A Comparison of the Effectiveness of Massage and Kinesio Taping in Neck Pain
Primary Purpose
Neck Pain
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Massage
Kinesio tape
Neck stabilization exercise
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring neck pain, massage, kinesio tape,
Eligibility Criteria
Inclusion Criteria:
- 18 to 65 years of age,
- having generalized neck pain for more than 3 months,
- being volunteer
Exclusion Criteria:
- pregnancy,
- inflammatory rheumatologic diseases,
- malignity,
- structural deformity,
- previous surgery related to the cervical spine,
- cervical spinal stenosis,
- being allergic to Kinesio tape
- severe psychological disorder,
- any intervention that included exercise or physical therapy in the last 3 months.
Sites / Locations
- Ankara Yildirim Beyazit UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Massage group
Kinesio taping group
Arm Description
Patients in this group were applied to massage plus neck stabilization exercise.
Patients in this group were applied to Kinesio taping plus neck stabilization exercise.
Outcomes
Primary Outcome Measures
Pain Level (Visual Analog Scale)
The pain level was assessed with the Visual Analog Scale, which consists of a horizontal line of 10 cm in length. For pain level assessment, "0" defines "no pain" and "10" defines "unbearable pain''. The participants are asked to mark the intensity of their pain level.
Secondary Outcome Measures
Turkish of the Short Form-36
The quality of life was assessed with the Turkish of the Short Form-36 (SF-36). The SF-36 consists of 36 questions: physical functioning (10 items), role limitations due to physical health (4 items), bodily pain (2 items), social functioning (2 items), vitality (4 items), role limitations due to emotional health (3 items), mental health (5 items), general health perceptions (5 items) and changes in health over time (1 item, not included in the final score). The SF-36 score ranges from 0 (the worst score) to 100 (the best score). Thus, higher scores indicate better health. The participants are asked to fulfill the questionnaire.
Turkish version of Neck Disability Index
The disability level was measured with the Turkish version of Neck Disability Index (NDI). It consists of 10 sections which include the severity of pain, personal care, lifting, reading, headache, concentration, work-life, driving, sleeping and leisure activities. There are 6 responses for each section, scored 0 (no pain and no functional limitation) and 5 (worst pain and maximum limitation). The total score ranges from 0 to 50. Patients were asked to select the most appropriate option for each section.
Range of Motion
The range of motion of the neck joints of the patients was measured with a clinical goniometer (Baseline Evaluation Tools, USA) for flexion, extension, lateral flexion and rotation movements while sitting upright on the stool.
Full Information
NCT ID
NCT04184024
First Posted
November 30, 2019
Last Updated
November 30, 2019
Sponsor
Ataturk Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04184024
Brief Title
A Comparison of the Effectiveness of Massage and Kinesio Taping in Neck Pain
Official Title
A Comparison of the Effectiveness of Massage and Kinesio Taping on Pain, Range of Motion, Disability and Quality of Life in Patients With Chronic Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to compare the effectiveness of massage and Kinesio taping on pain, range of motion, disability and quality of life in patients with chronic neck pain.
Detailed Description
Neck pain is a common condition, affecting 30% to 50% of the general population, and is most prevalent in middle age.33 It is usually accompanied by a substantial effect on daily life, resulting in an extensive use of health care resources.
Several physical therapy applications such as massage therapy, kinesio taping, thermal and electrophysiological agents, hydrotherapy/spa therapy, and therapeutic exercises especially neck stabilization exercise are used to manage FM. Both massage therapy and kinesio taping have a favorable effect on clinical symptoms. However, it is not clear which method is more effective. Therefore, this study aimed to compare the effectiveness of massage and Kinesio taping on pain, range of motion, disability and quality of life 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
Keywords
neck pain, massage, kinesio tape,
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Massage group
Arm Type
Active Comparator
Arm Description
Patients in this group were applied to massage plus neck stabilization exercise.
Arm Title
Kinesio taping group
Arm Type
Active Comparator
Arm Description
Patients in this group were applied to Kinesio taping plus neck stabilization exercise.
Intervention Type
Other
Intervention Name(s)
Massage
Intervention Description
Soft tissue massage known as "Swedish massage" technique was applied to the neck area for 20 minutes. This massage was carried out 3 days a week for 4 weeks (12 sessions) by the supervisor physiotherapist.
Intervention Type
Other
Intervention Name(s)
Kinesio tape
Intervention Description
Patients were taped according to the Kenzo Kase's Kinesio Taping Method by an experienced physical therapist. The application was carried out in a relaxed sitting position. Y banding with extensor muscles on the back of the neck with muscle technique, I banding with the upper trapezius with muscle technique and I banding with ligament technique to the middle region of the neck were performed.
Intervention Type
Other
Intervention Name(s)
Neck stabilization exercise
Intervention Description
Neck stabilization exercise was performed in stages with gradual progression according to the stages of motor learning and sensory-motor integration, namely, static, dynamic, and functional. The program started with postural training and then the cervical bracing technique with the activation of deep neck flexors for NSE was performed. The patients were asked to maintain a neutral spine during the exercises and throughout the day as much as possible. The difficulty and variety of exercises were increased weekly. It was carried out 3 days a week for 4 weeks (12 sessions) by the supervisor physiotherapist.
Primary Outcome Measure Information:
Title
Pain Level (Visual Analog Scale)
Description
The pain level was assessed with the Visual Analog Scale, which consists of a horizontal line of 10 cm in length. For pain level assessment, "0" defines "no pain" and "10" defines "unbearable pain''. The participants are asked to mark the intensity of their pain level.
Time Frame
change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Turkish of the Short Form-36
Description
The quality of life was assessed with the Turkish of the Short Form-36 (SF-36). The SF-36 consists of 36 questions: physical functioning (10 items), role limitations due to physical health (4 items), bodily pain (2 items), social functioning (2 items), vitality (4 items), role limitations due to emotional health (3 items), mental health (5 items), general health perceptions (5 items) and changes in health over time (1 item, not included in the final score). The SF-36 score ranges from 0 (the worst score) to 100 (the best score). Thus, higher scores indicate better health. The participants are asked to fulfill the questionnaire.
Time Frame
change from baseline at 4 weeks
Title
Turkish version of Neck Disability Index
Description
The disability level was measured with the Turkish version of Neck Disability Index (NDI). It consists of 10 sections which include the severity of pain, personal care, lifting, reading, headache, concentration, work-life, driving, sleeping and leisure activities. There are 6 responses for each section, scored 0 (no pain and no functional limitation) and 5 (worst pain and maximum limitation). The total score ranges from 0 to 50. Patients were asked to select the most appropriate option for each section.
Time Frame
change from baseline at 4 weeks
Title
Range of Motion
Description
The range of motion of the neck joints of the patients was measured with a clinical goniometer (Baseline Evaluation Tools, USA) for flexion, extension, lateral flexion and rotation movements while sitting upright on the stool.
Time Frame
change from baseline at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 65 years of age,
having generalized neck pain for more than 3 months,
being volunteer
Exclusion Criteria:
pregnancy,
inflammatory rheumatologic diseases,
malignity,
structural deformity,
previous surgery related to the cervical spine,
cervical spinal stenosis,
being allergic to Kinesio tape
severe psychological disorder,
any intervention that included exercise or physical therapy in the last 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
seyda toprak celenay, PT
Phone
+90-534-041-3986
Email
sydtoprak@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
seyda toprak celenay
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Yildirim Beyazit University
City
Ankara
ZIP/Postal Code
06760
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seyda Toprak Çelenay
12. IPD Sharing Statement
Plan to Share IPD
No
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A Comparison of the Effectiveness of Massage and Kinesio Taping in Neck Pain
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