Clinical trial NCT06891976: Effect of Acupressure Versus Kinesotape on Low Back Pain in Women Who Use Intrauterine Device
Official title: Effect of Acupressure Versus Kinesotape on Low Back Pain in Women Who Use Intrauterine Device
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 72
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assessment of pain intensity
timeFrame: 3 weeks
measure: Assessment of pain pressure threshold
timeFrame: 3 weeks
Secondary outcomes:
measure: Assessment of functional disability
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Kasr Al Ainy Hospital
Study officials:
affiliation: Professor, Cairo university
name: Hala Mohamed Hanfy Omaera, PhD
role: STUDY_CHAIR
affiliation: Professor, Al-Azhar university
name: Hossam El Deen Kamel, PhD
role: STUDY_DIRECTOR
References: