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

NCT06891976 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005281
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 weeks

Secondary Outcomes (1)

• Assessment of functional disability

  3 weeks

Study Arms (3)

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).

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).

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).

Drug: Non-steroidal anti-inflammatory drugs

Interventions

Acupressure therapy 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.

Acupressure therapy + Non-steroidal anti-inflammatory drugs

kinesio tape 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.

kinesio tape + Non-steroidal anti-inflammatory drugs

Non-steroidal anti-inflammatory drugs 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.

Also known as: Ibuprofen

Acupressure therapy + Non-steroidal anti-inflammatory drugs; Non-steroidal anti-inflammatory drugs; kinesio tape + Non-steroidal anti-inflammatory drugs

Eligibility Criteria

• Age: 25 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al Ainy Hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Acupressure; Athletic Tape; Ibuprofen

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Hala Mohamed Hanfy Omaera, PhD

  Professor, Cairo university

  STUDY CHAIR

• Hossam El Deen Kamel, PhD

  Professor, Al-Azhar university

  STUDY DIRECTOR

Central Study Contacts

Dana Abd Elaziz Mansour, B.Sc

CONTACT

+20 11 18886786; dana.aziz1992@gmail.com

Manal Ahmed El-Shafei, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: March 25, 2025
• Primary Completion: May 10, 2025
• Study Completion: May 31, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

EG (1)