- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04440293
Effects of Basic Body Awareness Therapy on Patients With Chronic Neck Pain
June 18, 2020 updated by: KTO Karatay University
Effects of Basic Body Awareness Therapy on Pain, Balance and Proprioceptive Sense in Patients With Chronic Neck Pain
The aim of this study was to compare the effects of Basic Body Awareness Therapy (BBAT) and conventional therapies (CT) on pain, balance and proprioceptive sensation of cervical region in patients with chronic neck pain.
As a cross-over study, patients were divided into BBAT / CT (n=17) and CT / BBAT (n=18) groups.
BBAT program has been implemented to patients within group BBAT / CT two days a week for 6 weeks while group CT / BBAT received the CT program during the same period.
After the interval of 5-week, group BBAT / CT was treated with CT and group CT / BBAT was treated with BBAT.
Pain severity with; Visual Analogue Scale (VAS), disability level with; Neck Disability Index (NDI), cervical proprioception with; Cervical Range of Motion Deluxe (CROM) device, balance with; Computerized Dynamic Posturography were evaluated.
The evaluations were conducted before and after the first and second treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Chronic neck pain is a common musculoskeletal disease that affects many people at some point in life.Its prevalence in the general population varies between 30-50% and is more common in women over 50 years old.The cervical area is an important body part due to the sensorial receptors of the muscles and joints as well as central and reflexes connections with visual, vestibular, and postural control systems.Numerous sensorimotor disorders have been detected in patients with chronic neck pain.Some patients with neck pain have impaired proprioceptive sensation and postural control.Pain can affect presynaptic inhibition of muscle afferents and modulation of proprioceptive muscle spindles, causing prolonged delays.These changes may result in decreased muscle control and increased postural release.Different updated and conventional therapy (CT) methods are used for the treatment of neck pain.
Mobilization of soft tissue and joint, stabilization techniques, cervical collars, relaxation training, strengthening exercises, and posture arrangement by body awareness are common therapeutic modalities.
Basic Body Awareness Therapy (BBAT) is a method used by physiotherapists to increase patient awareness and control posture.The method is increasingly used in the treatment of painful conditions related to the chronic musculoskeletal system.However, there are not enough studies in the literature examining the effects of proprioceptive senses and postural control in patients with chronic neck pain.
The aim of this study is to compare the effects of BBAT and conventional treatments (CT) on pain, balance and proprioceptive sensation of the cervical region in patients with chronic neck pain.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Konya, Turkey, 42020
- KTO Karatay University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Being 18 or over,
- Having neck pain for more than 3 months,
- Having neck problems that do not cause neurological deficits
Exclusion Criteria:
- History of cervical vertebra fracture or spinal tumor,
- Those diagnosed with cervical dystonia,
- Whiplash-related disorders,
- Those diagnosed with vertigo, fibromyalgia, or rheumatoid arthritis,
- The presence of inflammatory disease or infection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group BBAT / CT
Group BBAT / CT started treatment with BBAT and received 2 days a week for 6 weeks.
After the interval of 5-week, group BBAT / CT was treated with CT twice a week for 6 weeks.
|
The BBAT was applied by a trained and certified physiotherapist in this area for about an hour, two days a week, as a group therapy.
The BBAT program includes movements related to daily activities such as lying, sitting, standing and walking.
BBAT focuses on basic movement principles such as postural stability, energy adjustment in movements, comfortable breathing and coordination.
The CT program was applied two days a week for about an hour.
The CT program includes active range of motion (ROM) exercises, stretching, isometric and resistant strengthening, posture exercises and relaxation training.
|
Experimental: Group CT / BBAT
Group CT / BBAT started treatment with CT and received 2 days a week for 6 weeks.
After the interval of 5-week, group CT / BBAT was treated with BBAT twice a week for 6 weeks.
|
The BBAT was applied by a trained and certified physiotherapist in this area for about an hour, two days a week, as a group therapy.
The BBAT program includes movements related to daily activities such as lying, sitting, standing and walking.
BBAT focuses on basic movement principles such as postural stability, energy adjustment in movements, comfortable breathing and coordination.
The CT program was applied two days a week for about an hour.
The CT program includes active range of motion (ROM) exercises, stretching, isometric and resistant strengthening, posture exercises and relaxation training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance
Time Frame: at the beginning of treatments
|
The balance assessed by the Sensorial Organization Test (SOT) in the Computerized Dynamic Posturography device.The results of the SOT are calculated according to anterior-posterior sways.
A balance score ranging from 0 to 100 is achieved, where 0 indicates loss of balance and 100 indicates excellent stability.
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at the beginning of treatments
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Balance
Time Frame: 6 weeks later
|
The balance assessed by the Sensorial Organization Test (SOT) in the Computerized Dynamic Posturography device.The results of the SOT are calculated according to anterior-posterior sways.
A balance score ranging from 0 to 100 is achieved, where 0 indicates loss of balance and 100 indicates excellent stability.
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6 weeks later
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Balance
Time Frame: 11 weeks later
|
The balance assessed by the Sensorial Organization Test (SOT) in the Computerized Dynamic Posturography device.The results of the SOT are calculated according to anterior-posterior sways.
A balance score ranging from 0 to 100 is achieved, where 0 indicates loss of balance and 100 indicates excellent stability.
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11 weeks later
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Balance
Time Frame: 17 weeks later
|
The balance assessed by the Sensorial Organization Test (SOT) in the Computerized Dynamic Posturography device.The results of the SOT are calculated according to anterior-posterior sways.
A balance score ranging from 0 to 100 is achieved, where 0 indicates loss of balance and 100 indicates excellent stability.
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17 weeks later
|
Neck proprioception
Time Frame: at the beginning of treatments
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Proprioceptive sensation was evaluated using the Cervical Range of Motion Deluxe (CROM, Deluxe Performance Attainment Associates, Lindstrom, Minnesota, USA) device.Joint position error and deflection angles of the head in all 3 planes were measured with CROM device.
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at the beginning of treatments
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Neck proprioception
Time Frame: 6 weeks later
|
Proprioceptive sensation was evaluated using the Cervical Range of Motion Deluxe (CROM, Deluxe Performance Attainment Associates, Lindstrom, Minnesota, USA) device.Joint position error and deflection angles of the head in all 3 planes were measured with CROM device.
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6 weeks later
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Neck proprioception
Time Frame: 11 weeks later
|
Proprioceptive sensation was evaluated using the Cervical Range of Motion Deluxe (CROM, Deluxe Performance Attainment Associates, Lindstrom, Minnesota, USA) device.Joint position error and deflection angles of the head in all 3 planes were measured with CROM device.
|
11 weeks later
|
Neck proprioception
Time Frame: 17 weeks later
|
Proprioceptive sensation was evaluated using the Cervical Range of Motion Deluxe (CROM, Deluxe Performance Attainment Associates, Lindstrom, Minnesota, USA) device.Joint position error and deflection angles of the head in all 3 planes were measured with CROM device.
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17 weeks later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain severity
Time Frame: at the beginning of treatments
|
Visual Analogue Scale (VAS) was used to determine the severity of pain in the patients with neck pain.
Patients were asked to indicate their pain levels on a scale of 0-10 cm.
The value "0" indicates no pain while the value "10" indicates unbearable pain.
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at the beginning of treatments
|
Pain severity
Time Frame: 6 weeks later
|
Visual Analogue Scale (VAS) was used to determine the severity of pain in the patients with neck pain.
Patients were asked to indicate their pain levels on a scale of 0-10 cm.
The value "0" indicates no pain while the value "10" indicates unbearable pain.
|
6 weeks later
|
Pain severity
Time Frame: 11 weeks later
|
Visual Analogue Scale (VAS) was used to determine the severity of pain in the patients with neck pain.
Patients were asked to indicate their pain levels on a scale of 0-10 cm.
The value "0" indicates no pain while the value "10" indicates unbearable pain.
|
11 weeks later
|
Pain severity
Time Frame: 17 weeks later
|
Visual Analogue Scale (VAS) was used to determine the severity of pain in the patients with neck pain.
Patients were asked to indicate their pain levels on a scale of 0-10 cm.
The value "0" indicates no pain while the value "10" indicates unbearable pain.
|
17 weeks later
|
Neck disability level
Time Frame: at the beginning of treatments
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The Neck Disability Index was used to determine the patients' neck disability levels.
There are ten sections of the scale that question the severity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation, consisting of 6 questions.
Item scores range from 0 (no disability) to 5 (total disability).
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at the beginning of treatments
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Neck disability level
Time Frame: 6 weeks later
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The Neck Disability Index was used to determine the patients' neck disability levels.
There are ten sections of the scale that question the severity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation, consisting of 6 questions.
Item scores range from 0 (no disability) to 5 (total disability).
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6 weeks later
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Neck disability level
Time Frame: 11 weeks later
|
The Neck Disability Index was used to determine the patients' neck disability levels.
There are ten sections of the scale that question the severity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation, consisting of 6 questions.
Item scores range from 0 (no disability) to 5 (total disability).
|
11 weeks later
|
Neck disability level
Time Frame: 17 weeks later
|
The Neck Disability Index was used to determine the patients' neck disability levels.
There are ten sections of the scale that question the severity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation, consisting of 6 questions.
Item scores range from 0 (no disability) to 5 (total disability).
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17 weeks later
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2017
Primary Completion (Actual)
April 2, 2018
Study Completion (Actual)
May 16, 2018
Study Registration Dates
First Submitted
June 16, 2020
First Submitted That Met QC Criteria
June 18, 2020
First Posted (Actual)
June 19, 2020
Study Record Updates
Last Update Posted (Actual)
June 19, 2020
Last Update Submitted That Met QC Criteria
June 18, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KaratayUKY
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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