Low Back PainNCT06771310
Effect of Kinesiotaping Versus Endurance Exercise on Postmenopausal Low Back Pain
A study testing Endurance exercise and Kinesiotaping in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to determine the effect of kinesiotaping versus endurance exercise on postmenopausal low back pain. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Endurance exercise and Kinesiotaping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2025to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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) .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Asmaa Mohamed Gaballah
Giza
asmaa M. gaballah, Master, 01091864117, gaballa.asmaa@icloud.com
About this study
Official title: Effect of Kinesiotaping Versus Endurance Exercise on Postmenopausal Non Specific Low Back Pain
This study will be conducted to determine the effect of kinesiotaping versus endurance exercise on postmenopausal low back pain.
Read the detailed description
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.
- Conditions
- Low Back Pain
- Being tested
- Endurance exercise, Kinesiotaping
- Keywords
- Kinesiotape, Endurance exercise, Postmenopausal, Low back pain.
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance exerciseOther
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.
KinesiotapingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Endurance exercise group | Experimental | The participants will perform endurance exercise (three times per week for 12 weeks Receives: Other: Endurance exercise |
| Kinesiotaping group | Experimental | The participants will receive kinesiotaping (replaced every five days) for 12 weeks. Receives: Other: Kinesiotaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
Timed "Up and Go"Test (TUGT):
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.
Measured: 3 months
Unipodal stance test
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
Measured: 3 months
Evaluation of core endurance
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start16 Jan 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohamed Gaballah, Cairo University
- Investigators
- Hossam Hussien, Professor, Study director, Al-Azhar UniversitySoheir El-kosery, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771310
- Sponsor's protocol ID
- P.T.REC/012/002931
- Status last verified
- Jan 2025
- First submitted
- 10 Feb 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesiotaping Versus Endurance Exercise on Postmenopausal Non Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06771310
- Acronym / sponsor ID
- P.T.REC/012/002931
- Conditions
- Low Back Pain
- Keywords
- Kinesiotape, Endurance exercise, Postmenopausal, Low back pain.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Jan 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to determine the effect of kinesiotaping versus endurance exercise on postmenopausal low back pain.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endurance exercise group | Experimental | Other: Endurance exerciseThe participants will perform endurance exercise (three times per week for 12 weeks |
| Kinesiotaping group | Experimental | Other: KinesiotapingThe participants will receive kinesiotaping (replaced every five days) for 12 weeks. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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) .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurance exerciseThe 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. | Other | Endurance exercise group |
| KinesiotapingThe 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. | Other | Kinesiotaping group |
Primary outcome
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.
3 secondary outcomes
Timed "Up and Go"Test (TUGT):
Time frame: 3 months
Unipodal stance test
Time frame: 3 months
Evaluation of core endurance
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hossam Hussien, Professor study director
Al-Azhar University
Soheir El-kosery, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance exercise and Kinesiotaping in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Gaballah, Master (01091864117, gaballa.asmaa@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level assessment: (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.