Protocol summary

Study aim
The aim of this study was to evaluate the efficacy of two complementary therapies, biofeedback and acupuncture, in the treatment of chronic neck and back pain and comparison of these two with each other
Design
Double blind randomized clinical trial with control group, sample volume of 50 patients and parallel groups
Settings and conduct
Using VAS for pain intensity, neck disability index for assessment of cervical function, algometer for pain pressure thereshold and bubble inclinometer for range of motion of neck before. Evaluation and comparison will be done before, immediately and 12 weeks after treatment Department of physical medicine and rehabilitation, imam reza and shahid madani hospitals
Participants/Inclusion and exclusion criteria
Presence of neck and shoulder’s muscles pain for more than 2 months and less than 1 year Presence of at leats 3 trigger points around the neck and shoulder muscles, VAS between 4-10 The desire to participate in the study If there is radiculopathy based on history and the presence of one of radiculopathy’s findings such as weakness , radicular pain, reduced DTR, paresthesia and positive spurling test Presence of confirmed cervical discopathy with MRI Presence of severe cervical degenerative changes History of surgery or cervical spine trauma History of therapeutic intervention for recent neck problems Presence of systemic diseases that prevent acupuncture or biofeedback therapy, such as hemorrhagic, rhomatologic or cardiovascular disorders Patients with history of depression or Taking psychological drugs People with diagnosis of fibromyalgia Pregnancy Malignancy
Intervention groups
Group A for biofeedback and group B for acupuncture
Main outcome variables
Pain intensity, pain pressure thereshold, neck functional disability, Neck range of motion in flexion,extension and left and right lateral bending

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100127003217N12
Registration date: 2019-02-19, 1397/11/30
Registration timing: prospective

Last update: 2019-02-19, 1397/11/30
Update count: 0
Registration date
2019-02-19, 1397/11/30
Registrant information
Name
Fariba Eslamian
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3967
Email address
eslamiyanf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Biofeedback Therapy compared to Acupuncture for treatment of myofascial pain syndrome in neck and upper back area: A Randomized clinical trial
Public title
Effectiveness of Biofeedback Therapy compared to Acupuncture for treatment of myofascial pain syndrome in neck and upper back area: A Randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of neck and shoulder’s muscles pain for more than 2 months and less than 1 year Presence of at leats 3 trigger points around the neck and shoulder muscles VAS between 4-10 The desire to participate in the study
Exclusion criteria:
If there is radiculopathy based on history and the presence of one of radiculopathy’s findings such as weakness , radicular pain, reduced DTR, paresthesia and positive spurling test Presence of confirmed cervical discopathy with MRI Presence of severe cervical degenerative changes History of surgery or cervical spine trauma History of therapeutic intervention for recent neck problems Presence of systemic diseases that prevent acupuncture or biofeedback therapy, such as hemorrhagic, rhomatologic or cardiovascular disorders Patients with history of depression or Taking psychological drugs People with diagnosis of fibromyalgia Pregnancy Malignancy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method has been done based on a random number table with computer software or computerized random number generator
Blinding (investigator's opinion)
Double blinded
Blinding description
Acupuncture is performed by a physiatrist and patient assessment before and after treatment is performed by a resident of the Rehabilitation who are unaware of the type of group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Vice Chancellor of Research, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5123698741
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.TBZMED.REC.1397.030

Health conditions studied

1

Description of health condition studied
Myofacial pain syndrome
ICD-10 code
R52.2
ICD-10 code description
Other chronic pain

Primary outcomes

1

Description
Pain intensity
Timepoint
Before, immediately and 3 months after treatment
Method of measurement
Visual analogue scale ( VAS )

2

Description
Neck functional disability
Timepoint
Before, immediately and 3 months after treatment
Method of measurement
Neck disability Index questionare

3

Description
Pain pressure treshold
Timepoint
Before, immediately and 3 months after treatment
Method of measurement
Algometer

4

Description
Neck range of motion in flexion, extension, left and right lateral bending
Timepoint
Before, immediately and 3 months after treatment
Method of measurement
Bubble inclinometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients in group A were treated with biofeedback for 6 sessions. Patients, Before and after treatment( immediately and 12 weeks after treatment), were evaluated with VAS for pain intensity, neck disability index for assessment of function, algometer for pain pressure thereshold and bubble inclinometer for range of motion of neck.
Category
Treatment - Devices

2

Description
Intervention group: patients in group B were treated with acupuncture for 6 sessions. Patients, Before and after treatment( immediately and 12 weeks after treatment), were evaluated with VAS for pain intensity, neck disability index for assessment of function, algometer for pain pressure thereshold and bubble inclinometer for range of motion of neck
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Fariba Eslamiyan
Street address
Department of physical medicine and rehabilitation, Emam Reza hospital, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5698745213
Phone
+98 41 3336 1928
Email
eslamiyanf@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouiban
Street address
Vice Chancellor of Research, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5963876952
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali pirani
Position
Resident of physical medicine and rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Department of physical medicine and rehabilitation, imam reza hospital, daneshgah square, tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5169615901
Phone
+98 41 3384 6093
Email
A.pirani90@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Eslamiyan
Position
Associate professor of physical medicine and rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of physical medicine and rehabilitation,imam reza hospital, daneshgah square, tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5987463214
Phone
+98 41 3336 1928
Email
Eslamiyanf@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Eslamiyan
Position
Associate professor of physical medicine and rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Physical Medicine Departmen, Emam Reza Hospital, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5289764136
Phone
+98 41 3336 1928
Email
fariba_eslamian@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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