Low Back PainNCT04822428
Effect of Visceral Osteopathic Manipulations on Low Back Pain
A study testing Osteopathic manipulation in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Osteopathic manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2020to 12 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non-specific low back pain for more than 12 weeks
Who cannot join
- Malignant tumor
- Pregnancy
- Acute ischemic bowel disease,
- Intestinal obstruction,
- surgery in the last six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Visceral Osteopathic Manipulations on Low Back Pain Caused by Visceral Dysfunctions
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Osteopathic manipulation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulationOther
Osteopathic manipulative techniques including; suboccipital release technique,sacral release technique, diaphragmatic release, mesentery release, and Colonic manipulation
| Study group | Role | What they receive |
|---|---|---|
| study group(A) | Experimental | Group (A): included Twenty patients who received osteopathic manipulative techniques, 1 session per week for 3 weeks. Receives: Other: Osteopathic manipulation |
| Control group(B) | No intervention | Group (B): included twenty patients who received analgesic drugs only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change from baseline to after 3 weeks
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.
Measured: change from baseline to after 3 weeks
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.
Measured: change from baseline to after 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start20 Aug 2020
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, controlled, parallel study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Ali Abdeen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822428
- Sponsor's protocol ID
- SH2021
- Status last verified
- Mar 2021
- First submitted
- 26 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Visceral Osteopathic Manipulations on Low Back Pain Caused by Visceral Dysfunctions
- ClinicalTrials.gov ID
- NCT04822428
- Acronym / sponsor ID
- SH2021
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, controlled, parallel study
| Arm | Type | Receives |
|---|---|---|
| study group(A) | Experimental | Other: Osteopathic manipulationGroup (A): included Twenty patients who received osteopathic manipulative techniques, 1 session per week for 3 weeks. |
| Control group(B) | No intervention | –Group (B): included twenty patients who received analgesic drugs only. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Non-specific low back pain for more than 12 weeks
Key exclusion criteria (5 listed)
- Malignant tumor
- Pregnancy
- Acute ischemic bowel disease,
- Intestinal obstruction,
- surgery in the last six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic manipulationOsteopathic manipulative techniques including; suboccipital release technique,sacral release technique, diaphragmatic release, mesentery release, and Colonic manipulation | Other | study group(A) |
Primary outcome
The visual analog scale (VAS)
Time frame: change from baseline to after 3 weeks
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)
Time frame: change from baseline to after 3 weeks
(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)
Time frame: change from baseline to after 3 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic manipulation in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The visual analog scale (VAS) (time frame: change from baseline to after 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.