor Role lead

Responsible Party

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Samed Gulyilmaz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysenur Tuncer, PhD

Role: STUDY_DIRECTOR

Hasan Kalyoncu University

Locations

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İslahiye İlçe Hast.

Gaziantep, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2021/031

Identifier Type: -

Identifier Source: org_study_id

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