Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202101819362204 Date of Approval: 19/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF INSTRUMENT- ASSISTED SOFT TISSUE MOBILIZATION ON TRIGGER POINTS OF TENSION HEADACHE
Official scientific title EFFECT OF INSTRUMENT- ASSISTED SOFT TISSUE MOBILIZATION ON TRIGGER POINTS OF TENSION HEADACHE
Brief summary describing the background and objectives of the trial Instrument assisted soft tissue mobilization or simply (IASTM) is a new range of tool which enables clinicians to efficiently locate and treat individuals diagnosed with soft tissue dysfunction. Recently, practitioners have begun to depend on instrument-assisted soft tissue mobilization (IASTM) which is a useful tool in treating trigger points and their pain. IASTM is the use of a specially designed instrument to mobilize soft tissue, with the aim of reducing pain. IASTM improves the extensibility of soft tissues by treating their restrictions and when heat is generated from friction by the instrument, the viscosity of the tissue decreases, making it softer.Much of the existing literature surrounding the management of headache has focused on pharmacology, with a smaller emphasis on the role of allied health, such as physiotherapy. Within available literature there is gab in literature concerning the effect of instrument assistive soft tissue mobilization in tension type headache .the aim of this study to determine the effect of instrument assistive soft tissue mobilization on headache intensity level, frequency and functional disability in tension type headache.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 20/01/2021
Actual trial start date
Anticipated date of last follow up 20/04/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IASTM Treatment will be 12 sessions 3 session per weeks for one month. one month Participants with tension headache will be distributed randomly into four equal groups: group A, group B. Group A is control group which will receive conventional physical therapy program for neck pain which include (hot packs application, exercises for cervical spine). Group B will receive the same conventional physical therapy program in addition to IASTM. the treatment will be conducted at a frequency of three sessions per week for four weeks. The headache intensity level, frequency, neck disability level, pain pressure threshold will be assessed A lubricant (Vaseline) will be applied to the skin around the neck area prior to treatment and the M2t blade will be cleaned with an alcohol pad. First, the M2T blade will used to find the exact areas of restriction in affected muscles. Then the M2T blade will use at an angle of 45 and using treatment planes 1, 2, and 3, to apply slow strokes along the muscle before treatment, the instruments will move along the skin in a longitudinal fashion (angle between 30 to 60 degree ) to assess the quality of the musculotendinous structures. Changes in soft tissue consistency will detected by the clinician through vibrations of the instrument when it slides on areas of irregular fibrosis of the underneath connective tissue. Once an adhesion is discovered, strokes are repeated for a range of 40 sec to 120 sec /site 15
Control Group conventional treatment treatment will be 12 session 3 session per weeks for one month. one month All groups will receive conventional physical therapy program for neck pain that include. Hot Packs application: by application on the back of the neck for 15/20 minute, (Malanga et al., 2015) • Exercises which include: (Fletcher et al., 2008). • Active range-of-motion exercises for neck flexion, extension, lateral flexion and rotation to both directions : that includes active movement without • Stretching exercises for upper Trapezius muscles and suboccipital muscles of neck • Strengthening exercises for neck muscles in the form of isometric exercises as follow 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Their age ranged from 30 to 40 years, 2) BMI ranged from 18 to 25 kg /m2. 3) TTH criteria according to Headache Classification Committee of the International Headache Society (HIS 2013) has at least two of the following characteristics: a) Bilateral location. b) Pressing/tightening quality (non-pulsating). c) Mild or moderate intensity. d) Not aggravated by routine physical activity such as walking or climbing stairs. 4) Patients have Trigger points in suboccepital muscle and and trigger points 1, 2 in trapezius muscle The presence of MTrPs will determined using the diagnostic criteria described by Simons 1990, in which five major criteria and at least one of three minor criteria are needed for a clinical diagnosis of MPS, The major criteria were: 1) Regional neck pain. 2) Pain or altered sensation in the expected distribution of referred pain from a myofascial trigger point. 3) Taut band palpable in an accessible muscle. 4) Exquisite spot tenderness at one point along the length of the taut band. 5) Some degree of restricted range of motion (ROM) of cervical when measurable. The minor criteria were: 1) Reproduction of clinical pain or altered sensation by pressure on the tender spot. 2) Elicitation of a local twitch response by transverse snapping palpation at the tender spot or needle insertion into the tender spot of the taut band. 3) Pain alleviated by elongating (stretching) the muscle or by injecting the tender spot (trigger point). 1) Patients with a history of malignancy 2) Patients who had a history of cervical and cranial Surgery 3) Patients with major psychiatric disorders (major Depression) 4) Patients with uncontrolled hypertension 5) Patient with other causes of headache. 6) Dysfunctions in the temporomandibular joint 7) Headaches associated with high fever, stiff neck, or rash, problems with vision or profound dizziness Adult: 19 Year-44 Year 30 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 10/11/2020 Faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ElZayat Street Dooki,Giza, Egypt Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome frequency of headache pre and post treatment
Primary Outcome headache intensirty pre and post treatment
Secondary Outcome function by neck disability index pre and post treatment
Primary Outcome Pain Pressure Threshold by pressure algometer pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Out patient clinic at Faculty of Physical Therapy Cairo University 7 Ahmed Elzaiat ST,Ben Elsaryat ElDokki Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nada Gamal Saad 7 Ahmed ElZayat Street Dooki,Giza, Egypt Giza 12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nada Gamal Saad 7 Ahmed ElZayat Street Dooki,Giza, Egypt Giza 12612 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Nada Gamal Saad 7Ahmed ElZaiat ST. BenElsaryat ElDokki Giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nada Saad nadagamal004@gmail.com +201281940603 7Ahmed ElZaiat ST. ElDokki Giza
City Postal code Country Position/Affiliation
Giza 12612 Egypt Physical therapy practitioner
Role Name Email Phone Street address
Public Enquiries Nada Saad nadagamal004@gmail.com +201090415655 7Ahmed ElZaiat ST. ElDokki Giza
City Postal code Country Position/Affiliation
Giza 12612 Egypt practitioner physical therapy
Role Name Email Phone Street address
Scientific Enquiries Abeer Yamany dr.abeer_yamany@yahoo.com +201006899872 7 Ahmed ElZaiat Ben Elsaryat ST
City Postal code Country Position/Affiliation
Giza 12612 Egypt professor of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes • Participates with age 30- 40 years. • BMI from 18 to 25 kg /m2 . • Selected the study subjects based on International Headache society (HIS) criteria for diagnosis of TTH. • Headache lasting from 30 minutes to 7 days. • Headache has at least two of the following characteristics: o Bilateral location. o Pressing/tightening quality (non-pulsating). o Mild or moderate intensity. o Not aggravated by routine physical activity such as walking or climbing stairs. • Both of the following: o No nausea or vomiting (anorexia may occur) o No more than one of photophobia or phonophobia • Not attributed to another disorder. • Patient will be arranged in 2 groups and will be received three Session per week for 4 weeks. • Group A will receive only conventional physical therapy program (hot back application, stretching exercise, isometric strengthening exercise) (Fletcher et al., 2008). • Group B will receive IASTM and conventional therapy Study Protocol beginning 3 months and ending two year following article publication the criteria will be accessed by the publication of trials in international joutnal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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