Low Back PainNCT06891976
Effect of Acupressure Versus Kinesotape on Low Back Pain in Women Who Use Intrauterine Device
A study testing Acupressure therapy, kinesio tape and Non-steroidal anti-inflammatory drugs in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The study will be conducted to differentiate between the effect of acupressure and kinesiotape on low back pain in women who use intrauterine device. Read more about this study
- Who is it for?
- Ages 25 to 30 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Acupressure therapy, kinesio tape and Non-steroidal anti-inflammatory drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2025to 31 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females suffer from low back pain resulted from intrauterine device use, they are referred by the gynecologist.
- Their pain level will be> 4 on the visual analogue scale (VAS).
- Their ages will be ranged from 25 to 30 years.
- Their BMI will be less than 30 kg /m2
- Women diagnosed with low back pain upon recent insertion of intrauterine device (within a year)
- All patients will be clinically and medically stable when attending the study.
Who cannot join
- Current pelvic infection, usually pelvic inflammatory disease (PID), mucopurulent cervicitis with a suspected STI, pelvic tuberculosis, septic abortion, or puerperal endometritis or sepsis within the past 3 months
- Unexplained vaginal bleeding
- Patients having skin disease or known allergy to kinesio tape
- Having LBP due to trauma, spondylolisthesis, ankylosing spondylitis, fibromyalgia, diabetes mellitus or due to any gynecological problems that may cause LBP like polycystic ovarian syndrome (PCO), endometriosis, adenomyosis, cervicitis, uterine prolapse etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Manal Ahmed El-Shafei, PhD contact
Egypt1 site
Kasr Al Ainy Hospital
Giza
Dana Abd Elaziz Mansour, B.Sc, +20 11 18886786, dana.aziz1992@gmail.com
About this study
The study will be conducted to differentiate between the effect of acupressure and kinesiotape on low back pain in women who use intrauterine device.
Read the detailed description
Overall, the Egypt Demographic and Health Survey (EDHS) results indicate that 60% of currently married women in Egypt are using contraception. The IUD, pill, and injectable are the most widely used methods: 36% of currently married women interviewed for the Egypt Demographic and Health Survey (EDHS) use the IUD, 12% rely on the pill, and 7% utilize injectable.
IUD insertion possess numerous complications which includes low back pain, cervical problems, syncope, bradycardia, convulsions, perforation, expulsion, frequent bleeding , all affecting the quality of life of women.
Analgesia has been used by many patients for relieving their low back pain symptoms. Unfortunately, despite of its fast relieving effects, analgesics can cause side effects as heartburn, indigestion, nausea, vomiting, constipation, diarrhea, headaches, dizziness, drowsiness, stomach ulcers and liver damage. This draws the necessity to consider the use of physical therapy modalities for the treatment of low back pain like active exercises, various elecyrotherapy modalities with the emphasis on the use of acupressure and Kinesotape.
Numerous studies have addressed the effect of acupressure on LBP. A previous study showed that acupressure could reduce postpartum LBP intensity. Also, it was reported that applying pressure on specific acupoints reduced LBP among nurses.
Also, previous studies have shown that KT improves blood and lymph circulation, mitigates pain, adjusts joints, and relives muscle tension. Previous research examined the effects of Kinesiotaping on LBP associated with pregnancy and showed that the intensity of LBP was lower in the group of the Kinesiotape and paracetamol than in the group that took paracetamol alone.
Till now there is no previous study differentiate between the effect of kinesiotape and acupressure in the management of low back pain in women with intrauterine device. So, the study will be conducted to determine which of them is more effective on relieving intrauterine device related low back pain which will be of valuable benefits and increased body of knowledge of physical therapists in scientific field.
- Conditions
- Low Back Pain
- Being tested
- Acupressure therapy, kinesio tape, Non-steroidal anti-inflammatory drugs
- 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.
Acupressure therapyOther
It will be applied to the first experimental group, three times per week for 3 weeks, with each session lasting 30 minutes. Each woman will receive a brief explanation about acupressure therapy and its effects to ensure her confidence and cooperation. Before starting, participants will be asked to empty their bladder for relaxation and assume a prone position. The therapy involves applying prolonged, slow, firm pressure with both thumbs on five key points (BL20, GV3, GB30, GB34, and BL25), which are commonly used for low back pain. Each point will receive three cycles of one-minute pressure followed by one minute of relaxation.
kinesio tapeOther
It will be applied to the second experimental group, for 3 weeks. The tape, 5cm wide and 0.5mm thick, will be fixed in a standing lumbar flexion position on clean, grease-free skin. Four I-shaped bands, each 0.5mm in width, will be applied. The first 5cm of tape will be carefully placed on the skin without stretching, while the middle portion will be stretched 1-2 inches (50%). Two bands will be applied horizontally, and two more will be placed vertically along the lumbar spine, from the lower iliac crest to the upper twelfth rib. The tape will be rubbed to warm the adhesive, ensuring proper adhesion. It will be replaced every 3 days for 3 weeks.
Non-steroidal anti-inflammatory drugsDrug
Also called Ibuprofen
All the three groups will receive 400mg of Non-steroidal Anti-Inflammatory Drugs (Ibuprofen) once a day on the treatment days two hours before the session.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure therapy + Non-steroidal anti-inflammatory drugs | Experimental | Twenty four females will receive acupressure therapy (3 times per week, for 3 weeks), in addition to Non-steroidal anti-inflammatory drugs (25-50mg/daily). Receives: Other: Acupressure therapy; Drug: Non-steroidal anti-inflammatory drugs |
| kinesio tape + Non-steroidal anti-inflammatory drugs | Experimental | Twenty four females will receive kinesio tape (3 times per week, for 3 weeks), in addition to Non-steroidal anti-inflammatory drugs (25-50mg/daily). Receives: Other: kinesio tape; Drug: Non-steroidal anti-inflammatory drugs |
| Non-steroidal anti-inflammatory drugs | Other | Twenty four females will receive only Non-steroidal anti-inflammatory drugs (25-50mg/daily). Receives: Drug: Non-steroidal anti-inflammatory drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain intensity
The visual analog scale (VAS) will be used to assess pain intensity for all participating females in the three groups before and after the study program. It is a horizontal line whose length is 10 cm; its left end (zero) indicates no pain, while its right end (ten) reveals the worst imaginable pain. Each female will be asked to mark a point on the line between the extreme that is related to her pain intensity level.
Measured: 3 weeks
Assessment of pain pressure threshold
A pressure algometer will be used to measure pressure pain thresholds (PPT) for all participants in the three groups before and after the study. PPTs will be assessed at specific marked points on the body. All participants will be instructed to take non-steroidal anti-inflammatory drugs at least 4 hours before the procedure. Two measurements will be taken for the dominant forearm extensor muscle to ensure proper understanding, with a third if needed. Alcohol will clean the evaluation areas. A 1-cm² pressure probe will be used to record PPTs at five marked sites on the lumbar region (L1-S2), with three measurements per site and a 60-second interval between tests. The patient will be in a lateral decubitus position, reporting pain onset, and the mean value will be recorded.
Measured: 3 weeks
Secondary outcomes (1)
Assessment of functional disability
The Arabic version of the Oswestry Disability Index (ODI) will be used to assess functional disability in females in all three groups before and after the study. The ODI consists of ten sections, each with six response options describing functional impairments in daily activities. Scores range from 0 to 5, with the highest score taken if multiple boxes are marked. The total score is calculated by dividing the sum of the scores by the total possible score, multiplied by 100 to get a percentage. If a section is missed, the score is adjusted accordingly. A low score indicates low disability, while a high score indicates a higher degree of disability.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start25 Mar 2025 (estimated)
- Primary completion10 May 2025 (estimated)
- Study completion31 May 2025 (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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Abd Elaziz Mansour, Cairo University
- Investigators
- Hala Mohamed Hanfy Omaera, PhD, Study chair, Professor, Cairo universityHossam El Deen Kamel, PhD, Study director, Professor, Al-Azhar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891976
- Sponsor's protocol ID
- P.T.REC/012/005281
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupressure Versus Kinesotape on Low Back Pain in Women Who Use Intrauterine Device
- ClinicalTrials.gov ID
- NCT06891976
- Acronym / sponsor ID
- P.T.REC/012/005281
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (estimated)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 24 Mar 2025 (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 study will be conducted to differentiate between the effect of acupressure and kinesiotape on low back pain in women who use intrauterine device.
Detailed description
Overall, the Egypt Demographic and Health Survey (EDHS) results indicate that 60% of currently married women in Egypt are using contraception. The IUD, pill, and injectable are the most widely used methods: 36% of currently married women interviewed for the Egypt Demographic and Health Survey (EDHS) use the IUD, 12% rely on the pill, and 7% utilize injectable.
IUD insertion possess numerous complications which includes low back pain, cervical problems, syncope, bradycardia, convulsions, perforation, expulsion, frequent bleeding , all affecting the quality of life of women.
Analgesia has been used by many patients for relieving their low back pain symptoms. Unfortunately, despite of its fast relieving effects, analgesics can cause side effects as heartburn, indigestion, nausea, vomiting, constipation, diarrhea, headaches, dizziness, drowsiness, stomach ulcers and liver damage. This draws the necessity to consider the use of physical therapy modalities for the treatment of low back pain like active exercises, various elecyrotherapy modalities with the emphasis on the use of acupressure and Kinesotape.
Numerous studies have addressed the effect of acupressure on LBP. A previous study showed that acupressure could reduce postpartum LBP intensity. Also, it was reported that applying pressure on specific acupoints reduced LBP among nurses.
Also, previous studies have shown that KT improves blood and lymph circulation, mitigates pain, adjusts joints, and relives muscle tension. Previous research examined the effects of Kinesiotaping on LBP associated with pregnancy and showed that the intensity of LBP was lower in the group of the Kinesiotape and paracetamol than in the group that took paracetamol alone.
Till now there is no previous study differentiate between the effect of kinesiotape and acupressure in the management of low back pain in women with intrauterine device. So, the study will be conducted to determine which of them is more effective on relieving intrauterine device related low back pain which will be of valuable benefits and increased body of knowledge of physical therapists in scientific field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupressure therapy + Non-steroidal anti-inflammatory drugs | Experimental | Other: Acupressure therapy, Drug: Non-steroidal anti-inflammatory drugsTwenty four females will receive acupressure therapy (3 times per week, for 3 weeks), in addition to Non-steroidal anti-inflammatory drugs (25-50mg/daily). |
| kinesio tape + Non-steroidal anti-inflammatory drugs | Experimental | Other: kinesio tape, Drug: Non-steroidal anti-inflammatory drugsTwenty four females will receive kinesio tape (3 times per week, for 3 weeks), in addition to Non-steroidal anti-inflammatory drugs (25-50mg/daily). |
| Non-steroidal anti-inflammatory drugs | Other | Drug: Non-steroidal anti-inflammatory drugsTwenty four females will receive only Non-steroidal anti-inflammatory drugs (25-50mg/daily). |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Females suffer from low back pain resulted from intrauterine device use, they are referred by the gynecologist.
- Their pain level will be> 4 on the visual analogue scale (VAS).
- Their ages will be ranged from 25 to 30 years.
- Their BMI will be less than 30 kg /m2
- Women diagnosed with low back pain upon recent insertion of intrauterine device (within a year)
Key exclusion criteria (4 listed)
- Current pelvic infection, usually pelvic inflammatory disease (PID), mucopurulent cervicitis with a suspected STI, pelvic tuberculosis, septic abortion, or puerperal endometritis or sepsis within the past 3 months
- Unexplained vaginal bleeding
- Patients having skin disease or known allergy to kinesio tape
- Having LBP due to trauma, spondylolisthesis, ankylosing spondylitis, fibromyalgia, diabetes mellitus or due to any gynecological problems that may cause LBP like polycystic ovarian syndrome (PCO), endometriosis, adenomyosis, cervicitis, uterine prolapse etc.
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 |
|---|---|---|
| Acupressure therapyIt will be applied to the first experimental group, three times per week for 3 weeks, with each session lasting 30 minutes. Each woman will receive a brief explanation about acupressure therapy and its effects to ensure her confidence and cooperation. Before starting, participants will be asked to empty their bladder for relaxation and assume a prone position. The therapy involves applying prolonged, slow, firm pressure with both thumbs on five key points (BL20, GV3, GB30, GB34, and BL25), which are commonly used for low back pain. Each point will receive three cycles of one-minute pressure followed by one minute of relaxation. | Other | Acupressure therapy + Non-steroidal anti-inflammatory drugs |
| kinesio tapeIt will be applied to the second experimental group, for 3 weeks. The tape, 5cm wide and 0.5mm thick, will be fixed in a standing lumbar flexion position on clean, grease-free skin. Four I-shaped bands, each 0.5mm in width, will be applied. The first 5cm of tape will be carefully placed on the skin without stretching, while the middle portion will be stretched 1-2 inches (50%). Two bands will be applied horizontally, and two more will be placed vertically along the lumbar spine, from the lower iliac crest to the upper twelfth rib. The tape will be rubbed to warm the adhesive, ensuring proper adhesion. It will be replaced every 3 days for 3 weeks. | Other | kinesio tape + Non-steroidal anti-inflammatory drugs |
| Non-steroidal anti-inflammatory drugsAlso: IbuprofenAll the three groups will receive 400mg of Non-steroidal Anti-Inflammatory Drugs (Ibuprofen) once a day on the treatment days two hours before the session. | Drug | Acupressure therapy + Non-steroidal anti-inflammatory drugs, Non-steroidal anti-inflammatory drugs, kinesio tape + Non-steroidal anti-inflammatory drugs |
Primary outcome
Assessment of pain intensity
Time frame: 3 weeks
The visual analog scale (VAS) will be used to assess pain intensity for all participating females in the three groups before and after the study program. It is a horizontal line whose length is 10 cm; its left end (zero) indicates no pain, while its right end (ten) reveals the worst imaginable pain. Each female will be asked to mark a point on the line between the extreme that is related to her pain intensity level.
Assessment of pain pressure threshold
Time frame: 3 weeks
A pressure algometer will be used to measure pressure pain thresholds (PPT) for all participants in the three groups before and after the study. PPTs will be assessed at specific marked points on the body. All participants will be instructed to take non-steroidal anti-inflammatory drugs at least 4 hours before the procedure. Two measurements will be taken for the dominant forearm extensor muscle to ensure proper understanding, with a third if needed. Alcohol will clean the evaluation areas. A 1-cm² pressure probe will be used to record PPTs at five marked sites on the lumbar region (L1-S2), with three measurements per site and a 60-second interval between tests. The patient will be in a lateral decubitus position, reporting pain onset, and the mean value will be recorded.
1 secondary outcome
Assessment of functional disability
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
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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.
Manal Ahmed El-Shafei, PhD contact
Hala Mohamed Hanfy Omaera, PhD study chair
Professor, Cairo university
Hossam El Deen Kamel, PhD study director
Professor, Al-Azhar 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 Acupressure therapy, kinesio tape and Non-steroidal anti-inflammatory drugs 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 24 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana Abd Elaziz Mansour, B.Sc (+20 11 18886786, dana.aziz1992@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain intensity (time frame: 3 weeks). 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 24 Mar 2025.