Chronic Low-back PainNCT06234891
The Effect of Physiotherapy on Chronic Low Back Pain
A study testing Nsaid and Phsiotheraphy in people with Chronic Low-back Pain, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Demographic data of patients diagnosed with chronic low back pain and planned for medical treatment (n:30) and physical therapy in addition to medical treatment (n:30), as well as before and after treatment; Visual analog scale (VAS), Oswestry Disability Index (ODI) and Short form 36 (SF-36) quality of life scoring… Read more about this study
- Who is it for?
- Ages 20 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Nsaid and Phsiotheraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Nov 2020to 15 Sep 2023
- 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 20 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have been prescribed medical treatment or physiotherapy for mechanical back pain
- Those with demographic information as well as VAS, ODI information in their files
- Patients between the ages of 20-79 who applied to our hospital with the complaint of chronic low back pain
Who cannot join
- Non-mechanical back pain
- Patients with physiotherapy contraindications
- Those with inflammatory diseases
- Severe heart failure
- Stroke, spinal cord injury, plegia due to traumatic brain injury
- A history of malignancy
Show all 10Show fewer
- Active infection during treatment
- Having metal implants in the waist area
- Established osteoporosis
- Those with pacemakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Physiotherapy on Pain, Functionality and Quality of Life Scores in Patients With Chronic Low Back Pain
Demographic data of patients diagnosed with chronic low back pain and planned for medical treatment (n:30) and physical therapy in addition to medical treatment (n:30), as well as before and after treatment; Visual analog scale (VAS), Oswestry Disability Index (ODI) and Short form 36 (SF-36) quality of life scoring, Lumbar range of motion (LHA), straight leg raising test (DBK) and hand-finger ground distance (EPZM) were evaluated. Hot pack, transcutaneous electrical nerve stimulation (TENS) and ultrasound were given as physical therapy agents.
Read the detailed description
Patients with VAS, ODI and SF-36 quality of life values before treatment, in addition to demographic data, who have applied to our Physical Medicine and Rehabilitation Policlinic in our hospital with chronic low back pain in the last 3 (three) months, are determined, and at least 30 above the age of 18 who received physiotherapy and who did not receive physiotherapy.
patient consents obtained and VAS, ODI and SF-36 quality of life values questioned.
Pre- and post-treatment values compared, and intragroup changes compared in both groups and evaluated whether physiotherapy contributes to pain, functionality and quality of life in treatment.
- Conditions
- Chronic Low-back Pain
- Being tested
- Nsaid, Phsiotheraphy
- Keywords
- physiotherapy, low back pain, quality of life, functionality
- 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.
NsaidDrug
Also called Medical treatment
Medical treatment
PhsiotheraphyOther
Also called Medical treatment and phsiotheraphy
Nsaid and phsiotheraphy (hotpack-ultrasound therapy- tens)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | NSAID Receives: Drug: Nsaid |
| Group 2 | Active comparator | nsaid and physiotherapy Receives: Drug: Nsaid; Other: Phsiotheraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog scale (VAS)
It is a scale used to evaluate pain intensity. Patients are asked to mark the severity of their pain on a 10 cm line. Patients are asked to mark the place expressing their pain on a line on the scale, where the starting point is no pain and the end point is the most severe pain experienced in life. When calculating, the distance between the marked point and the starting point is measured in cm. An increase in the score means that the severity of pain increases.
Measured: at baseline and immediately after treatment
Oswestry Disability Index (ODI)
It is a valid and reliable scoring in Turkish to evaluate the degree of loss of function in low back pain. It consists of 10 items that question pain severity, self-care, lifting and carrying loads, walking, sitting, standing, sleeping, degree of pain change, travel and social life. Each item is scored between "0" and "5". The maximum score is "100" and the minimum score is "0". The results are evaluated as 0-20 points if it minimally affects daily life, 20-40 points if it is moderate, 40-60 points if it is serious, 60-80 points if it completely restricts it, and 80-100 points if it is bedridden. The disability percentage can be calculated by converting the total score obtained into a percentage system. As the total score increases, the level of disability also increases.
Measured: at baseline and immediately after treatment
Secondary outcomes (4)
SF 36
Short Form-36 (SF-36) Quality of Life Survey: It is a frequently used survey in studies to evaluate the quality of life. A Turkish adaptation study was conducted and its validity and reliability were demonstrated. It consists of a total of 36 items. SF-36 Quality of Life Questionnaire questions the quality of life considering the last 4 weeks. It has 8 subgroups: physical functions, social functions, role inhibition due to physical problems, physical pain, mental health, role inhibition due to emotional problems, life energy and general health.
Measured: at baseline and immediately after treatment
range of motion (ROM)
Lumbar flexion, extension and lateral flexion ROM measurements were evaluated as limited, painful, open.
Measured: at baseline and immediately after treatment
Straight leg raising
It was considered positive if the patient felt pain between 30-70 degrees when she lifted her leg straight while lying on her back and the knee was at 180 degrees.
Measured: at baseline and immediately after treatment
Finger-to-ground distance
When the patient lumbar flexed forward, the distance between the floor and the ground was measured in centimeters and evaluated.
Measured: at baseline and immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start26 Nov 2020
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
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.
- 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
- Model description
- Patients with VAS, ODI and SF-36 quality of life values before treatment, in addition to demographic data, who have applied to our Physical Medicine and Rehabilitation Policlinic in our hospital with chronic low back pain in the last 3 (three) months, are determined, and at least 30 above the age of 18 who received physiotherapy and who did not receive physiotherapy. By calling the patient on the phone and being called to our hospital; patient consents will be obtained and VAS, ODI and SF-36 quality of life values will be questioned.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Havva Talay Çalış, Kayseri City Hospital
- Investigators
- Havva Talay Çalış, Prof, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234891
- Sponsor's protocol ID
- Kayseri City Hospital
- Status last verified
- Feb 2024
- First submitted
- 21 Jan 2024
- Last updated
- 13 Feb 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physiotherapy on Pain, Functionality and Quality of Life Scores in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06234891
- Acronym / sponsor ID
- Kayseri City Hospital
- Conditions
- Chronic Low-back Pain
- Keywords
- physiotherapy, low back pain, quality of life, functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 31 Jan 2024 (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.
Demographic data of patients diagnosed with chronic low back pain and planned for medical treatment (n:30) and physical therapy in addition to medical treatment (n:30), as well as before and after treatment; Visual analog scale (VAS), Oswestry Disability Index (ODI) and Short form 36 (SF-36) quality of life scoring, Lumbar range of motion (LHA), straight leg raising test (DBK) and hand-finger ground distance (EPZM) were evaluated. Hot pack, transcutaneous electrical nerve stimulation (TENS) and ultrasound were given as physical therapy agents.
Detailed description
Patients with VAS, ODI and SF-36 quality of life values before treatment, in addition to demographic data, who have applied to our Physical Medicine and Rehabilitation Policlinic in our hospital with chronic low back pain in the last 3 (three) months, are determined, and at least 30 above the age of 18 who received physiotherapy and who did not receive physiotherapy.
patient consents obtained and VAS, ODI and SF-36 quality of life values questioned.
Pre- and post-treatment values compared, and intragroup changes compared in both groups and evaluated whether physiotherapy contributes to pain, functionality and quality of life in treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with VAS, ODI and SF-36 quality of life values before treatment, in addition to demographic data, who have applied to our Physical Medicine and Rehabilitation Policlinic in our hospital with chronic low back pain in the last 3 (three) months, are determined, and at least 30 above the age of 18 who received physiotherapy and who did not receive physiotherapy. By calling the patient on the phone and being called to our hospital; patient consents will be obtained and VAS, ODI and SF-36 quality of life values will be questioned.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: NsaidNSAID |
| Group 2 | Active comparator | Drug: Nsaid, Other: Phsiotheraphynsaid and physiotherapy |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have been prescribed medical treatment or physiotherapy for mechanical back pain
- Those with demographic information as well as VAS, ODI information in their files
- Patients between the ages of 20-79 who applied to our hospital with the complaint of chronic low back pain
Key exclusion criteria (10 listed)
- Non-mechanical back pain
- Patients with physiotherapy contraindications
- Those with inflammatory diseases
- Severe heart failure
- Stroke, spinal cord injury, plegia due to traumatic brain injury
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 |
|---|---|---|
| NsaidAlso: Medical treatmentMedical treatment | Drug | Group 1, Group 2 |
| PhsiotheraphyAlso: Medical treatment and phsiotheraphyNsaid and phsiotheraphy (hotpack-ultrasound therapy- tens) | Other | Group 2 |
Primary outcome
Visual Analog scale (VAS)
Time frame: at baseline and immediately after treatment
It is a scale used to evaluate pain intensity. Patients are asked to mark the severity of their pain on a 10 cm line. Patients are asked to mark the place expressing their pain on a line on the scale, where the starting point is no pain and the end point is the most severe pain experienced in life. When calculating, the distance between the marked point and the starting point is measured in cm. An increase in the score means that the severity of pain increases.
Oswestry Disability Index (ODI)
Time frame: at baseline and immediately after treatment
It is a valid and reliable scoring in Turkish to evaluate the degree of loss of function in low back pain. It consists of 10 items that question pain severity, self-care, lifting and carrying loads, walking, sitting, standing, sleeping, degree of pain change, travel and social life. Each item is scored between "0" and "5". The maximum score is "100" and the minimum score is "0". The results are evaluated as 0-20 points if it minimally affects daily life, 20-40 points if it is moderate, 40-60 points if it is serious, 60-80 points if it completely restricts it, and 80-100 points if it is bedridden. The disability percentage can be calculated by converting the total score obtained into a percentage system. As the total score increases, the level of disability also increases.
4 secondary outcomes
SF 36
Time frame: at baseline and immediately after treatment
range of motion (ROM)
Time frame: at baseline and immediately after treatment
Straight leg raising
Time frame: at baseline and immediately after treatment
Finger-to-ground distance
Time frame: at baseline and immediately after treatment
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 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Low-back Pain
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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.
Havva Talay Çalış, Prof study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nsaid and Phsiotheraphy in people with Chronic Low-back Pain, run by Kayseri City Hospital 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 3 inclusion and 10 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 Feb 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?
Visual Analog scale (VAS) (time frame: at baseline and immediately after treatment). 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?
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 Feb 2024.