Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000662864
Ethics application status
Approved
Date submitted
23/02/2016
Date registered
1/06/2021
Date last updated
1/06/2021
Date data sharing statement initially provided
1/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of strain counter strain approach on active & latent trigger points of upper fibers of trapezius for myofascial pain syndrome patients (Randomized Control Trial)
Scientific title
effect of strain counter strain technique on patients suffering from trigger points and they will be assessed before and after the approach using pressure pain threshold by algometry , visual analogue scale for pain and neck disability index for function.
Secondary ID [1] 303081 0
nil
Universal Trial Number (UTN)
U1111-1179-9608
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myofascial pain syndrome 297744 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297926 297926 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be assessed pre and post by the following steps by a trained physiotherapist with 10 years of experience:
A- Safety measures: history, use palpation and tuning fork to exclude any red flags.
B- Detecting the trigger points: According to this criteria of '' Janet Travell and David Simons'' Simons, David G. "Diagnostic criteria of myofascial pain caused by trigger points." Journal of Musculoskeletal Pain 7.1-2 (1999): 111-120.



Description of the technique:
The participant will lay in a supine position. The practitioner will grasp the participant's head and extended it moderately and laterally flexed and rotated it away from the trigger point side. Extension will increasing progressively as one treats progressively caudal lesions of ends of muscle length and lateral of upper fibers of trapezius, the technique will be applied five times each time is 90 seconds in one session, in a private clinic in Alexandria, Egypt.
Intervention code [1] 293995 0
Rehabilitation
Intervention code [2] 319376 0
Treatment: Other
Comparator / control treatment
Control group: will receive placebo by a light touch to the trigger point with no movement at the neck
Control group
Placebo

Outcomes
Primary outcome [1] 297444 0
Functional disability level of each patient will be assessed by Neck Disability Index (NDI). It is valid and reliable tool. It is consists of 10 multiple choice questions for neck pain, patient select one sentence out of six that best describe his pain, Higher scores indicate great pain
Timepoint [1] 297444 0
treatment will be a one shot study, the participant will be assessed pre and post the treatment and will be treated by the technique in five times , each time will be 90 seconds.
Primary outcome [2] 297445 0
pain severity level will be assessed using visual analogue scale to assess the neck pain severity. It consists of a continuous 10 cm line .The patient will be instructed to place a vertical mark on to indicate his pain, ranging from no pain or discomfort (0), to the worst pain he could possibly feel And also has validity and reliability.
Timepoint [2] 297445 0
treatment will be a one shot study, the participant will be assessed pre and post the treatment and will be treated by the technique in five times , each time will be 90 seconds.
Secondary outcome [1] 321069 0
pressure pain threshold will be measured using pressure algometry was multi capacity digital force gauge
Timepoint [1] 321069 0
treatment will be a one shot study, the participant will be assessed pre and post the treatment and will be treated by the technique in five times , each time will be 90 seconds.

Eligibility
Key inclusion criteria
the subjects will be chosen according to the following criteria:
1- Myofascial pain syndrome subjects with trigger points in upper trapezius muscle.
2- Male and female subjects
3- All patients will be diagnosed with active and latent MTrPs in the upper fibres of the trapezius muscle.
4- Age of the patients ranging from 20 to 50 years.
5- A MTrP will be with a taut band with spot tenderness and subject recognition of referred pain to ipsilateral neck and/or head.
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
the following subjects will be excluded from the study:
1- Subjects with history of a whiplash injury.
2- Subjects with history of cervical spine surgery.
3- Those who had diagnosis of cervical radiculopathy or myelopathy determined by their primary care physician.
4- Subject's undergone Myofascial Pain therapy within the past 3 months before the study.
5- Those who had Non-rheumatologic diseases as multiple sclerosis, thyroid dysfunction and chronic infections.
6- Patients with rheumatologic conditions as, mild systemic lupus erythematosus.
7- Patients with Polyarticular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative disease.
8- Patients with Vertebral basilar insufficiency.
9- Patients with Shoulder pain.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sample will be randomly allocated by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 7610 0
Egypt
State/province [1] 7610 0
Alexandria

Funding & Sponsors
Funding source category [1] 292945 0
Self funded/Unfunded
Name [1] 292945 0
AHMED ABDELFATTAH
Country [1] 292945 0
Egypt
Primary sponsor type
Individual
Name
AHMED ABDELFATTAH
Address
Faculty of Physical Therapy - Cairo university
7 Ahmed elzayat st, Giza
postcode: 12624
Country
Egypt
Secondary sponsor category [1] 291713 0
None
Name [1] 291713 0
Address [1] 291713 0
Country [1] 291713 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294450 0
Ethical committe of faculty of physical therapy - cairo university
Ethics committee address [1] 294450 0
Ethics committee country [1] 294450 0
Egypt
Date submitted for ethics approval [1] 294450 0
01/02/2016
Approval date [1] 294450 0
07/02/2016
Ethics approval number [1] 294450 0
234- 2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63782 0
Mr Ahmed Samir Ibrahim Abdelfattah
Address 63782 0
Faculty of Physical Therapy - Cairo university
7 Ahmed elzayat st, Giza
postcode: 12624
Country 63782 0
Egypt
Phone 63782 0
+201096483843
Fax 63782 0
Email 63782 0
[email protected]
Contact person for public queries
Name 63783 0
Hisham Mohamed Abdelraheem Hussien
Address 63783 0
Faculty of Physical Therapy - Cairo university
7 Ahmed elzayat st, Giza
postcode: 12624
Country 63783 0
Egypt
Phone 63783 0
+201020936303
Fax 63783 0
Email 63783 0
[email protected]
Contact person for scientific queries
Name 63784 0
omaima mohamed ali kattabei
Address 63784 0
Faculty of Physical Therapy - Cairo university
7 Ahmed elzayat st, Giza
postcode: 12624
Country 63784 0
Egypt
Phone 63784 0
+201222194545
Fax 63784 0
Email 63784 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
as these data are considered as raw data, and this ensuring the privacy


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.