Chronic Low-back PainNCT04824547
Evaluation of Long-Term Continuity of Exercises in Low Back Pain Individuals
A study testing exercise in people with Chronic Low-back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Identification of the long term effects of exercises in individuals with 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?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2021to 1 Mar 2024
- 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
- Must be low back pain at least 3 months
- Must be visual analog scale rating 3 or more
Who cannot join
- History of any lumbar spine surgery
- Severe/progressive scoliosis
- Spinal stenosis
- Spondylolisthesis
- Cancer
- Diabetes
- Metabolic syndrome
- History of exercise programs or yoga at least 12 weeks before the onset of study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, Altindag, 06100
About this study
Official title: Bel Ağrılı Bireylerde Egzersizlerin Uzun Dönem Devamlılığının Değerlendirilmesi
Identification of the long term effects of exercises in individuals with low back pain.
Read the detailed description
Individuals with low back pain who will participate in the study will be divided into two groups. In the stabilization exercise group will be instructed to perform spinal stabilization exercises and in the yoga group will be instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The intensity of the pain will be evaluated through visual analog scale, functional status and quality of life will be evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), respectively. The exercise adherence will evaluated Exercise Adherence Rating Scale (EARS). The time-distance characteristics of the gait will be evaluated by the OPTOGAIT photoelectric cell (OPTOGait, Microgate, Italy, 2010) and the treadmill system. Assessments will be repeated before, after the treatment, 6 and 12 month follow-up. Also,the number of back pain attacks of the individuals will be questioned and recorded.
- Conditions
- Chronic Low-back Pain
- Being tested
- exercise
- Keywords
- exercise, pain, yoga, function
- Medical subject headings
- Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
All exercises programs will applied two sessions per week, totally eight week..
| Study group | Role | What they receive |
|---|---|---|
| Stabilization exercise group | Active comparator | Spinal stabilization exercise will be applied all patients accompanied by physiotherapist.
Sessions will be included selected exercises according to motor learning phases. Receives: Other: exercise |
| yoga group | Active comparator | Yoga program will be applied all patients in this group accompanied by physiotherapist. Sessions will be included selected breathing exercises, warm up, asana and relaxation. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain severity
Patients' average pain intensities will be assessed by Visual Analog Scale (VAS). Participants asked to mark the intensity of pain on a 10 cm long line, explaining that the leftmost of the line does not have pain, that the pain increases while moving to the right, and that the pain is unbearable on the far right.
Measured: change from baseline in pain intensity at 8 weeks, 6 and 12 month follow-up.
Changes of functional status
Patient's pain related functional status will be measured by Oswestry Disability Index. The scale is considered the 'gold standard' of low back functional outcome tools. This scale contain questions related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The total score is between 0 and 100. The higher the score, the higher the level of disability.
Measured: change from baseline in functional status at 8 weeks, 6 and 12 month follow-up.
Secondary outcomes (3)
Changes in quality of life
Health-related quality of life will be assessed by Nottingham Health Profile (NHP). The NHP contain 38 questions in 6 subareas: pain, physical abilities, energy level, sleep, social isolation and emotional reaction. The scores range from 0 to 100, with each question assigned a weighted value; the sum of all weighted values in a given sub-area adds up to 100. Lower scores denoting a better quality of life.
Measured: Change from baseline in life quality levels at 8 weeks, 6 and 12 month follow-up.
Changes in Exercise Compliance
Exercise Adherence Rating Scale (EARS) will be used to evaluate the exercise compliance of individuals. The result score of the questionnaire is between 0 and 64. A higher score indicates greater compliance with exercise.
Measured: Change from baseline in exercise compliance at 8 weeks, 6 and 12 month follow-up.
Changes in the gait
The gait of individuals will be evaluated by the valid and reliable OPTOGait photoelectric cell and the treadmill system. The gait of individuals on flat ground at their own pace will be recorded for 1 minute. The effects of the exercises on gait will be determined.
Measured: Change from baseline in gait at 8 weeks, 6 and 12 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start30 Sep 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
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 Hacettepe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muzeyyen Oz, Hacettepe University
- Investigators
- Muzeyyen OZ, MSc, Principal investigator, Hacettepe UniversityOzlem ULGER, Proffessor, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824547
- Sponsor's protocol ID
- GO 19/602
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2021
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akhtar MW, Karimi H, Gilani SA. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial. Pak J Med Sci. 2017 Jul-Aug;33(4):1002-1006. doi: 10.12669/pjms.334.12664.
PubMed 29067082Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20.
PubMed 28631003Zhu F, Zhang M, Wang D, Hong Q, Zeng C, Chen W. Yoga compared to non-exercise or physical therapy exercise on pain, disability, and quality of life for patients with chronic low back pain: A systematic review and meta-analysis of randomized controlled trials. PLoS One. 2020 Sep 1;15(9):e0238544. doi: 10.1371/journal.pone.0238544. eCollection 2020.
PubMed 32870936Owen PJ, Miller CT, Mundell NL, Verswijveren SJJM, Tagliaferri SD, Brisby H, Bowe SJ, Belavy DL. Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis. Br J Sports Med. 2020 Nov;54(21):1279-1287. doi: 10.1136/bjsports-2019-100886. Epub 2019 Oct 30.
PubMed 31666220
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bel Ağrılı Bireylerde Egzersizlerin Uzun Dönem Devamlılığının Değerlendirilmesi
- ClinicalTrials.gov ID
- NCT04824547
- Acronym / sponsor ID
- GO 19/602
- Conditions
- Chronic Low-back Pain
- Keywords
- exercise, pain, yoga, function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 1 Apr 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.
Identification of the long term effects of exercises in individuals with low back pain.
Detailed description
Individuals with low back pain who will participate in the study will be divided into two groups. In the stabilization exercise group will be instructed to perform spinal stabilization exercises and in the yoga group will be instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The intensity of the pain will be evaluated through visual analog scale, functional status and quality of life will be evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), respectively. The exercise adherence will evaluated Exercise Adherence Rating Scale (EARS). The time-distance characteristics of the gait will be evaluated by the OPTOGAIT photoelectric cell (OPTOGait, Microgate, Italy, 2010) and the treadmill system. Assessments will be repeated before, after the treatment, 6 and 12 month follow-up. Also,the number of back pain attacks of the individuals will be questioned and recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stabilization exercise group | Active comparator | Other: exerciseSpinal stabilization exercise will be applied all patients accompanied by physiotherapist. Sessions will be included selected exercises according to motor learning phases. |
| yoga group | Active comparator | Other: exerciseYoga program will be applied all patients in this group accompanied by physiotherapist. Sessions will be included selected breathing exercises, warm up, asana and relaxation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must be low back pain at least 3 months
- Must be visual analog scale rating 3 or more
Key exclusion criteria (8 listed)
- History of any lumbar spine surgery
- Severe/progressive scoliosis
- Spinal stenosis
- Spondylolisthesis
- Cancer
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 |
|---|---|---|
| exerciseAll exercises programs will applied two sessions per week, totally eight week.. | Other | Stabilization exercise group, yoga group |
Primary outcome
Changes in pain severity
Time frame: change from baseline in pain intensity at 8 weeks, 6 and 12 month follow-up.
Patients' average pain intensities will be assessed by Visual Analog Scale (VAS). Participants asked to mark the intensity of pain on a 10 cm long line, explaining that the leftmost of the line does not have pain, that the pain increases while moving to the right, and that the pain is unbearable on the far right.
Changes of functional status
Time frame: change from baseline in functional status at 8 weeks, 6 and 12 month follow-up.
Patient's pain related functional status will be measured by Oswestry Disability Index. The scale is considered the 'gold standard' of low back functional outcome tools. This scale contain questions related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The total score is between 0 and 100. The higher the score, the higher the level of disability.
3 secondary outcomes
Changes in quality of life
Time frame: Change from baseline in life quality levels at 8 weeks, 6 and 12 month follow-up.
Changes in Exercise Compliance
Time frame: Change from baseline in exercise compliance at 8 weeks, 6 and 12 month follow-up.
Changes in the gait
Time frame: Change from baseline in gait at 8 weeks, 6 and 12 month follow-up.
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 4 Mar 2024.
- Background: PubMed 29067082Akhtar MW, Karimi H, Gilani SA. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial. Pak J Med Sci. 2017 Jul-Aug;33(4):1002-1006. doi: 10.12669/pjms.334.12664.
- Background: PubMed 28631003Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20.
- Background: PubMed 32870936Zhu F, Zhang M, Wang D, Hong Q, Zeng C, Chen W. Yoga compared to non-exercise or physical therapy exercise on pain, disability, and quality of life for patients with chronic low back pain: A systematic review and meta-analysis of randomized controlled trials. PLoS One. 2020 Sep 1;15(9):e0238544. doi: 10.1371/journal.pone.0238544. eCollection 2020.
- Background: PubMed 31666220Owen PJ, Miller CT, Mundell NL, Verswijveren SJJM, Tagliaferri SD, Brisby H, Bowe SJ, Belavy DL. Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis. Br J Sports Med. 2020 Nov;54(21):1279-1287. doi: 10.1136/bjsports-2019-100886. Epub 2019 Oct 30.
- 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.
Muzeyyen OZ, MSc principal investigator
Hacettepe University
Ozlem ULGER, Proffessor study director
Hacettepe 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 exercise in people with Chronic Low-back Pain, 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 2 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 4 Mar 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?
Changes in pain severity (time frame: change from baseline in pain intensity at 8 weeks, 6 and 12 month follow-up.). The study lists 2 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 NCT04824547, 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 4 Mar 2024.