Protocol summary

Summary
Purpose of study: The effect of integrated neuromuscular inhibition technique on pain threshold of neck and shoulder muscles trigger points؛ just interventional group؛ without control group؛ not blinded؛ without placebo؛ Inclusion criteria: age: 20-40 y/o - presenting active myofascial trigger points in neck and shoulder muscles with pain recognition when pressure applied؛ Exclusion criteria: previous neck surgery(during last year) - cervical radiculopathy - participants with fibromyalgia syndrome؛ Target sample size:15؛ Intervention: integrated neuromuscular inhibition technique؛ Material and methods: All subjects provided informed consent before enroll- ment in the study. Active myofascial trigger points in neck and shoulder muscles recognized in prone position. A visual analog scale(VAS) was used to grade their level of neck pain and algometer to grade pressure pain threshold. The subjects were placed in supine position with small towel roll under their neck to reduce tension in the upper trapezius muscle. The following three techniques applied in sequential order: Ischemic compression: Pressure applied through the thumb of physical therapist directy on myofascial trigger points to produce tolerable pain. The pressure applied sustained and progressively increased by reinforcing with the thumb or finger of the other hand until tissue resistance is encountered. Contact was maintained till the tissue barrier was released and pressure was maintained to 90 s. The procedure was repeated three times per session. Strain counter strain: The pressure was maintained without complaints of referred pain pattern. Patient‟s head was passively laterally flexed towards the affected side. The therapist then held forearm and moved the affected side shoulder passively to approximately 90 degree of abduction, while monitoring the tender point pain with the other hand. Then the fine tuning was made with slight flexion or extension of the shoulder so that maximum ease was achieved. It was held for 20–30 s and repeated for three repetitions per session. Muscle Energy Technique(MET): The patient in supine position was asked to take the stabilized shoulder towards the ear (a shrug movement) and the ear towards the shoulder. The degree of contraction was mild and pain free (20% of maximum voluntary contraction). The contraction was sustained for 10 seconds. The therapist gently eased the head/neck into an increased degree of side bending and flexion to unaffected side and rotation to affected side. The stretch was maintained for 30 seconds and repeated for three repetitions per session. After appling technique، visual analog scale(VAS) was used to grade their level of neck pain and algometer to grade pressure pain threshold. One day after treatment visual analog scale(VAS) was used to grade their level of neck pain and algometer to grade pressure pain threshold. Treatment applied in one day. One day after treatment reassesment done. Outcome: Maybe pain of trigger points decrease or pressure pain threshold increase.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201412129440N8
Registration date: 2015-09-12, 1394/06/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-12, 1394/06/21
Registrant information
Name
Soraya Pirouzi
Name of organization / entity
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 5108
Email address
piroozis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2015-09-12, 1394/06/21
Expected recruitment end date
2015-09-15, 1394/06/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of integrated neuromuscular inhibition technique on trigger points pain threshold in patients with neck and shoulder muscles trigger points
Public title
The effect of combined physiotherapy technique on pain of neck and shoulder muscles painful points
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age: 20-40 y/o ; presenting active myofascial trigger points in neck and shoulder muscles with pain recognition when pressure applied؛ Exclusion criteria: previous neck surgery(during last year) ; cervical radiculopathy ; participants with fibromyalgia syndrome
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Shiraz university of medical science
Street address
Central bulding of Shiraz university of medical science، Zand street، Shiraz
City
Shiraz
Postal code
14336 - 71348
Approval date
2015-08-19, 1394/05/28
Ethics committee reference number
94-01-06-9808-55791

Health conditions studied

1

Description of health condition studied
Trigger points pain
ICD-10 code
M70.8
ICD-10 code description
Other soft tissue disorders related to use, overuse and pressure

Primary outcomes

1

Description
Pain intensity
Timepoint
Before treatment، After treatment، One day after treatment
Method of measurement
Visual analoge scale

2

Description
Pressure pain threshold
Timepoint
Before treatment، After treatment، One day after treatment
Method of measurement
Algometer

Secondary outcomes

empty

Intervention groups

1

Description
Integrated neuromuscular inhibition technique in interventional group (no control group)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy clinic of School of Rehabilitation Sciences, Shiraz
Full name of responsible person
Soraya Pirouzi
Street address
School of Rehabilitation Sciences، Abiverdi1 street، Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyyed Basir Hashemi
Street address
Central bulding of Shiraz university of medical science، Zand street، Shiraz
City
Shiraz
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Rehabilitation Sciences, Shiraz
Full name of responsible person
Soraya Pirouzi
Position
Faculty member
Other areas of specialty/work
Street address
School of Rehabilitation Sciences، Abiverdi1 street، Shiraz
City
Shiraz
Postal code
Phone
+98 71 3627 1552
Fax
Email
piroozis@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Soraya Pirouzi
Position
Faculty member
Other areas of specialty/work
Street address
School of Rehabilitation Sciences، Abiverdi1 street، ُShiraz
City
Shiraz
Postal code
Phone
+98 71 3627 1552
Fax
Email
piroozis@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
Fateme Alimohammadi
Position
Bachelor student
Other areas of specialty/work
Street address
School of Rehabilitation Sciences، Abiverdi1 street، Shiraz
City
Shiraz
Postal code
33669-71947
Phone
+98 71 3626 5108
Fax
Email
alim1372ft@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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