Low Back PainNCT06640543
Effect of Kinesiotape Versus Myofascial Release on Postnatal Low Back Pain
A study testing Kinesiotape and Myofascial release in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to determine the difference between the effect of kinesiotape and myofascial release in the treatment of postnatal low back pain. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Kinesiotape and Myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Their ages will be ranged from 20 to 35 years old.
- Their body mass index (BMI) will not exceed 30 kg/m2.
- Women will be postnatal period by 6-8 weeks.
- All women will be diagnosed by the physician as postnatal low back pain.
Who cannot join
- Spinal fracture or any other neurological disorders.
- Lumbar disc herniation or degenerative disc disease
- Lumbar spinal stenosis from lumbar disc herniation, degenerative joint disease, or spondylolisthesis
- Women with BMI exceed 30 kg/m2.
- Patients who have polyneuropathy or other neurological disorders.
- Skin disease interferes with kinesiotape or myofascial release application.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Kinesiotape Versus Myofascial Release on Postnatal Low Back Pain: a Randomised Controlled Trial
This study aims to determine the difference between the effect of kinesiotape and myofascial release in the treatment of postnatal low back pain.
Read the detailed description
Postpartum back pain may occur in up to 44% of women after childbirth. People who have chronic back pain may have a limited range of motion and/or tenderness upon touch.
Therapeutic KT can benefit a wide variety of musculoskeletal and sports injuries, plus inflammatory conditions. According to the Kinesiotape Method Manual, this traction promotes an elevation of the epidermis and reduces pressure on the mechanoreceptors located below the dermis, thereby reducing nociceptive stimuli and low back pain.
Myofascial release (MFR) is a treatment that uses gentle pressure and stretching to facilitate the release of fascial restrictions caused by accidents, injury, stress, repetitive use, and traumatic or surgical scarring.
Myofascial release is a form of soft tissue therapy used to treat somatic dysfunction and accompanying pain and restriction of motion. This is accomplished by relaxing the contracted muscle, increasing circulation, increasing venous and lymphatic drainage, and stimulating the stretch reflex of muscles and overlying fascia so, reducing low back pain.
- Conditions
- Low Back Pain
- Being tested
- Kinesiotape, Myofascial release
- 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.
KinesiotapeOther
Postnatal women with low back pain will be treated with kinesiotape, three times per week for 4 weeks
Myofascial releaseOther
Postnatal women with low back pain will be treated with myofascial release for 25 minutes three times per week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| kinesiotape group | Experimental | The participants will be treated with kinesiotape for 4 weeks Receives: Other: Kinesiotape |
| myofascial release group | Experimental | The participants will be treated with myofascial release for 4 weeks Receives: Other: Myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity level
The intensity of postnatal low back pain will be assessed using a visual analogue scale (VAS) for all participants in both groups before and after treatment, which is a method of representing subjects' pain on a 10 cm linear scale. A score of 0 means " no pain" and 10 means " very high degree of pain
Measured: 4 weeks
Secondary outcomes (3)
Lumbar flexion range of motion
The modified Schober test will be used to measure the lumbar flexion range of motion (ROM) by using the tape measurement. Each participant will be asked to stand erect with her feet about shoulder-width apart to stabilize the pelvis. Then, the posterior superior iliac spines(PSIS) will be determined by the therapist's both thumbs, and then an ink line will be drawn along the midline of the lumbar spines horizontal to the PSIS to mark the midpoint between the two PSIS. Then tape will be used to identify and mark two points: one is 10 cm superior to the midpoint (A), and another is 5 cm inferior to the midpoint (B). The participant will be instructed to bend forward as much as she can while keeping both knees straight, the new distance between superior and inferior skin marking will be measured in centimeters. The increased distance along the tape due to lumbar flexion is normally about 6-7 cm (less than 5 cm should be considered abnormal).
Measured: 4 weeks
Lumbar extension range of motion
The modified Schober test will be used to measure the lumbar extension range of motion (ROM) by using the tape measurement while the patient is in a standing position. The participant will be instructed to put her hands on her buttocks and bend backward into full lumbar extension and the new distance between the superior and inferior skin markings will be measured in centimeters by the tape measurement. The change in the difference between the marks is used to indicate the amount of lumbar extension. The increased distance along the tape due to the extension of the lumbar spine is normally about 2-3 cm (less than 1cm should be considered abnormal).
Measured: 4 weeks
Lumbar lateral flexion range of motion
The participant will be asked to stand erect with her feet about shoulder-width apart. Both right and left lateral flexion will be measured by the tape as the distance from the tip of the index finger to the floor at maximal comfortable lateral flexion. The participant will be instructed to bend her trunk laterally as much as she can. The normal value of lateral spinal flexion is 16.2-28.0 cm.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 Oct 2024
- Primary completion20 Jan 2025
- Study completion30 Jan 2025
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Mahmoud Ahmed, Cairo University
- Investigators
- Afaf M Botla, Professor, Study director, Cairo UniversityMohamed Awad, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640543
- Sponsor's protocol ID
- P.T.REC/012/004348
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesiotape Versus Myofascial Release on Postnatal Low Back Pain: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06640543
- Acronym / sponsor ID
- P.T.REC/012/004348
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 15 Oct 2024 (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 aims to determine the difference between the effect of kinesiotape and myofascial release in the treatment of postnatal low back pain.
Detailed description
Postpartum back pain may occur in up to 44% of women after childbirth. People who have chronic back pain may have a limited range of motion and/or tenderness upon touch.
Therapeutic KT can benefit a wide variety of musculoskeletal and sports injuries, plus inflammatory conditions. According to the Kinesiotape Method Manual, this traction promotes an elevation of the epidermis and reduces pressure on the mechanoreceptors located below the dermis, thereby reducing nociceptive stimuli and low back pain.
Myofascial release (MFR) is a treatment that uses gentle pressure and stretching to facilitate the release of fascial restrictions caused by accidents, injury, stress, repetitive use, and traumatic or surgical scarring.
Myofascial release is a form of soft tissue therapy used to treat somatic dysfunction and accompanying pain and restriction of motion. This is accomplished by relaxing the contracted muscle, increasing circulation, increasing venous and lymphatic drainage, and stimulating the stretch reflex of muscles and overlying fascia so, reducing low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| kinesiotape group | Experimental | Other: KinesiotapeThe participants will be treated with kinesiotape for 4 weeks |
| myofascial release group | Experimental | Other: Myofascial releaseThe participants will be treated with myofascial release for 4 weeks |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Their ages will be ranged from 20 to 35 years old.
- Their body mass index (BMI) will not exceed 30 kg/m2.
- Women will be postnatal period by 6-8 weeks.
- All women will be diagnosed by the physician as postnatal low back pain.
Key exclusion criteria (6 listed)
- Spinal fracture or any other neurological disorders.
- Lumbar disc herniation or degenerative disc disease
- Lumbar spinal stenosis from lumbar disc herniation, degenerative joint disease, or spondylolisthesis
- Women with BMI exceed 30 kg/m2.
- Patients who have polyneuropathy or other neurological disorders.
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 |
|---|---|---|
| KinesiotapePostnatal women with low back pain will be treated with kinesiotape, three times per week for 4 weeks | Other | kinesiotape group |
| Myofascial releasePostnatal women with low back pain will be treated with myofascial release for 25 minutes three times per week for 4 weeks | Other | myofascial release group |
Primary outcome
Pain intensity level
Time frame: 4 weeks
The intensity of postnatal low back pain will be assessed using a visual analogue scale (VAS) for all participants in both groups before and after treatment, which is a method of representing subjects' pain on a 10 cm linear scale. A score of 0 means " no pain" and 10 means " very high degree of pain
3 secondary outcomes
Lumbar flexion range of motion
Time frame: 4 weeks
Lumbar extension range of motion
Time frame: 4 weeks
Lumbar lateral flexion range of motion
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Afaf M Botla, Professor study director
Cairo University
Mohamed Awad, 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 Kinesiotape and Myofascial release 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 11 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity level (time frame: 4 weeks). 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 11 Feb 2025.