Protocol summary

Study aim
To evaluate and to generalize the comparative effects of Hold-Relax technique and Ischemic compression followed by a sustained stretch in reducing pain and disability in patients with myofascial trigger points of upper trapezius.
Design
A single blind Randomized controlled trial with a parallel group design of 60 patients will have a random allocation by Chit-Box method.
Settings and conduct
Patients from the Physical-Therapy departments of Khyber Teaching Hospital, Lady Reading Hospital, Peshawar Pakistan. The patients will be recruited in three groups i.e. Group A, Group B and Group C by Randomization through Chit-box method. The outcome assessor will be kept blind during the trial.The readings will be taken for two times during the whole session (one at the start and other at the end of session).
Participants/Inclusion and exclusion criteria
1. Inclusion Criteria Age group between 20- 45 years ,Both Male and Female patients ,Chronic cases of Upper trapezius myofacial pain ,Patients with at least 15-24 points (30-48%) score in NDI 2. Exclusion Criteria Patients receiving treatment by other methods like vapocoolants, dry needling, acupuncture injections ,Neck or shoulder surgery within the past year ,Neurological or rheumatic disorders ,Radiculopathy, myelopathy or joint disorders ,Whiplash in the previous 6 months ,Recent fracture of the cervical spine ,Cervical instability ,Cervical spondylosis ,Ankylosing spondylitis ,Disc prolapsed
Intervention groups
Group-A patients will be treated with Hold-Relax technique, Group-B patients with Ischemic Compression followed by sustained stretch and Group-C with Both techniques. The patients in all three groups will receive a series of twelve treatments and a follow up consultation over a maximum period of four weeks.
Main outcome variables
Pain ,Disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190707044128N1
Registration date: 2019-08-30, 1398/06/08
Registration timing: retrospective

Last update: 2019-08-30, 1398/06/08
Update count: 0
Registration date
2019-08-30, 1398/06/08
Registrant information
Name
Ishaq Ahmed
Name of organization / entity
The university of Lahore
Country
Pakistan
Phone
+92 42 37592112
Email address
ishaqpt786@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-06-15, 1393/03/25
Expected recruitment end date
2014-07-30, 1393/05/08
Actual recruitment start date
2014-10-10, 1393/07/18
Actual recruitment end date
2014-12-28, 1393/10/07
Trial completion date
2015-05-10, 1394/02/20
Scientific title
Comparative Analysis on the effectiveness of Hold Relax Technique and Ischemic Compression followed by a sustained stretch in treating Myofacial Trigger Points of Upper Trapezius: A Randomized Controlled Trial
Public title
Hold Relax Technique and Ischemic Compression followed by a sustained stretch in treating Myofacial Trigger Points of Upper Trapezius
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group between 20- 45 years,, , Both Male and Female patients Chronic cases of Upper trapezius myofacial pain Patients with at least 15-24 points (30-48%) score in Neck Disability Index
Exclusion criteria:
Patients receiving treatment by other methods like vapocoolants, dry needling, acupuncture injections etc. Neck or shoulder surgery within the past year Neurological or rheumatic disorders Clinical evidence of radiculopathy, myelopathy or joint disorders Whiplash in the previous 6 months Recent fracture of the cervical spine Cervical instability Cervical spondylosis Ankylosing spondylitis Disc prolapsed Osteoporosis Mental disorders
Age
From 20 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be recruited in three groups i.e. Group A (Hold-Relax technique), Group B (Ischemic Compression followed by sustained stretch) and Group C (Both techniques) by randomization through Chit-box method. Chit-Box Method: For random allocation of 60 cases into three groups equally, prepare 60 chits writing “A” (for Group-A) on 20 chits, “B” (for Group-B) on 20 chits and “C” (for Group-C) on 20 chits. After folding the chits and putting in a box and well mixing, draw a chit, note the letter written on it, and then draw the second chit without replacing the first, note it and proceed similarly until the last i.e. 60th chit is drawn. The generated random allocation sequence may be one as appears in Table below. According to this sequence the first case registered will go to the Group-A, second case again to the Group-A, third to the Group-C and so on to the last case to Group-B. Table: Chit-Box Method for Randomization Draw 1st 2nd 3rd -- 15th Result (Letters on chit) A A C B C B B A A A B C - C A B B Registered Case No. 1 2 3 4 5 6 7 8 9 10 11 12 -- 57 58 59 60 (No. Allocation)
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor will be kept blind about the treatment protocols and randomization process during the whole trial.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Advanced Studies & Research Board of Khyber Medical University
Street address
Block-IV PDA building, Phase-V Hayatabad
City
Islamabad
Postal code
25000
Approval date
2014-09-29, 1393/07/07
Ethics committee reference number
ASRB000222/CA/IPM&R

Health conditions studied

1

Description of health condition studied
The Myofascial Pain Syndrome (MPS)
ICD-10 code
M79.1
ICD-10 code description
Myalgia

Primary outcomes

1

Description
Pain
Timepoint
At the start of intervention and then after one month (12sessions) of treatment administration
Method of measurement
VAS (Visual Analogue Scale) for measuring the Pain.

Secondary outcomes

1

Description
Disability
Timepoint
At the start of intervention and then after one month (12sessions) of treatment administration.
Method of measurement
NDI (Neck Disability Index) for measuring the Disability

Intervention groups

1

Description
Intervention group: Group-A of 20 patients (Experimental group) will be treated with a Hold-Relax technique that will be applied on the upper Trapezius muscle of the affected side for 1 set of 5 repetitions with 10 seconds hold. It involves a stretch of the muscle up to a point of a resistance barrier. The patient then contracts the muscle to about 25% of their own muscle force against the practitioner’s resistance. The body part remains in a static position resulting in an isometric contraction. The patient holds this contraction for 10 seconds. After this the patient is asked to relax for the next 10 seconds. This is then followed by a further 10 seconds stretch in order to find a new barrier position.
Category
Treatment - Other

2

Description
Control group: Group-B of 20 patients (Control group) will be treated with Ischemic compression followed by a sustained stretch technique. Firstly, the trapezius muscle is stretched to the point of discomfort then a digital pressure is applied for 20 seconds with the examiners thumb or finger which temporarily occludes the blood supply to the area. It is then followed by a sustained stretch of 15 seconds on the same muscle. This procedure will be repeated for five times in one session.
Category
Treatment - Other

3

Description
Control group: Group-C of 20 patients will be treated with a combined therapy containing Hold relax technique plus Ischemic compression followed by a sustained stretch technique for 1 set of 5 repetitions.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Khyber Teaching Hospital
Full name of responsible person
Dr. Abid Ali
Street address
University Rd, Rahat Abad
City
Peshawer
Postal code
25000
Phone
+92 922 440008
Fax
+92 91 9224423
Email
info@kth.com.pk
Web page address
https://www.kth.gov.pk/

2

Recruitment center
Name of recruitment center
Lady Reading Hospital
Full name of responsible person
Dr. Muhammad Khan
Street address
Hospital Road
City
Peshawer
Postal code
25000
Phone
+92 91 9211441
Fax
+92 91 9211401
Email
info@lrh.gov.pk
Web page address
https://lrh.edu.pk/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
khyber medical university
Full name of responsible person
Dr. Mohammad Bin Afser Jan
Street address
Block-IV, PDA building, Phase-V Hayatabad
City
Peshawer
Postal code
25000
Phone
+92 91 5892885
Email
ipmr@kmu.edu.pk
Web page address
http://www.kmu.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
khyber medical university
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Ishaq Ahmed
Position
Assistant Professor/ Head of Department
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Soan Garden, Islamabad
City
Islamabad
Province
Punjab
Postal code
75500
Phone
+92 42 111 865 865
Email
ishaqpt786@gmail.com
Web page address
https://www.uol.edu.pk/campuses/islamabadcampus

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Ishaq Ahmed
Position
Assistant Professor/ Head of Department
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Soan Garden, Islamabad
City
Islamabad
Province
Punjab
Postal code
75500
Phone
+92 42 111 865 865
Email
ishaqpt786@gmail.com
Web page address
https://www.uol.edu.pk/campuses/islamabadcampus

Person responsible for updating data

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Ishaq Ahmed
Position
Assistant Professor/ Head of Department
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Soan Garden, Islamabad
City
Islamabad
Province
Punjab
Postal code
75500
Phone
+92 42 111 865 865
Email
ishaqpt786@gmail.com
Web page address
https://www.uol.edu.pk/campuses/islamabadcampus

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
there is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Informed Consent Form, Clinical Study Report, Analytic Code files could be shared
When the data will become available and for how long
2 months after publication
To whom data/document is available
people working in academic institutions or people working in businesses can also apply to receive it
Under which criteria data/document could be used
Intervention purpose
From where data/document is obtainable
ishaqpt786@gmail.com
What processes are involved for a request to access data/document
Full description about the Purpose/Aim of using the documents Insight about the Disorder and intervention of the research
Comments
Loading...