Effects of Foundation and Functional Inspiratory Muscle Training in Non-Specific Chronic Low Back Pain

Kirsehir Ahi Evran Universitesi

Status: Enrolling

Conditions: Low Back Pain, Mechanical; Non Specific Chronic Low Back Pain; Low Back Pain, Chronic

Treatments: Other: Classical Physiotherapy Group; Other: Foundation Inspiratory Muscle Training in Addition to Classical Physiotherapy; Other: Functional Inspiratory Muscle Training Group in Addition to Classical Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06696300

2024/19

Details and patient eligibility

About

This study was planned to examine the effects of basic and functional respiratory muscle training on pain, disability level, and functionality. In this study, participants will be randomly divided into 3 groups. The first group will be treated with physical therapy applications applied in state hospitals for 10 weeks. The second group will receive basic respiratory muscle training treatment in addition to physical therapy in state hospitals. The third group will receive respiratory muscle training with exercise in addition to physical therapy in state hospitals. Evaluations will be made before the first session, after the 30th session, in the 3rd month, in the 6th month, and in the 1st year. There is no interventional method in the evaluations. Pain intensity, disability level, physical activity status, quality of life, fear of movement, pain catastrophizing, anxiety and depression levels will be questioned with scales. In physical measurements, participant's aerobic capacity will be measured with the 2-Minute Walk Test, participants's flexibility with the sit-and-long test, participants's respiratory muscle strength with the MIP/MEP device, participants's core endurance with the trunk flexor muscle endurance test, participants's lower and upper extremity muscle strength with a handheld dynamometer, participants's postural control with the Biodex balance device, and participants's muscle thickness with an ultrasound.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Volunteering to participate in the study,
• Being between the ages of 18-65,
• Having low back pain that has been ongoing for at least 3 months (12 weeks),
• Having a Visual Analog Scale (VAS) of pain intensity of ≥3,
• Being right-hand dominant.

Exclusion criteria

• Not volunteering to participate in the study,
• Having a history of cancer,
• Having a spinal infection,
• Having a rheumatological condition,
• Having a spinal fracture,
• Having red flag signs (sudden and unexpected weight loss, fever, etc.)
• Having a psychological disorder,
• Having a previous spinal surgery,
• Having radiculopathy (neuropathic pain along the lower extremity due to nerve root compression),
• Not continuing home exercises more than 80%,
• Having an anatomical and congenital abnormality

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Classical Physiotherapy Group

Active Comparator group

Treatment:

Other: Classical Physiotherapy Group

Foundation Inspiratory Muscle Training

Experimental group

Treatment:

Other: Foundation Inspiratory Muscle Training in Addition to Classical Physiotherapy

Other: Classical Physiotherapy Group

Functional Inspiratory Muscle Training Group

Experimental group

Treatment:

Other: Functional Inspiratory Muscle Training Group in Addition to Classical Physiotherapy

Other: Classical Physiotherapy Group