Back to resultsEffect of Visceral Osteopathic Manipulations on Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Osteopathic manipulation
Sponsored by
About this trial
This is an interventional supportive care trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Non-specific low back pain for more than 12 weeks
Exclusion Criteria:
- Malignant tumor
- Pregnancy
- Acute ischemic bowel disease,
- Intestinal obstruction,
- surgery in the last six months
Sites / Locations
- Faculty of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
study group(A)
Control group(B)
Arm Description
Group (A): included Twenty patients who received osteopathic manipulative techniques, 1 session per week for 3 weeks.
Group (B): included twenty patients who received analgesic drugs only.
Outcomes
Primary Outcome Measures
The visual analog scale (VAS)
The patient determined the pain intensity on a 10 cm scale marked with points ranging from predetermined no pain and excruciating pain
The Oswestry Disability Index (ODI)
(ODI) consists of 10 items on the degree of severity to which back (or leg) trouble has affected the ability to manage in everyday life.
Modified Schober's test (MST)
the participant stood erect while the lumbosacral junction was marked as indicated by the dimples of Venus. For measuring the MST, we put a mark 5 cm below and 10 cm above the junction. The participant was asked to bend forward as far as possible and the stretched distance of these two points was measured as the MST value.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04822428
Brief Title
Effect of Visceral Osteopathic Manipulations on Low Back Pain
Official Title
Effect of Visceral Osteopathic Manipulations on Low Back Pain Caused by Visceral Dysfunctions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 20, 2020 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Forty female patients with age ranging from 30-40 years old were suffering from low back pain due to visceral dysfunctions participated in this study. They were recruited from a private clinic. They were assigned into two groups equal in number; Group (A): included twenty patients who received osteopathic manipulative techniques, 1 session per week for 3 weeks, and Group (B): included twenty patients who received only analgesic drugs.
Detailed Description
Twenty patients received osteopathic manipulative techniques including Suboccipital release technique, diaphragmatic release.,mesentery release and Colonic manipulation were applied to the study group according to the patients' needs.
The treatment program comprised a total of 3 sessions for 3 weeks at one session per week for an average of 50 minutes per session. Twenty patients in the second group (control ) took only analgesics during the three weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, controlled, parallel study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group(A)
Arm Type
Experimental
Arm Description
Group (A): included Twenty patients who received osteopathic manipulative techniques, 1 session per week for 3 weeks.
Arm Title
Control group(B)
Arm Type
No Intervention
Arm Description
Group (B): included twenty patients who received analgesic drugs only.
Intervention Type
Other
Intervention Name(s)
Osteopathic manipulation
Intervention Description
Osteopathic manipulative techniques including; suboccipital release technique,sacral release technique, diaphragmatic release, mesentery release, and Colonic manipulation
Primary Outcome Measure Information:
Title
The visual analog scale (VAS)
Description
The patient determined the pain intensity on a 10 cm scale marked with points ranging from predetermined no pain and excruciating pain
Time Frame
change from baseline to after 3 weeks
Title
The Oswestry Disability Index (ODI)
Description
(ODI) consists of 10 items on the degree of severity to which back (or leg) trouble has affected the ability to manage in everyday life.
Time Frame
change from baseline to after 3 weeks
Title
Modified Schober's test (MST)
Description
the participant stood erect while the lumbosacral junction was marked as indicated by the dimples of Venus. For measuring the MST, we put a mark 5 cm below and 10 cm above the junction. The participant was asked to bend forward as far as possible and the stretched distance of these two points was measured as the MST value.
Time Frame
change from baseline to after 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-specific low back pain for more than 12 weeks
Exclusion Criteria:
Malignant tumor
Pregnancy
Acute ischemic bowel disease,
Intestinal obstruction,
surgery in the last six months
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Cairo
ZIP/Postal Code
12316
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Visceral Osteopathic Manipulations on Low Back Pain
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