Effect of Basic Body Awareness Therapy on Pain, Sleep, Disability and Quality of Life

Sponsor
Hacettepe University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05080101
Collaborator
(none)
28
1
2
6.7
4.2

Study Details

Study Description

Brief Summary

The aim of the study is to investigate the effect of The Basic Body Awareness Therapy (BBAT) in addition to conventional physiotherapy on pain, body awareness, disability, sleep quality, quality of life in patients diagnosed with chronic low back pain (CLBP). Therefore, a total of 28 patients with CLBP will be included in the study, and will be divided into two groups: BBAT group and control group. The control group will receive conventional physiotherapy consisting of stretching and strengthening exercises, stabilization exercises and electrotherapy. The BBAT group will receive postural alignment exercises, breathing exercises and cognitive exercises in addition to conventional physiotherapy. We hypothesized that BBAT in addition to conventional physiotherapy will be more effective improving the symptoms in patients with CLBP.

Condition or Disease Intervention/Treatment Phase
  • Other: Conventional Therapy Program
  • Other: Basic Body Awareness Therapy Group Program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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 exercisesA 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
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Basic Body Awareness Therapy on Posture, Pain, Disability, Quality of Life, Sleep Quality and Body Awareness in Individual With Chronic Low Back Pain
Actual Study Start Date :
Sep 29, 2021
Anticipated Primary Completion Date :
Mar 21, 2022
Anticipated Study Completion Date :
Apr 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Other: 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.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Oswestry Disability Index Score [5 mins]

    The Oswestry Disability Index (ODI) is the gold standard, valid and reliable outcome measurement tool for assessing functionality in patients with low back pain. For 10 different functional activities, there are 6 different answers for which the patient does not know the score equivalent. Each activity is scored between 0 (functional level adequate) and 5 (severe limitation). The measurement result is expressed over the total score and the ratio of the score to the total maximum score is determined as a percentage. 0-20% minimal disability, 21-40% moderate disability, 41-60% severe disability, 61-80% bedridden, 81-100% completely bedridden or interpreted as exaggerating their situation. The minimal clinical significance level is accepted as 10%, changes occurring less than this rate are considered as measurement error.

  2. Functional Rating Index Score [5 mins]

    The Functional Rating Index (FRI) is a valid and reliable method that evaluates the functionality and the decrease in functions caused by low back pain. FRI evaluates the functional level in 10 different domain (sleep, personal care, travel, work, etc.) that may be affected due to low back pain. FRI is a scale in which each item is scored between 0 (no pain, no restriction while doing the activity) and 4 (totally dependent, need someone else's help). Maximum score of FRI is 40 which indicates that the patient can easily perform functional activities.

  3. New York Posture Analysis Score [5 mins]

    The New York Posture Analysis (NYPA) will be used to assess patients' posture. NYPA consists of 13 items that evaluate the static posture of the body from the lateral and posterior aspects, and each item is given a score of five (5) if the person has a correct posture, three (3) if the posture is moderately impaired, and one (1) point if there is a severe deterioration. . The posture score that the patient will receive is one of 25 different scores ranging from 13 to 65, and a higher score indicates better posture. Standard evaluation criteria developed for this test were determined as "very good" if the total score is ≥45, "good" if 40-44, "moderate" if 30-39, "poor" if 20-29, and "poor" if ≤19.

  4. Pain Level assessed by McGill Pain Scale [5 mins]

    The McGill Pain Scale Short Form, which is a valid and reliable method used to evaluate pain, consists of three parts. In the first part, there are 15 descriptive word groups. Of these, 11 evaluate the sensory dimension of the pain, and 4 evaluate the perceptual dimension. These descriptors are rated on an intensity scale from 0 to 3 (0= none, 1= Mild, 2=Moderate, 3= Excess). In the first part of the scale, a total of 3 pain scores are obtained: sensory pain score, perceptual pain score and total pain score. In the second part of the form, there were five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of the patient's pain. In the third part, the current pain intensity of the patient was evaluated using a visual comparison scale.

  5. Sleep Quality assessed by Pittsburgh Sleep Quality Index [5 mins]

    Sleep quality of patients will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), a valid and reliable assessment tool. The PSQI consists of 7 components that assess subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and loss of daytime functionality. Some of the components consist of a single item, while others consist of groupings of several items. Each item is evaluated between 0 and 3 points. It is accepted that a total scale score of 5 and above indicates poor sleep quality. The sum of these 7 component scores gives the overall index score. The total score is between 0-21. A high total score indicates poor sleep quality.

  6. Quality of Life assessed by Short Form-12 [5 mins]

    The Health Scale Short Form-12 (SF-12), which is a valid and reliable tool, will be used to assess patients' quality of life. The SF-12 scale evaluates 8 sub-dimensions as physical function, physical role difficulty, social function, pain, mental health, emotional role difficulty, vitality, general perception of health, and 2 areas, mental health and physical health, which is a combination of these dimensions. Considering the last month, the patient scores some of the items between 1 and 3, some of them between 1 and 5, and the sum of the scores for 8 sub-dimensions and 2 domains separately is expressed as %. A higher percentage indicates a better quality of life.

  7. Beck Depression Inventory Score [5 mins]

    Beck Depression Inventory (BDI) will be used to evaluate the depression status of the patients. BDI is a valid and reliable scale with 21 items, each of which can be scored between 0 (minimal) and 3 (severe hopelessness). The patient answers this scale himself, thinking about the last week. The sum of the scores of the items represents the scale score, and this score ranges from 0 to 63. 0-9 points are interpreted as minimal depression, 10-16 points as mild depression, 17-29 points as moderate depression and 30-63 points as severe depression.

  8. The Body Awareness Scale Score [5 mins]

    Body Awareness Questionnaire is a valid and reliable scale that measures body awareness of individuals for different situations (illness, cold, change in energy level, etc.). It consists of a total of 18 items, each of which can be scored between 1 (completely true for me) and 7 (not true for me at all).

  9. The Awareness: Body Chart Score [5 mins]

    The Awareness: Body Chart (ABC) is a newly developed, valid and reliable scale used to evaluate individuals' body awareness. ABC divides the human body into 51 separate regions and grades each of them separately. It does this by painting with colors, not by grading with numbers. In this coloring, orange is interpreted as "I can perceive in great detail", yellow as "I can perceive clearly", green as "I can perceive", blue as "I can perceive vaguely" and black as "I cannot perceive". The evaluator then converts these colors to numerical values from 5 to 1, respectively (for example, orange = 5). If the patient feels pain using a red felt-tip pen, he marks the area and rates the pain intensity between 0 and 100. A high ABC score of the patient means good awareness, while a high pain score means severe pain.

  10. Body Image Questionnaire Score [5 mins]

    Body Image Questionnaire (BIQ) is a scale that determines satisfaction with one's body parts or functions. Hovardaoğlu et al. found that the scale was valid and reliable. demonstrated in the study by The scale consists of a total of 40 different items, and each item is scored between 1 (I quite like it) and 5 (I don't like it at all). A low score means that the person is satisfied with their body and functions.

  11. Fremantle Back Awareness Questionnaire Score [5 mins]

    The Fremantle Back Awareness Questionnaire (FBAQ) is the only known valid and reliable awareness scale specific to the waist area. This scale consists of 9 items assessing denial-like symptoms, decreased proprioception, perceived body shape and size, and each item is scored between 0 (never) and 4 (always). High scores indicate decreased awareness.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Hospital Ankara Turkey 06100

Sponsors and Collaborators

  • Hacettepe University

Investigators

  • Principal Investigator: Kaniye Unes, PT, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kaniye Üneş, Researcher, Hacettepe University
ClinicalTrials.gov Identifier:
NCT05080101
Other Study ID Numbers:
  • bodyawarenessandchronicpain
First Posted:
Oct 15, 2021
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kaniye Üneş, Researcher, Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2021