Chronic Low Back PainNCT03886636
Neuroscience Pain Education in Patients with Chronic Low Back Pain
A study testing neuroscience pain education, manual therapy and home exercises in people with Chronic Low Back Pain and Manual Therapy, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The cognitive educational strategies such as neuroscience pain education, has been a popular and promising technique for treatment patients with chronic pain. However, there are not sufficient randomized controlled and blinded studies to explore clinical effectiveness of these techniques. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain, Manual Therapy, Neuroscience Pain Education
- What is being tested?
- neuroscience pain education, manual therapy and home exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 1 Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteered to participate in the study.
- Patients with 18-65 years
- Had low back pain for at least 6 months,
- Reported pain severity of 5 or greater according to the numeric pain rating scale
- Used pregabalin and gabapentin derivatives,
Who cannot join
- Previous spine or lower extremity surgery
- Severe osteoporosis
- Spondyloarthropathy
- Spondylolisthesis
- Lumbar stenosis
- Systemic inflammatory diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yoncali Physical Therapy and Rehabilitation Hospital
Kütahya, 43000
About this study
Official title: The Effectiveness of Neuroscience Pain Education Combining Manual Therapy in Patients with Chronic Low Back Pain: a Single-blinded Randomized Controlled Trial
The cognitive educational strategies such as neuroscience pain education, has been a popular and promising technique for treatment patients with chronic pain. However, there are not sufficient randomized controlled and blinded studies to explore clinical effectiveness of these techniques. Therefore, the aim of this study was determining the short- and mid-term effects of neuroscience pain education combined with manual therapy and home exercise on pain level, disability, and kinesiophobia in patients with chronic low back pain.
- Being tested
- neuroscience pain education, manual therapy, home exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuroscience pain educationOther
A total of 4 NPE (Neuroscience paine education) sessions were held, once each week, before an MT session. The NPE sessions were conducted by an experienced physiotherapist certified in NPE in face-to-face, one-on-one sessions lasting 40-45 minutes. In NPE, the patient is taught about the physiology of pain, central sensitization, representation of the different body regions in the brain, pain-related changes in body perception, and the psychosocial dimensions of pain.
manual therapyOther
In our study, Manual therapy (MT) was individualized according to each patient's response to treatment. In this method, the physiotherapist identifies and performs techniques suitable for the patient's symptoms. If the selected techniques do not have a direct positive effect on the patient's symptoms, they are replaced with other techniques.MT were performed in a total of 8 sessions, held twice a week for 4 weeks. Treatment sessions lasted an average of 40-45 minute.The entire treatment program was carried out by the same physiotherapist who is trained and experienced in this area.
home exercisesOther
All participants in all groups were assigned the home exercise program. The program aims to increase strength and flexibility of the abdominal, erector spinae, gluteal, quadriceps, and hamstring muscles. The participants were then asked to perform all of the exercises with 10 repetitions of each exercise 3 times a day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Neuroscience pain education group | Experimental | in Group 1, participants received Neuroscience pain education, manual therapy and a home exercise program. Receives: Other: neuroscience pain education; Other: manual therapy; Other: home exercises |
| Manual therapy group | Experimental | in Group 2, participants received manual therapy and a home exercise program. Receives: Other: manual therapy; Other: home exercises |
| Control group | Active comparator | in Group 3, participants received home exercise program only. Receives: Other: home exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale (NPRS)
The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale from 0 to 10. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme.
Measured: Change from Baseline NPRS at 4th weeks and 12th weeks
Secondary outcomes (3)
Oswestry Disability Index (ODI)
The participants' level of functioning was evaluated using the Turkish adaptation of the ODI. The scale comprises 10 items, each with 6 options worth 0 to 5 points. For each item, participants are asked to mark the option that best describes their current condition. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Measured: Change from Baseline ODI at 4th weeks and 12th weeks
Back Performance Scale (BPS)
The BPS includes five tests of trunk mobility. Each test is scored from 0 to 3 based on the observed level of physical performance, and total score ranges from 0 to 15 points (18). High score indicates poor performance.
Measured: Change from Baseline BPS at 4th weeks and 12th weeks
Tampa Scale for Kinesiophobia (TSK)
TSK was used for the assessment of kinesiophobia. The items are rated on a 4-point Likert-type scale (1=definitely disagree, 4=completely agree) and the total score is between 17 and 68 points. Higher total score indicates higher level of kinesiophobia.
Measured: Change from Baseline TSK at 4th weeks and 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start1 Feb 2018
- Primary completion30 Oct 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Saracoglu, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886636
- Sponsor's protocol ID
- KutahyaMSU
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2019
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Neuroscience Pain Education Combining Manual Therapy in Patients with Chronic Low Back Pain: a Single-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03886636
- Acronym / sponsor ID
- KutahyaMSU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 22 Mar 2019 (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 cognitive educational strategies such as neuroscience pain education, has been a popular and promising technique for treatment patients with chronic pain. However, there are not sufficient randomized controlled and blinded studies to explore clinical effectiveness of these techniques. Therefore, the aim of this study was determining the short- and mid-term effects of neuroscience pain education combined with manual therapy and home exercise on pain level, disability, and kinesiophobia in patients with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neuroscience pain education group | Experimental | Other: neuroscience pain education, Other: manual therapy, Other: home exercisesin Group 1, participants received Neuroscience pain education, manual therapy and a home exercise program. |
| Manual therapy group | Experimental | Other: manual therapy, Other: home exercisesin Group 2, participants received manual therapy and a home exercise program. |
| Control group | Active comparator | Other: home exercisesin Group 3, participants received home exercise program only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteered to participate in the study.
- Patients with 18-65 years
- Had low back pain for at least 6 months,
- Reported pain severity of 5 or greater according to the numeric pain rating scale
- Used pregabalin and gabapentin derivatives,
Key exclusion criteria (6 listed)
- Previous spine or lower extremity surgery
- Severe osteoporosis
- Spondyloarthropathy
- Spondylolisthesis
- Lumbar stenosis
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 |
|---|---|---|
| neuroscience pain educationA total of 4 NPE (Neuroscience paine education) sessions were held, once each week, before an MT session. The NPE sessions were conducted by an experienced physiotherapist certified in NPE in face-to-face, one-on-one sessions lasting 40-45 minutes. In NPE, the patient is taught about the physiology of pain, central sensitization, representation of the different body regions in the brain, pain-related changes in body perception, and the psychosocial dimensions of pain. | Other | Neuroscience pain education group |
| manual therapyIn our study, Manual therapy (MT) was individualized according to each patient's response to treatment. In this method, the physiotherapist identifies and performs techniques suitable for the patient's symptoms. If the selected techniques do not have a direct positive effect on the patient's symptoms, they are replaced with other techniques.MT were performed in a total of 8 sessions, held twice a week for 4 weeks. Treatment sessions lasted an average of 40-45 minute.The entire treatment program was carried out by the same physiotherapist who is trained and experienced in this area. | Other | Manual therapy group, Neuroscience pain education group |
| home exercisesAll participants in all groups were assigned the home exercise program. The program aims to increase strength and flexibility of the abdominal, erector spinae, gluteal, quadriceps, and hamstring muscles. The participants were then asked to perform all of the exercises with 10 repetitions of each exercise 3 times a day for 4 weeks. | Other | Control group, Manual therapy group, Neuroscience pain education group |
Primary outcome
Numeric pain rating scale (NPRS)
Time frame: Change from Baseline NPRS at 4th weeks and 12th weeks
The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale from 0 to 10. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme.
3 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Change from Baseline ODI at 4th weeks and 12th weeks
Back Performance Scale (BPS)
Time frame: Change from Baseline BPS at 4th weeks and 12th weeks
Tampa Scale for Kinesiophobia (TSK)
Time frame: Change from Baseline TSK at 4th weeks and 12th 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 15 Oct 2024.
- 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 neuroscience pain education, manual therapy and home exercises in people with Chronic Low Back Pain and Manual Therapy, run by Kutahya Health Sciences 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 5 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 15 Oct 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?
Numeric pain rating scale (NPRS) (time frame: Change from Baseline NPRS at 4th weeks and 12th 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 15 Oct 2024.