(1)Objectives: The purpose of the present study was to compare the two methods of manual therapy; manipulation and manipulation with dry needlling in treatment of patients with non-specific chronic low back pain.(2)The essential inclusion and exclusion criteria: The main criterion for attending a study is non-specific chronic low back pain for more than 12 weeks and having painful points by touching at least three muscles from five muscles in study ,the age range is between 18 to 32.the patient satisfaction is the main reason for exclusion criteria, Patients who have had surgery for the last six months.(3)Population and sample size: The total number of participants is 30 people in the study.(4)Intervention and period of treatment: people are randomly divided into two groups. In the control group , the patient only recieve manipulation treatment and in the intervention group ,the patient recieve manipulation and dry needling treatment.The intervention period is one week, including three times a week for each patient.(5)Main outcome measure:the degree of pain and functional disability is measured in three times; before the intervention, immediately after the intervention and at the end of the third session of intervention. At the end, the results are compared together.
General information
Acronym
none
IRCT registration information
IRCT registration number:IRCT2017090224149N37
Registration date:2017-09-21, 1396/06/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-21, 1396/06/30
Registrant information
Name
Fahimeh Kamali
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
kamalif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of Rehabilitation, Shiraz University of Medical Sciences
Expected recruitment start date
2017-09-01, 1396/06/10
Expected recruitment end date
2017-10-02, 1396/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare two method of manual therapy; Manipulation and Dry Needling in treatment of non-specific low back pain in athlete
Public title
Treatment of chronic low back pain using a method of manual therapy and dry needlling
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The age range is between 18-32 ;Athletes with last three times a week exersice, every time two hours ;The pain based on the Vas scale is not less than 3 in excess of 6 ;Functional disability based on the Oswestry scale is less than 20 at most 40 ;non-specific chronic low back pain ;The tender points with or without bundles in at least three of the five muscles studied
exclusion criteria:Patient dissatisfaction ;Additional therapies apart from treatment specified in the study ;Patients who include one of the cases of contraindication of interventions, such as recent infections, cancer, anticoagulants, lymphademas, etc. ;Patients who have had surgery for the last six months ;Patients who cancel for any reason during treatment
Age
From 18 years old to 32 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical science faculty of rehabilitation
Street address
Shiraz ,Chamran blvd, Abiverdi street 1 , faculty of rehabilitation
City
Shiraz
Postal code
7194733669
Approval date
2017-07-09, 1396/04/18
Ethics committee reference number
IR.SUMS.REC.1396.67
Health conditions studied
1
Description of health condition studied
Non specific chronic low back pain
ICD-10 code
M70.8, M79
ICD-10 code description
Other soft tissue disorders related to use, overuse and pressure , Other specified soft tissue disorders , Other disorders of muscle in diseases classified elsewhere
Primary outcomes
1
Description
Functional disability
Timepoint
Before the intervention ,immediately after the first session of treatment , the end of the third session of treatment
Method of measurement
Oswestry scale
2
Description
Pain
Timepoint
Before the intervention - immediately after the first session of treatment - the end of the third session of treatment
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
The control group will receive a manipulation treatment for one week during 3 sessions of treatment.
Category
Rehabilitation
2
Description
The intervention group will receive dry needle treatment for one week in 3 sessions in addition to the control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Saadat Physiotherapy and hydrotherapy clinic
Full name of responsible person
Maryam Shahroozi
Street address
Shiraz-Goldasht Mohamadi-Shabnam Alley 54
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. Gholamreza Hatam
Street address
Central building of Shiraz University of Medical Sciences, Zand blvd
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
-
Full name of responsible person
Iman faghihzadeh Gorji
Position
physical therapist
Other areas of specialty/work
Street address
Shiraz-Bagh Safa
City
Shiraz
Postal code
-
Phone
00
Fax
-
Email
iman_faghih_gorji@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
-
Full name of responsible person
Jamal Sharifian
Position
physicaltherapist
Other areas of specialty/work
Street address
Shiraz ,Aryan minicity
City
Shiraz
Postal code
7197679657
Phone
+98 71 3654 3593
Fax
-
Email
Sharifian.pt@gmail.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
-
Full name of responsible person
Jamal Sharifian
Position
Physicaltherapist
Other areas of specialty/work
Street address
Shiraz ,Aryan minicity
City
Shiraz
Postal code
7197679657
Phone
+98 71 3654 3593
Fax
-
Email
Sharifian.pt@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)