Back Pain Without RadiationNCT03984903
Different Learning Methods of Motor Control Exercises
A study testing Multimedia Learning of Exercises, Face-to-face Learning of Exercises and Manual Therapy in people with Back Pain Without Radiation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Back Pain Without Radiation
- What is being tested?
- Multimedia Learning of Exercises, Face-to-face Learning of Exercises and Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2019to 30 Oct 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic (>3 month), non-specific low back pain
- 25- 55 years old
- Have a capacity can understand exercise instructions (Montreal Cognitive Assessment > 21)
- Being a computer literate
Who cannot join
- Root nerve signs
- Cauda equina syndrome
- Fracture in the vertebra
- Tumour
- Have a neurologic disease
- History of spine surgery
Show all 9Show fewer
- Knowing motor control exercises
- Visual impairment
- Hearing loss
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Samanpazari, 06100
About this study
Official title: Learning of Motor Control Exercises With Different Methods and Its Effects on Treatment Outcomes in Patients With Chronic Non-specific Low Back Pain: A Randomised Controlled Trial
This study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain.
Read the detailed description
For see the full effect of exercise treatment, exercise adherence should be high. In patients with chronic non-specific low back pain, the complex nature of the core-stabilization exercises decrease the exercise adherence. Some novel studies show that multimedia learning can increase efficiancy of complex skill learning and can be better from classic face to face learning.
So this study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain.
- Conditions
- Back Pain Without Radiation
- Being tested
- Multimedia Learning of Exercises, Face-to-face Learning of Exercises, Manual Therapy, Home Exercise Program
- Keywords
- Back Pain without Radiation, Low Back Pain, Mechanical
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia Learning of ExercisesOther
Patients learn exercise from multimedia content.
Face-to-face Learning of ExercisesOther
Physiotherapist teach exercises to patients
Manual TherapyOther
Myofascial Release Techniques and Joint Mobilizations to the Lumbal Area
Home Exercise ProgramOther
Patients do at least 20 minutes motor control exercise in a day at home.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face Learning Group | Active comparator | Not described Receives: Other: Face-to-face Learning of Exercises; Other: Manual Therapy; Other: Home Exercise Program |
| Multimedia Learning Group | Experimental | Not described Receives: Other: Multimedia Learning of Exercises; Other: Manual Therapy; Other: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Pain Level at Eight Week and Third Month
Full Scale Name: Visual Analog Scale
Pain change will be measured throughout Study and Follow-up with Visual Analog Scale. This scale is a 100 millimeter line drawn horizontally on an A4 sheet of paper. The left end of the line shows "no pain at all", the right end shows "my pain is as bad as it could be", while the remaining part shows the intermediate values. So minimum score was 0, and maximum score was 100. The patient is asked to mark the severity of the pain on the chart. Validity and reliability were made. The minimal clinical significance difference in chronic low back pain was 20 millimeters.
Measured: At baseline, eighth week and third month
Change from Baseline Disability Score Level at Eight Week and Third Month
Full Scale Name: Turkish version of the Oswestry Disability Index (ODI) (2.0)
The last reliable and validate Turkish Version of Oswestry Disability Index will be used. This version contains 10 multiple-choice questions that question how low back pain affects a person in his or her daily life. Each question has 6 options. As the disability increases, the score of each problem increases. In the worst case you can get 50 points. The last point is the patient's score 100.
Measured: At baseline, eighth week and third month
Change in Exercise Adherence Level between Eight Week and Third Month
The Exercise Adherence Rating Scale (EARS), which evaluates exercise compliance, will be administered 2 times to determine change at eight weeks and third month. This scale consists of 3 parts: A, B, C.
Section A, consists of 6 items not included in the scale scoring.
Section B consists 6 items, and every item have five point likert scale and describes how to do the recommended home exercise. Minimum point for this section 0, and maximum point is 24. The higher score shown exercise adherece is high.
Section C is the section that evaluates the reason for the absence of compliance with the recommended home exercise and contains 10 items, every item have five point likert scale. Sections are calculated to result in a possible score between 0 and 40. The higher score shown exercise adherece is high.
Measured: At eighth week and third month
Secondary outcomes (1)
Change from Baseline Walking Parameters at Eight Week and Third Month
Mean Step Length and Total Walking Distance in Six Minute Walk Test
Measured: At baseline, eighth week and third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start30 Jun 2019
- Primary completion30 Sep 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Back Pain Without RadiationStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Utku BERBEROĞLU, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984903
- Sponsor's protocol ID
- KA-180060
- Status last verified
- Feb 2023
- First submitted
- 30 May 2019
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
PubMed 21982256Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
PubMed 16550448Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG. Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev. 2016 Jan 8;2016(1):CD012004. doi: 10.1002/14651858.CD012004.
PubMed 26742533
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning of Motor Control Exercises With Different Methods and Its Effects on Treatment Outcomes in Patients With Chronic Non-specific Low Back Pain: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03984903
- Acronym / sponsor ID
- KA-180060
- Conditions
- Back Pain Without Radiation
- Keywords
- Back Pain without Radiation, Low Back Pain, Mechanical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 13 Jun 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.
This study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain.
Detailed description
For see the full effect of exercise treatment, exercise adherence should be high. In patients with chronic non-specific low back pain, the complex nature of the core-stabilization exercises decrease the exercise adherence. Some novel studies show that multimedia learning can increase efficiancy of complex skill learning and can be better from classic face to face learning.
So this study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-face Learning Group | Active comparator | Other: Face-to-face Learning of Exercises, Other: Manual Therapy, Other: Home Exercise Program |
| Multimedia Learning Group | Experimental | Other: Multimedia Learning of Exercises, Other: Manual Therapy, Other: Home Exercise Program |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chronic (>3 month), non-specific low back pain
- 25- 55 years old
- Have a capacity can understand exercise instructions (Montreal Cognitive Assessment > 21)
- Being a computer literate
Key exclusion criteria (9 listed)
- Root nerve signs
- Cauda equina syndrome
- Fracture in the vertebra
- Tumour
- Have a neurologic 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 |
|---|---|---|
| Multimedia Learning of ExercisesPatients learn exercise from multimedia content. | Other | Multimedia Learning Group |
| Face-to-face Learning of ExercisesPhysiotherapist teach exercises to patients | Other | Face-to-face Learning Group |
| Manual TherapyMyofascial Release Techniques and Joint Mobilizations to the Lumbal Area | Other | Face-to-face Learning Group, Multimedia Learning Group |
| Home Exercise ProgramPatients do at least 20 minutes motor control exercise in a day at home. | Other | Face-to-face Learning Group, Multimedia Learning Group |
Primary outcome
Change from Baseline Pain Level at Eight Week and Third Month
Time frame: At baseline, eighth week and third month
Full Scale Name: Visual Analog Scale Pain change will be measured throughout Study and Follow-up with Visual Analog Scale. This scale is a 100 millimeter line drawn horizontally on an A4 sheet of paper. The left end of the line shows "no pain at all", the right end shows "my pain is as bad as it could be", while the remaining part shows the intermediate values. So minimum score was 0, and maximum score was 100. The patient is asked to mark the severity of the pain on the chart. Validity and reliability were made. The minimal clinical significance difference in chronic low back pain was 20 millimeters.
Change from Baseline Disability Score Level at Eight Week and Third Month
Time frame: At baseline, eighth week and third month
Full Scale Name: Turkish version of the Oswestry Disability Index (ODI) (2.0) The last reliable and validate Turkish Version of Oswestry Disability Index will be used. This version contains 10 multiple-choice questions that question how low back pain affects a person in his or her daily life. Each question has 6 options. As the disability increases, the score of each problem increases. In the worst case you can get 50 points. The last point is the patient's score 100.
Change in Exercise Adherence Level between Eight Week and Third Month
Time frame: At eighth week and third month
The Exercise Adherence Rating Scale (EARS), which evaluates exercise compliance, will be administered 2 times to determine change at eight weeks and third month. This scale consists of 3 parts: A, B, C. Section A, consists of 6 items not included in the scale scoring. Section B consists 6 items, and every item have five point likert scale and describes how to do the recommended home exercise. Minimum point for this section 0, and maximum point is 24. The higher score shown exercise adherece is high. Section C is the section that evaluates the reason for the absence of compliance with the recommended home exercise and contains 10 items, every item have five point likert scale. Sections are calculated to result in a possible score between 0 and 40. The higher score shown exercise adherece is high.
1 secondary outcome
Change from Baseline Walking Parameters at Eight Week and Third Month
Time frame: At baseline, eighth week and third month
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 28 Feb 2023.
- Background: PubMed 21982256Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
- Background: PubMed 16550448Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
- Background: PubMed 26742533Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG. Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev. 2016 Jan 8;2016(1):CD012004. doi: 10.1002/14651858.CD012004.
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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 Multimedia Learning of Exercises, Face-to-face Learning of Exercises and Manual Therapy in people with Back Pain Without Radiation, run by Hacettepe 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 9 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 28 Feb 2023. 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?
Change from Baseline Pain Level at Eight Week and Third Month (time frame: At baseline, eighth week and third month). 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 NCT03984903, which also lists 3 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 28 Feb 2023.