1. Home
  2. Approved trials
  3. » فارسی

Effects of integrated neuromuscular inhibition technique on upper trapezius trigger points in patients with non specific neck pain: a randomized controlled trail

Protocol summary

Study aim
To check effect of integrated neuromuscular inhibition technique on upper trapezius trigger points in patients with non-specific neck pain
Design
Two arm parallel Randomized, single blinded, pre and post treatment outcome assessment
Settings and conduct
It will be a signle blinded randomized controlled trial and outcomes assessor will be unaware of the treatment given to patients and it will be carried out at the jacobabad Institute of Medical Science Jacobabad, sindh.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: (1)Subjects suffering from non-specific neck pain. (2) Subjects will be required to have neck pain of less than 3 months duration as well as active TrPs in the upper trapezius muscle. Exclusion Criteria: (1)Patients with neck symptoms related to a motor vehicle collision or significant trauma (2)patients with signs of serious pathology (e.g. malignancy, infection, inflammatory disorder, or fracture) (3)Patients with signs of cervical spinal cord compromise (e.g. diffuse sensory abnormality, diffuse weakness, hyperreflexia, or the presence of clonus), two or more signs of nerve root involvement (e.g. dermatomal sensation changes, myotomal weakness) (4) History of neck surgery during the previous 12 months, and a history of cervical degenerative joint disease, endocrine disorders, and autoimmune conditions (e.g. rheumatoid arthritis, fibromyalgia, etc.) (5) Patients who had received trigger point injections in the upper trapezius muscle within the past 6 months
Intervention groups
It will be a randomized controlled trial in which people will be randomly allocated into either control or intervention group. Control group will receive Routine physical therapy while Experimental Group will receive integrated Neuromuscular inhibition Technique along with routine physical therapy
Main outcome variables
Pain, functional disability

General information

Reason for update
Acronym
Randomized controlled trial
IRCT registration information
IRCT registration number: IRCT20220104053617N1
Registration date: 2022-03-23, 1401/01/03
Registration timing: registered_while_recruiting

Last update: 2022-03-23, 1401/01/03
Update count: 0
Registration date
2022-03-23, 1401/01/03
Registrant information
Name
Nargis Jamali
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 333 3631236
Email address
msptn02193003@student.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-24, 1400/10/03
Expected recruitment end date
2022-05-10, 1401/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of integrated neuromuscular inhibition technique on upper trapezius trigger points in patients with non specific neck pain: a randomized controlled trail
Public title
Effects of integrated neuromuscular inhibition technique on upper trapezius trigger points in patients with non specific neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects suffering from non-specific neck pain, defined as non-articular or non-systemic as per the referring physician. Subjects will be required to have neck pain of less than 3 months duration as well as active TrPs inthe upper trapezius muscle, defined as a tender nodule in a taut band that referred pain beyondthe area of contact
Exclusion criteria:
If patiant with neck symptoms will be related to a motor vehicle collision or significant trauma, they will not be included in our study If patiants will be presenting with signs of serious pathology (e.g. malignancy, infection, inflammatorydisorder, or fracture), then he/she will not be included in the trial Patients with signs of cervical spinal cord compromise (e.g. diffuse sensory abnormality, diffuse weakness, hyperreflexia, or the presence of clonus), two or more signs of nerve rootinvolvement (e.g. dermatomal sensation changes, myotomal weakness, or diminished/absenttendon jerk reflexes) A history of neck surgery during the previous 12 months, and a history of cervical degenerativejoint disease as per radiographs, endocrine disorders, and autoimmune conditions (e.g. rheumatoid arthritis, fibromyalgia, etc.) If pateints had received trigger point injections in the upper trapezius muscle within the past 6 months, they will not be included in our study
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Sample size was collected and it turned out to be 48. Subjects meeting the inclusion criteria will be randomly allocated into two groups using computer generated randomization method in which computer software will be utilized to allocate 24 subjects in each group. Purposive Random Sampling will be carried out for this purpose. Allocation concealment will be Carried out.
Blinding (investigator's opinion)
Single blinded
Blinding description
Our study will be single blinded. Outcome assessor will be unaware of the treatment given to patient.. He will not be given any information on which treatment is applied on which patient.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Lahore
Street address
1km.off defence road, Lahore
City
Lahore
Postal code
537000
Approval date
2021-12-23, 1400/10/02
Ethics committee reference number
REC-UOL-/52-02/2022

Health conditions studied

1

Description of health condition studied
Non specific neck pain
ICD-10 code
M54.02
ICD-10 code description
Panniculitis affecting regions of neck and back, cervical region

Primary outcomes

1

Description
Pain
Timepoint
Pain will be assessed at Baseline and after every week for 4 weeks
Method of measurement
Visual Analog Scale will be utilized for the assessment of pain

2

Description
Functional disability
Timepoint
Functional Disability will be assessed at Baseline and after every week for 4 weeks
Method of measurement
Neck Disability Index will be utilized for this purpose

Secondary outcomes

empty

Intervention groups

1

Description
Control group:this group will receive training in 30-minute sessions, 5times per week, for 8 weeks. Total duration of treatment in this group will be 30 minutes. Thirty minutes for conventional treatment like low level of the heating at the neck for 5-10 minutes.(2)Posture corrective exercises , alignment and neck-strengthening exercises, Transcutaneous electrical nerve stimulation (TENS). Traction. Short-term immobilization at cervical. Acupuncture. Chiropractic massage.
Category
Treatment - Other

2

Description
Intervention group:- In a intervention group Patients will receive conventional physical therapy in 30-minute sessions, 5 times per week, for 8 weeks.that will include low level of the heating at the neck for 5-10 minutes.(2)Posture corrective exercises , alignment and neck-strengthening exercises, Transcutaneous electrical nerve stimulation (TENS). Traction. Short-term immobilization. Acupuncture. Chiropractic Massage. 2- Along with Conventional Treatment Protocol there will be additional treatment Technique integrated Neuromuscular inhibitionTechnique must be applied to get better outcomes , the duration of thistechnique will be 20-30 minutes data Collection Tools (Proforma/Questionnaire) thirty minutes of integrated neuromuscular inhibition technique.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Jacobabad Institute of Medical Science, Jacobabad
Full name of responsible person
Ghalib Hussain
Street address
7FF2+694, channa mohalla, channa mohalla, Jacobabad, Sindh
City
Jacobabad
Postal code
79000
Phone
+92 21 111 844 844
Email
myhwash15khan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Dr. Asad Gillani
Street address
1km.off defence road, Lahore
City
Lahore
Postal code
537000
Email
asadshahgilani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Lahore
Proportion provided by this source
100
Public or private sector
Private
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
University of Lahore
Full name of responsible person
Nusrat Qamar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
1km.off defence road, Lahore
City
Lahore
Province
Punjab
Postal code
537000
Phone
092 021 111 844 844
Email
dr.nusratqamar55@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Nusrat Qamar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
1km.off defence road, Lahore
City
Lahore
Province
Punjab
Postal code
537000
Phone
092 021 111 844 844
Email
dr.nusratqamar55@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Nusrat Qamar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
1km.off defence road, Lahore
City
Lahore
Province
Punjab
Postal code
537000
Phone
092 021 111 844 844
Email
dr.nusratqamar55@gmail.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
EFFECTS OF INTEGRATED NEUROMUSCULAR INHIBITION TECHNIQUE ON UPPER TRAPEZIUS TRIGGER POINTS IN PATIENTS WITH NON SPECIFIC NECK PAIN: RANDOMIZED CONTROLLED TRIAL. All collected deidentified IPD
When the data will become available and for how long
Data will be available from December 2022 for three years.
To whom data/document is available
Data will be available for those working in academics or involved in clinical research work
Under which criteria data/document could be used
Data can be used for citation purposes
From where data/document is obtainable
Data will be made available through email. Applicants wanted to have access can email on following e mail address and it could take 3 working days to make data available for applicant. Ema Address: dr.nusratqamar55@gmail.com
What processes are involved for a request to access data/document
Data will be made available through email. Applicants wanted to have access can email on following e mail address and it could take 3 working days to make data available for applicant. Ema Address: dr.nusratqamar55@gmail.com
Comments
Loading...