Kasr Al Ainy Hospital
Giza, Egypt
NCT Number: NCT06891976
The study will be conducted to differentiate between the effect of acupressure and kinesiotape on low back pain in women who use intrauterine device.
Trial opening soon.
Get Notified25 year–30 year
Female
Interventional
Not applicable
Giza, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Other names: Ibuprofen
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.
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.
Time frame: 3 weeks
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.
Contact information is provided by the study sponsor or research team.
Dana Abd Elaziz Mansour, B.Sc
CONTACT
Manal Ahmed El-Shafei, PhD
CONTACT
Cairo University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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