NCT04954716

Brief Summary

This project will explore the effect of deep friction massage and post isometric relaxation techniques in Cervicogenic headache. The population sample will be 20 divided randomly into two groups by Lottery method. Then i will collect data from central hospital, Gujranwala. One group will be treated with a deep friction massage technique thrice a week for 3 weeks. Another group will be treated with a post isometric relaxation technique thrice a week for 3 weeks. Both groups will receive a heating pad and neck isometric as baseline treatment. Baseline measurements are taken by an inclinometer. After a treatment plan, the group will be assessed again and post-treatment measured values will be compared with the pretest values. Subjects will be asked to come for follow-up after 4 weeks. The follow-up will show which technique is more effective in subjects having Cervicogenic headaches. Both the techniques used are non-invasive and having minimum side effects. This project will help Physical Therapy Practitioner to explore which technique is more useful to treat Cervicogenic headaches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

July 6, 2021

Last Update Submit

August 23, 2021

Conditions

Keywords

Cervicogenic headache (CH, CGH)Muscle Energy Technique (MET),Post-isometric relaxation(PIR)

Outcome Measures

Primary Outcomes (1)

  • Headache disability index

    This scale is used to identify difficulties that you may be experiencing because of your headache. Please check off "YES", "SOMETIMES", or "NO" to each item. Proforma consist of 25 question Scoring The following responses are given the following values: Response Points Yes 4 Sometimes 2 No 0 Interpretation A 29 point change (95% confidence interval) or greater in the total score from test to retest must occur before the change can be attributed to treatment effects.

    3 week

Secondary Outcomes (1)

  • Upper cervical spine(ROM)

    3 weeks

Study Arms (2)

Deep Neck Flexor Massage

EXPERIMENTAL

INTERVENTIONAL GROUP(DEEP Neck FLEXOR MASSAGE)

Other: Deep Neck Flexor Massage

Post-Isometric Relaxation Technique

ACTIVE COMPARATOR

CONTROL GROUP (POST-ISOMETRIC RELAXATION TECHNIQUE)

Other: Post-Isometric Relaxation Technique

Interventions

Deep friction massage is a specific connective tissue massage that was given across the affected fibers.The therapist's fingers and patient's skin must move as one, otherwise moving subcutaneous fascia against muscle or ligament could lead to blister formation or subcutaneous bruising.The friction massage must have sufficient sweep and be deep enough.

Deep Neck Flexor Massage

The PIR technique is performed as follows.The hypertonic muscle is taken to a length just short of pain, or to the point where resistance to movement is first noted.A submaximal (10-20%) contraction of the hypertonic muscle is performed away from the barrier for between 5 and 10 seconds and the therapist applies resistance in the opposite direction . The patient should inhale during this effort.After the isometric contraction the patient is asked to relax and exhale while doing so.Following this a gentle stretch is applied to take up the slack till the new barrier.Starting from this new barrier, the procedure is repeated two or three times.

Post-Isometric Relaxation Technique

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders.
  • Symptoms duration more than 6 months.
  • Age 18 -60
  • Patient has confirmed the diagnosis of cervicogenic headache

You may not qualify if:

  • Rule out cervical malignancy
  • infection (such as osteomyelitis or diskitis)
  • osteoporosis, inflammatory arthritis.
  • fracture, pregnancy
  • cord compression, uncontrolled hypertension
  • cardiovascular disease
  • in the setting of carotid or vertebral artery disease.
  • Trauma cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central hospital Gujranwala

Gujranwala, Punjab Province, 54560, Pakistan

Location

Related Publications (11)

  • Martelletti P, van Suijlekom H. Cervicogenic headache: practical approaches to therapy. CNS Drugs. 2004;18(12):793-805. doi: 10.2165/00023210-200418120-00004.

    PMID: 15377169BACKGROUND
  • Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.

    PMID: 17381554BACKGROUND
  • Castien RF, De Hertogh W, Scholten-Peeters GG. Letter to the Editor: Physical examination tests for screening and diagnosis of cervicogenic headache: A systematic review by Rubio-Ochoa et al. (2015). Man Ther. 2016 Jun;23:e7-8. doi: 10.1016/j.math.2016.01.006. Epub 2016 Jan 29. No abstract available.

    PMID: 26934859BACKGROUND
  • Fernandez-de-Las-Penas C, Alonso-Blanco C, Cuadrado ML, Pareja JA. Spinal manipulative therapy in the management of cervicogenic headache. Headache. 2005 Oct;45(9):1260-3. doi: 10.1111/j.1526-4610.2005.00253_1.x.

    PMID: 16178960BACKGROUND
  • Garcia JD, Arnold S, Tetley K, Voight K, Frank RA. Mobilization and Manipulation of the Cervical Spine in Patients with Cervicogenic Headache: Any Scientific Evidence? Front Neurol. 2016 Mar 21;7:40. doi: 10.3389/fneur.2016.00040. eCollection 2016.

    PMID: 27047446BACKGROUND
  • 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
  • Li L, Stoop R, Clijsen R, Hohenauer E, Fernandez-de-Las-Penas C, Huang Q, Barbero M. Criteria Used for the Diagnosis of Myofascial Trigger Points in Clinical Trials on Physical Therapy: Updated Systematic Review. Clin J Pain. 2020 Dec;36(12):955-967. doi: 10.1097/AJP.0000000000000875.

    PMID: 32841969BACKGROUND
  • Chamberlain GJ. Cyriax's Friction Massage: A Review. J Orthop Sports Phys Ther. 1982;4(1):16-22. doi: 10.2519/jospt.1982.4.1.16.

    PMID: 18810110BACKGROUND
  • Emary P. Use of post-isometric relaxation in the chiropractic management of a 55-year-old man with cervical radiculopathy. J Can Chiropr Assoc. 2012 Mar;56(1):9-17.

    PMID: 22457537BACKGROUND
  • Youssef EF, Shanb AS. Mobilization versus massage therapy in the treatment of cervicogenic headache: a clinical study. J Back Musculoskelet Rehabil. 2013;26(1):17-24. doi: 10.3233/BMR-2012-0344.

    PMID: 23411644BACKGROUND
  • Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain. 2012 Jul;13(5):351-9. doi: 10.1007/s10194-012-0436-7. Epub 2012 Mar 30.

    PMID: 22460941BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Muhammad Sana ullah, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 8, 2021

Study Start

January 10, 2021

Primary Completion

August 10, 2021

Study Completion

August 10, 2021

Last Updated

August 24, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations