Low Back Pain, MechanicalNCT02088463
Mobilization for Post Partum Low Back Pain
A study testing mobilization (manual therapy) and Ultrasound and infrared devices in people with Low Back Pain, Mechanical, run by Cairo University at 1 site in Egypt.
Trial summary
The study was conducted to the following purposes 1. To investigate the effect of lumbar mobilization on muscle activity in postpartum mechanical low back pain. 2. To investigate the effect of lumbar mobilization on pain intensity in postpartum mechanical low back pain patients. 3. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- mobilization (manual therapy) and Ultrasound and infrared devices
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2012to Oct 2013
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females with LBP lasting more than 3 months since their delivery
- their age range 25-35 years old with body mass index (BMI) less than 30kg/m2
Who cannot join
- medical conditions that don't allow the subject to lie prone comfortably as, cardiovascular disease, uncontrolled hypertension, abdominal hernia, severe respiratory diseases, as well as problems in the back e.g. previous low back surgery, spinal malignancy. In addition to known rheumatic joint disease, and upper or lower motor neuron lesion that affects lower limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Lumbar Mobilization on Postpartum Low Back Pain in Egyptian Females: A Randomized Control Trial
The study was conducted to the following purposes
- To investigate the effect of lumbar mobilization on muscle activity in postpartum mechanical low back pain.
- To investigate the effect of lumbar mobilization on pain intensity in postpartum mechanical low back pain patients.
- To investigate the effect lumbar mobilization on functional disability in postpartum mechanical low back pain patients.
- To compare between the effects of lumbar mobilization, tactile stimulation (placebo treatment) and traditional treatment in postpartum mechanical low back pain patients.
Read the detailed description
all participants divided randomly into three groups, Group A (Study group) received PA lumbar mobilization plus traditional treatment which consisted of Ultrasonic and Infra-red. Group B (Placebo group) received placebo mobilization plus traditional treatment. Group C (Control group) received traditional treatment only
- Conditions
- Low Back Pain, Mechanical
- Being tested
- mobilization (manual therapy), Placebo mobilization, Ultrasound and infrared devices
- Keywords
- Mechanical LBP, Mobilization, Postpartum
- 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.
mobilization (manual therapy)Procedure or surgery
Also called PA mobilization
mobilization is one of the manual therapy or treatments with the application of a gentle oscillatory passive movement to the spinal region specifically at the level of L3 in this study at the posterio-anterior direction.
Placebo mobilizationProcedure or surgery
Also called tactile stimulation
placebo mobilization is a tactile stimulation at the same level L3 without application of any force.
Ultrasound and infrared devicesDevice
Also called US & IR
ultrasound and infrared are the traditional treatment for low back pain , they are electrical modalities used in the field of physiotherapy to decrease the inflammation and the pain in musculoskeletal systems
| Study group | Role | What they receive |
|---|---|---|
| Mobilization (manual therapy) | Experimental | Mobilization (manual therapy) posterior- anterior at the L3 for 2 minutes in addition to the traditional treatment in the form of infra-red and ultrasound. The treatment duration for the three groups was 3 times/week for 4 weeks. Receives: Procedure: mobilization (manual therapy); Device: Ultrasound and infrared devices |
| placebo mobilization | Placebo comparator | placebo mobilization applied without force application. The treatment duration for the three groups was 3 times/week for 4 weeks Receives: Procedure: Placebo mobilization; Device: Ultrasound and infrared devices |
| Ultrasound and infrared therapy | Other | ultrasound and infrared are a traditional treatment for low back painThe treatment duration for the three groups was 3 times/week for 4 weeks. Receives: Device: Ultrasound and infrared devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
each case assessed two times pre- post intervention, intervention was lasted for 4 weeks
Measured: after 4 weeks from starting the intervention
functional disability
each case assessed two times pre-post intervention, intervention lasted for 4 weeks
Measured: after 4 weeks from starting the intervention
back muscle activity
each case assessed two time pre- post intervention, intervention lasted for 4 weeks
Measured: after 4 weeks from starting the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Dalia Mohamed Kame, Cairo University
- Investigators
- Dalia Shewitta, PhD, Principal investigator, Assocciate Professor of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088463
- Sponsor's protocol ID
- P.T.REC/012/00368
- Status last verified
- Apr 2016
- First submitted
- 5 Mar 2014
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lumbar Mobilization on Postpartum Low Back Pain in Egyptian Females: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02088463
- Acronym / sponsor ID
- P.T.REC/012/00368
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Mechanical LBP, Mobilization, Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Mar 2014 (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.
The study was conducted to the following purposes
- To investigate the effect of lumbar mobilization on muscle activity in postpartum mechanical low back pain.
- To investigate the effect of lumbar mobilization on pain intensity in postpartum mechanical low back pain patients.
- To investigate the effect lumbar mobilization on functional disability in postpartum mechanical low back pain patients.
- To compare between the effects of lumbar mobilization, tactile stimulation (placebo treatment) and traditional treatment in postpartum mechanical low back pain patients.
Detailed description
all participants divided randomly into three groups, Group A (Study group) received PA lumbar mobilization plus traditional treatment which consisted of Ultrasonic and Infra-red. Group B (Placebo group) received placebo mobilization plus traditional treatment. Group C (Control group) received traditional treatment only
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mobilization (manual therapy) | Experimental | Procedure: mobilization (manual therapy), Device: Ultrasound and infrared devicesMobilization (manual therapy) posterior- anterior at the L3 for 2 minutes in addition to the traditional treatment in the form of infra-red and ultrasound. The treatment duration for the three groups was 3 times/week for 4 weeks. |
| placebo mobilization | Placebo comparator | Procedure: Placebo mobilization, Device: Ultrasound and infrared devicesplacebo mobilization applied without force application. The treatment duration for the three groups was 3 times/week for 4 weeks |
| Ultrasound and infrared therapy | Other | Device: Ultrasound and infrared devicesultrasound and infrared are a traditional treatment for low back painThe treatment duration for the three groups was 3 times/week for 4 weeks. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Females with LBP lasting more than 3 months since their delivery
- their age range 25-35 years old with body mass index (BMI) less than 30kg/m2
Key exclusion criteria (1 listed)
- medical conditions that don't allow the subject to lie prone comfortably as, cardiovascular disease, uncontrolled hypertension, abdominal hernia, severe respiratory diseases, as well as problems in the back e.g. previous low back surgery, spinal malignancy. In addition to known rheumatic joint disease, and upper or lower motor neuron lesion that affects lower limbs
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 |
|---|---|---|
| mobilization (manual therapy)Also: PA mobilizationmobilization is one of the manual therapy or treatments with the application of a gentle oscillatory passive movement to the spinal region specifically at the level of L3 in this study at the posterio-anterior direction. | Procedure or surgery | Mobilization (manual therapy) |
| Placebo mobilizationAlso: tactile stimulationplacebo mobilization is a tactile stimulation at the same level L3 without application of any force. | Procedure or surgery | placebo mobilization |
| Ultrasound and infrared devicesAlso: US & IRultrasound and infrared are the traditional treatment for low back pain , they are electrical modalities used in the field of physiotherapy to decrease the inflammation and the pain in musculoskeletal systems | Device | Mobilization (manual therapy), Ultrasound and infrared therapy, placebo mobilization |
Primary outcome
Pain intensity
Time frame: after 4 weeks from starting the intervention
each case assessed two times pre- post intervention, intervention was lasted for 4 weeks
functional disability
Time frame: after 4 weeks from starting the intervention
each case assessed two times pre-post intervention, intervention lasted for 4 weeks
back muscle activity
Time frame: after 4 weeks from starting the intervention
each case assessed two time pre- post intervention, intervention lasted for 4 weeks
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 15 Apr 2016.
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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.
Dalia Shewitta, PhD principal investigator
Assocciate Professor of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobilization (manual therapy) and Ultrasound and infrared devices in people with Low Back Pain, Mechanical, 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 2 inclusion and 1 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 15 Apr 2016. 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. Some participants in this study may receive a placebo. 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?
Pain intensity (time frame: after 4 weeks from starting the intervention). 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 15 Apr 2016.