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

Primary Purpose

Low Back Pain, Sleep Hygiene, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional physical therapy
Lumbar stabilization exercises
Breathing exercises
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Nonspecific Chronic Low Back Pain, Sleep Quality, Breathing Exercises

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • İslahiye İlçe Hast.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Conventional Physical Therapy Group

Stabilization Group

Breathing Exercise Group

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

Change from Baseline in Pain at 3 weeks and 8 weeks
Visual Analogue Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 3 weeks intervention and at the end 8 weeks from baseline.
Change from Baseline in Form of Pain at 3 weeks and 8 weeks
Form of Pain will be assessed with the Mcgill Melzack Pain Questionnaire. The questionnaire consists of four parts. In the first part, the individual marks the place where they feel pain on a representative body picture and indicates with the letters "D" if the pain is deep, "S" if it is on the body surface, and "D-S" if it is both deep and superficial. In the second part, there are 20 statements that examine pain from various aspects. The individual is asked to choose the word group that fits their pain and to marks only one word in the selected group that fits their pain. In the third part, there are questions about the relationship between time and pain. In the fourth part, five word-groups ranging from "mild to unbearable" pain are defined to determine the severity of pain.
Change from Baseline in Sleep Quality at 3 weeks and 8 weeks
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). PSQI is a 19-item self-report questionnaire that measures subjective sleep quality over the previous month. The individual 19 items in the PSQI are aggregated into seven components that assess various aspects of sleep, and the sum of these seven components yields a score that distinguishes between "good" and "bad" sleepers.
Change from Baseline in Anxiety at 3 weeks and 8 weeks
Anxiety will be assessed with the Spielberger State-Trait Anxiety Inventory. It consists of two separate scales, each with 20 questions, assessing the levels of state anxiety and trait anxiety. The score that can be obtained from both scales is a minimum of 20 and a maximum of 80. If the score from the scale is high, the person's anxiety is high.
Change from Baseline in Fatigue at 3 weeks and 8 weeks
Fatigue will be assessed with the Fatigue Severity Scale. This scale consists of 9 items in total. Individuals give points from 1 to 7 for each item. If the average score is greater than 6.1, it is concluded as chronic fatigue.

Secondary Outcome Measures

Obstructive Sleep Apnea Risk Screening İn İndividuals With Chronic Non-Specific Low Back Pain
Stop-Bang Survey, used as a screening tool for obstructive sleep apnea (OSAS), is a questionnaire consisting of 8-item yes/no responses with a score for each positive answer. Moderate risk of OSAS: yes to 3-4 questions, and high risk of OSAS: yes to 5-8 questions.

Full Information

First Posted
January 16, 2022
Last Updated
August 14, 2023
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT05212753
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
July 25, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Sleep Hygiene, Anxiety
Keywords
Nonspecific Chronic Low Back Pain, Sleep Quality, Breathing Exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Physical Therapy Group
Arm Type
Active Comparator
Arm Description
The conventional physical therapy group will receive Transcutaneous Electrical Nerve Stimulation (TENS) and hot pack application.
Arm Title
Stabilization Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Breathing Exercise Group
Arm Type
Active Comparator
Arm Description
The breathing exercise group will receive breathing exercises including sleep hygiene, and the stabilization group program. Breathing exercises include diaphragmatic breathing and pursed-lip.
Intervention Type
Device
Intervention Name(s)
Conventional physical therapy
Intervention Description
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
Other
Intervention Name(s)
Lumbar stabilization exercises
Intervention Description
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
Intervention Name(s)
Breathing exercises
Intervention Description
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,
Primary Outcome Measure Information:
Title
Change from Baseline in Pain at 3 weeks and 8 weeks
Description
Visual Analogue Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 3 weeks intervention and at the end 8 weeks from baseline.
Time Frame
Baseline, 3 weeks, 8 weeks
Title
Change from Baseline in Form of Pain at 3 weeks and 8 weeks
Description
Form of Pain will be assessed with the Mcgill Melzack Pain Questionnaire. The questionnaire consists of four parts. In the first part, the individual marks the place where they feel pain on a representative body picture and indicates with the letters "D" if the pain is deep, "S" if it is on the body surface, and "D-S" if it is both deep and superficial. In the second part, there are 20 statements that examine pain from various aspects. The individual is asked to choose the word group that fits their pain and to marks only one word in the selected group that fits their pain. In the third part, there are questions about the relationship between time and pain. In the fourth part, five word-groups ranging from "mild to unbearable" pain are defined to determine the severity of pain.
Time Frame
Baseline, 3 weeks, 8 weeks
Title
Change from Baseline in Sleep Quality at 3 weeks and 8 weeks
Description
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). PSQI is a 19-item self-report questionnaire that measures subjective sleep quality over the previous month. The individual 19 items in the PSQI are aggregated into seven components that assess various aspects of sleep, and the sum of these seven components yields a score that distinguishes between "good" and "bad" sleepers.
Time Frame
Baseline, 3 weeks, 8 weeks
Title
Change from Baseline in Anxiety at 3 weeks and 8 weeks
Description
Anxiety will be assessed with the Spielberger State-Trait Anxiety Inventory. It consists of two separate scales, each with 20 questions, assessing the levels of state anxiety and trait anxiety. The score that can be obtained from both scales is a minimum of 20 and a maximum of 80. If the score from the scale is high, the person's anxiety is high.
Time Frame
Baseline, 3 weeks, 8 weeks
Title
Change from Baseline in Fatigue at 3 weeks and 8 weeks
Description
Fatigue will be assessed with the Fatigue Severity Scale. This scale consists of 9 items in total. Individuals give points from 1 to 7 for each item. If the average score is greater than 6.1, it is concluded as chronic fatigue.
Time Frame
Baseline, 3 weeks, 8 weeks
Secondary Outcome Measure Information:
Title
Obstructive Sleep Apnea Risk Screening İn İndividuals With Chronic Non-Specific Low Back Pain
Description
Stop-Bang Survey, used as a screening tool for obstructive sleep apnea (OSAS), is a questionnaire consisting of 8-item yes/no responses with a score for each positive answer. Moderate risk of OSAS: yes to 3-4 questions, and high risk of OSAS: yes to 5-8 questions.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysenur Tuncer, PhD
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
Facility Information:
Facility Name
İslahiye İlçe Hast.
City
Gaziantep
ZIP/Postal Code
05547
Country
Turkey

12. IPD Sharing Statement

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

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