Non-Specific Chronic Low Back Pain Treatment Methods

NCT07057687 | Active Not Recruiting

• 1 other identifier: E-10840098-202.3.02-5282
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

In Turkish society, almost all people experience back pain. When this pain lasts longer than 3 months and is not related to any cause, it is called "non-specific chronic back pain". The source of back pain is often not known for sure. While it can be seen with some physical loads; since humans are biopsychosocial beings, it is possible to say that psychological factors can also cause this pain. Along with the pain, the quality of life and functionality of people are negatively affected. In order to avoid situations such as loss of work, loss of muscle strength or depression, treatment should be at the center of the individual and a multidisciplinary health team. Many treatment methods are used for back pain, these are pharmacological and non-pharmacological methods. One of the non-pharmacological methods is physical therapy. Physiotherapy methods also have many contents such as mobilization, relaxation, massage, electrotherapy. The physiotherapy methods to be used within the scope of this research include conventional treatment (TENS, US and Hot Pack) application. The Mulligan mobilization technique (Continuous Natural Apophyseal Gliding technique, which is the same as the natural gliding movement of the vertebrae) involves manual application. The relaxation technique involves deep-slow diaphragmatic breathing and the application of progressive relaxation exercise with verbal commands. Individuals between the ages of 18-60 who have been diagnosed with back pain that has not been caused by any reason and has lasted longer than 3 months will be included in the study. The study is planned to be conducted with 45 participants and they will be asked to fill out a "voluntary consent form" before participation. The study consists of 3 groups: conventional (control) group, mobilization group and relaxation group. Conventional treatment will be applied to each group and mobilization and relaxation techniques will be applied in addition to the group determined as a result of randomization. The treatment lasts 4 weeks in certain protocols. 3 evaluations will be made at the beginning, end and 3 months after the treatments. Demographic information, pain and perception questionnaires, shortness test, mobility test, quality of life questionnaire and joint range of motion measurement will be used within the scope of the evaluation.

Conditions

Non-Specific Chronic Low Back Pain

Keywords

Pain; Relaxation; Chronic Low Back Pain; Mobilization

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  Pain intensity will be measured according to VAS. The scale consists of a 10 cm line. There are numbers from 0 to 10 on this line. It will be explained to the patient that 0 means no pain and 10 is the last point of unbearable pain. The patient will be asked to mark the level that is most suitable for him/her on this scale.

  Recorded 8 weeks and 3 months after the end of treatment

Secondary Outcomes (6)

• McGill Melzack Pain Questionnaire

  Recorded 8 weeks and 3 months after the end of treatment

• Goniometric Measurement

  Recorded 8 weeks and 3 months after the end of treatment

• Hand-Ground Distance Measurement

  Recorded 8 weeks and 3 months after the end of treatment

• Schober Testi

  Recorded 8 weeks and 3 months after the end of treatment

• Pain Catastrophizing Scale

  Recorded 8 weeks and 3 months after the end of treatment

Study Arms (3)

Mulligan Treatment Group

EXPERIMENTAL

Application of the Technique: The direction of the technique will be shaped according to the direction of movement of the patient's pain. If the patient's pain occurs during flexion, flexion will be applied, if it occurs during extension, extension SNAGS will be applied. In the flexion SNAGS application, the physiotherapist places the mobilization belt at the patient's spina iliaca anterior superior (SIAS) level while the patient is sitting or standing. The physiotherapist places his hand, thumbs or the hypothenar part of the hand parallel to the spinous processes one level above the relevant segment. Then, he asks the patient to flex until he feels pain. The physiotherapist continues the flexion by applying force towards the cranium with his hand. After waiting for a while at the end point, the starting position is returned. During this time, the physiotherapist maintains the natural shift in the facet joint. If the pain does not disappear, the application is applied unilaterally.

Other: Mulligan Treatment Group

Relaxation Techniques Group

EXPERIMENTAL

The individual will be in a sitting or lying position without muscle tension, and progressive relaxation will be provided with verbal commands given for each body part in order. The patient is asked to place their hand on their abdomen and by applying light resistance, they are provided with the direction in which the breath will go. During diaphragmatic breathing, the person breathes deeply and slowly through the nose and out through the mouth for 5-7 seconds, holds it for 2 seconds and exhales for 6-8 seconds. During this time, the abdomen is inflated in 4 directions and care is taken to ensure that there is no auxiliary muscle activity. First, after taking a deep breath, the muscles are tensed, this tension is maintained for 5-7 seconds and then the muscles are relaxed (8-10 seconds). This application will be applied in 3 sets, with 5/6 repetitions and then returning to calm/normal breathing. The treatment will be applied 3 days a week and will last for 4 weeks.

Other: Relaxation Techniques Group

Conventional Physical Therapy Group

ACTIVE COMPARATOR

Conventional physical therapy applied to patients consists of Transcutaneous Electrical Nerve Stimulation (TENS), Ultrasound (US) and Hot Pack. TENS will be applied for 20 minutes at a frequency of 100 hertz. US will be applied for 5 minutes at an intensity of 1.2-1.5 W/cm2. Hot Pack will be applied for 20 minutes. Treatment will be applied to the lumbar region. Application will be made 3 days a week for 4 weeks.

Other: Conventional Physical Therapy Group

Interventions

Relaxation Techniques Group OTHER

The individual will be in a sitting or lying position without muscle tension, and progressive relaxation will be provided with verbal commands given for each body part in order. The patient is asked to place their hand on their abdomen and by applying light resistance, they are provided with the direction in which the breath will go. During diaphragmatic breathing, the person breathes deeply and slowly through the nose and out through the mouth for 5-7 seconds, holds it for 2 seconds and exhales for 6-8 seconds. During this time, the abdomen is inflated in 4 directions and care is taken to ensure that there is no auxiliary muscle activity. First, after taking a deep breath, the muscles are tensed, this tension is maintained for 5-7 seconds and then the muscles are relaxed (8-10 seconds). This application will be applied in 3 sets, with 5/6 repetitions and then returning to calm/normal breathing. The treatment will be applied 3 days a week and will last for 4 weeks.

Relaxation Techniques Group

Mulligan Treatment Group OTHER

Application of the Technique: The direction of the technique will be shaped according to the direction of movement of the patient's pain. If the patient's pain occurs during flexion, flexion will be applied, if it occurs during extension, extension SNAGS will be applied. In the flexion SNAGS application, the physiotherapist places the mobilization belt at the patient's spina iliaca anterior superior (SIAS) level while the patient is sitting or standing. The physiotherapist places his hand, thumbs or the hypothenar part of the hand parallel to the spinous processes one level above the relevant segment. Then, he asks the patient to flex until he feels pain. The physiotherapist continues the flexion by applying force towards the cranium with his hand. After waiting for a while at the end point, the starting position is returned. During this time, the physiotherapist maintains the natural shift in the facet joint. If the pain does not disappear, the application is applied unilaterally.

Mulligan Treatment Group

Conventional Physical Therapy Group OTHER

Conventional physical therapy applied to patients consists of Transcutaneous Electrical Nerve Stimulation (TENS), Ultrasound (US) and Hot Pack. TENS will be applied for 20 minutes at a frequency of 100 hertz. US will be applied for 5 minutes at an intensity of 1.2-1.5 W/cm2. Hot Pack will be applied for 20 minutes. Treatment will be applied to the lumbar region. Application will be made 3 days a week for 4 weeks.

Conventional Physical Therapy Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Non-specific low back pain lasting at least 12 weeks
• Pain must be at least 3 and at most 7 on the Visual Analog Scale (VAS)
• Age range 18-60
• Diagnosed by a physician

You may not qualify if:

• Fractures in the spine
• Pregnancy
• Cardiac and/or pulmonary diseases
• Deformities in the spine
• Surgery in the spine within the last year
• Systemic diseases
• Advanced osteoporosis
• Disc herniation

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Moutzouri M, Perry J, Billis E. Investigation of the effects of a centrally applied lumbar sustained natural apophyseal glide mobilization on lower limb sympathetic nervous system activity in asymptomatic subjects. J Manipulative Physiol Ther. 2012 May;35(4):286-94. doi: 10.1016/j.jmpt.2012.04.016.

  PMID: 22632588 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 10, 2025
• Study Start: September 2, 2024
• Primary Completion (Estimated): June 2, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)