Low Back PainNCT06198647
Manual Therapy for Pregnancy Related Back Pain
A study testing Tui-na massage and positional release technique in people with Low Back Pain, run by Benha University at 1 site in Egypt.
Trial summary
More than 50% of women experience pain in the lumbopelvic area during pregnancy. The prevalence of pain increases with the duration of pregnancy. Trunk muscles are needed to sustain low levels of activity for an extended duration. Preventing muscles from fatiguing is very important. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Tui-na massage and positional release technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2024to 15 Mar 2024
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- low back pain
- mild to moderate disability concurring to the Oswestry Disability Index (up to 40%),
- age ranged from 20 - 40 years
Who cannot join
- Current physical therapy or medical treatment for low back pain,
- contracture or surgery affecting the lumbar spine,
- scoliosis,
- pathologies such as inflammatory diseases,
- skin diseases,
- congenital diseases,
Show all 10Show fewer
- neurological diseases,
- dislocations, neoplasms,
- disc prolapse,
- visual or auditory problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tui-Na Versus Positional Release Techniques on Pregnancy Related Low Back Pain in the Third Trimester. A Randomized Trial
More than 50% of women experience pain in the lumbopelvic area during pregnancy. The prevalence of pain increases with the duration of pregnancy. Trunk muscles are needed to sustain low levels of activity for an extended duration. Preventing muscles from fatiguing is very important. Manual therapy techniques can minimize loading of the spine while improving muscular endurance and preventing fatigue. Moreover, inhibition of the trigger points of the spinal musculature is an important factor to consider.
Read the detailed description
Tui-Na massage and positional release therapy are both of the common manual therapies used recently for low back pain. However, no studies have compared their effects on pregnancy related low back pain in third trimester.
- Conditions
- Low Back Pain
- Being tested
- Tui-na massage, positional release technique
- Keywords
- manual therapy
- 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.
Tui-na massageProcedure or surgery
Using Tui-na massage for the back muscles
positional release techniqueProcedure or surgery
using positional release manual technique to relax the back muscles
| Study group | Role | What they receive |
|---|---|---|
| tui-na | Experimental | Application of tui-na techniques for the women while being in prone lying position. Receives: Procedure: Tui-na massage |
| positional release techniques | Active comparator | Application of positional release techniques for the women while being in prone lying position. Receives: Procedure: positional release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
back pain intensity
will be measure by the visual analogue scale that range from 0 to 10 with higher scores indicating greater pain intensity.
Measured: through study completion, an average of 2 months
Secondary outcomes (1)
The pressure pain threshold (kg/cm2)
will be measured using a pressure algometer that will be placed vertically on the most tender point at the low back para spinal muscles.
Measured: through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion27 Feb 2024 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Benha 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Mohamed Elabd, Benha University
- Investigators
- Aliaa M Elabd, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198647
- Sponsor's protocol ID
- PT.BU.EC.2
- Status last verified
- Jan 2024
- First submitted
- 7 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: will be available upon reasonable request
Publications
Elabd AM, Hasan S, Alghadir AH, Elabd OM, Shawky GM, Iqbal A, Marwan YN. Effect of Tui-Na versus positional release techniques on pregnancy-related low back pain in the third-trimester: A randomized comparative trial. Medicine (Baltimore). 2024 Dec 13;103(50):e40879. doi: 10.1097/MD.0000000000040879.
PubMed 39686497
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tui-Na Versus Positional Release Techniques on Pregnancy Related Low Back Pain in the Third Trimester. A Randomized Trial
- ClinicalTrials.gov ID
- NCT06198647
- Acronym / sponsor ID
- PT.BU.EC.2
- Conditions
- Low Back Pain
- Keywords
- manual therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 27 Feb 2024 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 10 Jan 2024 (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.
More than 50% of women experience pain in the lumbopelvic area during pregnancy. The prevalence of pain increases with the duration of pregnancy. Trunk muscles are needed to sustain low levels of activity for an extended duration. Preventing muscles from fatiguing is very important. Manual therapy techniques can minimize loading of the spine while improving muscular endurance and preventing fatigue. Moreover, inhibition of the trigger points of the spinal musculature is an important factor to consider.
Detailed description
Tui-Na massage and positional release therapy are both of the common manual therapies used recently for low back pain. However, no studies have compared their effects on pregnancy related low back pain in third trimester.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tui-na | Experimental | Procedure: Tui-na massageApplication of tui-na techniques for the women while being in prone lying position. |
| positional release techniques | Active comparator | Procedure: positional release techniqueApplication of positional release techniques for the women while being in prone lying position. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- low back pain
- mild to moderate disability concurring to the Oswestry Disability Index (up to 40%),
- age ranged from 20 - 40 years
Key exclusion criteria (10 listed)
- Current physical therapy or medical treatment for low back pain,
- contracture or surgery affecting the lumbar spine,
- scoliosis,
- pathologies such as inflammatory diseases,
- skin diseases,
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 |
|---|---|---|
| Tui-na massageUsing Tui-na massage for the back muscles | Procedure or surgery | tui-na |
| positional release techniqueusing positional release manual technique to relax the back muscles | Procedure or surgery | positional release techniques |
Primary outcome
back pain intensity
Time frame: through study completion, an average of 2 months
will be measure by the visual analogue scale that range from 0 to 10 with higher scores indicating greater pain intensity.
1 secondary outcome
The pressure pain threshold (kg/cm2)
Time frame: through study completion, an average of 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 39686497Elabd AM, Hasan S, Alghadir AH, Elabd OM, Shawky GM, Iqbal A, Marwan YN. Effect of Tui-Na versus positional release techniques on pregnancy-related low back pain in the third-trimester: A randomized comparative trial. Medicine (Baltimore). 2024 Dec 13;103(50):e40879. doi: 10.1097/MD.0000000000040879.
- Individual participant dataSharing planned: Yes. will be available upon reasonable request
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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.
Aliaa M Elabd principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tui-na massage and positional release technique in people with Low Back Pain, run by Benha 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 3 inclusion and 10 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 10 Jan 2024. 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?
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?
back pain intensity (time frame: through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198647, which also lists 1 linked publication.
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 10 Jan 2024.