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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05849545
Other study ID # Jaweria Syed
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 10, 2021
Est. completion date July 15, 2021

Study information

Verified date May 2023
Source Health Education Research Foundation (HERF)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

A randomized controlled trial in which Graston Technique and Neuromuscular Re-education technique would be applied on patients presenting with cervicogenic headaches by using different tools and the changes would be examined pre and post intervention. The participants fulfilling inclusion criteria would be randomly allocated to two groups. Both groups received different protocols and will be assessed on data collection tool on their first and last visit using Goniometer, Headache Disability Index (HDI), Neck pain Disability Index (NDI) and Numeric Pain Rating Scale (NPRS). Participants of both groups will be pre-tested before the application of interventional techniques and post-tested after the application of respective intervention.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 15, 2021
Est. primary completion date July 15, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Garston tool
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.
Procedure:
Neuromuscular Re-education
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.

Locations

Country Name City State
Pakistan Nazma Islamabad

Sponsors (1)

Lead Sponsor Collaborator
Health Education Research Foundation (HERF)

Country where clinical trial is conducted

Pakistan, 

References & Publications (17)

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.

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

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. — View Citation

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.

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. — View Citation

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. — View Citation

Elsocht G, Delaunaij T, Van Durme M, Van Hautegem E. Cervicogenic Headache.

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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

Warren 1. Hammer M D, DABCO. Functional Soft-Tissue Examination and Treatment by Manual Methods 2007 2007.

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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