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Comparison of Kinesiology Taping and Instrument Assisted Soft Tissue Mobilization in Cervicogenic Headache

Primary Purpose

Headache, Cervical Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
kinesiology taping with conventional therapy
Instrument assisted soft tissue mobilization with conventional therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache focused on measuring Cervicogenic Headache, Instrument Assisted Soft Tissue Mobilization, Kinesiology taping, Cervical range of motion, Neck disability index, Numeric pain rating scale

Eligibility Criteria

30 Years - 44 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Clinically diagnosed cervicogenic headache patients.

  • Headache with neck stiffness and pain
  • Positive flexion rotation test with restriction 6-10 degree.
  • Unilateral headache with referred pattern
  • Age between 30-44 years
  • Both males and females

Exclusion Criteria:

  • Head and neck surgery
  • Congenital deformity
  • Erosive bone diseases
  • Obese
  • Disc pathologies
  • Malignancy and infection of neck region
  • Osteoarthritis
  • Rheumatoid arthritis
  • Dislocation of vertebraes

Sites / Locations

  • Pakistan Railway General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

kinesiology taping with conventional therapy

Instrument Assisted Soft Tissue Mobilization with Conventional therapy

Arm Description

Patients in group A is treated with conventional treatment (include stretching exercises of SCM, Scaleni and upper fibers of trapezius followed by strengthening (isometrics) of Neck flexors (SCM, rectus capitis, anterior and longus capitis) and then with kinesiology taping. Two pieces of the tape cutted in a Y-shape. Applied on deep cervical extensors and upper fibers of trapezius.

Patients in group B is treated with conventional treatment (stretching exercises of SCM, Scaleni and upper fibers of trapezius followed by strengthening (isometrics) of Neck flexors (SCM, rectus capitis, anterior and longus capitis) and then with Instrument Assisted soft tissue mobilization technique. IASTM using tools over the length of targeted muscles (SCM, descending fiber of trapezius, suboccipitalis muscles) in a multidirectional stroking fashion applied to the skin at 30°- 60° for 5 minutes.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
Changes from baseline Numeric pain Rating Scale is used to objectively assess musculoskeletal pain as marked by the patient. It is a 10 point scale from 0 to 10. 0 depicts no pain at all and 10 shows worst pain ever felt. It is measured at baseline and after 4 weeks of the intervention

Secondary Outcome Measures

Neck disability index
Changes from baseline NDI is the most widely used instrument for assessing self-rated disability in patients with neck pain. The NDI is a self-report questionnaire with 10-items. The response to each item is rated on a 6-point scale from 0 (no disability) to 5 (complete disability). The numeric responses for each item are summed for a total score ranging between 0 and 50. Most of the subjects did not know how to drive so their total score is taken from 45. The questionnaire is filled by the subjects at basline and after 4 weeks of the intervention

Full Information

First Posted
July 24, 2022
Last Updated
July 25, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05474612
Brief Title
Comparison of Kinesiology Taping and Instrument Assisted Soft Tissue Mobilization in Cervicogenic Headache
Official Title
Comparison of Kinesiology Taping and Instrument Assisted Soft Tissue Mobilization in Cervicogenic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 25, 2021 (Actual)
Primary Completion Date
July 5, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the effects of kinesiology taping and Instrument Assisted Soft Tissue Mobilization in cervicogenic headache
Detailed Description
Cervicogenic headache (CGH) is a clinical syndrome characterized by primarily unilateral pain that originates in the neck, typically provoked by neck movement or pressure over tender points in the neck, with reduced range of movement of the cervical spine . It is characterized by unilateral headache with signs and symptoms of neck involvement, such as, pain by movement, by external pressure over the upper cervical, and/or sustained awkward head positions . Functional impairments (diminished strength and endurance) in the cervical muscles and poorer muscle control of the deep cervical flexors have been shown in patients with cervicogenic headache . The International Headache Society (IHS) has declared CGH as a secondary type of headache.The main cause of CGH is dysfunction in the upper cervical spine, and the mechanism of headache involves nociceptive structures such as the disks, upper cervical spinal nerves, facet joints, ganglia, muscles, and ligaments , pain most commonly arises from the second and third cervical spine (C2/3) facet joints, followed by C5/6 facet joints This sign and symptoms are described as the pain being unilateral or bilateral, affecting the head or face but has most commonly affected the occipital region, frontal region, or retro-orbital region, commonly associated with suboccipital neck pain, but can also be associated with ipsilateral arm discomfort. Other symptoms associated with CGH include dizziness, nausea, lightheadedness, inability to concentrate, retro-ocular pain, and visual disturbances.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Cervical Pain
Keywords
Cervicogenic Headache, Instrument Assisted Soft Tissue Mobilization, Kinesiology taping, Cervical range of motion, Neck disability index, Numeric pain rating scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
36 participants were recruited in study and divided into two groups. Group A is given intervention with kinesiology taping and group B is given Instrument Assisted Soft Tissue Mobilization treatment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
kinesiology taping with conventional therapy
Arm Type
Experimental
Arm Description
Patients in group A is treated with conventional treatment (include stretching exercises of SCM, Scaleni and upper fibers of trapezius followed by strengthening (isometrics) of Neck flexors (SCM, rectus capitis, anterior and longus capitis) and then with kinesiology taping. Two pieces of the tape cutted in a Y-shape. Applied on deep cervical extensors and upper fibers of trapezius.
Arm Title
Instrument Assisted Soft Tissue Mobilization with Conventional therapy
Arm Type
Active Comparator
Arm Description
Patients in group B is treated with conventional treatment (stretching exercises of SCM, Scaleni and upper fibers of trapezius followed by strengthening (isometrics) of Neck flexors (SCM, rectus capitis, anterior and longus capitis) and then with Instrument Assisted soft tissue mobilization technique. IASTM using tools over the length of targeted muscles (SCM, descending fiber of trapezius, suboccipitalis muscles) in a multidirectional stroking fashion applied to the skin at 30°- 60° for 5 minutes.
Intervention Type
Other
Intervention Name(s)
kinesiology taping with conventional therapy
Intervention Description
Two pieces of the tape cutted in a Y-shape. Applied on deep cervical extensors and upper fibers of trapezius. Length of the tape may vary from person to person. Patient is instructed to keep the tape for at-least 2 days.
Intervention Type
Other
Intervention Name(s)
Instrument assisted soft tissue mobilization with conventional therapy
Intervention Description
IASTM using tools over the length of targeted muscles (SCM, descending fiber of trapezius, suboccipitalis muscles) in a multidirectional stroking fashion applied to the skin at 30°- 60° for 5 minutes. Participants are in a comfortable position during treatment.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
Changes from baseline Numeric pain Rating Scale is used to objectively assess musculoskeletal pain as marked by the patient. It is a 10 point scale from 0 to 10. 0 depicts no pain at all and 10 shows worst pain ever felt. It is measured at baseline and after 4 weeks of the intervention
Time Frame
4th week
Secondary Outcome Measure Information:
Title
Neck disability index
Description
Changes from baseline NDI is the most widely used instrument for assessing self-rated disability in patients with neck pain. The NDI is a self-report questionnaire with 10-items. The response to each item is rated on a 6-point scale from 0 (no disability) to 5 (complete disability). The numeric responses for each item are summed for a total score ranging between 0 and 50. Most of the subjects did not know how to drive so their total score is taken from 45. The questionnaire is filled by the subjects at basline and after 4 weeks of the intervention
Time Frame
4th week
Other Pre-specified Outcome Measures:
Title
inclinometer
Description
Changes from baseline Bubble inclinometers are portable, lightweight, inexpensive and require training. With the movement of neck the ink in the inclinometer moves and the level of ink gives the measure of the range of motion. For flexion, extension and lateral flexion of cervical Range of motion in sitting position and inclinometer is positioned at the top of head in sagittal plane. For rotations the subject is in supine position and inclinometer is placed over the forehead. Cervical ranges of motions are measured at baseline and then after 4 weeks of intervention.
Time Frame
4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinically diagnosed cervicogenic headache patients. Headache with neck stiffness and pain Positive flexion rotation test with restriction 6-10 degree. Unilateral headache with referred pattern Age between 30-44 years Both males and females Exclusion Criteria: Head and neck surgery Congenital deformity Erosive bone diseases Obese Disc pathologies Malignancy and infection of neck region Osteoarthritis Rheumatoid arthritis Dislocation of vertebraes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Affan Iqbal, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Railway General Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46010
Country
Pakistan

12. IPD Sharing Statement

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Comparison of Kinesiology Taping and Instrument Assisted Soft Tissue Mobilization in Cervicogenic Headache

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