Low Back PainNCT04762563
Effect of Treatment on Connective Tissue in Low Back Pain
A study testing IASTM application and Kinesio Tape® Tex Gold) in people with Low Back Pain and Connective Tissue Defect (Diagnosis), run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is to investigate the effects of instrument assisted soft tissue mobilization (IASTM) and kinesiology taping (KT) that are additional treatment to the conservative treatment for the lumbar region and hamstrings and connective tissue thickness in patients with chronic non-specific low back pain… Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Low Back Pain, Connective Tissue Defect (Diagnosis)
- What is being tested?
- IASTM application and Kinesio Tape® Tex Gold)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 27 Aug 2021
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- between the ages of 30 and 50
- who had low back pain for at least 12 weeks,
- received no physical therapy in the last 6 months,
- received no IASTM or chemotherapy,
- had normal movement of the hip joint
- Visual Analog Scale value above 3
Who cannot join
- the presence of allergy and skin diseases,
- pregnancy,
- major structural spinal deformity (scoliosis, kyphosis, stenosis),
- inflammatory disease,
- presence of extruded and sequestered herniation, -signs of neurological disease, -
- presence of orthopedic diseases such as fracture
- a history of spinal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Instrument Assisted Soft Tissue Mobilization and Kinesiology Taping on Connective Tissue Thickness in Patients With Chronic Low Back Pain
The purpose of the study is to investigate the effects of instrument assisted soft tissue mobilization (IASTM) and kinesiology taping (KT) that are additional treatment to the conservative treatment for the lumbar region and hamstrings and connective tissue thickness in patients with chronic non-specific low back pain (CNSLBP).
- Being tested
- IASTM application, Kinesio Tape® Tex Gold)
- Medical subject headings
- Low Back Pain, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASTM applicationOther
IASTM application .
Kinesio Tape® Tex Gold)Other
Kinesio Tape® Tex Gold)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Study Group | Experimental | Patients in the IASTM group were asked to lie face down on a stretcher, exposing the entire lumbar region. IASTM was applied to all paraspinal muscles for a total of 5 minutes after massage cream was applied. Immediately afterwards, the same application was performed for the right and left hamstring muscles from the gluteal line to the bottom of the popliteal fossa for 3 minutes after massage cream was applied. IASTM application was performed vertically, horizontally and diagonally using instruments of different sizes and shapes at an angle of 45 degrees to the skin surface. Receives: Other: IASTM application |
| Active Comparator | Active comparator | KT application (Kinesio Tape® Tex Gold) was performed using the "muscle technique". In lumbar region application, while the patient was standing, the tape was cut as a Y-strip with a base of 5 cm. Receives: Other: Kinesio Tape® Tex Gold) |
What is being measured
The primary outcome is the main question the study is designed to answer.
straight leg test
Straight leg raise (SLR) was used to determine hamstring shortness. For SLR application, while the patient was lying on the back, the leg was lifted by the researcher to the level where the pain began, and the flexion angle in the hip was recorded
Measured: 4 weeks
sit and reach test
The sit and reach test (SRT) to measure the flexibility.During SRT application, the distance between the middle fingers of the hands and the feet was recorded while the patient was in the long sitting position in the bed and reached the toes with their hands without bending the knees
Measured: 4 weeks
Modified Schober test
Modified Schober Test and finger-ground distance evaluation for the spinal mobility assessment. For the Modified Schober Test, after marking 5 cm below and 10 cm above the spinous process of the lumbar vertebra while the patient was standing, the patient was asked to bend forward without bending the knees, and the change in the same range was recorded
Measured: 4 weeks
finger-ground distance measurement
While measuring "finger-ground distance", the patient was asked to touch the ground with both hands while standing with the knees in extension. The distance between the fingertip and the ground was recorded
Measured: 4 weeks
Ultrasonography
In this study, Siemens Acuson S 3000 device and Siemens HD 10 MHz linear probe were used for subcutaneous and perimuscular zone measurements.2 cm lateral to the midpoint of the L2-3 interspinous ligament is the area where the fascia planes are most parallel to the skin. In this study, the probe was centered at this point, which was determined while the patient was lying face down on the stretcher, and measurements were made from the right and left. For the measurement location in the hamstring region, the point where the fascia planes were most parallel to the skin was determined, as in the lumbar region. Measurement was performed in the area where the zones were most clearly seen lateral to the popliteal fossa.
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 posted21 Feb 2021
- Study start1 Mar 2021
- Primary completion27 Aug 2021
- Study completion27 Aug 2021
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.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Park Hospital Istanbul
- Responsible party
- Principal investigator, Emine Atıcı, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762563
- Sponsor's protocol ID
- 003
- Status last verified
- Jul 2024
- First submitted
- 12 Feb 2021
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Instrument Assisted Soft Tissue Mobilization and Kinesiology Taping on Connective Tissue Thickness in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04762563
- Acronym / sponsor ID
- 003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Medical Park Hospital Istanbul
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 21 Feb 2021 (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.
The purpose of the study is to investigate the effects of instrument assisted soft tissue mobilization (IASTM) and kinesiology taping (KT) that are additional treatment to the conservative treatment for the lumbar region and hamstrings and connective tissue thickness in patients with chronic non-specific low back pain (CNSLBP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Study Group | Experimental | Other: IASTM applicationPatients in the IASTM group were asked to lie face down on a stretcher, exposing the entire lumbar region. IASTM was applied to all paraspinal muscles for a total of 5 minutes after massage cream was applied. Immediately afterwards, the same application was performed for the right and left hamstring muscles from the gluteal line to the bottom of the popliteal fossa for 3 minutes after massage cream was applied. IASTM application was performed vertically, horizontally and diagonally using instruments of different sizes and shapes at an angle of 45 degrees to the skin surface. |
| Active Comparator | Active comparator | Other: Kinesio Tape® Tex Gold)KT application (Kinesio Tape® Tex Gold) was performed using the "muscle technique". In lumbar region application, while the patient was standing, the tape was cut as a Y-strip with a base of 5 cm. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- between the ages of 30 and 50
- who had low back pain for at least 12 weeks,
- received no physical therapy in the last 6 months,
- received no IASTM or chemotherapy,
- had normal movement of the hip joint
Key exclusion criteria (7 listed)
- the presence of allergy and skin diseases,
- pregnancy,
- major structural spinal deformity (scoliosis, kyphosis, stenosis),
- inflammatory disease,
- presence of extruded and sequestered herniation, -signs of neurological disease, -
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 |
|---|---|---|
| IASTM applicationIASTM application . | Other | Experimental: Study Group |
| Kinesio Tape® Tex Gold)Kinesio Tape® Tex Gold) | Other | Active Comparator |
Primary outcome
straight leg test
Time frame: 4 weeks
Straight leg raise (SLR) was used to determine hamstring shortness. For SLR application, while the patient was lying on the back, the leg was lifted by the researcher to the level where the pain began, and the flexion angle in the hip was recorded
sit and reach test
Time frame: 4 weeks
The sit and reach test (SRT) to measure the flexibility.During SRT application, the distance between the middle fingers of the hands and the feet was recorded while the patient was in the long sitting position in the bed and reached the toes with their hands without bending the knees
Modified Schober test
Time frame: 4 weeks
Modified Schober Test and finger-ground distance evaluation for the spinal mobility assessment. For the Modified Schober Test, after marking 5 cm below and 10 cm above the spinous process of the lumbar vertebra while the patient was standing, the patient was asked to bend forward without bending the knees, and the change in the same range was recorded
finger-ground distance measurement
Time frame: 4 weeks
While measuring "finger-ground distance", the patient was asked to touch the ground with both hands while standing with the knees in extension. The distance between the fingertip and the ground was recorded
Ultrasonography
Time frame: 4 weeks
In this study, Siemens Acuson S 3000 device and Siemens HD 10 MHz linear probe were used for subcutaneous and perimuscular zone measurements.2 cm lateral to the midpoint of the L2-3 interspinous ligament is the area where the fascia planes are most parallel to the skin. In this study, the probe was centered at this point, which was determined while the patient was lying face down on the stretcher, and measurements were made from the right and left. For the measurement location in the hamstring region, the point where the fascia planes were most parallel to the skin was determined, as in the lumbar region. Measurement was performed in the area where the zones were most clearly seen lateral to the popliteal fossa.
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 1 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IASTM application and Kinesio Tape® Tex Gold) in people with Low Back Pain and Connective Tissue Defect (Diagnosis), run by Okan University at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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 1 Aug 2024. 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 Turkey (Türkiye). 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?
straight leg test (time frame: 4 weeks). The study lists 5 primary outcomes in all. 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 1 Aug 2024.