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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05249647
Other study ID # REC/RCR&AH/21/0128/Warda Zafar
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 25, 2022
Est. completion date July 13, 2022

Study information

Verified date December 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study will be randomized clinical trial. Data will be collected from non probability consecutive sampling technique. Total 44 participants from Rafiqa Hospital and District Headquarter (DHQ) Sargodha will be selected and randomly allocated to two different groups i.e Group A and Group B. Group A will be treated with Instrument assisted Fascial Abrasion and Conventional Therapy for 5 minutes, 6 sessions (3 sessions per week) (12) while Group B will be treated with Myofascial Release Technique and Conventional Therapy for 2 to 3 minutes, 5-7 repetitions and 3 sessions per week on alternate days were given for 6 weeks. NPRS, MOS-36, NDI will be used as outcome measuring tool before and after treatment. Data will be analyzed by using Statistical package for social sciences 25.


Description:

Cervicogenic headache is a symptomatic headache characterized by chronic, hemi cranial pain syndrome in which pain sensations originates in cervical spine and soft tissues of the neck and basically referred to head. Cervicogenic headache originates in the upper cervical region, and the headache mechanism involves nociceptive structures such as the upper cervical spinal nerves, ganglia, disks, facet joints, muscles, and ligaments. Consequently, the anatomical structures innervated by cervical roots C1-C3 are potential sources of Cervicogenic headache. Myofascial Release (MFR) is a therapeutic technique that uses gentle pressure and stretching (in both forms of direct and indirect approaches) with the intention of restoring decrease pain, optimizing length and facilitating the release of fascial restrictions caused by injury, stress, repetitive use, etc. There are some studies about MFR and its effects which include: increase extensibilities of soft tissues, increase ROM, improves joint biomechanics, increases temperature of fascia, increases blood circulation to the muscles and decreases pain and muscles tone significantly. Although; a lot of remedies such as physiotherapy, electrotherapy, exercises therapy and spinal mobilization are used for cervicogenic headache, but sub-occipital MFR for Cervicogenic headache has not been studied specifically. Another technique used for cervicogenic headache includes Fascial Abrasion Technique tool that is a revolutionary tool that can quickly and effectively loosen muscle tissue/fascia. It improves range and quality of movement.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date July 13, 2022
Est. primary completion date July 13, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 66 Years
Eligibility Inclusion Criteria: - Patients having headaches with neck stiffness and pain. - Headache for the past 3 months at least once per week. - Positive flexion rotation test and restriction greater than 10° - Patient aged 18-66 years old. Exclusion Criteria: - Headache not of cervical origin. - Physiotherapy or chiropractic treatment in the past 3 months. - Headache with autonomic involvement, dizziness and visual disturbance. - Congenital conditions of Cervical spine

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Instrument based Fascial abrasion technique
Participants were in a comfortable position during treatment. Emollient (anti-allergic) was applied to prevent skin irritation prior to Fascial Abrasion application. Each session included 1 minute of sweeping (longitudinal strokes performed parallel to the muscle fibers similar to compression with oscillations) directly over the Myofascial trigger points, 2 minutes of fanning (one end of the instrument was held in place & the other end moved through a semicircular pattern similar to petrissage) and concluded with 1 min of sweeping. Fascial Abrasion tool was washed in alcohol-based sanitizer before and after every treatment session and all norms of COVID-19 precautions were maintained. Myofascial trigger points were marked with a 1×1 cm piece of tape/under wrap to confirm consistency of subsequent treatments.
Myofascial release technique
All participants will get Conventional therapy i.e heating pad for 10 minutes. For the application of technique, the patient position will be supine lying with head fully supported on therapist hands and therapist places 3 middle fingers just inferior to the nucle line, lifts the finger tips towards the ceiling while resting the head on the table and then therapist applied a gentle upward pull. This procedure done for 2-3 minutes, 5-7 repetitions, 3 sessions per week on alternate days given for 6 weeks.

Locations

Country Name City State
Pakistan Warda Zafar Sargodha Sargodha,Punjab,Pakistan

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric pain rating scale for pain Scale consists of 4 questions regarding actual pain level, zero indicates no pain and 10 indicates worst pain imaginable 6 weeks
Primary Neck disability index to measure functional status of neck Scale consists of 10 sections,each section contains questions regarding head/ neck pain and some questions regarding the daily activities that we perform. 6 weeks
Primary Medical outcome study( MOS-36) to measure functions of daily living Questionnaire consists of 11 questions regarding functions of daily living 6 weeks
Secondary Measuring tape for measuring ranges at cervical region It is used to measure the ranges of cervical region (cervical flexion, extension, rotation and side banding) 6 weeks
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