This study will be conducted to for the purpose of determining the effect of energy therapy on low back pain severity and the activities of daily living in the patients with intervertebral disk herniation. Energy therapy relieves pain and improves the activity daily living and reduces the dependency. The inclusion criterion is to have a herniated intervertebral disk which approved by an orthopedist. The exclusion criteria are to have other spinal disk problem such as stenosis and osteoporosis, different length of the lower limbs, acute strain of lumbosacral muscles, renal disorders, pelvic diseases, pregnancy, addiction to opioids, and having an experience of energy therapy. The study population will be the patients with low back pain due to intervertebral disk herniation who referred to the Edalat clinic in Zahedan, Iran. Forty patients who have inclusion and exclusion criteria will be randomized into control and experimental groups. The intervention will be conducted 3 times in the first week and will be proceed 1 time for two weeks. The data will be gathered every week after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050233765N1
Registration date:2017-06-06, 1396/03/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-06, 1396/03/16
Registrant information
Name
Farnaz Jahantigh
Name of organization / entity
Zabol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 0389
Email address
farnaz1011@gmail.com
Recruitment status
Recruitment complete
Funding source
Deputy dean of Research and Technology of the Zabol Universiy of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Reiki therapy on low back pain intensity and activities of daily living in patients with vertebral disc herniation
Public title
The effect of Reiki therapy on low back pain intensity and activities of daily living in patients with vertebral disc herniation
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criterion: having a herniated intervertebral disk which approved by an orthopedist. The exclusion criteria: having other spinal disk problem such as stenosis and osteoporosis; different length of the lower limbs; acute strain of lumbosacral muscles; renal disorders; pelvic diseases; pregnancy; addiction to opioids; having an experience of energy therapy.
Age
From 30 years old
Gender
Both
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zabol University of Medical Sciences
Street address
Jahad Sq.
City
Zabol
Postal code
Approval date
2017-04-16, 1396/01/27
Ethics committee reference number
zbmu.i.rec.1396.36
Health conditions studied
1
Description of health condition studied
Intervertebral disc herniation
ICD-10 code
M51.1
ICD-10 code description
Lumbar and other intervertebral disc disorders with radiculopathy
Primary outcomes
1
Description
Pain
Timepoint
before and after intervention, every week for one month
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Activities of daily living
Timepoint
Before and after intervention; Every week for one month after intervention
Method of measurement
ADL-IADL Questionnaire
Intervention groups
1
Description
In the intervention group Reiki energy will transfer for 30 minutes. In the first the energy will be transfer to the aura for 10 minutes. Then, Energy will be transferred to the root chakra, which located in the perineal area without touching for 20 minutes. In the first week, the patients receive energy for three sessions and for the next three weeks receive one treatment session only.
Category
Rehabilitation
2
Description
In the control group, the patients receive rehabilitation treatments such as pelvic traction and performing isometric exercises under supervisor a physiotherapist based on order of an orthopedist.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Edalat clinic in Zahedan, Iran
Full name of responsible person
Ms. Eslami
Street address
Khayyam St.,
City
Zahadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Zabol University of Medical Sciences
Full name of responsible person
Hosein Shahdadi
Street address
Shahid Rejaei st.,
City
Zabol
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 and Technology of Zabol 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
Zabol University of Medical Sciences
Full name of responsible person
Farnaz Jahantigh
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Republic BlV.
City
Zahedan
Postal code
Phone
+98 54 3343 0389
Fax
Email
farnaz1011@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Abdolghani Abdollahimohammad
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nursing and Miwifery
City
Zabol
Postal code
Phone
+98 54 3222 3947
Fax
Email
abdollahi@zbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Farnaz Jahantigh
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Republic BLV.
City
Zahedan
Postal code
Phone
+98 54 3343 0389
Fax
Email
farnaz1011@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)