NCT05849545

Brief Summary

Patients suffering from Cervicogenic headache have restricted range of motion and pain which in turn causes functional disability and reduced quality of life. The aim of this research was to determine the effects of Graston technique to improve range of motion, function, and reduction of pain and in patients having Cervicogenic headache

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 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

March 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

December 23, 2022

Last Update Submit

May 8, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline in pain on 10 points on Numeric Pain Rating Scale at 4th week

    The Numeric Pain Rating Scale, is a validated, self reported tool assessing average pain intensity over period of last 24 hours. Possible pain ranges from 0( No pain) to 10 (Worst pain). Change= (Week 4 Score - Baseline Score )

    Baseline and 4th week

  • Change from Baseline in pain on 27 items on Headache Disability Index at 4th week

    Headache Disability Index is a 27 items questionnaire that identify the limitations experienced due to headache. It includes questions to identify the frequency ranges from one per month, more than one but less than four per months, more than one per week and intensity of headache ranges from mild to moderate and to severe.

    Baseline and 4th week

  • Change from Baseline in pain on 10 items on Neck Disability Index at 4th week

    Neck Pain Disability Index is a 10 items questionnaire that identify the functional status of patients based on their conditions. it includes questions related to pain, personal care, reading, lifting, headaches, driving, sleeping , work, focus and leisure.

    Baseline and 4th week

Study Arms (2)

Graston Tool

EXPERIMENTAL

Graston instrument, 20 strokes per minute proximal to distal and 20 strokes per minute distal to proximal for a period of 3 minutes was given over the painful area. GT group protocol included the use application of IASTM along with the application of ice therapy at the end of the session. The assessment of patients was done at the initial and last visit before the completion of the treatment program. Three treatment sessions per week were given to each patient for a total of four weeks.

Device: Garston tool

Neuromuscular Re-Education

ACTIVE COMPARATOR

General stretching and strengthening exercises for the neck muscles. The protocol of treatment for the NMR group included the use of the Neuromuscular re-education soft tissue mobilization technique (NMR) followed by active movements of the patient.

Procedure: Neuromuscular Re-education

Interventions

GT group protocol included the use application of IASTM along with the application of ice therapy at the end of the session. Using the Graston instrument, 20 strokes per minute proximal to distal and 20 strokes per minute distal to proximal for a period of 3 minutes were given over the painful area. Baseline values were recorded for demographics evaluation and episodes of pain onsets. The assessment of patients was done at the initial and last visit before the completion of the treatment program. Three treatment sessions per week were given to each patient for a total of four weeks.

Also known as: Neuromuscular Re-education
Graston Tool

General stretching and strengthening exercises for the neck muscles. The protocol of treatment for the NMR group included the use of the Neuromuscular re-education soft tissue mobilization technique (NMR) followed by active movements of the patient.

Neuromuscular Re-Education

Eligibility Criteria

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

You may qualify if:

  • Age: Minimum 20years- Maximum 50 years (Male/Female)
  • Unilateral pain
  • Neck stiffness and ROM restrictions
  • Pain exacerbated by posture and neck movements
  • Pain effecting QOL
  • Positive flexion-rotation test

You may not qualify if:

  • Headache not of cervical origin
  • Congenital condition of cervical spine
  • Headache with autonomic involvement, dizziness or visual impairment
  • Inability to tolerate the flexion rotation test
  • Conditions contraindicated for graston technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nazma

Islamabad, 46000, Pakistan

Location

Related Publications (17)

  • Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.

    PMID: 23771276BACKGROUND
  • Elsocht G, Delaunaij T, Van Durme M, Van Hautegem E. Cervicogenic Headache.

    BACKGROUND
  • Biondi DM. Cervicogenic headache: a review of diagnostic and treatment strategies. J Am Osteopath Assoc. 2005 Apr;105(4 Suppl 2):16S-22S.

    PMID: 15928349BACKGROUND
  • Bogduk N. Cervicogenic headache: anatomic basis and pathophysiologic mechanisms. Curr Pain Headache Rep. 2001 Aug;5(4):382-6. doi: 10.1007/s11916-001-0029-7.

    PMID: 11403743BACKGROUND
  • Fredriksen TA, Antonaci F, Sjaastad O. Cervicogenic headache: too important to be left un-diagnosed. J Headache Pain. 2015;16:6. doi: 10.1186/1129-2377-16-6. Epub 2015 Jan 20.

    PMID: 25604994BACKGROUND
  • Warren 1. Hammer M D, DABCO. Functional Soft-Tissue Examination and Treatment by Manual Methods 2007 2007.

    BACKGROUND
  • Portillo-Soto A, Eberman LE, Demchak TJ, Peebles C. Comparison of blood flow changes with soft tissue mobilization and massage therapy. J Altern Complement Med. 2014 Dec;20(12):932-6. doi: 10.1089/acm.2014.0160.

    PMID: 25420037BACKGROUND
  • Stow R. Instrument-assisted soft tissue mobilization. International journal of athletic therapy and training. 2011;16(3):5-8.

    BACKGROUND
  • Hall TM, Robinson KW, Fujinawa O, Akasaka K, Pyne EA. Intertester reliability and diagnostic validity of the cervical flexion-rotation test. J Manipulative Physiol Ther. 2008 May;31(4):293-300. doi: 10.1016/j.jmpt.2008.03.012.

    PMID: 18486750BACKGROUND
  • Sandmark H, Nisell R. Validity of five common manual neck pain provoking tests. Scand J Rehabil Med. 1995 Sep;27(3):131-6.

    PMID: 8602474BACKGROUND
  • Page P. Cervicogenic headaches: an evidence-led approach to clinical management. Int J Sports Phys Ther. 2011 Sep;6(3):254-66.

    PMID: 22034615BACKGROUND
  • Racicki S, Gerwin S, Diclaudio S, Reinmann S, Donaldson M. Conservative physical therapy management for the treatment of cervicogenic headache: a systematic review. J Man Manip Ther. 2013 May;21(2):113-24. doi: 10.1179/2042618612Y.0000000025.

    PMID: 24421621BACKGROUND
  • Schoensee SK, Jensen G, Nicholson G, Gossman M, Katholi C. The effect of mobilization on cervical headaches. J Orthop Sports Phys Ther. 1995 Apr;21(4):184-96. doi: 10.2519/jospt.1995.21.4.184.

    PMID: 7773270BACKGROUND
  • Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.

    PMID: 26852024BACKGROUND
  • Boyer S, Novack J, Madsen L, Kingma J, Schrader J, Docherty C. The Immediate Effects of Graston Technique© on Hamstring Flexibility Compared to a Control. Journal of Athletic Training. 2017;52(6):S94.

    BACKGROUND
  • Barger KM. Compressive versus decompressive soft tissue therapy on acute hamstring flexibility and pain in male athletes with perceived hamstring tightness: Oklahoma State University; 2016.

    BACKGROUND
  • Cheatham SW, Lee M, Cain M, Baker R. The efficacy of instrument assisted soft tissue mobilization: a systematic review. J Can Chiropr Assoc. 2016 Sep;60(3):200-211.

    PMID: 27713575BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Nazma Namroz

    Riphah International Univeristy, Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2022

First Posted

May 9, 2023

Study Start

March 10, 2021

Primary Completion

July 15, 2021

Study Completion

July 15, 2021

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

there is a plan

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations