Effects of Basic Body Awareness Therapy on Pain, Sleep, Disability and Quality of Life in Chronic Low Back Pain

NCT ID: NCT05080101

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-01-21

Brief Summary

Chronic low back pain is a common problem worldwide. In treatment, conservative methods usually are used. Basic Body Awareness Therapy is related to mindfulness-based therapies and meditation techniques. It is a method that has been used and found effective in some diseases affecting the musculoskeletal system. Therefore, in this study, body awareness was applied in addition to conventional treatment in patients with chronic low back pain.

Detailed Description

Throughout a lifetime, chronic low back pain is a common problem that affects approximately 80% of people. Among musculoskeletal system problems, it is one of the most commonly observed issues. There are various treatment methods available. The absence of evidence-based treatment guidelines negatively affects the choice of treatment to be applied. There are medical and conservative treatment options. These methods include acupuncture, transcutaneous electrical nerve stimulation, injection therapy, non-steroidal anti-inflammatory drugs, and lumbar supports. Basic Body Awareness Therapy is a physiotherapy treatment method that has been developed in the Scandinavian countries over the course of the last two decades. This innovative approach focuses on enhancing body awareness and has gained recognition as an effective therapeutic technique in the field of physiotherapy. Basic Body Awareness Therapy has been applied as a secondary treatment method in various conditions such as fibromyalgia, neck pain, and ankylosing spondylitis, and has been found to be effective. It has yielded positive results when used in addition to conventional treatments for musculoskeletal problems, as demonstrated in the literature. This study aims to apply Basic Body Awareness Therapy to individuals with chronic low back pain, based on its effectiveness in musculoskeletal issues, and create a new treatment combination. Twenty-eight patients were included in the study, and in addition to the standard treatment protocol, Basic Body Awareness Therapy exercises were administered.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Physiotherapy Group

Patients in control group (n=14) will receive 40-mins conventional physiotherapy session for 3-days per week, over 6 weeks. Conventional physiotherapy will consist of stretching and strengthening exercises, postural alignment exercises, as well as electrotherapy such as transcutaneous electric magnetic stimulation (TENS) which will be applied to lumbar region with a frequency of 100 Hz, 50-100 μsec current duration for 20 minutes, hotpack which will be applied to lumbar region for 20 mins, and ultrasound application which will be applied to the lumbar region with a Chattanooga Intelect Mobile device at a frequency of 1 MHz, at a dose of 1.5 W/cm2, for 6 minutes using a 10 cm2 head.

Group Type: ACTIVE_COMPARATOR

Conventional Therapy Program

Intervention Type: OTHER

Patients in control group (n=14) will receive 40-mins conventional physiotherapy session for 3-days per week, over 6 weeks. Conventional physiotherapy will consist of stretching and strengthening exercises, postural alignment exercises, as well as electrotherapy such as transcutaneous electric magnetic stimulation (TENS) which will be applied to lumbar region with a frequency of 100 Hz, 50-100 μsec current duration for 20 minutes, hotpack which will be applied to lumbar region for 20 mins, and ultrasound application which will be applied to the lumbar region with a Chattanooga Intelect Mobile device at a frequency of 1 MHz, at a dose of 1.5 W/cm2, for 6 minutes using a 10 cm2 head.

Basic Body Awareness Therapy Group

Patients in study group (n=14) will receive Basic Body Awareness Therapy (BBAT) 3 days in a week, over 6 weeks in addition to conventional physiotherapy. BBAT will consist of flexibility exercises and various cognitive exercises in supine, position, sitting position and standing position. These exercises will be consist of exercises such as body scanning, breathing, sound resonance.

Group Type: EXPERIMENTAL

Basic Body Awareness Therapy Group Program

Intervention Type: OTHER

Patients in study group (n=14) will receive Basic Body Awareness Therapy (BBAT) 3 days in a week, over 6 weeks in addition to conventional physiotherapy. BBAT will consist of flexibility exercises and various cognitive exercises in supine, position, sitting position and standing position. These exercises will be consist of exercises such as body scanning, breathing, sound resonance.

Interventions

Conventional Therapy Program

Patients in control group (n=14) will receive 40-mins conventional physiotherapy session for 3-days per week, over 6 weeks. Conventional physiotherapy will consist of stretching and strengthening exercises, postural alignment exercises, as well as electrotherapy such as transcutaneous electric magnetic stimulation (TENS) which will be applied to lumbar region with a frequency of 100 Hz, 50-100 μsec current duration for 20 minutes, hotpack which will be applied to lumbar region for 20 mins, and ultrasound application which will be applied to the lumbar region with a Chattanooga Intelect Mobile device at a frequency of 1 MHz, at a dose of 1.5 W/cm2, for 6 minutes using a 10 cm2 head.

Intervention Type: OTHER

Basic Body Awareness Therapy Group Program

Patients in study group (n=14) will receive Basic Body Awareness Therapy (BBAT) 3 days in a week, over 6 weeks in addition to conventional physiotherapy. BBAT will consist of flexibility exercises and various cognitive exercises in supine, position, sitting position and standing position. These exercises will be consist of exercises such as body scanning, breathing, sound resonance.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Having low back pain for 3 months or more
• Being between the ages of 18-65
• Not having received any back-related treatment before
• Volunteer to participate in the study

Exclusion Criteria

• Pregnancy
• History of tumor / metastatic disease
• History of spinal trauma, spinal cord injury
• History of infection
• Presence of congenital deformity in the spine
• History of previous spinal surgery
• Having a neurological disease (Alzheimer's, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's, Stroke)
• Having musculoskeletal problems other than low back pain (rheumatoid arthritis, pathological fractures, avascular necrosis or osteonecrosis, severe osteoarthritis, spondylo-arthropathy)
• Patients who received a physiotherapy rehabilitation program in the last 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Kaniye Üneş

PT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kaniye Unes, PT

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Hacettepe University Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2020/14-11 (KA-20021)

Identifier Type: -

Identifier Source: org_study_id