Evaluation of the effect of hydrotherapy in patients with lumbar disc herniation
Design
A Single-Blinded, Randomized clinical trial, with parallel groups on 96 patients followed for 3 to 6 months
Settings and conduct
96 patients suffering from Lumbar disc herniation referred to orthopedic clinic of Imam Khomeini Hospital will be Randomized to one of two groups of Analgesic Treatment and Hydrotherapy with analgesic treatment. Patients could not be blinded but the data collectors and outcome assessors are blinded to assignment.
Participants/Inclusion and exclusion criteria
Lumbar Disc Herniation Patients with informed consent who meet the inclusion criteria will enter the study.
Inclusion Criteria:
Absence of Cardiovascular Disease,
Absence of Gastrointestinal Disease,
Absence of any mental disorder related to water
Exclusion Criteria:
Adverse reaction to study drugs
Intervention groups
Intervention group: 2 hour Hydrotherapy sessions twice weekly, for 3 to 6 months with Analgesic Treatment with Celecoxib or Naproxen Twice a day
Control group: Analgesic Treatment with Celecoxib or Naproxen Twice a day for 3-6 months
Main outcome variables
The amount of change in Lower back and lower limb pain after 3 to 6 months based on Visual Analogue Scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200819048460N1
Registration date:2020-11-04, 1399/08/14
Registration timing:retrospective
Last update:2020-11-04, 1399/08/14
Update count:0
Registration date
2020-11-04, 1399/08/14
Registrant information
Name
Akram Vahabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3780 2973
Email address
paradise682002@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-23, 1397/02/03
Expected recruitment end date
2020-02-29, 1398/12/10
Actual recruitment start date
2018-06-10, 1397/03/20
Actual recruitment end date
2020-04-13, 1399/01/25
Trial completion date
2020-04-13, 1399/01/25
Scientific title
The effect of hydrotherapy in the treatment of patients with lumbar disc herniation
Public title
Evaluation of the effect of hydrotherapy in lumbar disc herniation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with lumbar disc herniation confirmed by an orthopedic specialist
Consent to enter the study
Absence of Cardiac disease (due to the possibility of complications of celecoxib consumption in coronary artery disease patients)
Absence of gastrointestinal disease(like peptic ulcer disease)
Absence of Mental Disorders related to water (like phobias)
Exclusion criteria:
Hypersensitivity to naproxen or celecoxib that patients can not use any of these two drugs.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
96
Actual sample size reached:
96
Randomization (investigator's opinion)
Randomized
Randomization description
In this study computerized block randomization (block sizes of 4 and 6) will be carried out. An independent clinical epidemiologist, who will not be involved in the conduct of the study, uses a computerized block randomization program (STATA14 software) to produce the allocation codes. The randomization sequences will be concealed in lightproof, sealed envelopes. The research assistant opens sealed, numbered, opaque envelopes containing allocation codes. The eligible participants will be randomly divided into two equal groups (Hydrotherapy or control) according to the randomization list after signing informed consent form.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the allocation of a group to hydrotherapy, it is not possible to blind patients. But the second investigator of the research project who is blinded to the assignment of patients, will complete the questionnaire at the end of the treatment. Also the data will be analyzed without any information about group selection
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Street, Golestan, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2019-10-05, 1398/07/13
Ethics committee reference number
IR.AJUMS.REC.1398.481
Health conditions studied
1
Description of health condition studied
Disc bulging
ICD-10 code
M51.16
ICD-10 code description
Intervertebral disc disorders with radiculopathy, lumbar region
Primary outcomes
1
Description
Back and lower limb pain score in patients with lumbar disc herniation based on Visual Analogue Scale
Timepoint
At the beginning of the intervention and 3 to 6 months after hydrotherapy and medication.
Method of measurement
Visual Analogue Scale questionnaire
Secondary outcomes
1
Description
Daily quality of life score based on Oswestry low back pain disability questionnaire
Timepoint
En At the beginning of the intervention and 3 to 6 months after hydrotherapy and medication.
Method of measurement
The Oswestry low back pain disability questionnaire
Intervention groups
1
Description
Intervention group: Patients assigned to this group undergo Hydrotherapy sessions, which include walking in a pool filled with water with a depth of 1.5 meters, twice a week, with each session lasting for two hours, for a duration of three to six months. Treatment with 500 mg Celecoxib capsules (Dr Aabidi Pharmaceutical Company) is used twice a day. Naproxen capsules (500 mg, Twice a day Tolid Daru Pharmaceutical Company, Tehran) is used instead of Celecoxib if the patients suffer from coronary artery disease.
Category
Treatment - Other
2
Description
Control group: Patients in this group will undergo daily treatment with 500 mg Celecoxib capsules (Dr Aabidi Pharmaceutical Company) used twice a day. Naproxen capsules (500 mg, Twice Daily Tolid Daro Pharmaceutical Company, Tehran) is used instead of Celecoxib if the patients suffer from coronary artery disease.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Payam Mohammad Hosseini
Street address
Imam Khomeini Hospital, 24 meters Avenue, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 3818
Email
Payam_m_h@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahdi Ahmadi Moghadam
Street address
Ahwaz Jundishapur University of Medical Sciences, Golestan BLVD, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
iitc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Payam Mohammad Hosseini
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini hospital, 24m street
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 3818
Email
Payam_m_h@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Payam Mohammad Hoseeini
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini Hospital, 24m street
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 3818
Email
Payam_m_h@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Payam Mohammad Hosseini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeini Hospital,24M Street
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 3818
Email
Payam_m_h@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD