Low Back PainNCT05212753
The Effect of Breathing Exercise and Stabilization Exercise With Chronic Low Back Pain
A study testing Conventional physical therapy, Lumbar stabilization exercises and Breathing exercises in people with Low Back Pain and Sleep Hygiene, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Sleep Hygiene, Anxiety
- What is being tested?
- Conventional physical therapy, Lumbar stabilization exercises and Breathing exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Low Back Pain, Sleep Hygiene, Anxiety
- Being tested
- Conventional physical therapy, Lumbar stabilization exercises, Breathing exercises
- Keywords
- Nonspecific Chronic Low Back Pain, Sleep Quality, Breathing Exercises
- Medical subject headings
- Low Back Pain, Sleep Hygiene, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapyDevice
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 exercisesOther
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 exercisesOther
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,
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physical Therapy Group | Active comparator | The conventional physical therapy group will receive Transcutaneous Electrical Nerve Stimulation (TENS) and hot pack application. Receives: Device: Conventional physical therapy |
| Stabilization Group | Active comparator | 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. Receives: Device: Conventional physical therapy; Other: Lumbar stabilization exercises |
| Breathing Exercise Group | Active comparator | The breathing exercise group will receive breathing exercises including sleep hygiene, and the stabilization group program. Breathing exercises include diaphragmatic breathing and pursed-lip. Receives: Device: Conventional physical therapy; Other: Lumbar stabilization exercises; Other: Breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 weeks, 8 weeks
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.
Measured: Baseline, 3 weeks, 8 weeks
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.
Measured: Baseline, 3 weeks, 8 weeks
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.
Measured: Baseline, 3 weeks, 8 weeks
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.
Measured: Baseline, 3 weeks, 8 weeks
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Nov 2021
- Primary completion25 Jul 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samed Gulyilmaz, Hasan Kalyoncu University
- Investigators
- Aysenur Tuncer, PhD, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212753
- Sponsor's protocol ID
- 2021/031
- Status last verified
- Jan 2022
- First submitted
- 16 Jan 2022
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05212753
- Acronym / sponsor ID
- 2021/031
- Conditions
- Low Back Pain, Sleep Hygiene, Anxiety
- Keywords
- Nonspecific Chronic Low Back Pain, Sleep Quality, Breathing Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Physical Therapy Group | Active comparator | Device: Conventional physical therapyThe conventional physical therapy group will receive Transcutaneous Electrical Nerve Stimulation (TENS) and hot pack application. |
| Stabilization Group | Active comparator | Device: Conventional physical therapy, Other: Lumbar stabilization exercisesThe 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. |
| Breathing Exercise Group | Active comparator | Device: Conventional physical therapy, Other: Lumbar stabilization exercises, Other: Breathing exercisesThe breathing exercise group will receive breathing exercises including sleep hygiene, and the stabilization group program. Breathing exercises include diaphragmatic breathing and pursed-lip. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional physical therapyHot 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. | Device | Breathing Exercise Group, Conventional Physical Therapy Group, Stabilization Group |
| Lumbar stabilization exercisesTraining 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. | Other | Breathing Exercise Group, Stabilization Group |
| Breathing exercisesBreathing 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, | Other | Breathing Exercise Group |
Primary outcome
Change from Baseline in Pain at 3 weeks and 8 weeks
Time frame: Baseline, 3 weeks, 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
Time frame: Baseline, 3 weeks, 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
Time frame: Baseline, 3 weeks, 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
Time frame: Baseline, 3 weeks, 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
Time frame: Baseline, 3 weeks, 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.
1 secondary outcome
Obstructive Sleep Apnea Risk Screening İn İndividuals With Chronic Non-Specific Low Back Pain
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysenur Tuncer, PhD study director
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physical therapy, Lumbar stabilization exercises and Breathing exercises in people with Low Back Pain and Sleep Hygiene, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pain at 3 weeks and 8 weeks (time frame: Baseline, 3 weeks, 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.