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NCT Number: NCT06771310

Effect of Kinesiotaping Versus Endurance Exercise on Postmenopausal Low Back Pain

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

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Key information

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Non-specific back pain is more frequent in women than men, mainly in postmenopausal women. High prevalence of hypovitaminosis D has been detected in postmenopausal women, and it is associated with decreased bone mass, sarcopenia, which can be related to back pain.

Postural control, can be defined as "the ability to maintain the body's center of gravity within the limits of stability as determined by the base of support , Differences in motor behavior between Low Back Pain (LBP) patients and healthy control subjects have been demonstrated in a variety of tasks, e.g. during walking and in response to several perturbations.

Published evidence indicates that LBP patients may have impaired control over trunk posture and movement, Dynamic controls is important in many functional tasks as it requires integration of appropriate levels of proprioception, range of motion, and strength. Endurance exercise is characterized by continues submaximal muscular contractions . It is an effective mean of maintaining or improving cardiovascular and musculoskeletal health, both of which are critical for preserving physiological functioning, independence and improving standing balance.

kinesiotape allows the joint to move through its full range of motion. It has also been reported to increase blood circulation and lymphatic drainage, which leads to a reduction of pain and stimulates large-fibre cutaneous mechanoreceptors that may inhibit proprioceptive impulses in the spinal column and decrease pain via an ascending pathway.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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) .

Treatment and study plan

Endurance Exercise

Other

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.

Kinesiotaping

Other

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.

Primary outcomes

  1. Pain level assessment:

    Time frame: 3 months

    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.

Secondary outcomes

  1. Timed "Up and Go"Test (TUGT):

    Time frame: 3 months

    It will be used to evaluate postural balance for all participants in both groups before and after end of the treatment. it will be used to determine how many seconds the individual takes to perform the task of rising from a standard chair (seat approximately 46cm and arms 65cm high), walking 3 meters, turning around, returning to and sitting back on the chair. The participants will be instructed to perform at their usual speed and not enter into dialogues, They should have their usual footwear and if necessary a cane. Ten seconds to run the test was considered as a normal healthy adult performance; a period of 20 seconds is considered normal for frail elderly or disabled; however, a period above 20 seconds indicates the need to observe the level of functional impairment of the subject.

  2. Unipodal stance test

    Time frame: 3 months

    It is a simple and good predictor of falls to evaluate the performance of the individual instructed to remain in single leg stance on each leg with eyes open or closed.

    The test starts with the legs parallel, maintaining a base of 10 cm away from the midline of each calcaneus, with the upper limbs hanging along the body. The subject is instructed to fix his gaze on a point that is at eye level and at a distance of one meter. Then, the examiner instructs the subject to take one foot from the ground, performing a hip flexion, and records the time during which the individual remains in position. The stay-in-position for more than 30 seconds indicates low risk of falling, whereas a time shorter than 5 sec shows a high risk of falls

  3. Evaluation of core endurance

    Time frame: 3 months

    McGill's Core endurance tests will be used to evaluate core endurance for all participants in both groups before and after the end of the treatment. For the trunk anterior flexor test, participants sit with their backs flat against a wooden wedge angled at 60° with hands across their chest and their knees both flexed to a 90-degree angle as determined by a goniometer (Time recording is started when the wedge is moved back 10 cm and stopped when the trunk is deviated either forward or backward from the 60° angle

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa Gaballah, Master

CONTACT

[email protected]

01091864117

Elham Shahat, PHD

CONTACT

[email protected]

+201206146539

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Kinesiotaping Versus Endurance Exercise on Postmenopausal Non Specific Low Back Pain

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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