Protocol summary

Summary
The goal of this study is a comparison of pulsed vacuum and friction massage therapeutic effects on treatment of trapezius muscle trigger points in men with non- specific chronic mechanical neck pain. This study is a not-blinded clinical trial. Forty patients suffering from chronic neck pains will be divided in two equal groups by the block randomization method and then they will be treated by two different methods of pulsed vacuum and friction massage. Inclusion criteria: 20 to 50 year old men suffering mechanical neck pain more than 2 months and they have not had injections for the treatment of trigger points during the last 6 months. They did not treat myofascial pain during the last month; having passive and active trigger points in the upper trapezius muscle at one or both sides of the body; having a palpable tight band in the skeletal muscle; having a sensitive painful spot in the palpable tight band; reproduction of myofascial trigger points obvious shooting pain in response to pressure; the presence of spontaneous obvious shooting pain; no histories of trauma, myelopathy, nerve root entrapment, cancer, infection, neck fracture, autoimmune diseases, diabetes, cervical vertebrae osteoarthritis, sensory disorders and skin injuries in the trigger point site, cardiovascular disorders, deep veins thrombosis, nerve roots involvement based on foraminal compression and distraction tests Exclusion criteria: Neck pain enhancement After the inclusion of patients in the study, trigger points will be identified and the pain pressure threshold, pain numeric rating scale and grip power will be evaluated. Patients in group 1 will receive a pulsed vacuum on the key trigger point for 10 minutes. Patients in group 2 will receive a friction massage on the key trigger point for 5 minutes. Both groups will receive a one treatment session. All the patients again will be evaluated 2 minutes after the completion of the treatment session and 48 hours later. Pain pressure threshold and neck pain are primary outcomes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201506089440N9
Registration date: 2015-10-21, 1394/07/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-21, 1394/07/29
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
Shiraz University of Medical Sciences and Health Services
Expected recruitment start date
2015-07-25, 1394/05/03
Expected recruitment end date
2015-09-06, 1394/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pulsed Vacuum and Friction massage therapeutic effects on the treatment of trapezius muscle trigger points in men with non- specific chronic mechanical Neck Pain
Public title
Pulsed Vacuum and Friction massage effects in the treatment of neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 20 to 50 year old men suffering mechanical neck pain more than 2 months and they have not had injections for the treatment of trigger points during the last 6 months; they did not treat myofascial pain during the last month; having passive and active trigger points in the upper trapezius muscle at one or both sides of the body; having a palpable tight band in the skeletal muscle; having a sensitive painful spot in the palpable tight band; reproduction of myofascial trigger points obvious shooting pain in response to pressure; the presence of spontaneous obvious shooting pain; no histories of trauma, myelopathy, nerve root entrapment, cancer, infection, neck fracture, autoimmune diseases, diabetes, cervical vertebrae osteoarthritis, sensory disorders and skin injuries in the trigger point site, cardiovascular disorders, deep veins thrombosis and nerve roots involvement based on foraminal compression and distraction tests Exclusion criteria: Neck pain enhancement
Age
From 20 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Blvd., Central Building of Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2015-08-19, 1394/05/28
Ethics committee reference number
IR.SUMS.REC.1394.98

Health conditions studied

1

Description of health condition studied
Neck pain
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia

Primary outcomes

1

Description
Pain pressure threshold
Timepoint
Before the intervention, 2 minutes after the intervention, 48 hours after the intervention
Method of measurement
Algometer

2

Description
Neck pain
Timepoint
Before the intervention, 2 minutes after the intervention, 48 hours after the intervention
Method of measurement
Pain Numeric Rating Scale

Secondary outcomes

1

Description
Power grip
Timepoint
Before the intervention, 2 minutes after the intervention, 48 hours after the intervention
Method of measurement
Dynamometer

Intervention groups

1

Description
Control group will receive a friction massage on the key trigger point for 5 minutes in a session.
Category
Rehabilitation

2

Description
Intervention group will receive a pulsed vacuum on the key trigger point for 10 minutes in a session.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic of Shiraz Rehabilitation Sciences School
Full name of responsible person
Majid Beyat
Street address
Rehabilitation Sciences School, Abiverdi 1st Ave., Chamran Blvd., Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, vice chancellor of research
Full name of responsible person
Dr. Seyyed Basir Hashemi
Street address
Vice chancellor of research, Seventh floor, Central Building of Shiraz University of Medical Sciences, Zand Blvd., Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, vice chancellor of research
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
Shiraz University of Medical Sciences
Full name of responsible person
Ramin Fallahzadeh
Position
B.Sc. / M.Sc. student
Other areas of specialty/work
Street address
Rehabilitation Sciences School, Abiverdi 1st Ave., Chamran Blvd., Shiraz
City
Shiraz
Postal code
Phone
+98 71 3825 0985
Fax
Email
raminfallahzadeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rehabilitation Sciences School of Shiraz University of Medical Sciences
Full name of responsible person
Dr.Soraya Piroozi
Position
Assistant Professor / PhD
Other areas of specialty/work
Street address
Rehabilitation Sciences School, Chamran Blvd., Abiverdi 1st Ave., Shiraz
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
piroozis@sums.ac.ir
Web page address
www.rehab.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rehabilitation Sciences School of Shiraz University of Medical Sciences
Full name of responsible person
Ramin Fallahzadeh
Position
B.Sc. / M.Sc. student
Other areas of specialty/work
Street address
Rehabilitation Sciences School, Abiverdi 1st Ave., Chamran Blvd., Shiraz
City
Shiraz
Postal code
Phone
00
Fax
Email
raminfallahzadeh@yahoo.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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