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Effects of Basic Body Awareness Therapy on Patients With Chronic Neck Pain

Primary Purpose

Neck Pain, Proprioceptive Disorders, Balance; Distorted

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
BBAT
CT
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, proprioception, balance, body awareness, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • KTO Karatay University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group BBAT / CT

Group CT / BBAT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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).
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).
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).
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).

Full Information

First Posted
June 16, 2020
Last Updated
June 18, 2020
Sponsor
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT04440293
Brief Title
Effects of Basic Body Awareness Therapy on Patients With Chronic Neck Pain
Official Title
Effects of Basic Body Awareness Therapy on Pain, Balance and Proprioceptive Sense in Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
April 2, 2018 (Actual)
Study Completion Date
May 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KTO Karatay University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Proprioceptive Disorders, Balance; Distorted
Keywords
neck pain, proprioception, balance, body awareness, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group BBAT / CT
Arm Type
Experimental
Arm Description
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.
Arm Title
Group CT / BBAT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
BBAT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Balance
Description
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.
Time Frame
at the beginning of treatments
Title
Balance
Description
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.
Time Frame
6 weeks later
Title
Balance
Description
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.
Time Frame
11 weeks later
Title
Balance
Description
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.
Time Frame
17 weeks later
Title
Neck proprioception
Description
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.
Time Frame
at the beginning of treatments
Title
Neck proprioception
Description
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.
Time Frame
6 weeks later
Title
Neck proprioception
Description
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.
Time Frame
11 weeks later
Title
Neck proprioception
Description
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.
Time Frame
17 weeks later
Secondary Outcome Measure Information:
Title
Pain severity
Description
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.
Time Frame
at the beginning of treatments
Title
Pain severity
Description
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.
Time Frame
6 weeks later
Title
Pain severity
Description
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.
Time Frame
11 weeks later
Title
Pain severity
Description
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.
Time Frame
17 weeks later
Title
Neck disability level
Description
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).
Time Frame
at the beginning of treatments
Title
Neck disability level
Description
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).
Time Frame
6 weeks later
Title
Neck disability level
Description
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).
Time Frame
11 weeks later
Title
Neck disability level
Description
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).
Time Frame
17 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamil Yılmaz, 1
Organizational Affiliation
KTO Karatay University
Official's Role
Principal Investigator
Facility Information:
Facility Name
KTO Karatay University
City
Konya
ZIP/Postal Code
42020
Country
Turkey

12. IPD Sharing Statement

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Effects of Basic Body Awareness Therapy on Patients With Chronic Neck Pain

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