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

Summary

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.

Conditions

• Low Back Pain, Mechanical
• Low Back Pain, Chronic
• Non Specific Chronic Low Back Pain

Interventions

OTHER

Classical Physiotherapy Group

Classical physiotherapy group (CF) will be treated face to face for 30 sessions in total, 3 days a week, 10 weeks. Hotpack, Ultrasound, TENS and Basic Exercises will be applied to the CF group. Hotpack will be applied superficially to the lumbar region for 15 minutes. Ultrasound 1MHz- 1.5 Wt/cm2 will be applied to the lumbar region. TENS 50 Hz will be applied for 15 minutes, leaving the painful area in the middle. Basic exercises will be applied as 8-12 repetitions, 2 sets. The number of repetitions and sets will be increased as the tolerance of the patients increases. Pelvic tilt exercises Supine hip flexor stretch Supine lumbar extensor stretch Crunches Cat-Camel Exercises

OTHER

Foundation Inspiratory Muscle Training in Addition to Classical Physiotherapy

In addition to Classical Physiotherapy, Foundation Inspiratory Muscle Training (IKE) will be treated face to face for 30 sessions, 3 days a week, 10 weeks. On other days, IKE will be applied at home for 15 minutes in the morning and evening for a total of 30 minutes and will be followed up with a diary. IKE will be applied with a device that can load with threshold pressure. The IKE group will continue the exercise program for 10 weeks. The intensity of the exercise will be adjusted to 40-50% MIP for the exercise group. After 10 consecutive respiratory cycles, 3-4 respiratory controls will be asked. As tolerance increases, the consecutive respiratory cycle will be increased. The intensity will be adjusted by taking weekly MIP measurements. Daily monitoring forms will be created for each participant to ensure exercise follow-up.

OTHER

Functional Inspiratory Muscle Training Group in Addition to Classical Physiotherapy

Functional Inspiratory Muscle Training Group will receive functional inspiratory muscle training in addition to classical physiotherapy, 3 days a week, 10 weeks, 30 sessions in total, face-to-face treatment. On other days, foundation-ICE will be applied at home for 15 minutes in the morning and evening, for a total of 30 minutes, and will be followed with a diary. The same protocol will be applied with the foundation IKE group for teaching the respiratory cycle in the first 4 weeks, and resisted breathing will be worked simultaneously with the exercises in Table 2 in the last 6 weeks. The exercise program will be continued for a total of 10 weeks, including F-ICE, foundation IKE for the first 4 weeks, and F-ICE for 6 weeks thereafter. The intensity of the exercise will be adjusted to 40-50% MIP for the exercise group. After 10 consecutive respiratory cycles, 3-4 respiratory controls will be requested. As tolerance increases, the number of consecutive respiratory cycles will be increase

Sponsors & Collaborators

• Hacettepe University

  collaborator OTHER

• Selcuk University

  collaborator OTHER

• Kirsehir Ahi Evran Universitesi

  lead OTHER

Principal Investigators

• Türkan Akbayrak, Professor · Hacettepe University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-15

Primary Completion

2026-07-01

Completion

2026-12-01

Countries

• Turkey (Türkiye)

Study Locations