NCT04521218

Brief Summary

The purpose of the study was to compare the effect of upper cervical thrust joint manipulation and reverse Sustained Natural apophyseal Glide on intensity of pain, pain pressure threshold, range of motion and headache disability in patients with cervicogenic headache. A randomized control trial was conducted at Max Rehab and Physical therapy center, Islamabad. The sample size was calculated through open epi tool is 16. The participants were divided in two groups, 8 participants in experimental group and 8 participants in control group. The study duration was six months. Sampling technique applied was Purposive sampling for recruitment and group randomization using sealed envelope method. Only 20 to 40 years participants with cervicogenic headache and associated symptoms were included in the study. Tools used in this study are Numeric pain rating Scale (NPRS), Algometer, Inclinometer and headache disability index (HDI). Data analyzed through Statistical Package for the Social Sciences (SPSS) version 23.

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 May 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

1.6 years

First QC Date

August 18, 2020

Last Update Submit

December 16, 2020

Conditions

Keywords

Thrust joint manipulationReverse sustained natural apophyseal glidesCervicogenic headacheMobilization and Manipulation

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating Scale

    Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.

    12th Day

Secondary Outcomes (6)

  • Pressure Pain Threshold (PPT)

    12th Day

  • Headache Disability Index

    12th Day

  • Range of Motion(ROM) Cervical (Flexion)

    12th Day

  • ROM Cervical (Extension)

    12th Day

  • ROM Cervical (Side Bend)

    12th Day

  • +1 more secondary outcomes

Study Arms (2)

Thrust joint Manipulation

EXPERIMENTAL

Thrust joint Manipulation, heat application, Strengthening exercise and home plan

Other: Thrust Joint Manipulation

Reverse Sustained Natural apophyseal glides

ACTIVE COMPARATOR

Reverse Sustained Natural apophyseal glides (SNAG), heat application, Strengthening exercise and home plan.

Other: Reverse Sustained Natural apophyseal glides

Interventions

Experimental group included TJM, Cervical hot pack, strengthening exercises and home plan; 3 sessions of manipulation per week and total of 4 weeks. Measurement will be taken at base level and after the last session, i.e. Pain intensity, pain pressure threshold, ROM, and disability. These exercises included. Cervical Flexion, Extension Rotation, lateral flexion and back strengthening exercises. These all exercises were performed 3 x 15 Repetitions with 10 sec hold. This protocol was for 4 weeks and 3 sessions per week. Home plan exercises includes Craniocervical Flexion, Craniocervical Extension, Rotation Exercise, Lateral Flexion Exercise, Chin Tuck in and Shoulder blade exercise were advised to perform 3 x 10 Repetition with 10 - 30 sec hold.

Thrust joint Manipulation

Control group included Moist Hot Pack (Cervical contour- 8.25 x 10 x 2) for 10 Mins, Reverse SNAGS (10 Repetitions holding for 10 sec in each glide with a rest time of 30 seconds in between), Strengthening exercise and home plan. 3 sessions of mobilization per week and total of 4 weeks. Measurement will be taken at base level and after the last session, i.e. Pain intensity, pain pressure threshold, ROM, and disability. These exercises included. Cervical Flexion, Extension Rotation, lateral flexion and back strengthening exercises. These all exercises were performed 3 x 15 Repetitions with 10 sec hold. This protocol was for 4 weeks and 3 sessions per week. Home plan exercises includes Craniocervical Flexion, Craniocervical Extension, Rotation Exercise, Lateral Flexion Exercise, Chin Tuck in and Shoulder blade exercise were advised to perform 3 x 10 Repetition with 10 - 30 sec hold

Reverse Sustained Natural apophyseal glides

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Headache frequency of at least 1 per week for a minimum of 3 months
  • Secondary Headache (cervical spine dysfunction)
  • International Classification of headache Disorder:
  • Pain localized in the neck and occiput, which can spread to other areas in the head, such as forehead, orbital region, temples, vertex, or ears, usually unilateral.
  • Pain is precipitated or aggravated by specific neck movements or sustained postures.
  • At least one of the following:
  • Resistance to or limitation of passive neck movements
  • Changes in neck muscle contour, texture, tone, or response to active and passive stretching and contraction
  • Abnormal tenderness of neck musculature

You may not qualify if:

  • Other types of headache
  • Trigger points of upper cervical muscles
  • Congenital conditions of cervical spine
  • Cervical Disc herniation
  • Fracture
  • Cervical Artery disease
  • Red flags of Thrust Joint Manipulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Max health Rehabilitation Centre

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (18)

  • Sjaastad O, Saunte C, Hovdahl H, Breivik H, Gronbaek E. "Cervicogenic" headache. An hypothesis. Cephalalgia. 1983 Dec;3(4):249-56. doi: 10.1046/j.1468-2982.1983.0304249.x. No abstract available.

    PMID: 6640659BACKGROUND
  • Sjaastad O, Fredriksen TA, Pfaffenrath V. Cervicogenic headache: diagnostic criteria. The Cervicogenic Headache International Study Group. Headache. 1998 Jun;38(6):442-5. doi: 10.1046/j.1526-4610.1998.3806442.x. No abstract available.

    PMID: 9664748BACKGROUND
  • Haldeman S, Dagenais S. Cervicogenic headaches: a critical review. Spine J. 2001 Jan-Feb;1(1):31-46. doi: 10.1016/s1529-9430(01)00024-9.

    PMID: 14588366BACKGROUND
  • Lord SM, Barnsley L, Wallis BJ, Bogduk N. Third occipital nerve headache: a prevalence study. J Neurol Neurosurg Psychiatry. 1994 Oct;57(10):1187-90. doi: 10.1136/jnnp.57.10.1187.

    PMID: 7931379BACKGROUND
  • Fleming R, Forsythe S, Cook C. Influential variables associated with outcomes in patients with cervicogenic headache. J Man Manip Ther. 2007;15(3):155-64. doi: 10.1179/106698107790819846.

    PMID: 19066663BACKGROUND
  • Evers S. Comparison of cervicogenic headache with migraine. Cephalalgia. 2008 Jul;28 Suppl 1:16-7. doi: 10.1111/j.1468-2982.2008.01609.x. No abstract available.

    PMID: 18494987BACKGROUND
  • Bogduk N, Govind J. Cervicogenic headache: an assessment of the evidence on clinical diagnosis, invasive tests, and treatment. Lancet Neurol. 2009 Oct;8(10):959-68. doi: 10.1016/S1474-4422(09)70209-1.

    PMID: 19747657BACKGROUND
  • van Suijlekom JA, Weber WE, van Kleef M. Cervicogenic headache: techniques of diagnostic nerve blocks. Clin Exp Rheumatol. 2000 Mar-Apr;18(2 Suppl 19):S39-44.

    PMID: 10824286BACKGROUND
  • Biondi DM. Cervicogenic headache: diagnostic evaluation and treatment strategies. Curr Pain Headache Rep. 2001 Aug;5(4):361-8. doi: 10.1007/s11916-001-0026-x.

    PMID: 11403740BACKGROUND
  • Bogduk N. The neck and headaches. Neurol Clin. 2004 Feb;22(1):151-71, vii. doi: 10.1016/S0733-8619(03)00100-2.

    PMID: 15062532BACKGROUND
  • Jull G, Barrett C, Magee R, Ho P. Further clinical clarification of the muscle dysfunction in cervical headache. Cephalalgia. 1999 Apr;19(3):179-85. doi: 10.1046/j.1468-2982.1999.1903179.x.

    PMID: 10234466BACKGROUND
  • Mohamed AA, Shendy WS, Semary M, Mourad HS, Battecha KH, Soliman ES, Sayed SHE, Mohamed GI. Combined use of cervical headache snag and cervical snag half rotation techniques in the treatment of cervicogenic headache. J Phys Ther Sci. 2019 Apr;31(4):376-381. doi: 10.1589/jpts.31.376. Epub 2019 Apr 1.

    PMID: 31037013BACKGROUND
  • Umar M, Naeem A, Badshah M, Zaidi S. A randomized control trial to review the effectiveness of cervical mobilization combined with stretching exercises in cervicogenic headache. J Public Health Biolo Sci. 2012;1(1):09-13.

    BACKGROUND
  • Jamil M, Janjua U. Comparison of cervicogenic headache between housewives and working women. Rawal Medical Journal. 2020 Jan;45(1):77-9.

    BACKGROUND
  • Umar M, Badshah M, Maryam M, Naeem A, Rehman L, Ahmed M. Prevalence Of Different Types Of Headache In Medical Students Of Rawalpindi & Islamabad. International Journal of Rehabilitation Sciences (IJRS). 2018 Mar 15;4(01):15-9.

    BACKGROUND
  • Coelho M, Ela N, Garvin A, Cox C, Sloan W, Palaima M, et al. The effectiveness of manipulation and mobilization on pain and disability in individuals with cervicogenic and tension-type headaches: a systematic review and meta-analysis. Physical Therapy Reviews. 2019;24(1-2):29-43

    BACKGROUND
  • Rani M, Kulandaivelan S, Bansal A, Pawalia A. Physical therapy intervention for cervicogenic headache: an overview of systematic reviews. European Journal of Physiotherapy. 2019:1-7

    BACKGROUND
  • Rasul HNU, Dustagir A, Malik AN. Role of Mobilization to Improve Cervicogenic Headache

    BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Dr Saira Waqqar, PP-DPT, MHPE

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 20, 2020

Study Start

May 4, 2019

Primary Completion

December 15, 2020

Study Completion

December 15, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations