NCT04625387

Brief Summary

Headache is an important health problem. It is the commonest type of all signs of illness in the people worldwide. Cervicogenic Headache is commonest musculoskeletal condition in physiotherapy practice. This study's main objective was to evaluate effectiveness of Dry Needle with exercise in decreasing pain and improving function in patients with Cervicogenic Headache.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

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

May 15, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 6, 2020

Last Update Submit

November 10, 2020

Conditions

Cervicogenic Headache

Keywords

Dry NeedleExerciseNeck painTrigger point

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Scale

    Visual analogue scale is a subjective outcome measurement where patients judge the intensity of their pain on a scale of 0-10, which is in the form of a 10cm straight line . On this 0-10 scale, zero denotes no pain and ten denotes severe pain intensity

    four weeks

  • Neck Disability Index

    The Neck Disability index contains 10 items, seven related to activities of daily living, two related to pain, and one item related to concentration. Each item is scored ranging from 0 (no pain or disability) to 5 (severe pain and disability); and the total score is expressed as a percentage, with higher scores corresponding to greater disability.

    four weeks

Secondary Outcomes (1)

  • Cervical Range of Motion

    four weeks

Study Arms (2)

Dry Needle plus exercise

EXPERIMENTAL

Group A received Dry Needling along with exercise having 25 individuals. Treatment lasted four weeks duration, twice a week.

Other: Dry Needle and Exercise

Dry Needling alone

EXPERIMENTAL

Group B received Dry Needling alone having 25 individuals. Treatment lasted four weeks duration, twice a week.

Other: Dry Needle and Exercise

Interventions

Dry Needle and ExerciseOTHER

A 0.25 X 15 mm acupuncture needle was used for sub occipital muscle and 0.25 X 40 mm needle was used for paraspinal and trapezius muscle. All the necessary precautions were maintained before inserting the needle. Therapists wore hand gloves for all purposes. The exercise for the muscles of cervical group, for group A was carried out by elevating head from lying in supine position repeating 20 times in three sets and pressing a theraband forward in one set of 15 repetitions, to right side and to left side and back side

Also known as: Ice pack
Dry Needle plus exerciseDry Needling alone

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20-50 years.
  • Male and female both gender
  • Worker in the Office.
  • Employed permanently.
  • Self-motivated for working continuously for rehab.
  • Persistent or regular pain in the neck over a span of at least 6 months.

You may not qualify if:

  • Cervical spine injury or surgery.
  • Congenital spinal deformity.
  • Participants having age less than 20 or elder than 50 years.
  • Cervical radiculopathy,
  • The participants had experienced any recent trauma or suffering from dizzy spells, any vascular neurological disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sharick Shamsi

Gorakhpur, Uttar Pradesh, 273001, India

Location

MeSH Terms

Conditions

Post-Traumatic HeadacheMotor ActivityNeck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sharick Shamsi, PhD

    Raj Nursing and Paramedical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 12, 2020

Study Start

May 15, 2020

Primary Completion

June 25, 2020

Study Completion

June 25, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)