To Investigate Influence of a Combined Interferential Current Stimulation and Abdominal Draw -in Exercises in Patients with Chronic NNCT06066567
INFLUENCE of COMBINED INTERFERENTIAL CURRENT STIMULATION and ABDOMINAL DRAW-IN EXERCISES in the TREATMENT of CHRONIC NON-SPECIFIC LOW BACK PAIN
A study testing Interferential current stimulation and Draw- In exercises,, in people with To Investigate Influence of a Combined Interferential Current Stimulation and Abdominal Draw -in Exercises in Patients with Chronic N, run by Cairo University at 2 sites in Egypt.
Trial summary
The purpose of this study is to investigate influence of a combined interferential (IF) current stimulation and abdominal draw-in exercises on the abdominal muscle thickness, TrA endurance, pain intensity and function disability in patients with chronic non-specific LBP (CNSLBP) CNSLBP is considered the second most… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- To Investigate Influence of a Combined Interferential Current Stimulation and Abdominal Draw -in Exercises in Patients with Chronic N
- What is being tested?
- Interferential current stimulation and Draw- In exercises,,
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2023to 1 Jun 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 60 patients with chronic non-specific low back pain (>3 months).
- 2. Age of participants will range from 20 to 45 years.
- 3.Both sexes will participate in this study.
- 4.Body mass index (BMI) will range from 25 to 29.9 (Kg / m2).
Who cannot join
- Subjects will be excluded from the study if they have previous spinal surgery, spinal cord injury or unstable neurological signs, Lumbar intervertebral disc, congenital postural deformities, inability to contract the abdominal muscles, cauda equine symptoms related to the spine including changes in bowel and bladder control, cardiac pacemaker, and females during pregnancy.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo University
Giza, Giza Governorate, 3387722
Faculty of physical therapy
Giza
About this study
The purpose of this study is to investigate influence of a combined interferential (IF) current stimulation and abdominal draw-in exercises on the abdominal muscle thickness, TrA endurance, pain intensity and function disability in patients with chronic non-specific LBP (CNSLBP) CNSLBP is considered the second most common health problem after headache. The lifetime of LBP among Egyptian patients in a family center reached 48%, which indicates that LBP is a prevalent symptom that deserves more attention.
One hypothesis for the development of LBP is due to a dysfunction in the control of the abdominal and back muscles and this change in spinal control is due in part to in local segmental muscles dysfunction, such as the transversus abdominis (TrA). Interferential therapy (IFT) is capable of achieving uniform stimulation and high reproducibility, it is thought to be less stressful, as well as enhance deep muscle contraction.
Read more
Also, there is the specific training of the TrA provided functional and therapeutic benefits, such as unloading of the spine, anticipatory postural control, intersegmental stabilization of the spine, and long-term pain relief. Draw-in is a typical TrA exercise.
Many studies have mainly focused on the morphological aspects of paraspinal muscles which play an essential role in patients with CNSLBP while our study focused on influence of a combined IFT stimulation and abdominal draw-in exercises on the abdominal muscle thickness, TrA endurance, pain intensity and function disability in patients with chronic non-specific LBP (CNSLBP
Read the detailed description
60 patients suffering from chronic non-specific low back pain will participate in this study. Both sexes will participate in this study; aged 20-45 years. will be diagnosed and referred from Orthopedist. The study will be conducted at outpatient clinic of Deraya university Elmina government. The patients will be divided randomly into two groups equal in numbers (group A), (group B).
Group(A): (Experimental group) :( 30 patients will receive IFC stimulation, Draw In exercises from prone position, hot pack, back muscles stretching and strengthening exercises for the back and abdominal muscles).
Group(B): (control group) (30 patients will receive Draw In exercises from prone position, hot pack, back muscles stretching and strengthening exercises for the back and abdominal muscles).
- Being tested
- Interferential current stimulation, Draw- In exercises,,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferential current stimulationDevice
Also called Draw- In exercises,,, hot pack, back muscles stretching, strengthening exercises for the back and abdominal muscles.
IF Current parameters will be applied as follow: Amplitude modulated frequency (AMF) 30Hz, Autosweep-5 sec, Dose-15 minutes, type of current dynamic vector field (Mitra, 2006), three days per week over four weeks (Corrêa et al., 2016) and current intensity will be increased gradually, according to the subject's condition
Draw- In exercises,,Other
Also called back muscles stretching, strengthening exercises for the back and abdominal muscles., hot pack
From prone position, participants will lay face down on the bed and flexed their hips and knees at 0°. A PBU will be positioned below the pubis symphysis with the decreasing edge consistent with the ASIS and will be overstated to 70 mmHg. The participants will be trained to gently draw in the lower part of the abdomen under the navel. In addition, while maintaining the neutral pelvic position, the movement of the upper part of the abdomen will be restricted so that the pressure will be decreased by approximately 10 mmHg. The participants will maintain this position for 10 s
| Study group | Role | What they receive |
|---|---|---|
| Experimental: treatment group | Experimental | Not described Receives: Device: Interferential current stimulation; Other: Draw- In exercises,, |
| control group | Active comparator | Not described Receives: Other: Draw- In exercises,, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal muscle thickness
TrA, External Oblique (EO) and Internal Oblique (IO) with Ultrasonography imaging examination.
Measured: 4 weeks
Transverse abdominis (TrA) muscle endurance
Transverse abdominis (TrA) muscle endurance with prone endurance test guided by Pressure Biofeedback Unit (PBU).
Measured: 4 weeks
Pain intensity
Pain intensity with visual analogue scale (VAS).
Measured: 4 weeks
. Functional disability
Functional disability with Arabic version of Oswestry Disability Index (ODI).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Investigate Influence of a Combined Interferential Current Stimulation and Abdominal Draw -in Exercises in Patients with Chronic NStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Rafat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066567
- Sponsor's protocol ID
- P.T.REC/012/004618
- Status last verified
- Mar 2025
- First submitted
- 27 Sep 2023
- Last updated
- 19 Mar 2025
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFLUENCE of COMBINED INTERFERENTIAL CURRENT STIMULATION and ABDOMINAL DRAW-IN EXERCISES in the TREATMENT of CHRONIC NON-SPECIFIC LOW BACK PAIN
- ClinicalTrials.gov ID
- NCT06066567
- Acronym / sponsor ID
- P.T.REC/012/004618
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 4 Oct 2023 (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.
The purpose of this study is to investigate influence of a combined interferential (IF) current stimulation and abdominal draw-in exercises on the abdominal muscle thickness, TrA endurance, pain intensity and function disability in patients with chronic non-specific LBP (CNSLBP) CNSLBP is considered the second most common health problem after headache. The lifetime of LBP among Egyptian patients in a family center reached 48%, which indicates that LBP is a prevalent symptom that deserves more attention.
One hypothesis for the development of LBP is due to a dysfunction in the control of the abdominal and back muscles and this change in spinal control is due in part to in local segmental muscles dysfunction, such as the transversus abdominis (TrA). Interferential therapy (IFT) is capable of achieving uniform stimulation and high reproducibility, it is thought to be less stressful, as well as enhance deep muscle contraction.
Also, there is the specific training of the TrA provided functional and therapeutic benefits, such as unloading of the spine, anticipatory postural control, intersegmental stabilization of the spine, and long-term pain relief. Draw-in is a typical TrA exercise.
Many studies have mainly focused on the morphological aspects of paraspinal muscles which play an essential role in patients with CNSLBP while our study focused on influence of a combined IFT stimulation and abdominal draw-in exercises on the abdominal muscle thickness, TrA endurance, pain intensity and function disability in patients with chronic non-specific LBP (CNSLBP
Detailed description
60 patients suffering from chronic non-specific low back pain will participate in this study. Both sexes will participate in this study; aged 20-45 years. will be diagnosed and referred from Orthopedist. The study will be conducted at outpatient clinic of Deraya university Elmina government. The patients will be divided randomly into two groups equal in numbers (group A), (group B).
Group(A): (Experimental group) :( 30 patients will receive IFC stimulation, Draw In exercises from prone position, hot pack, back muscles stretching and strengthening exercises for the back and abdominal muscles).
Group(B): (control group) (30 patients will receive Draw In exercises from prone position, hot pack, back muscles stretching and strengthening exercises for the back and abdominal muscles).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: treatment group | Experimental | Device: Interferential current stimulation, Other: Draw- In exercises,, |
| control group | Active comparator | Other: Draw- In exercises,, |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 60 patients with chronic non-specific low back pain (>3 months).
- 2. Age of participants will range from 20 to 45 years.
- 3.Both sexes will participate in this study.
- 4.Body mass index (BMI) will range from 25 to 29.9 (Kg / m2).
Key exclusion criteria (1 listed)
- Subjects will be excluded from the study if they have previous spinal surgery, spinal cord injury or unstable neurological signs, Lumbar intervertebral disc, congenital postural deformities, inability to contract the abdominal muscles, cauda equine symptoms related to the spine including changes in bowel and bladder control, cardiac pacemaker, and females during pregnancy.
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 |
|---|---|---|
| Interferential current stimulationAlso: Draw- In exercises,,, hot pack, back muscles stretching, strengthening exercises for the back and abdominal muscles.IF Current parameters will be applied as follow: Amplitude modulated frequency (AMF) 30Hz, Autosweep-5 sec, Dose-15 minutes, type of current dynamic vector field (Mitra, 2006), three days per week over four weeks (Corrêa et al., 2016) and current intensity will be increased gradually, according to the subject's condition | Device | Experimental: treatment group |
| Draw- In exercises,,Also: back muscles stretching, strengthening exercises for the back and abdominal muscles., hot packFrom prone position, participants will lay face down on the bed and flexed their hips and knees at 0°. A PBU will be positioned below the pubis symphysis with the decreasing edge consistent with the ASIS and will be overstated to 70 mmHg. The participants will be trained to gently draw in the lower part of the abdomen under the navel. In addition, while maintaining the neutral pelvic position, the movement of the upper part of the abdomen will be restricted so that the pressure will be decreased by approximately 10 mmHg. The participants will maintain this position for 10 s | Other | Experimental: treatment group, control group |
Primary outcome
Abdominal muscle thickness
Time frame: 4 weeks
TrA, External Oblique (EO) and Internal Oblique (IO) with Ultrasonography imaging examination.
Transverse abdominis (TrA) muscle endurance
Time frame: 4 weeks
Transverse abdominis (TrA) muscle endurance with prone endurance test guided by Pressure Biofeedback Unit (PBU).
Pain intensity
Time frame: 4 weeks
Pain intensity with visual analogue scale (VAS).
. Functional disability
Time frame: 4 weeks
Functional disability with Arabic version of Oswestry Disability Index (ODI).
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 19 Mar 2025.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interferential current stimulation and Draw- In exercises,, in people with To Investigate Influence of a Combined Interferential Current Stimulation and Abdominal Draw -in Exercises in Patients with Chronic N, run by Cairo University at 2 sites 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 4 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Abdominal muscle thickness (time frame: 4 weeks). The study lists 4 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 19 Mar 2025.