Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000632392
Ethics application status
Approved
Date submitted
22/03/2017
Date registered
1/05/2017
Date last updated
1/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Manual therapy Techniques in Neck Pain
Scientific title
Efficacy of muscle energy technique compared to active isolated stretching technique in cervical pain and range of motion (ROM) limitation
Secondary ID [1] 291503 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neck Pain 302580 0
Neck Stiffness 302581 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302105 302105 0 0
Physiotherapy
Musculoskeletal 302250 302250 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Muscle Energy Techniques: The shortened muscle is placed in a mid­ range position about halfway between a fully stretched and a fully relaxed state. The patient contracts the muscle isometrically, using a maximum degree of effort for 5-10 seconds while the effort is resisted completely. On release of the effort, a rapid stretch is made to a new barrier, without any 'bounce', and this is held for at least 10 seconds. The patient relaxes for approximately 20 seconds and the procedure is repeated up to complete session.
Active Isolated Stretching: Targeted muscle was identified patient was guided to actively contract the opposite muscle. At the end of patient range of motion the therapist stretch the targeted muscles by adding stretch force of less then 1 pound so that muscles are not excessively irritated. The duration of stretch should not be more then 2 seconds. The patient is now supported and guided back?to the starting position. This step is called the recovery phase. The protocol of the stretch and recovery phases is repeated for complete session. Each successive repetition usually allows for an incremental gain of a few degrees of motion of the stretch. The client should breathe out during the stretch phase and breathe in during the recovery phase.
Patients full filling Inclusion criteria were randomly assigned into two equal groups (30 in each). Group A got treatment of Muscle Energy Techniques (1 set of 10 repetitions per session, 3 sessions per week on alternate days) and Group B got Active isolated stretching (1 set of 10 repetitions per session, 3 sessions per week on alternate days). The patients were treated for the period of six weeks. Pre and post assessment was done using Inclinometer for cervical Range of Motion, Neck Disability index for disability and Visual Analogue Scale for pain.
10 Minutes Individual one-on-one Sessions for each group in the clinic performed by Manual Therapist (MS Orthopedic Manual Physical Therapy ) having at least 1 year experience.
Intervention code [1] 297572 0
Rehabilitation
Intervention code [2] 297573 0
Treatment: Other
Comparator / control treatment
Comparison between muscle energy techniques and active isolated stretching
Control group
Active

Outcomes
Primary outcome [1] 301546 0
Visual Analogue Scale for Pain
Timepoint [1] 301546 0
Baseline and at 6 weeks
Primary outcome [2] 301547 0
Inclinometer for cervical Range of Motion
Timepoint [2] 301547 0
Baseline and at 6 weeks
Secondary outcome [1] 332990 0
Neck Disability index for Disability
Timepoint [1] 332990 0
Baseline and At 6 weeks

Eligibility
Key inclusion criteria
Patients having Mechanical neck pain for more than 3 days i.e. cervical pain and ROM limitation
Minimum age
20 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patients having cervical RA, trauma, tumor or instability were excluded from the study.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing for the participants of the study.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2015
Date of last participant enrolment
Anticipated
Actual
26/12/2016
Date of last data collection
Anticipated
Actual
16/01/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 8754 0
Pakistan
State/province [1] 8754 0
Khyber Pukhtunkhwa

Funding & Sponsors
Funding source category [1] 295990 0
Self funded/Unfunded
Name [1] 295990 0
Aftab Ahmad
Country [1] 295990 0
Pakistan
Primary sponsor type
Hospital
Name
Northwest General Hospital & Research Centre
Address
Habib Physiotherapy Complex Phase V, near Rehman Medical Institue, Peshawar, Khyber Pukhtoon Khwa
Country
Pakistan
Secondary sponsor category [1] 294877 0
University
Name [1] 294877 0
Riphah International University
Address [1] 294877 0
7th Avenue, Sector G-7/4, Islamabad
Country [1] 294877 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297252 0
Institutional Ethical Committee, Riphah International university
Ethics committee address [1] 297252 0
Ethics committee country [1] 297252 0
Pakistan
Date submitted for ethics approval [1] 297252 0
Approval date [1] 297252 0
31/07/2015
Ethics approval number [1] 297252 0

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

Contacts
Principal investigator
Name 73470 0
Dr Yasir Jalal
Address 73470 0
Street Saeed Abad, pajagi road, Peshawa, Khyber Pukhtunkhwa
National College of Sciences (NCS) University System
Country 73470 0
Pakistan
Phone 73470 0
+92 3158582732
Fax 73470 0
Email 73470 0
[email protected]
Contact person for public queries
Name 73471 0
Aftab Ahmad
Address 73471 0
Mahboob Gari, Post Office Kabayan, Warsak Road Peshawar Khyber Pukhtoonkhwa
Hayatabad Medical Complex
Country 73471 0
Pakistan
Phone 73471 0
+92 3239260705
Fax 73471 0
Email 73471 0
[email protected]
Contact person for scientific queries
Name 73472 0
Aftab Ahmad
Address 73472 0
Mahboob Gari, Post Office Kabayan, Warsak Road Peshawar Khyber Pukhtoonkhwa
Hayatabad Medical Complex
Country 73472 0
Pakistan
Phone 73472 0
+92 3239260705
Fax 73472 0
Email 73472 0
[email protected]

No information has been provided regarding IPD availability


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.