Comparison of the Effectiveness of Cupping and Proprioceptive Neuromuscular Facilitation (PNF) on neck and shoulder muscle pain and Range of Motion in neck and shoulder pain patients
-Determination of the effect of ventilation and neuromuscular facilitation of deep sense on pain intensity and range of motion of neck and shoulder area
Design
A clinical trial with two groups of intervention and control group, 4-of permutation blocks, No blinding
Settings and conduct
Participants are asked to attend the research site at Tehran University of Medical Sciences for a period of four weeks, three days a week. Prior to starting the first session, participants are asked to fill out a consent form, demographic information and, a pain questionnaire. Hold Relax method is used to perform PNF. Visual Analogue Scale (VAS) questionnaire is used to measure pain severity. In addition to the questionnaire, the goniometer is measured using the neck and shoulder range of motion in Extension, Flexion and, Rotation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People between 30 and 70 years with a history of neck pain over the past year or more, at least twice a week, unless the treating physician has specified a specific cause for neck pain and pain intensity based on visual acuity of pain greater than 30 mm: Exclusion criteria: People with severe osteoporosis, pregnancy, eczema, epilepsy, spine fractures, spine surgery history, and Whiplash during the past year
The severity of neck and shoulder pain: Range of motion of the neck and shoulder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190918044812N1
Registration date:2019-10-21, 1398/07/29
Registration timing:registered_while_recruiting
Last update:2019-10-21, 1398/07/29
Update count:0
Registration date
2019-10-21, 1398/07/29
Registrant information
Name
Fatemeh Noughani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 6968
Email address
noghanif@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-07, 1398/07/15
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Cupping and Proprioceptive Neuromuscular Facilitation (PNF) on neck and shoulder muscle pain and Range of Motion in neck and shoulder pain patients
Public title
The Effect of Cupping and Proprioceptive Neuromuscular Facilitation (PNF) on neck and shoulder muscle pain and Range of Motion
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People between the ages of 30 and 70
The history of neck pain over the past year or more, at least twice a week, with mechanical neck and shoulder pain
The pain intensity was more than 30 mm according to the visual analogue scale.
Exclusion criteria:
severe osteoporosis
Pregnancy
Eczema
Epilepsy
Spine fractures
Spine surgery history
Whiplash over the past year
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
According to the method of permutation blocks of size 4, individuals are randomly divided into two equal groups.
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 Tehran University of Medical Sciences
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.TUMS.FNM.REC.1398.068
Health conditions studied
1
Description of health condition studied
Neck and shoulder pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
2
Description of health condition studied
Neck and Shoulder Range of Motion
ICD-10 code
G89.29
ICD-10 code description
Other chronic pain
Primary outcomes
1
Description
Severity of neck and Shoulder pain Visual Analoqoe scale questionnaire
Timepoint
Before intervention, at the beginning of each intervention session. End of intervention session
Method of measurement
Visual Analoqoe scale questionnaire
2
Description
Neck and Shoulder Range of Motion
Timepoint
Before intervention, at the beginning of each intervention session. End of intervention session
Method of measurement
Goniometer
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group1: Cupping(12 sessions 3 days a week hot and dry cupping for 10-20 minutes in the neck and shoulder area with glass mug and industrial alcohol).
Category
Treatment - Devices
2
Description
Intervention group2: Proprioceptive Neuromuscular Facilitation (PNF)(In Hold Relax method, where the volunteer is asked to sit on a chair, the researcher stands behind the volunteer and asks him to raise his hands so that the elbow rests on his shoulder, then the researcher with his hands Put the candidate's arms in front of him and ask him to move his hands for ten seconds against the resistance the researcher exerts on his arms (the researcher must adjust his strength with the strength of the volunteer). The volunteer finishes in relaxation mode within ten seconds and repeats the move for 3-5 times).
Category
Treatment - Devices
3
Description
Control group3: sample
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
tehran university of medical science
Full name of responsible person
Elham Janani
Street address
No.588,Food & Drug Administration Of Tehran, University Of Medical Science,Taleghani Ave,Qods Ave,Enqelab Ave, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Phone
+98 21 6641 5727
Email
elham.jpt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Noghani
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4517
Email
elham.jpt@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Noghani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4517
Email
elham.jpt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh noghani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
009861054517
Email
elham.jpt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Noghani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4517
Email
elham.jpt@gmail.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