Low Back PainPhase 1/2NCT02813330
Subcutaneous Sterile Water Injection for Relief of Low Back Pain
A Phase 1/2 study testing Subcutaneous sterile water injection and saline injection in people with Low Back Pain, run by Woman's Health University Hospital, Egypt.
Trial summary
To compare the effect of subcutenous sterile water injection technique with the subcutaneous saline injection technique in the degree and duration of low back pain-relieving during childbirth Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Subcutaneous sterile water injection and saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jun 2016
- Phase
- Phase 1/2
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- In labour (spontaneous or induced record
- During first stage of labour
- Primary and multiparous women
- A term singleton pregnancy (between 37 + 0 and 41 weeks)
- Have a fetus in a cephalic presentation
- Experience back pain assessed by visual analogue scale VAS and Face pain analogue
- Provide informed consent.
Who cannot join
- Women with chronic disease
- Medical condition associated with pregnancy ( Pre-eclampsia- Eclampsia- Diabetic pregnancy.... etc)
- Complicated labor process ( obstructed, preterm labor, twins)
About this study
Official title: Subcutaneous Sterile Water Injection for Relief of Low Back Pain During Normal Labor: Randomized Controlled Study
To compare the effect of subcutenous sterile water injection technique with the subcutaneous saline injection technique in the degree and duration of low back pain-relieving during childbirth
Read the detailed description
Study sample:
The convenience sample will be recruited randomly on the basic of odd number will have saline injection and even number will be given a placebo (Sterile water injection)
Setting:
Labor ward in Women's health center at Assiut university hospital
Study design:
Experimental Randomized control study
Sample size:
The sample size was calculated using the formula N= (Zα+Zβ)2 x 2p(1-p)÷d2 ,taking the level of significance as 5%, Zα=1.96 and power of the test as 80%, Zβ=0.84. p=0.113. A sample size of 165 in each group was calculated. Total of 330 women will be studied (165 in each arm) Inclusion criteria
- In labour (spontaneous or induced
- During first stageof labour
- Primary and multiparous women
- A term singleton pregnancy (between 37 + 0 and 41 weeks)
- Have a fetus in a cephalic presentation
- Experience back pain assessed by visual analogue scale VAS and Face pain analogue ( Warden V, Hurley AC, Volicer L.2003)
- Provide informed consent.
Exclusion criteria
- Multiple pregnancy
- Malpresentation (breech, transverse, shoulder)
- Previous CS
- Infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. Thrombocytopenia.
Study Tools:
- Personal data questionnaire
- Visual Analogue Scale and Face analogue scale
- Satisfaction scale
- Conditions
- Low Back Pain
- Being tested
- Subcutaneous sterile water injection, saline injection
- Keywords
- Women, severe, low back ache, labor
- Medical subject headings
- Low Back Pain, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous sterile water injectionOther
Also called sterile water injection
sterile water injection in two points of low back pain
saline injectionOther
Also called Natural pain relief
Saline injection in two points of low back pain
| Study group | Role | What they receive |
|---|---|---|
| Sterile Water injection | Experimental | Subcutenous injection at low back portion during labor pain Receives: Other: Subcutaneous sterile water injection; Other: saline injection |
| saline injection | Experimental | Subcutenous injection at low back portion during labor pain Receives: Other: Subcutaneous sterile water injection; Other: saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
the investigator spend two hours with each client to measure the effect of pain relief
Measured: two hours for each client
Women's Saisfaction
measuring pain relief within different minutes
Measured: each 15 min until 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startFeb 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
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.
- 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howieda Fouly, Woman's Health University Hospital, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813330
- Sponsor's protocol ID
- Women Health Hospital
- Status last verified
- Jun 2016
- First submitted
- 18 Jun 2016
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Protocol or seminar discussion
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Sterile Water Injection for Relief of Low Back Pain During Normal Labor: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02813330
- Acronym / sponsor ID
- Women Health Hospital
- Conditions
- Low Back Pain
- Keywords
- Women, severe, low back ache, labor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 27 Jun 2016 (estimated)
- 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.
To compare the effect of subcutenous sterile water injection technique with the subcutaneous saline injection technique in the degree and duration of low back pain-relieving during childbirth
Detailed description
Study sample:
The convenience sample will be recruited randomly on the basic of odd number will have saline injection and even number will be given a placebo (Sterile water injection)
Setting:
Labor ward in Women's health center at Assiut university hospital
Study design:
Experimental Randomized control study
Sample size:
The sample size was calculated using the formula N= (Zα+Zβ)2 x 2p(1-p)÷d2 ,taking the level of significance as 5%, Zα=1.96 and power of the test as 80%, Zβ=0.84. p=0.113. A sample size of 165 in each group was calculated. Total of 330 women will be studied (165 in each arm) Inclusion criteria
- In labour (spontaneous or induced
- During first stageof labour
- Primary and multiparous women
- A term singleton pregnancy (between 37 + 0 and 41 weeks)
- Have a fetus in a cephalic presentation
- Experience back pain assessed by visual analogue scale VAS and Face pain analogue ( Warden V, Hurley AC, Volicer L.2003)
- Provide informed consent.
Exclusion criteria
- Multiple pregnancy
- Malpresentation (breech, transverse, shoulder)
- Previous CS
- Infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. Thrombocytopenia.
Study Tools:
- Personal data questionnaire
- Visual Analogue Scale and Face analogue scale
- Satisfaction scale
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sterile Water injection | Experimental | Other: Subcutaneous sterile water injection, Other: saline injectionSubcutenous injection at low back portion during labor pain |
| saline injection | Experimental | Other: Subcutaneous sterile water injection, Other: saline injectionSubcutenous injection at low back portion during labor pain |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- In labour (spontaneous or induced record
- During first stage of labour
- Primary and multiparous women
- A term singleton pregnancy (between 37 + 0 and 41 weeks)
- Have a fetus in a cephalic presentation
Key exclusion criteria (3 listed)
- Women with chronic disease
- Medical condition associated with pregnancy ( Pre-eclampsia- Eclampsia- Diabetic pregnancy.... etc)
- Complicated labor process ( obstructed, preterm labor, twins)
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 |
|---|---|---|
| Subcutaneous sterile water injectionAlso: sterile water injectionsterile water injection in two points of low back pain | Other | Sterile Water injection, saline injection |
| saline injectionAlso: Natural pain reliefSaline injection in two points of low back pain | Other | Sterile Water injection, saline injection |
Primary outcome
Pain relief
Time frame: two hours for each client
the investigator spend two hours with each client to measure the effect of pain relief
Women's Saisfaction
Time frame: each 15 min until 120 min
measuring pain relief within different minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
- Individual participant dataSharing planned: Yes. Protocol or seminar discussion
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Subcutaneous sterile water injection and saline injection in people with Low Back Pain, run by Woman's Health University Hospital, 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Pain relief (time frame: two hours for each client). The study lists 2 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 27 Jun 2016.