Effects of Basic Body Awareness Therapy on Patients With Chronic Neck Pain
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2018
CompletedFirst Submitted
Initial submission to the registry
June 16, 2020
CompletedFirst Posted
Study publicly available on registry
June 19, 2020
CompletedJune 19, 2020
June 1, 2020
5 months
June 16, 2020
June 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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.
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.
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.
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.
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.
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.
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.
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.
17 weeks later
Secondary Outcomes (8)
Pain severity
at the beginning of treatments
Pain severity
6 weeks later
Pain severity
11 weeks later
Pain severity
17 weeks later
Neck disability level
at the beginning of treatments
- +3 more secondary outcomes
Study Arms (2)
Group BBAT / CT
EXPERIMENTALGroup 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
EXPERIMENTALGroup 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Being 18 or over,
- Having neck pain for more than 3 months,
- Having neck problems that do not cause neurological deficits
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KTO Karatay University
Konya, 42020, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kamil Yılmaz, 1
KTO Karatay University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2020
First Posted
June 19, 2020
Study Start
November 1, 2017
Primary Completion
April 2, 2018
Study Completion
May 16, 2018
Last Updated
June 19, 2020
Record last verified: 2020-06