NCT05474612

Brief Summary

To compare the effects of kinesiology taping and Instrument Assisted Soft Tissue Mobilization in cervicogenic headache

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 25, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

July 24, 2022

Last Update Submit

July 25, 2022

Conditions

Keywords

Cervicogenic HeadacheInstrument Assisted Soft Tissue MobilizationKinesiology tapingCervical range of motionNeck disability indexNumeric pain rating scale

Outcome Measures

Primary Outcomes (1)

  • 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

    4th week

Secondary Outcomes (1)

  • Neck disability index

    4th week

Other Outcomes (1)

  • inclinometer

    4th week

Study Arms (2)

kinesiology taping with conventional therapy

EXPERIMENTAL

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.

Other: kinesiology taping with conventional therapy

Instrument Assisted Soft Tissue Mobilization with Conventional therapy

ACTIVE COMPARATOR

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.

Other: Instrument assisted soft tissue mobilization with conventional therapy

Interventions

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.

kinesiology taping with conventional therapy

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.

Instrument Assisted Soft Tissue Mobilization with Conventional therapy

Eligibility Criteria

Age30 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, 46010, Pakistan

Location

MeSH Terms

Conditions

HeadacheNeck PainPost-Traumatic Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Muhammad Affan Iqbal, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2022

First Posted

July 26, 2022

Study Start

November 25, 2021

Primary Completion

July 5, 2022

Study Completion

July 15, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations