Low Back PainNCT05015842
Effectiveness of Kinesio Tapping for the Treatment of Patients With Acute Low Back Pain: A Randomized Control Trial
A study testing Conventional Physical Therapy and Kinesio Tapping in people with Low Back Pain, run by NCS University System at 1 site in Pakistan.
Trial summary
The objective of the study was to determine the effectiveness of Kinesio Taping (KT) for the treatment of patients with acute low back pain. In this study a total of 56 patients with acute low back pain were randomly allocated to the experimental group, KT along with conventional Physical therapy (PT), or the control… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Conventional Physical Therapy and Kinesio Tapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jan 2019to 3 Jun 2019
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both Genders
- Age between 18 and 60 years
- History of LBP less than
Who cannot join
- Patients having diagnosed conditions of spondylolisthesis, spondylosis, lumbar stenosis, spinal tumor, lumber fracture, renal disease and trauma were excluded from the study.
- Patients either with chronic LBP (duration more than 3 months) or contraindicated to KT (skin allergy or pre-existing skin lesion or infection) were also excluded.
- Female Pregnant patients were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
NCS University System, Department of Physical Therapy and Rehabilitation
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
The objective of the study was to determine the effectiveness of Kinesio Taping (KT) for the treatment of patients with acute low back pain.
In this study a total of 56 patients with acute low back pain were randomly allocated to the experimental group, KT along with conventional Physical therapy (PT), or the control group, conventional PT alone.
Read the detailed description
The objective of the study was to determine the effectiveness of Kinesio Taping (KT) for the treatment of patients with acute low back pain.
In this study a total of 56 patients with acute low back pain were randomly allocated to the experimental group, KT along with conventional Physical therapy (PT), or the control group, conventional PT alone. 28 Patients received KT in addition to conventional PT while 28 patients received conventional PT alone for two weeks. Oswestry disability index (ODI) and numeric pain rating scale (NPRS) were used for the measurement of outcomes.
- Conditions
- Low Back Pain
- Being tested
- Conventional Physical Therapy, Kinesio Tapping
- Keywords
- Low back pain, Kinesio tapping, conventional physical therapy, Oswestry disability index
- 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.
Conventional Physical TherapyOther
This is a combine protocol of different therapeutic exercises and heat therapy.
Kinesio TappingOther
Kinesio Tapping is an adhesive and elastic fiber used for different outcomes like pain and swelling reduction among physical therapists.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Tapping plus Conventional Physical Therapy - Experimental Group | Experimental | Both groups received conventional physical therapy treatment consisting of therapeutic exercise, heat therapy and manual therapy. All the patients received manual therapy techniques that including joint mobilization and therapeutic exercise that including piriformis stretching as well as bridging exercises to strengthen the core stability muscles (i.e., strengthening of transverses abdominis, erector spinae and lumbar multifidus).
The KT was applied to the back once a week with a treatment duration of 2 weeks. Each KT was applied for continuous three days and the next KT was applied after a break of two days. Each participant in the experimental group was assessed for any allergy reaction of the skin to KT. Receives: Other: Conventional Physical Therapy; Other: Kinesio Tapping |
| Conventional Physical Therapy alone - Control Group | Other | Both groups received conventional physical therapy treatment consisting of therapeutic exercise, heat therapy and manual therapy. All the patients received manual therapy techniques that including joint mobilization and therapeutic exercise that including piriformis stretching as well as bridging exercises to strengthen the core stability muscles (i.e., strengthening of transverses abdominis, erector spinae and lumbar multifidus). Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain was measured on numerical pain rating scale. it is a scale with score from 0 to 10 where 0 is no pain and 10 is maximum pain. The minimum score mean better outcome while higher score mean worse outcome. simply lesser the score better would be the outcome.
Measured: 2 weeks
Secondary outcomes (1)
Functional Disability
Functional disability was measured using Oswestry Disability Index (ODI. ODI score was converted to percentage so the score ranges from 0% to 100%. Where 0% mean no disability and 100 mean very severe (maximum) disability. The minimum score mean better outcome while higher score mean worse outcome. simply lesser the score better would be the outcome.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start2 Jan 2019
- Primary completion11 Apr 2019
- Study completion3 Jun 2019
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCS University System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazrat Bilal PT, NCS University System
- Investigators
- Dr. Haider Darain, PhD, Study director, Khyber Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015842
- Sponsor's protocol ID
- DIR/KMU-ASR&B/EK/000678
- Status last verified
- Aug 2021
- First submitted
- 13 Aug 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Kinesio Tapping for the Treatment of Patients With Acute Low Back Pain: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05015842
- Acronym / sponsor ID
- DIR/KMU-ASR&B/EK/000678
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Kinesio tapping, conventional physical therapy, Oswestry disability index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- NCS University SystemUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 20 Aug 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 the study was to determine the effectiveness of Kinesio Taping (KT) for the treatment of patients with acute low back pain.
In this study a total of 56 patients with acute low back pain were randomly allocated to the experimental group, KT along with conventional Physical therapy (PT), or the control group, conventional PT alone.
Detailed description
The objective of the study was to determine the effectiveness of Kinesio Taping (KT) for the treatment of patients with acute low back pain.
In this study a total of 56 patients with acute low back pain were randomly allocated to the experimental group, KT along with conventional Physical therapy (PT), or the control group, conventional PT alone. 28 Patients received KT in addition to conventional PT while 28 patients received conventional PT alone for two weeks. Oswestry disability index (ODI) and numeric pain rating scale (NPRS) were used for the measurement of outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio Tapping plus Conventional Physical Therapy - Experimental Group | Experimental | Other: Conventional Physical Therapy, Other: Kinesio TappingBoth groups received conventional physical therapy treatment consisting of therapeutic exercise, heat therapy and manual therapy. All the patients received manual therapy techniques that including joint mobilization and therapeutic exercise that including piriformis stretching as well as bridging exercises to strengthen the core stability muscles (i.e., strengthening of transverses abdominis, erector spinae and lumbar multifidus). The KT was applied to the back once a week with a treatment duration of 2 weeks. Each KT was applied for continuous three days and the next KT was applied after a break of two days. Each participant in the experimental group was assessed for any allergy reaction of the skin to KT. |
| Conventional Physical Therapy alone - Control Group | Other | Other: Conventional Physical TherapyBoth groups received conventional physical therapy treatment consisting of therapeutic exercise, heat therapy and manual therapy. All the patients received manual therapy techniques that including joint mobilization and therapeutic exercise that including piriformis stretching as well as bridging exercises to strengthen the core stability muscles (i.e., strengthening of transverses abdominis, erector spinae and lumbar multifidus). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both Genders
- Age between 18 and 60 years
- History of LBP less than
Key exclusion criteria (3 listed)
- Patients having diagnosed conditions of spondylolisthesis, spondylosis, lumbar stenosis, spinal tumor, lumber fracture, renal disease and trauma were excluded from the study.
- Patients either with chronic LBP (duration more than 3 months) or contraindicated to KT (skin allergy or pre-existing skin lesion or infection) were also excluded.
- Female Pregnant patients were also excluded from the study.
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 |
|---|---|---|
| Conventional Physical TherapyThis is a combine protocol of different therapeutic exercises and heat therapy. | Other | Conventional Physical Therapy alone - Control Group, Kinesio Tapping plus Conventional Physical Therapy - Experimental Group |
| Kinesio TappingKinesio Tapping is an adhesive and elastic fiber used for different outcomes like pain and swelling reduction among physical therapists. | Other | Kinesio Tapping plus Conventional Physical Therapy - Experimental Group |
Primary outcome
Pain intensity
Time frame: 2 weeks
Pain was measured on numerical pain rating scale. it is a scale with score from 0 to 10 where 0 is no pain and 10 is maximum pain. The minimum score mean better outcome while higher score mean worse outcome. simply lesser the score better would be the outcome.
1 secondary outcome
Functional Disability
Time frame: 2 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 20 Aug 2021.
- 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.
Dr. Haider Darain, PhD study director
Khyber Medical 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 Conventional Physical Therapy and Kinesio Tapping in people with Low Back Pain, run by NCS University System at 1 site in Pakistan.
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 3 inclusion and 3 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 20 Aug 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 Pakistan. 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 (time frame: 2 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 20 Aug 2021.