Neck PainNCT04440293
Effects of Basic Body Awareness Therapy on Patients With Chronic Neck Pain
A study testing BBAT and CT in people with Neck Pain and Proprioceptive Disorders, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain, Proprioceptive Disorders, Balance; Distorted
- What is being tested?
- BBAT and CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 16 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 or over,
- Having neck pain for more than 3 months,
- Having neck problems that do not cause neurological deficits
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neck Pain, Proprioceptive Disorders, Balance; Distorted
- Being tested
- BBAT, CT
- Keywords
- neck pain, proprioception, balance, body awareness, exercise
- Medical subject headings
- Neck Pain, Somatosensory Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBATOther
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.
CTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group BBAT / CT | Experimental | 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. Receives: Other: BBAT; Other: CT |
| Group CT / BBAT | Experimental | 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. Receives: Other: BBAT; Other: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
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.
Measured: at the beginning of treatments
Balance
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.
Measured: 6 weeks later
Balance
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.
Measured: 11 weeks later
Balance
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.
Measured: 17 weeks later
Neck proprioception
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.
Measured: at the beginning of treatments
Neck proprioception
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.
Measured: 6 weeks later
Neck proprioception
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.
Measured: 11 weeks later
Neck proprioception
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.
Measured: 17 weeks later
Secondary outcomes (8)
Pain severity
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.
Measured: at the beginning of treatments
Pain severity
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.
Measured: 6 weeks later
Pain severity
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.
Measured: 11 weeks later
Pain severity
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.
Measured: 17 weeks later
Neck disability level
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).
Measured: at the beginning of treatments
Neck disability level
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).
Measured: 6 weeks later
Neck disability level
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).
Measured: 11 weeks later
Neck disability level
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).
Measured: 17 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Nov 2017
- Primary completion2 Apr 2018
- Study completion16 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kamil Yılmaz, 1, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440293
- Sponsor's protocol ID
- KaratayUKY
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Basic Body Awareness Therapy on Pain, Balance and Proprioceptive Sense in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04440293
- Acronym / sponsor ID
- KaratayUKY
- Conditions
- Neck Pain, Proprioceptive Disorders, Balance; Distorted
- Keywords
- neck pain, proprioception, balance, body awareness, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group BBAT / CT | Experimental | Other: BBAT, Other: CTGroup 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. |
| Group CT / BBAT | Experimental | Other: BBAT, Other: CTGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18 or over,
- Having neck pain for more than 3 months,
- Having neck problems that do not cause neurological deficits
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBATThe 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. | Other | Group BBAT / CT, Group CT / BBAT |
| CTThe 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. | Other | Group BBAT / CT, Group CT / BBAT |
Primary outcome
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.
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.
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.
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.
Neck proprioception
Time frame: at the beginning of treatments
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.
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.
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.
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.
8 secondary outcomes
Pain severity
Time frame: at the beginning of treatments
Pain severity
Time frame: 6 weeks later
Pain severity
Time frame: 11 weeks later
Pain severity
Time frame: 17 weeks later
Neck disability level
Time frame: at the beginning of treatments
Neck disability level
Time frame: 6 weeks later
Neck disability level
Time frame: 11 weeks later
Neck disability level
Time frame: 17 weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamil Yılmaz, 1 principal investigator
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BBAT and CT in people with Neck Pain and Proprioceptive Disorders, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: at the beginning of treatments). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.