Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Thrust Joint Manipulation and Reverse SNAGS (Sustained Natural Apophyseal Glides) in Cervicogenic Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04521218
Recruitment Status : Completed
First Posted : August 20, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Cervicogenic Headache Other: Thrust Joint Manipulation Other: Reverse Sustained Natural apophyseal glides Not Applicable

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Thrust Joint Manipulation and Reverse SNAGS (Sustained Natural Apophyseal Glides) of Upper Cervical Spine in Cervicogenic Headache
Actual Study Start Date : May 4, 2019
Actual Primary Completion Date : December 15, 2020
Actual Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Thrust joint Manipulation
Thrust joint Manipulation, heat application, Strengthening exercise and home plan
 Other: Thrust Joint Manipulation

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

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Numeric Pain Rating Scale [ Time Frame: 12th Day ]
    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.


Secondary Outcome Measures :
  1. Pressure Pain Threshold (PPT) [ Time Frame: 12th Day ]
    Changes from Baseline Pressure Pain Threshold (PPT) were taken with the help of algometer.

  2. Headache Disability Index [ Time Frame: 12th Day ]
    Scoring instructions: Yes = 4 points, Sometimes = 2, No = 0. Using this system, a total score of 10-28 is considered to indicate mild disability; 30-48 is moderate disability; 50-68 is severe disability; 72 or more is complete disability

  3. Range of Motion(ROM) Cervical (Flexion) [ Time Frame: 12th Day ]
    Changes from the baseline ROM range of motion of cervical spine flexion was taken with the help of inclinometer

  4. ROM Cervical (Extension) [ Time Frame: 12th Day ]
    Changes from the baseline ROM range of motion of cervical spine Extension was taken with the help of inclinometer

  5. ROM Cervical (Side Bend) [ Time Frame: 12th Day ]
    Changes from the baseline ROM range of motion of cervical spine Side bending was taken with the help of inclinometer

  6. ROM Cervical Rotation [ Time Frame: 12th Day ]
    Changes from the baseline ROM range of motion of cervical spine rotation was taken with the help of inclinometer


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Headache frequency of at least 1 per week for a minimum of 3 months
  • Secondary Headache (cervical spine dysfunction)

  • International Classification of headache Disorder:

    1. 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.
    2. Pain is precipitated or aggravated by specific neck movements or sustained postures.

    3. At least one of the following:

      1. Resistance to or limitation of passive neck movements
      2. Changes in neck muscle contour, texture, tone, or response to active and passive stretching and contraction
      3. Abnormal tenderness of neck musculature

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04521218


Locations
Layout table for location information
Pakistan
Max health Rehabilitation Centre
Islamabad, Fedral, Pakistan, 44000
Sponsors and Collaborators
Riphah International University
Investigators
Layout table for investigator information
Principal Investigator: Dr Saira Waqqar, PP-DPT, MHPE Riphah International University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
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.
Jamil M, Janjua U. Comparison of cervicogenic headache between housewives and working women. Rawal Medical Journal. 2020 Jan;45(1):77-9.
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.
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
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
Rasul HNU, Dustagir A, Malik AN. Role of Mobilization to Improve Cervicogenic Headache

Layout table for additonal information
Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT04521218    
Other Study ID Numbers: REC/00694 Amna Arshad
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Thrust joint manipulation
Reverse sustained natural apophyseal glides
Cervicogenic headache
Mobilization and Manipulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Post-Traumatic Headache
Headache
Pain
Neurologic Manifestations
Headache Disorders, Secondary
 Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases