Protocol summary

Study aim
Muscle energy technique is an emerging type of manual therapy. It is not common in clinical setups. Nowadays, clients and patients want results of a treatment on the spot. So, the scholar want to find out immediate effects of MET on cervical pain and range of motion
Design
This study will have 2 groups. A will be experimental group and B control . Sample size: 50 Randomization: will be done using lottery method Center: Single center
Settings and conduct
(Hayatabad medical complex, MTI, Peshawar)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male and female, Age 18-50 years, Subjects having neck pain from previous 3 or more than 3 months Exclusion criteria: Cervical radiculopathy or disc prolapse, trauma, bone fractures, joint dislocation or cervical instability, dermatitis, abnormal sensations, active bleeding and open wounds, History of the neck surgery in the past 12 months, Diagnosed cases of serious pathologies like infection, inflammation or malignancy
Intervention groups
Experimental Group (Group A): This group will be same as control group (as in having conventional physical therapy) but with addition of the intervention which will be muscle energy techniques (MET). Therapist will give resistance to produce isometric contraction in the muscles just short of the barrier. The patient strength of muscle contraction will be less than the therapist counter force of resistance. Therapist will hold the position for 7-10 seconds. Then a 30 seconds stretch will be given and the process will be repeated three times. Control Group (Group B): This group will comprise of conventional therapy for the participants. Conventional therapy will include heating pad for 15-20 minutes and soft tissue release for 5 minutes.
Main outcome variables
Outcome will be measured on the basis of means of NPRS score and neck ROMs.

General information

Reason for update
Acronym
MET
IRCT registration information
IRCT registration number: IRCT20220209053976N1
Registration date: 2022-02-14, 1400/11/25
Registration timing: prospective

Last update: 2022-02-14, 1400/11/25
Update count: 0
Registration date
2022-02-14, 1400/11/25
Registrant information
Name
Ghulam Hussain
Name of organization / entity
Khyber Medical University
Country
Pakistan
Phone
+92 341 3219734
Email address
ghulamhussain.ipmr@kmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-01, 1400/12/10
Expected recruitment end date
2022-08-01, 1401/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Immediate effects of muscle energy techniques and conventional physical therapy versus conventional physical therapy alone on pain and range of motion in patients with chronic mechanical neck pain: A randomized controlled trial
Public title
A manual therapy technique used in physiotherapy to decrease pain and increase range of motion in chronic mechanical neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female Age 18-50 years Subjects having neck pain from previous 3 or more than 3 months
Exclusion criteria:
Cervical radiculopathy or disc prolapse Absolute contraindications for MET include trauma, bone fractures, joint dislocation or cervical instability Absolute contraindications for hot pack include dermatitis, abnormal sensations, active bleeding and open wounds History of the neck surgery in the past 12 months Diagnosed cases of serious pathologies like infection, inflammation or malignancy
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
After participants are selected, they will be randomly allocated to control group and experimental group using lottery method in which they will be asked to select a piece of paper from a box. The piece of paper will be marked with initial of the groups (such as A or B) and then the participants will be allocated to the group initial that was on paper.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to nature of study, it will not be feasible to blind researcher/therapist and subjects. However, assessor, who will assess pre and post scores, will be blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
KMU ethics committee
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad
City
Peshawar
Postal code
25000 (25100)
Approval date
2022-02-25, 1400/12/06
Ethics committee reference number
not yet provided

Health conditions studied

1

Description of health condition studied
Chronic mechanical neck pain
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia

Primary outcomes

1

Description
Cervical pain and range of motion
Timepoint
before intervention and immediately post intervention
Method of measurement
Pain will be measured using numerical pain rating scale and range of motion by goniometer

Secondary outcomes

empty

Intervention groups

1

Description
Experimental/Interventional Group (Group A): This group will be same as control group (as in having conventional physical therapy) but with addition of the intervention which will be muscle energy techniques (MET). Therapist will give resistance to produce isometric contraction in the muscles just short of the barrier. The patient strength of muscle contraction will be less than the therapist counter force of resistance. Therapist will hold the position for 7-10 seconds. Then a 30 seconds stretch will be given and the process will be repeated three times.
Category
Rehabilitation

2

Description
Control group B: This group will comprise of conventional therapy for the participants. Conventional therapy will include heating pad for 15-20 minutes and soft tissue release for 5 minutes.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy department, Hayatabad medical complex, Peshawar khyber pakhtoonkhwa, Pakistan
Full name of responsible person
Dr. Zara PT
Street address
Phase 4 Hayatabad, Peshawar
City
Pashto
Postal code
25000
Phone
+92 313 9913036
Email
zara.kmu20@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khyber medical university
Full name of responsible person
Dr. Aatik Arsh PT
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad
City
Peshawar
Postal code
25000 (25100)
Phone
+92 344 6997046
Email
aatikarshkmu@yahoo.com
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
50
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Khyber medical university
Full name of responsible person
Dr. Aatik Arsh PT
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad
City
Peshawar
Province
Khyber Pakhtoonkhwa
Postal code
25000
Phone
+92 344 6997046
Email
aatikarshkmu@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khyber medical university
Full name of responsible person
Dr. Aatik Arsh PT
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad
City
Peshawar
Province
Khyber Pakhtoonkhwa
Postal code
25000
Phone
+92 344 6997046
Email
aatikarshkmu@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Khyber medical university
Full name of responsible person
Dr. Aatik Arsh PT
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad
City
Peshawar
Province
Khyber Pakhtoonkhwa
Postal code
25000
Phone
+92 344 6997046
Email
aatikarshkmu@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not 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
Yes - There is a plan to make this available
Title and more details about the data/document
I will provide study protocols, data analysis, codes
When the data will become available and for how long
After completion of my thesis and will provide for long time
To whom data/document is available
To IRCT and other members
Under which criteria data/document could be used
For research and educational purposes
From where data/document is obtainable
from websites and journals
What processes are involved for a request to access data/document
online
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