Clinical trial NCT05080101: Effects of Basic Body Awareness Therapy on Pain, Sleep, Disability and Quality of Life in Chronic Low Back Pain
Official title: Effect Sof Basic Body Awareness Therapy on Posture, Pain, Disability, Quality of Life, Sleep Quality and Body Awareness in Individual With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Pain
Quality of Life
Disability
Sleep
Body Awareness
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 28 individual diagnosed with chronic low back pain will be included in this study. The patients who meet the inclusion criteria will be divided into 2 groups randomly as study (n=14) and control (n=14). Patients in control group 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. Patients in study group 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 cognitive exercises
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Oswestry Disability Index Score
timeFrame: 5 mins
measure: Functional Rating Index Score
timeFrame: 5 mins
measure: New York Posture Analysis Score
timeFrame: 5 mins
measure: Pain Level assessed by McGill Pain Scale
timeFrame: 5 mins
measure: Sleep Quality assessed by Pittsburgh Sleep Quality Index
timeFrame: 5 mins
measure: Quality of Life assessed by Short Form-12
timeFrame: 5 mins
measure: Beck Depression Inventory Score
timeFrame: 5 mins
measure: The Body Awareness Scale Score
timeFrame: 5 mins
measure: The Awareness: Body Chart Score
timeFrame: 5 mins
measure: Body Image Questionnaire Score
timeFrame: 5 mins
measure: Fremantle Back Awareness Questionnaire Score
timeFrame: 5 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Hospital
Study officials:
affiliation: Hacettepe University
name: Kaniye Unes, PT
role: PRINCIPAL_INVESTIGATOR
References: