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

NCT05212753 | Completed DMC

• 1 other identifier: 2021/031
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Sleep Hygiene; Anxiety

Keywords

Nonspecific Chronic Low Back Pain; Sleep Quality; Breathing Exercises

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Baseline, 3 weeks, 8 weeks

Secondary Outcomes (1)

• Obstructive Sleep Apnea Risk Screening İn İndividuals With Chronic Non-Specific Low Back Pain

  Baseline

Study Arms (3)

Conventional Physical Therapy Group

ACTIVE COMPARATOR

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

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.

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.

Device: Conventional physical therapy; Other: Lumbar stabilization exercises; Other: Breathing exercises

Interventions

Conventional physical therapy 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.

Breathing Exercise Group; Conventional Physical Therapy Group; Stabilization Group

Lumbar stabilization exercises 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; Stabilization Group

Breathing exercises 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,

Breathing Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

İslahiye İlçe Hast.

Gaziantep, 05547, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Sleep Hygiene; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Aysenur Tuncer, PhD

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: January 28, 2022
• Study Start: November 1, 2021
• Primary Completion: July 25, 2022
• Study Completion: August 30, 2022
• Last Updated: August 15, 2023

Record last verified: 2022-01

Locations

TU (1)