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The Effect of Cervical Taping on Neck Pain and Kinematics in Patients With Chronic Neck Pain

Primary Purpose

Neck Pain, Cervical Pain, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Cervical Taping
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, chronic, taping, kinematics, motion analysis, physiotherapy

Eligibility Criteria

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

Inclusion Criteria:

  • Chronic neck pain (>3 months), with or without referral to the upper limb;
  • Age of 18 years or more;
  • Pain intensity ≥ 30% on Visual Analogue Scale (VAS).

Exclusion Criteria:

  • Subjects were excluded if they had physiotherapy in the previous 2 months, known skin allergy to the tape, evidence for active vestibular disorders, medical conditions that may affect performance such as Rheumatic Arthritis, Diabetes Mellitus, neurological disorders, head injuries, lower limb pathologies, local or systemic infections, inability to communicate and provide informed consent, unstable fracture/dislocation, post-orthopaedic surgery in the upper body or spine, and pregnancy.

Sites / Locations

  • The Faculty of Social Welfare and Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cervical taping

Arm Description

Participants received treatment including elastic taping application to the neck. They were assessed 3 times: Pre taping, 20 minutes post-taping on day 1, and 7 days post-taping.

Outcomes

Primary Outcome Measures

Self-reported pain intensity was measured by theVisual Analogue Scale (VAS, 0-100mm)
The Visual Analogue Scale (VAS) was used to measure neck pain intensity (0- 100mm).
Cervical range of motion was measured by the neck VR system (ROM, degrees)
Cervical range of motion was measured to four directions- flexion, extension, right and left rotation, during the VR assessment.

Secondary Outcome Measures

Cervical motion accuracy was measured by the VR system (Accuracy, degrees).
Cervical motion accuracy was collected in the VR accuracy module. It was defined as the difference in degrees between target and player position at each given sample to provide values for accumulated accuracy error in degrees.
Self-reported disability was measured using the Neck Disability Index (NDI, 0-100%)
Disability due to neck pain was measured using the neck disability index (NDI)
Fear of movement was assessed using the TAMPA Scale of Kinesiophobia (TSK, 0-68)
Tampa Scale of Kinesiophobia (TSK) was used to assess fear of movement or re-injury. TSK was found to be associated with measures of behavioral avoidance and disability.

Full Information

First Posted
September 18, 2016
Last Updated
September 26, 2016
Sponsor
University of Haifa
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1. Study Identification

Unique Protocol Identification Number
NCT02915887
Brief Title
The Effect of Cervical Taping on Neck Pain and Kinematics in Patients With Chronic Neck Pain
Official Title
The Short-term Effect of Cervical Taping on Neck Pain, Disability and Kinematics in Patients With Chronic Neck Pain: A Non-randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective: This study examined the effects of elastic tape applied to the neck on patients experiencing chronic neck pain. Background: Neck pain is often persistent or recurrent. Various treatments have been described, including exercises and manual therapy. Taping is commonly used clinically in the management of neck pain, however research in this field is sparse. Methods: Elastic tape was applied over the posterior cervical extensor muscles from insertion to origin on patients experiencing chronic neck pain. Patients were assessed pre-taping, immediately post-taping, and one week post-taping and did not receive additional physiotherapy during the study. Subjective measures included the Visual Analogue Scale (VAS) for pain intensity, the Neck Disability Index (NDI) to determine the level of disability in daily living, and the Tampa Scale of Kinesiophobia (TSK) to assess fear of movement or re-injury. Objective outcome measures included cervical range of motion, velocity, smoothness, and accuracy of cervical motion. These kinematic measures were collected using a customised virtual reality system designed to evaluate neck motion disorders.
Detailed Description
Neck pain is a common disorder, affecting 30-50% of the general population annually, comprising approximately 25% of the patients receiving physiotherapy in outpatient clinics. Symptoms include pain and stiffness in the neck, headache, dizziness, and pain radiating to the shoulders or upper limbs. Physical impairments associated with neck pain can include decreased cervical range of motion (ROM), increased fatigability, compromised strength and endurance of the cervical muscles, and impaired sensorimotor control. A variety of Physiotherapeutic interventions have been described for the treatment of neck pain. Taping is a passive technique, widely used for the treatment of sport injuries, muscle imbalance, and impaired neural control. Clinically, taping is used for neck pain in spite of lack of research regarding its effectiveness. In addition, the mechanism by which elastic tape application affects tissue and function is yet unknown, but various effects have been described such as the ability to increase ROM, facilitate muscles and proprioception, and decrease pain. A literature search retrieved only 3 relevant studies examining the use and efficacy of elastic tape on the cervical spine. Gonzalez-Iglesias et al. (2009) conducted a randomized trial in whiplash patients, Karatas et al. (2012) studied the effect of taping in surgeons with cervical pain after performing surgery, and Saavedra-Hernandez et al (2012)- in patients with mechanical neck pain. All three studies demonstrated short-term effectiveness of elastic taping on pain relief and cervical ROM. However, all samples were small, of mostly young participants, and effect size was not described. Reported changes were small implying that further research is needed. The objective of this study was to evaluate the short-term effect of cervical elastic taping on pain intensity, disability and neck kinematics in patients with chronic neck pain. Materials and Methods This study was a non-controlled trial with a pre-post test design and a single intervention group. Ethics approval was obtained from the ethics committee, the Faculty of Social welfare and Health Sciences at the University of Haifa, and from the Helsinki committee at Rambam Health Care Campus Helsinki Committee. Participants A convenience sample of 27 individuals, 13 males and 14 females, was recruited via electronic media. Inclusion criteria were (a) chronic neck pain (>3 months), with or without referral to the upper limb; (b) age of 18 years or more; (c) pain intensity≥ 30% on Visual Analogue Scale (VAS). Subjects were excluded if they had physiotherapy in the previous 2 months, known skin allergy to the tape, evidence for active vestibular disorders, medical conditions that may affect performance such as Rheumatic Arthritis, Diabetes Mellitus, neurological disorders, head injuries, lower limb pathologies, local or systemic infections, inability to communicate and provide informed consent, unstable fracture/dislocation, post-orthopaedic surgery in the upper body or spine, and pregnancy. Following screening, each participant signed a consent form. Virtual Reality Assessment A neck virtual reality (VR) system was used to assess cervical motion kinematics by the protocol of Sarig-Bahat et al. (2010). This system included off-the-shelf hardware and customized software. Hardware included a head-mounted display with a built-in tracker. Virtual environment software was developed using Unity-pro software, version 3.40f520. Cervical motion was elicited by interaction with images during a video game displayed on the two monitors embedded in the HMD. All dynamic motion data was recorded during the VR session and analysed by the software in real-time. During the game, the participant acts as a pilot flying an airplane. The position of the airplane was controlled by the participant's head motion. Yellow targets were displayed on the HMD monitors and the participant had to contact them within 5 seconds by aligning the airplane with the virtual target. Once the target was contacted, a new target would appear at a random location and the player's task was to move towards it. Based on this principle, the VR assessment included (a) evaluating cervical ROM, (b) cervical motion velocity, and (c) cervical motion accuracy during a smooth head pursuit task. Taping Technique Kinesio®Tex Tape 23 was used in this study. Two strips of tape were applied: The first layer was a Y-shaped strip with 2 tails on 2 sides of the cervical vertebrae, placed over the posterior cervical extensor muscles and applied from the insertion to origin. The second strip was an I-shaped approximately 20cm long, transversally applied over the C5-C7 vertebra with a tension-on-base technique in a space correction technique. Study Procedure Patients were screened by inclusion and exclusion criteria. The physiotherapist performing the assessments and taping techniques was a qualified physiotherapist with 13 years of clinical experience in musculoskeletal physiotherapy and was a qualified Kinesio® taping practitioner. Each patient was assessed 3 times: pre- and 20 minutes post-taping on day 1, and in a follow-up assessment 7 days later. Following the subjective examination and completion of the questionnaires, an explanatory VR session was provided to minimize training effects and to reach a stable level of VR control. Patients were evaluated in upright sitting position, with the trunk strapped to the back of a rigid chair to eliminate thoracic motion. Calibration was performed at each session for each participant, as instructed by the manufacturer. Each VR evaluation took up to 15 minutes. Breaks were provided when needed. Following the assessment, tape was applied. After a washout period 20 minutes post-taping application, the second examination was performed. No other physiotherapy procedures were provided. Patients were instructed to maintain the elastic tape for up to 5 days. They were instructed to remove the tape if symptoms were aggravated or if any topical irritation appeared. The third examination was one-week after the initial examination and included VR assessment without tape application. A paired-samples t-test was used to evaluate the pre-post differences in studied outcome measures. Two paired-sample t-tests were run: pre- vs. immediate post-, and pre- vs. one week post-taping. Significance level was set at 5%. Cohen's d was calculated to determine the effect size. Data were analyzed using the SPSS software, version 17.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Cervical Pain, Chronic Pain
Keywords
neck pain, chronic, taping, kinematics, motion analysis, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cervical taping
Arm Type
Experimental
Arm Description
Participants received treatment including elastic taping application to the neck. They were assessed 3 times: Pre taping, 20 minutes post-taping on day 1, and 7 days post-taping.
Intervention Type
Other
Intervention Name(s)
Cervical Taping
Intervention Description
Kinesio®Tex Tape 23 was used in this study. Two strips of tape were applied. The first layer was a Y-shaped strip with 2 tails on 2 sides of the cervical vertebrae, placed over the posterior cervical extensor muscles and applied from the insertion to origin. The second strip was an I-shaped approximately 20cm long, transversally applied over the C5-C7 vertebra with a tension-on-base technique in a space correction technique.
Primary Outcome Measure Information:
Title
Self-reported pain intensity was measured by theVisual Analogue Scale (VAS, 0-100mm)
Description
The Visual Analogue Scale (VAS) was used to measure neck pain intensity (0- 100mm).
Time Frame
One week
Title
Cervical range of motion was measured by the neck VR system (ROM, degrees)
Description
Cervical range of motion was measured to four directions- flexion, extension, right and left rotation, during the VR assessment.
Time Frame
One week
Secondary Outcome Measure Information:
Title
Cervical motion accuracy was measured by the VR system (Accuracy, degrees).
Description
Cervical motion accuracy was collected in the VR accuracy module. It was defined as the difference in degrees between target and player position at each given sample to provide values for accumulated accuracy error in degrees.
Time Frame
one week
Title
Self-reported disability was measured using the Neck Disability Index (NDI, 0-100%)
Description
Disability due to neck pain was measured using the neck disability index (NDI)
Time Frame
One week
Title
Fear of movement was assessed using the TAMPA Scale of Kinesiophobia (TSK, 0-68)
Description
Tampa Scale of Kinesiophobia (TSK) was used to assess fear of movement or re-injury. TSK was found to be associated with measures of behavioral avoidance and disability.
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic neck pain (>3 months), with or without referral to the upper limb; Age of 18 years or more; Pain intensity ≥ 30% on Visual Analogue Scale (VAS). Exclusion Criteria: Subjects were excluded if they had physiotherapy in the previous 2 months, known skin allergy to the tape, evidence for active vestibular disorders, medical conditions that may affect performance such as Rheumatic Arthritis, Diabetes Mellitus, neurological disorders, head injuries, lower limb pathologies, local or systemic infections, inability to communicate and provide informed consent, unstable fracture/dislocation, post-orthopaedic surgery in the upper body or spine, and pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilla Sarig Bahat, PT, PhD
Organizational Affiliation
Department of Physical Therapy, University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Faculty of Social Welfare and Health Sciences
City
Haifa
ZIP/Postal Code
3498838
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Macdonald, Taping techniques principles and practice. second edition ed. 2004: Elsevier limited.
Results Reference
background
PubMed Identifier
19574662
Citation
Gonzalez-Iglesias J, Fernandez-de-Las-Penas C, Cleland JA, Huijbregts P, Del Rosario Gutierrez-Vega M. Short-term effects of cervical kinesio taping on pain and cervical range of motion in patients with acute whiplash injury: a randomized clinical trial. J Orthop Sports Phys Ther. 2009 Jul;39(7):515-21. doi: 10.2519/jospt.2009.3072.
Results Reference
background
PubMed Identifier
20537313
Citation
Kalichman L, Vered E, Volchek L. Relieving symptoms of meralgia paresthetica using Kinesio taping: a pilot study. Arch Phys Med Rehabil. 2010 Jul;91(7):1137-9. doi: 10.1016/j.apmr.2010.03.013.
Results Reference
background
PubMed Identifier
22274976
Citation
Karatas N, Bicici S, Baltaci G, Caner H. The effect of Kinesiotape application on functional performance in surgeons who have musculo-skeletal pain after performing surgery. Turk Neurosurg. 2012;22(1):83-9. doi: 10.5137/1019-5149.JTN.5377-11.1.
Results Reference
background
PubMed Identifier
17578750
Citation
Yoshida A, Kahanov L. The effect of kinesio taping on lower trunk range of motions. Res Sports Med. 2007 Apr-Jun;15(2):103-12. doi: 10.1080/15438620701405206.
Results Reference
background
PubMed Identifier
24497814
Citation
Halseth T, McChesney JW, Debeliso M, Vaughn R, Lien J. The effects of kinesio taping on proprioception at the ankle. J Sports Sci Med. 2004 Mar 1;3(1):1-7. eCollection 2004 Mar.
Results Reference
background
PubMed Identifier
22523090
Citation
Saavedra-Hernandez M, Castro-Sanchez AM, Arroyo-Morales M, Cleland JA, Lara-Palomo IC, Fernandez-de-Las-Penas C. Short-term effects of kinesio taping versus cervical thrust manipulation in patients with mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2012 Aug;42(8):724-30. doi: 10.2519/jospt.2012.4086. Epub 2012 Apr 20.
Results Reference
background
PubMed Identifier
21112430
Citation
Sarig Bahat H, Weiss PL, Laufer Y. The effect of neck pain on cervical kinematics, as assessed in a virtual environment. Arch Phys Med Rehabil. 2010 Dec;91(12):1884-90. doi: 10.1016/j.apmr.2010.09.007.
Results Reference
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The Effect of Cervical Taping on Neck Pain and Kinematics in Patients With Chronic Neck Pain

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