The effect of hypnotherapy with physiotherapy on pain intensity, psychological distress and functional disability among patients with non- specific low back pain
Objective the study: The effectiveness of hypnotherapy with physical therapy on pain and functional disability and psychological distress in patients with non-specific low back pain is. Inclusion criteria: age 20 to 45 years; non-specific low back pain by orthopedic specialist, a higher education cycle, with a score of higher than 3 suggestibility suggestibility tests Spiegel.
Exclusion criteria: psychotic disorders, lack of participation in the sessions.
30 patients, two groups of intervention and control up to 15 people.
Interventions and primary outcomes of the study and its time: In order to control confounding variables before starting treatment, patients are given the option variables such as age and gender as well as education and pain are matched. In the control group only 10 sessions of physiotherapy and hypnotherapy in the intervention group 6 sessions (one session of physical therapy) with 10 sessions of hypnotherapy for 60 minutes before the physiotherapy carried an action plan and run according to the protocols. At its first meeting the required measures are taken to determine the base lines. In the fourth session Surveys conducted for the second time and once again take place at the end of treatment measures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011926111N1
Registration date:2016-05-01, 1395/02/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-01, 1395/02/12
Registrant information
Name
Nader Abazari
Name of organization / entity
semnan university
Country
Iran (Islamic Republic of)
Phone
+98 21 5514 0585
Email address
abazari@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2016-02-09, 1394/11/20
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hypnotherapy with physiotherapy on pain intensity, psychological distress and functional disability among patients with non- specific low back pain
Public title
The effect of hypnotherapy with physiotherapy on pain intensity, psychological distress and functional disability among patients with non- specific low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20 to 45 years; diagnosed with nonspecific low back pain by orthopedic specialist; a higher education cycle; with a score of higher than 3 suggestibility suggestibility tests Spiegel.
Exclusion criteria: psychotic disorders; lack of participation in the sessions.
Age
From 76 years old to 49 years old
Gender
Both
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Semnan University of Medical sciences
Street address
Semnan, Basij Blvd, Semnan University of Medical Sciences
City
Semnan
Postal code
1366757558
Approval date
2016-01-18, 1394/10/28
Ethics committee reference number
IR.SEMUMS.REC.1394.128
Health conditions studied
1
Description of health condition studied
Non specific low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain intensity
Timepoint
Before intervention, fourth session, after intervention, three mounth after intervention
Method of measurement
Numeric assessment of pain intensity
2
Description
Psychological distress
Timepoint
Before intervention, fourth session, after intervention, three mounth after intervention
Method of measurement
DASS-21
3
Description
Functional disability
Timepoint
Before intervention, fourth session of intervention, after intervention, three mounth after intervention
Method of measurement
Mouris questionair of functional disabiity
Secondary outcomes
empty
Intervention groups
1
Description
Group intervention: 15 people randomly placed in groups. in this Group 6 with 10 sessions of physiotherapy done hypnotherapy session. During the hypnotherapy treatment is performed for 60 minutes before physical therapy. At its first meeting the required measures are taken to determine the base lines. Hypnotherapy session of physiotherapy is executed. Physical therapy and hypnotherapy are operating in accordance with the protocols provided. In the fourth session Surveys conducted for the second time and once again take place at the end of treatment measures.
Category
Diagnosis
2
Description
Control Group: 15 people randomly placed in groups. In this group only 10 sessions of physiotherapy done. Physiotherapy in accordance with the operational protocols are provided. In the fourth session Surveys conducted for the second time and once again take place at the end of treatment measures.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic of Red Crescent
Full name of responsible person
Dr Atefe Aminianfar
Street address
Mashahir Squer, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Semnan University.
Full name of responsible person
Dr Isagh Rahimian Bouger
Street address
Semnan, Saadi Plaza, Deputy of Research and Technology, Semnan University.
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Semnan University.
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
Semnan university
Full name of responsible person
Isagh Rahimian Bouger
Position
PhD in Health Psychology
Other areas of specialty/work
Street address
Semnan
City
Semnan
Postal code
3519899951
Phone
+98 23 3344 8996
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan university
Full name of responsible person
Nader Abazari
Position
Master student of Clinical Psychology
Other areas of specialty/work
Street address
Semnan university, Darband, Mahdishahr
City
Mahdishahr
Postal code
3519899951
Phone
+98 23 3344 8996
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan university
Full name of responsible person
Nader Abazari
Position
Master Student of Clinical Psychology
Other areas of specialty/work
Street address
Semnan university, Darband, Mahdishahr
City
Mahdishahr
Postal code
3519899951
Phone
+98 23 3344 8996
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)