NCT06771310

Brief Summary

This study will be conducted to determine the effect of kinesiotaping versus endurance exercise on postmenopausal low back pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2024

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

January 16, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

February 10, 2024

Last Update Submit

January 10, 2025

Conditions

Keywords

KinesiotapeEndurance exercisePostmenopausalLow back pain.

Outcome Measures

Primary Outcomes (1)

  • Pain level assessment:

    Assessment of pain level for all participants will be measured before and after the treatment program by using the visual analogue scale (VAS) which is valid and reliable measure for pain intensity. It is a 10 cm horizontal line with two ends, 0 at one end which means no pain and 10 at the other end which means worst pain.

    3 months

Secondary Outcomes (3)

  • Timed "Up and Go"Test (TUGT):

    3 months

  • Unipodal stance test

    3 months

  • Evaluation of core endurance

    3 months

Study Arms (2)

Endurance exercise group

EXPERIMENTAL

The participants will perform endurance exercise (three times per week for 12 weeks

Other: Endurance exercise

Kinesiotaping group

EXPERIMENTAL

The participants will receive kinesiotaping (replaced every five days) for 12 weeks.

Other: Kinesiotaping

Interventions

The exercise-training program will be consisted of 10 minutes warming up, 30 minutes of treadmill walking, and 10 min cooling down three times per week. Warming up: It will be in the form of stretching of muscle groups for 10 minutes (3-5 stretch for the key muscle group (iliopsoas muscle, gluteus maximus ,quadriceps ,tibialis anterior , calf muscle, hold for 20-30 seconds), before the actual aerobic training session. Actual session: Participants will receive aerobic exercises in the form of Moderate aerobic exercise training in the form of 30 min of treadmill walking and corresponding to a target heart rate of 65% to 75% of HR max (Maximum HR = 220 - Age ) to be gradually achieved and maintained throughout the training program. Cooling down: It will be in the form of a treadmill walking at very slow speed for ten minutes.

Endurance exercise group

The participants will be asked to assume standing position then to flex back to reach its maximum point. * Two bands, 1 on each side of the lumbar spine, will be applied vertically from the lower posterior iliac crest region to the upper twelfth rib region, with inhibition technique. * The remaining 2 bands will be attached horizontally, with space correction technique. * All 4 bands will be placed to allow for 50% longitudinal stretching. The stretching directions for the vertical and horizontal applications were bottom-up and sideways, respectively.

Kinesiotaping group

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A convenient sample of fifty postmenopausal women suffering from non-specific low back pain and postural instability was enrolled in this study.
  • Praticipants were chosen healthy and medically stable.
  • Their ages ranged from 50 - 60 years to be included in the study.
  • Their body mass index (BMI) is not exceed 35 kg m2.
  • All of them are diagnosed by the gynecologist.

You may not qualify if:

  • They were excluded from the study if they had:
  • Premature menopause or surgical menopause.
  • Mental , neurological , vestibular , cardiovascular disorders, metabolic disease. -----
  • Musculoskeletal disorders ( disc lesion , ankylosing spondylitis , rheumatoid arthritis , osteomalacia , spinal deformities, lumber vertebre fractures) .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asmaa Mohamed Gaballah

Giza, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hossam Hussien, Professor

    Al-Azhar University

    STUDY DIRECTOR
  • Soheir El-kosery, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Asmaa Gaballah, Master

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

February 10, 2024

First Posted

January 13, 2025

Study Start

January 16, 2025

Primary Completion

May 1, 2025

Study Completion

May 15, 2025

Last Updated

January 13, 2025

Record last verified: 2025-01

Locations