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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Konya, Turkey, 42020
        • KTO Karatay University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: BBAT
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.
Other: CT
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.
Other: BBAT
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.
Other: CT
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
at the beginning of treatments
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.
6 weeks later
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.
11 weeks later
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.
17 weeks later
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.
at the beginning of treatments
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.
6 weeks later
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.
17 weeks later

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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
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).
at the beginning of treatments
Neck disability level
Time Frame: 6 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).
6 weeks later
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).
17 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KTO Karatay University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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