NCT05545423

Brief Summary

This study will be conducted to investigate the effect of instrument assisted soft tissue mobilization technique In pain intensity, frequency of headache, medication Uptake, Suboccipital movement in flexion and extension, rounded shoulder, forward head posture and proprioception of cervical spine in cases of cervicogenic headache related to trigger points and myofascial restrictions when combined with conventional physical therapy modalities.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

September 14, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

September 14, 2022

Last Update Submit

September 16, 2022

Conditions

Keywords

instrumented assisted soft tissue mobilizationcervicogenic headacheproprioception

Outcome Measures

Primary Outcomes (1)

  • joint position error

    The Cervical Joint Position Error (JPE) Test is a measurement tool used to clinically assess an individual's cervicocephalic proprioception ability. Cervicocephalic proprioception describes one's sense of position of their head and neck in space. The Cervical JPE Test measures the ability of a blindfolded patient to accurately relocate their head position back to a predetermined neutral point after cervical joint movement. The test is most commonly performed with head movement in the transverse and sagittal planes by cervical range of motion device (CROM).

    up to eight weeks

Secondary Outcomes (9)

  • disability

    up to eight weeks

  • headache frequency

    up to eight weeks

  • headache duration

    up to eight weeks

  • medication intake

    up to eight weeks

  • pain intensity

    up to eight weeks

  • +4 more secondary outcomes

Study Arms (2)

instrumented assisted soft tissue mobilization

EXPERIMENTAL

patients will receive IASTM three times a week for eight weeks

Other: instrumented assisted soft tissue mobilizationOther: traditional therapy

traditional therapy

ACTIVE COMPARATOR

patients will receive traditional therapy three times a week for eight weeks

Other: traditional therapy

Interventions

the appropriate Graston technique instrument will be selected to scan, and then treat the affected area for 30 to 60 seconds per treated area. The procedure will be applied to the superficial cervical fascia and invested the layers of deep cervical fascia that surround all the structures in the neck. Strokes will be applied on the sternocleidomastoids and upper fibers of trapezius muscles. The IASTM technique was applied at a 45° angle in a direction parallel to the treated muscle fibers for 20 seconds, following immediately by an additional 20-seconds application at a 45° angle in a perpendicular direction to the muscle fibers, resulting in a total treatment time of approximately 40 seconds.

instrumented assisted soft tissue mobilization

The exercise program will be in the form of stretching exercises for the sternocleidomastoids (SCM), the scalenes, and upper fibers of trapezius; strengthening isometric exercises for the neck flexors, extensors, lateral flexors, and neck rotators; and postural correction and scapular stabilization exercises

instrumented assisted soft tissue mobilizationtraditional therapy

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 50 years old
  • unilaterality of the head pain
  • pain triggered by external pressure over the upper cervical joints (C1-C3)
  • pain elicited by the neck movements, and/or sustained awkward positions, reduced neck ROM
  • headache intensity pain score of at least 20mm on the Visual Analogue Scale,
  • headache frequency of at least once a week for at least 3 months
  • minimum neck disability index score of 10 points or greater.

You may not qualify if:

  • migraine
  • tension-type headache
  • tumor
  • osteoporosis
  • fracture
  • rheumatoid arthritis and metabolic diseases
  • prolonged history of steroid use
  • resting blood pressure greater than 140/90 mmHg
  • cervical spinal stenosis
  • diminished sensation
  • central nervous system involvement
  • previous head or neck surgery
  • whiplash injury history within the last 6 weeks
  • head or neck pain treatment within the last month from any practitioner and PT approach for head or neck pain within the last 3 months
  • open wounds and psychiatric/cognitive disorders
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelop
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: instrument-assisted soft tissue mobilization and traditional therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 19, 2022

Study Start

September 30, 2022

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

September 19, 2022

Record last verified: 2022-09