Effect of Acupressure Versus Kinesotape on Low Back Pain in Women Who Use Intrauterine Device

NCT ID: NCT06891976

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2025-05-31

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acupressure therapy + Non-steroidal anti-inflammatory drugs

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).

Group Type: EXPERIMENTAL

Acupressure therapy

Intervention Type: OTHER

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.

Non-steroidal anti-inflammatory drugs

Intervention Type: DRUG

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.

kinesio tape + Non-steroidal anti-inflammatory drugs

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).

Group Type: EXPERIMENTAL

kinesio tape

Intervention Type: OTHER

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 drugs

Intervention Type: DRUG

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.

Non-steroidal anti-inflammatory drugs

Twenty four females will receive only Non-steroidal anti-inflammatory drugs (25-50mg/daily).

Group Type: OTHER

Non-steroidal anti-inflammatory drugs

Intervention Type: DRUG

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.

Interventions

Acupressure therapy

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.

Intervention Type: OTHER

kinesio tape

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.

Intervention Type: OTHER

Non-steroidal anti-inflammatory drugs

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.

Intervention Type: DRUG

Other Intervention Names

Ibuprofen

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Dana Abd Elaziz Mansour

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala Mohamed Hanfy Omaera, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Hossam El Deen Kamel, PhD

Role: STUDY_DIRECTOR

Professor, Al-Azhar university

Locations

Kasr Al Ainy Hospital

Giza, , Egypt

Countries

Egypt

Central Contacts

Dana Abd Elaziz Mansour, B.Sc

Role: CONTACT

dana.aziz1992@gmail.com

+20 11 18886786

Manal Ahmed El-Shafei, PhD

Role: CONTACT

Facility Contacts

Dana Abd Elaziz Mansour, B.Sc

Role: primary

dana.aziz1992@gmail.com

+20 11 18886786

Other Identifiers

P.T.REC/012/005281

Identifier Type: -

Identifier Source: org_study_id