Chronic Low-back PainNCT05173948
The Effectiveness of Kinesio Taping in Patients With Chronic Low Back Pain
A study testing Kinesio taping and Conventional physical therapy in people with Chronic Low-back Pain, run by University of Tabuk at 1 site in Saudi Arabia.
Trial summary
The objective of this study is to determine the effectiveness of Kinesio taping (KT) with Conventional Physical therapy (CPT) - Transcutaneous Electrical Nerve Stimulation (TENS) and Supervised Exercise therapy and CPT in the management of CLBP. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Kinesio taping and Conventional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Jun 2019to 30 Aug 2020
- 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Pain caused by mechanical/nonspecific low back pain.
- Degeneration of the spine and intervertebral disc.
- The visual analog scale of pain 4 and above
- Low back pain for at least three months
Who cannot join
- Physical therapy treatment is taken in the past 6 months period
- Previous spinal surgery with fixation
- Structural anomalies
- Spinal cord compression
- Severe osteoporosis
- Acute infections
- Severe cardiovascular or metabolic diseases
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Kinesio Taping and Conventional Physical Therapy in the Management of Chronic Low Back Pain
The objective of this study is to determine the effectiveness of Kinesio taping (KT) with Conventional Physical therapy (CPT) - Transcutaneous Electrical Nerve Stimulation (TENS) and Supervised Exercise therapy and CPT in the management of CLBP.
Read the detailed description
Chronic low back pain (CLBP) is one of the most common causes of chronic disability which leads to major social and economic consequences. The role and effectiveness of the Kinesio taping (KT) and Conventional Physical therapy (CPT) are evident from the existing literature but no comparison was found on the combination of other physical therapy techniques such as supervised exercise therapy and Transcutaneous Electrical Nerve Stimulation (TENS) with CLBP in the Kingdom of Saudi Arabia
- Conditions
- Chronic Low-back Pain
- Being tested
- Kinesio taping, Conventional physical therapy
- Keywords
- Low back pain, Chronic, Kinesio taping, TENS, Exercises
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapingOther
Kinesio taping: The tape is measured from the sacrum to the 12th thoracic vertebra with forwarding flexion of the trunk. The base is affixed to the insertion in the resting position. The muscle is elongated and the base anchored with skin displacement. The tape is then affixed with 10% stretch paravertebrally over the muscle bundles up to T12. The tape is rubbed with the muscle in the elongated state.
Conventional physical therapyDevice
Transcutaneous electrical nerve stimulation device settings, such as the frequency of 80 Hz, the pulse width of 100 µs, and symmetrical biphasic waveform. Four mediums sized (2 × 2 cm) carbon-impregnated rubber cutaneous electrodes were placed bilaterally in a standard dermatomal pattern over the most painful lumbar region. The current intensity was increased up to the patient's perception of paraesthesia. The supervised exercise therapy management consisted of stretching exercises for the back, iliopsoas, gluteal and hamstring muscles, and strengthening exercises for the abdominal and back muscles. Three sets of stretching exercises, each involving a 30-sec hold and 30-sec of rest repeated three times, were performed in three sessions per week over four weeks. One set of strengthening exercises, consisting of 10 repetitions with a 5-sec hold, was performed in three sessions per week over four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio taping and Conventional Physical therapy | Experimental | Kinesio taping with Transcutaneous Electrical Nerve Stimulation and Supervised Exercise therapy Receives: Other: Kinesio taping; Device: Conventional physical therapy |
| Conventional Physical therapy | Experimental | Transcutaneous Electrical Nerve Stimulation and Supervised Exercise therapy Receives: Device: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale
Pain, for the Average pain intensity over the last week was measured on a numerical pain rating scale, where 0 represented no pain and 10 represented the worst pain possible
Measured: Six weeks
Modified Oswestry low back pain disability questionnaire
Disability were measured using the Modified Oswestry Disability Index (MODI) which is a self-rating questionnaire used to evaluate functional physical disability
Measured: Six weeks
Lumbar range of motion-Modified Schober test
Lumbar flexion range of motion were measured by using modified Schober method
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start15 Jun 2019
- Primary completion30 Jun 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tabuk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahul Hameed Pakkir Mohamed, University of Tabuk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173948
- Sponsor's protocol ID
- UT-79-11-2019
- Status last verified
- Dec 2021
- First submitted
- 23 Nov 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pakkir Mohamed SH, Al Amer HS, Nambi G. The effectiveness of Kinesio taping and conventional physical therapy in the management of chronic low back pain: a randomized clinical trial. Clin Rheumatol. 2023 Jan;42(1):233-244. doi: 10.1007/s10067-022-06352-3. Epub 2022 Sep 1.
PubMed 36045306
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Kinesio Taping and Conventional Physical Therapy in the Management of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05173948
- Acronym / sponsor ID
- UT-79-11-2019
- Conditions
- Chronic Low-back Pain
- Keywords
- Low back pain, Chronic, Kinesio taping, TENS, Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of TabukUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 30 Dec 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 objective of this study is to determine the effectiveness of Kinesio taping (KT) with Conventional Physical therapy (CPT) - Transcutaneous Electrical Nerve Stimulation (TENS) and Supervised Exercise therapy and CPT in the management of CLBP.
Detailed description
Chronic low back pain (CLBP) is one of the most common causes of chronic disability which leads to major social and economic consequences. The role and effectiveness of the Kinesio taping (KT) and Conventional Physical therapy (CPT) are evident from the existing literature but no comparison was found on the combination of other physical therapy techniques such as supervised exercise therapy and Transcutaneous Electrical Nerve Stimulation (TENS) with CLBP in the Kingdom of Saudi Arabia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio taping and Conventional Physical therapy | Experimental | Other: Kinesio taping, Device: Conventional physical therapyKinesio taping with Transcutaneous Electrical Nerve Stimulation and Supervised Exercise therapy |
| Conventional Physical therapy | Experimental | Device: Conventional physical therapyTranscutaneous Electrical Nerve Stimulation and Supervised Exercise therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pain caused by mechanical/nonspecific low back pain.
- Degeneration of the spine and intervertebral disc.
- The visual analog scale of pain 4 and above
- Low back pain for at least three months
Key exclusion criteria (8 listed)
- Physical therapy treatment is taken in the past 6 months period
- Previous spinal surgery with fixation
- Structural anomalies
- Spinal cord compression
- Severe osteoporosis
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 |
|---|---|---|
| Kinesio tapingKinesio taping: The tape is measured from the sacrum to the 12th thoracic vertebra with forwarding flexion of the trunk. The base is affixed to the insertion in the resting position. The muscle is elongated and the base anchored with skin displacement. The tape is then affixed with 10% stretch paravertebrally over the muscle bundles up to T12. The tape is rubbed with the muscle in the elongated state. | Other | Kinesio taping and Conventional Physical therapy |
| Conventional physical therapyTranscutaneous electrical nerve stimulation device settings, such as the frequency of 80 Hz, the pulse width of 100 µs, and symmetrical biphasic waveform. Four mediums sized (2 × 2 cm) carbon-impregnated rubber cutaneous electrodes were placed bilaterally in a standard dermatomal pattern over the most painful lumbar region. The current intensity was increased up to the patient's perception of paraesthesia. The supervised exercise therapy management consisted of stretching exercises for the back, iliopsoas, gluteal and hamstring muscles, and strengthening exercises for the abdominal and back muscles. Three sets of stretching exercises, each involving a 30-sec hold and 30-sec of rest repeated three times, were performed in three sessions per week over four weeks. One set of strengthening exercises, consisting of 10 repetitions with a 5-sec hold, was performed in three sessions per week over four weeks. | Device | Conventional Physical therapy, Kinesio taping and Conventional Physical therapy |
Primary outcome
Numerical Pain Rating Scale
Time frame: Six weeks
Pain, for the Average pain intensity over the last week was measured on a numerical pain rating scale, where 0 represented no pain and 10 represented the worst pain possible
Modified Oswestry low back pain disability questionnaire
Time frame: Six weeks
Disability were measured using the Modified Oswestry Disability Index (MODI) which is a self-rating questionnaire used to evaluate functional physical disability
Lumbar range of motion-Modified Schober test
Time frame: Six weeks
Lumbar flexion range of motion were measured by using modified Schober method
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 30 Dec 2021.
- Derived from this study: PubMed 36045306Pakkir Mohamed SH, Al Amer HS, Nambi G. The effectiveness of Kinesio taping and conventional physical therapy in the management of chronic low back pain: a randomized clinical trial. Clin Rheumatol. 2023 Jan;42(1):233-244. doi: 10.1007/s10067-022-06352-3. Epub 2022 Sep 1.
- Individual participant dataSharing planned: No
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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 Kinesio taping and Conventional physical therapy in people with Chronic Low-back Pain, run by University of Tabuk at 1 site in Saudi Arabia.
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 8 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 30 Dec 2021. 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 Saudi Arabia. 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?
Numerical Pain Rating Scale (time frame: Six weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05173948, which also lists 1 linked publication.
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 30 Dec 2021.