Chronic Low-back PainNCT04643756
Investigation of the Effects of Two Different Treatment Programs on Chronic Low Back Pain
A study testing conventional physiotherapy and conventional physiotherapy plus kinesiotaping in people with Chronic Low-back Pain, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine the effects of two different treatment programs on pain intensity, back awareness, functional and psychosocial factors in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- conventional physiotherapy and conventional physiotherapy plus kinesiotaping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients aged 18 to 60 years with chronic low back pain
- Those who have complained of low back pain for at least 3 months
- Individuals whose pain intensity is above 3.5 cm according to VAS
- Pain and numbness that does not spread to the legs
Who cannot join
- Situations that prevent the evaluation or communication with the individual
- Illiterate individuals
- Individuals who have undergone surgical operations on the spine and / or extremities
- Conditions where specific pathological conditions are proven such as malignant condition, fracture, systemic rheumatoid disease
- Orthopedic and neurological problems that prevent evaluation and / or treatment
- Complaints of pain and numbness spreading to the lower extremities
Show all 11Show fewer
- Individuals with a diagnosed psychiatric illness
- Individuals who have received physiotherapy in the last 6 months
- Individuals who use another treatment method during the study
- Individuals with musculoskeletal pain in any other part of the body during work
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Two Different Treatment Programs on Pain Severity, Low Back Awareness, Functional and Psychosocial Factors in Patients With Chronic Low Back Pain
This study was planned to examine the effects of two different treatment programs on pain intensity, back awareness, functional and psychosocial factors in patients with chronic low back pain.
Read the detailed description
Recent study will be carried out on volunteer patients who applied to the Physical Therapy Clinic of "Mugla Sitki Kocman University" Training and Research Hospital, who were diagnosed with chronic non-specific low back pain and who comply with the study criteria.
The sample size has been calculated that 80% power can be obtained at 95% confidence level. It was found that at least 21 cases, a total of 44 cases, were required for each group.
Volunteers will be divided into 2 groups by randomization. Conventional physiotherapy applications will be applied to the control group. In addition to conventional physiotherapy methods, kinesio-taping (KT) will be applied to the study group. Patients in both groups will be treated 5 days a week for a total of 10 sessions for 2 weeks. KT will be renewed in each session on weekdays.
- Conditions
- Chronic Low-back Pain
- Being tested
- conventional physiotherapy, conventional physiotherapy plus kinesiotaping
- Keywords
- chronic low back pain, kinesiotape, physiotherapy, awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physiotherapyOther
Classical electrotherapy method consisting of tens, hotpack and ultrasound.
conventional physiotherapy plus kinesiotapingOther
Conventional physiotherapy plus kinesiotaping
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy | Active comparator | Classical electrotherapy method consisting of tens, hotpack and ultrasound. Procedure/Device: Conventional Physiotherapy Conventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in prone and supported with a pillow under the abdomen, 20 min hot pack was applied. Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm2 and duration of 5 minute. TENS was applied to the lumbar region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes. Receives: Other: conventional physiotherapy |
| Conventional Physiotherapy + Kinesiotaping | Active comparator | Kinesiotaping application in addition to classical electrotherapy method consisting of tens, hotpack and ultrasound.It will be applied to reduce pain, increase proprioception and awareness. Kinesiotaping will be re-applicated every day. Space taping will be applied to the waist area. Space taping creates a vacuum effect on the skin, loosening the adhesions in the tissue layers. With this lifting effect, it creates a space under the skin, causing an increase in circulation and a decrease in pain. Four pieces of I-tape will be used for taping. The middle point of the first tape will be attached with maximum tension. The ends of the tape will be tensionless. The second tape will also be applied at a 90 degree angle. The third and fourth tapes will be taped at an angle of 45 degrees. Receives: Other: conventional physiotherapy plus kinesiotaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
Visual Analogue Scale (VAS): The patient is asked to mark the pain felt on a 10 cm.
Measured: Baseline, 3 weeks, 6 weeks
Awareness Assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
Fremantle Back Awareness Questionnaire (FreBAQ): FreBAQwill be used for awareness.
Measured: Baseline, 3 weeks, 6 weeks
Functional assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
Repeated Sit-to-Stand Test
Measured: Baseline, 3 weeks, 6 weeks
Assessment of depression and anxiety level Change from baseline at 3 weeks and Change from baseline at 6 weekschanging from baseline at 6 weeks
Hospital and Anxiety Depression Scale (HADS):Anxiety and depression levels will be evaluated subjectively with the Hospital Anxiety and Depression Scale.
Measured: Baseline, 3 weeks, 6 weeks
Assessing Kinesophobia Change from baseline at 3 weeks and Change from baseline at 6 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ):It measures the patient's fear of movement caused by low back pain.
Measured: Baseline, 3 weeks, 6 weeks
Timed Up and Go Test Change from baseline at 3 weeks and Change from baseline at 6 weeks
Timed Up and Go Test
Measured: Baseline, 3 weeks, 6 weeks
Modified Schober Test Change from baseline at 3 weeks and Change from baseline at 6 weeks
Modified Schober Test
Measured: Baseline, 3 weeks, 6 weeks
Disability level Change from baseline at 3 weeks and Change from baseline at 6 weeks.
Roland Morris Disability Questionnaire.
Measured: Baseline, 3 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Jan 2020
- Primary completion1 Feb 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgür Nadiye Karaman, Pamukkale University
- Investigators
- Emine PT Aslan Telci, Prof. Dr, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643756
- Sponsor's protocol ID
- 60116787-020/62195
- Status last verified
- Sep 2021
- First submitted
- 5 Nov 2020
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nelson NL. Kinesio taping for chronic low back pain: A systematic review. J Bodyw Mov Ther. 2016 Jul;20(3):672-81. doi: 10.1016/j.jbmt.2016.04.018. Epub 2016 Apr 27.
PubMed 27634093Paoloni M, Bernetti A, Fratocchi G, Mangone M, Parrinello L, Del Pilar Cooper M, Sesto L, Di Sante L, Santilli V. Kinesio Taping applied to lumbar muscles influences clinical and electromyographic characteristics in chronic low back pain patients. Eur J Phys Rehabil Med. 2011 Jun;47(2):237-44. Epub 2011 Mar 24.
PubMed 21430611Kachanathu SJ, Alenazi AM, Seif HE, Hafez AR, Alroumim MA. Comparison between Kinesio Taping and a Traditional Physical Therapy Program in Treatment of Nonspecific Low Back Pain. J Phys Ther Sci. 2014 Aug;26(8):1185-8. doi: 10.1589/jpts.26.1185. Epub 2014 Aug 30.
PubMed 25202177Li Y, Yin Y, Jia G, Chen H, Yu L, Wu D. Effects of kinesiotape on pain and disability in individuals with chronic low back pain: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2019 Apr;33(4):596-606. doi: 10.1177/0269215518817804. Epub 2018 Dec 11.
PubMed 30526011
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Two Different Treatment Programs on Pain Severity, Low Back Awareness, Functional and Psychosocial Factors in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04643756
- Acronym / sponsor ID
- 60116787-020/62195
- Conditions
- Chronic Low-back Pain
- Keywords
- chronic low back pain, kinesiotape, physiotherapy, awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 25 Nov 2020 (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 was planned to examine the effects of two different treatment programs on pain intensity, back awareness, functional and psychosocial factors in patients with chronic low back pain.
Detailed description
Recent study will be carried out on volunteer patients who applied to the Physical Therapy Clinic of "Mugla Sitki Kocman University" Training and Research Hospital, who were diagnosed with chronic non-specific low back pain and who comply with the study criteria.
The sample size has been calculated that 80% power can be obtained at 95% confidence level. It was found that at least 21 cases, a total of 44 cases, were required for each group.
Volunteers will be divided into 2 groups by randomization. Conventional physiotherapy applications will be applied to the control group. In addition to conventional physiotherapy methods, kinesio-taping (KT) will be applied to the study group. Patients in both groups will be treated 5 days a week for a total of 10 sessions for 2 weeks. KT will be renewed in each session on weekdays.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy | Active comparator | Other: conventional physiotherapyClassical electrotherapy method consisting of tens, hotpack and ultrasound. Procedure/Device: Conventional Physiotherapy Conventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in prone and supported with a pillow under the abdomen, 20 min hot pack was applied. Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm2 and duration of 5 minute. TENS was applied to the lumbar region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes. |
| Conventional Physiotherapy + Kinesiotaping | Active comparator | Other: conventional physiotherapy plus kinesiotapingKinesiotaping application in addition to classical electrotherapy method consisting of tens, hotpack and ultrasound.It will be applied to reduce pain, increase proprioception and awareness. Kinesiotaping will be re-applicated every day. Space taping will be applied to the waist area. Space taping creates a vacuum effect on the skin, loosening the adhesions in the tissue layers. With this lifting effect, it creates a space under the skin, causing an increase in circulation and a decrease in pain. Four pieces of I-tape will be used for taping. The middle point of the first tape will be attached with maximum tension. The ends of the tape will be tensionless. The second tape will also be applied at a 90 degree angle. The third and fourth tapes will be taped at an angle of 45 degrees. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female patients aged 18 to 60 years with chronic low back pain
- Those who have complained of low back pain for at least 3 months
- Individuals whose pain intensity is above 3.5 cm according to VAS
- Pain and numbness that does not spread to the legs
Key exclusion criteria (11 listed)
- Situations that prevent the evaluation or communication with the individual
- Illiterate individuals
- Individuals who have undergone surgical operations on the spine and / or extremities
- Conditions where specific pathological conditions are proven such as malignant condition, fracture, systemic rheumatoid disease
- Orthopedic and neurological problems that prevent evaluation and / or treatment
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 physiotherapyClassical electrotherapy method consisting of tens, hotpack and ultrasound. | Other | Conventional Physiotherapy |
| conventional physiotherapy plus kinesiotapingConventional physiotherapy plus kinesiotaping | Other | Conventional Physiotherapy + Kinesiotaping |
Primary outcome
Pain assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
Time frame: Baseline, 3 weeks, 6 weeks
Visual Analogue Scale (VAS): The patient is asked to mark the pain felt on a 10 cm.
Awareness Assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
Time frame: Baseline, 3 weeks, 6 weeks
Fremantle Back Awareness Questionnaire (FreBAQ): FreBAQwill be used for awareness.
Functional assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
Time frame: Baseline, 3 weeks, 6 weeks
Repeated Sit-to-Stand Test
Assessment of depression and anxiety level Change from baseline at 3 weeks and Change from baseline at 6 weekschanging from baseline at 6 weeks
Time frame: Baseline, 3 weeks, 6 weeks
Hospital and Anxiety Depression Scale (HADS):Anxiety and depression levels will be evaluated subjectively with the Hospital Anxiety and Depression Scale.
Assessing Kinesophobia Change from baseline at 3 weeks and Change from baseline at 6 weeks
Time frame: Baseline, 3 weeks, 6 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ):It measures the patient's fear of movement caused by low back pain.
Timed Up and Go Test Change from baseline at 3 weeks and Change from baseline at 6 weeks
Time frame: Baseline, 3 weeks, 6 weeks
Timed Up and Go Test
Modified Schober Test Change from baseline at 3 weeks and Change from baseline at 6 weeks
Time frame: Baseline, 3 weeks, 6 weeks
Modified Schober Test
Disability level Change from baseline at 3 weeks and Change from baseline at 6 weeks.
Time frame: Baseline, 3 weeks, 6 weeks
Roland Morris Disability Questionnaire.
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 13 Sep 2021.
- Background: PubMed 27634093Nelson NL. Kinesio taping for chronic low back pain: A systematic review. J Bodyw Mov Ther. 2016 Jul;20(3):672-81. doi: 10.1016/j.jbmt.2016.04.018. Epub 2016 Apr 27.
- Background: PubMed 21430611Paoloni M, Bernetti A, Fratocchi G, Mangone M, Parrinello L, Del Pilar Cooper M, Sesto L, Di Sante L, Santilli V. Kinesio Taping applied to lumbar muscles influences clinical and electromyographic characteristics in chronic low back pain patients. Eur J Phys Rehabil Med. 2011 Jun;47(2):237-44. Epub 2011 Mar 24.
- Background: PubMed 25202177Kachanathu SJ, Alenazi AM, Seif HE, Hafez AR, Alroumim MA. Comparison between Kinesio Taping and a Traditional Physical Therapy Program in Treatment of Nonspecific Low Back Pain. J Phys Ther Sci. 2014 Aug;26(8):1185-8. doi: 10.1589/jpts.26.1185. Epub 2014 Aug 30.
- Results publication: PubMed 30526011Li Y, Yin Y, Jia G, Chen H, Yu L, Wu D. Effects of kinesiotape on pain and disability in individuals with chronic low back pain: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2019 Apr;33(4):596-606. doi: 10.1177/0269215518817804. Epub 2018 Dec 11.
- 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.
Emine PT Aslan Telci, Prof. Dr study director
Pamukkale 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 physiotherapy and conventional physiotherapy plus kinesiotaping in people with Chronic Low-back Pain, run by Pamukkale 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 4 inclusion and 11 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 13 Sep 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 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?
Pain assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks (time frame: Baseline, 3 weeks, 6 weeks). The study lists 8 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 NCT04643756, which also lists 4 linked publications.
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 Sep 2021.