Acute Low Back PainPT-EDNCT06987656
Physiotherapy in Emergency Department for Acute Lumbar Spasm
An observational study of Acute Low Back Pain and Musculoskeletal Pain, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study aims to evaluate the effectiveness of physiotherapy interventions-such as manual therapy, electrotherapy (TENS), and individualized exercise programs-in managing acute lumbar spasm in patients presenting to the emergency department. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Low Back Pain, Musculoskeletal Pain, Emergency Care
- What is being tested?
- Standard Pharmacologic Treatment and Physiotherapy Intervention
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Jul 2025
- Phase
- Observational
- 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
Study population: This study will include adult patients aged 18 to 65 who are admitted to the Emergency Department of Düzce University Faculty of Medicine between June 1, 2025, and December 25, 2025, with a diagnosis of non-specific acute lumbar spasm. The study will retrospectively analyze data from electronic medical records to evaluate physiotherapy and pharmacologic treatment outcomes.
Who may be able to join
- Adults aged between 18 and 65 years
- Presented to the emergency department with non-specific acute lumbar spasm
- No serious pathology on initial evaluation (e.g., infection, malignancy, fracture)
- No contraindications to physiotherapy or physical activity
- Agreed to participate in the study and signed the informed consent (if applicable in prospective cases)
Who cannot join
- History of chronic low back pain
- Presence of neurological deficits (e.g., paresis, paralysis)
- Diagnosed with serious medical conditions such as infection, malignancy, or spondylodiscitis
- Pregnancy or contraindications related to reproductive health
- History of spinal surgery within the past year
- Cognitive or physical impairments limiting treatment participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Physiotherapy in the Management of Acute Lumbar Spasm in Emergency Departments: A Retrospective Observational Study
This retrospective observational study aims to evaluate the effectiveness of physiotherapy interventions-such as manual therapy, electrotherapy (TENS), and individualized exercise programs-in managing acute lumbar spasm in patients presenting to the emergency department. By analyzing medical records from January to June 2024 at Düzce University Faculty of Medicine, the study will compare outcomes between patients receiving only pharmacological treatment and those receiving additional physiotherapy. Primary outcomes include changes in pain levels (measured by Visual Analog Scale), medication usage, patient satisfaction, and re-admission rates within an 8-week follow-up period. The findings aim to inform the integration of physiotherapy into emergency care protocols for acute lumbar spasm.
Read the detailed description
This retrospective observational study investigates the role of physiotherapy in managing acute lumbar spasm in emergency department settings. The study will review medical records of 100 patients aged 18 to 65 who presented to Düzce University Faculty of Medicine Emergency Department between January and June 2024 with non-specific acute low back spasm.
Patients will be divided into two groups based on documented treatment: (1) those receiving pharmacological treatment only, and (2) those receiving both pharmacological and physiotherapy interventions. Physiotherapy interventions include spinal mobilization, myofascial release, TENS (Transcutaneous Electrical Nerve Stimulation), and individualized exercise protocols.
Primary outcomes include changes in pain intensity (measured by Visual Analog Scale), medication consumption, re-admission rates within 8 weeks, and overall patient satisfaction. The study also incorporates a cost analysis based on national reimbursement tariffs (SUT) to evaluate the financial impact of integrating physiotherapy into emergency care.
This study does not involve any direct intervention, and data are collected exclusively from existing electronic health records. Ethical approval has been obtained. The findings are expected to guide future protocols involving the integration of physiotherapy into emergency departments in Turkey.
- Conditions
- Acute Low Back Pain, Musculoskeletal Pain, Emergency Care
- Being tested
- Standard Pharmacologic Treatment, Physiotherapy Intervention
- Keywords
- Physiotherapy, Acute Low Back Spasm, Emergency Department, Manual Therapy, Exercise Therapy, Pain Management
- Medical subject headings
- Musculoskeletal Pain, Emergencies, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Pharmacologic TreatmentDrug
Standard pharmacologic management including nonsteroidal anti-inflammatory drugs (NSAIDs), muscle relaxants (e.g., thiocolchicoside), and analgesics (e.g., paracetamol, tramadol) for acute lumbar spasm.
Physiotherapy InterventionOther
Physiotherapy interventions included spinal mobilization (Maitland techniques), myofascial release, transcutaneous electrical nerve stimulation (TENS), and personalized exercise programs, as documented in patient medical records.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacologic Treatment Only Group | Patients who received standard pharmacologic treatment only, including NSAIDs, muscle relaxants, and analgesics, without any physiotherapy intervention. Receives: Drug: Standard Pharmacologic Treatment | |
| Pharmacologic + Physiotherapy Group | Patients who received standard pharmacologic treatment along with physiotherapy interventions, including spinal mobilization, electrotherapy (TENS), and individualized exercise programs. Receives: Drug: Standard Pharmacologic Treatment; Other: Physiotherapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity Measured by Visual Analog Scale (VAS) From Admission to Discharge
At Emergency Department Admission and at Time of Discharge (up to 12 hours)
Measured: VAS score (0-10 scale)
Secondary outcomes (1)
Level of Patient Satisfaction Recorded at Discharge
Patient satisfaction levels will be assessed using standardized satisfaction forms documented in the electronic medical record system at the time of discharge. Data will be extracted retrospectively and categorized as satisfied, neutral, or dissatisfied, based on the available hospital documentation.
Measured: At Discharge (within 12 hours of Emergency Department Admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Jan 2025
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University
- Responsible party
- Principal investigator, Veysel Uludag, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987656
- Sponsor's protocol ID
- 2024/254
- Acronym
- PT-ED
- Status last verified
- Sep 2025
- First submitted
- 15 May 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the retrospective nature of the study and the use of sensitive patient information obtained from electronic medical records. The study does not include prior consent for data sharing, and confidentiality regulations prohibit the distribution of such data.
Publications
Uludag V, Tekin RT, Bogan M, Senguldur E, Demir MC. Integrating physiotherapy into the emergency department for acute low back spasm: a retrospective comparative study. Physiother Theory Pract. 2026 Jan 30:1-10. doi: 10.1080/09593985.2026.2624519. Online ahead of print.
PubMed 41614542
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Physiotherapy in the Management of Acute Lumbar Spasm in Emergency Departments: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT06987656
- Acronym / sponsor ID
- PT-ED / 2024/254
- Conditions
- Acute Low Back Pain, Musculoskeletal Pain, Emergency Care
- Keywords
- Physiotherapy, Acute Low Back Spasm, Emergency Department, Manual Therapy, Exercise Therapy, Pain Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 23 May 2025 (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 retrospective observational study aims to evaluate the effectiveness of physiotherapy interventions-such as manual therapy, electrotherapy (TENS), and individualized exercise programs-in managing acute lumbar spasm in patients presenting to the emergency department. By analyzing medical records from January to June 2024 at Düzce University Faculty of Medicine, the study will compare outcomes between patients receiving only pharmacological treatment and those receiving additional physiotherapy. Primary outcomes include changes in pain levels (measured by Visual Analog Scale), medication usage, patient satisfaction, and re-admission rates within an 8-week follow-up period. The findings aim to inform the integration of physiotherapy into emergency care protocols for acute lumbar spasm.
Detailed description
This retrospective observational study investigates the role of physiotherapy in managing acute lumbar spasm in emergency department settings. The study will review medical records of 100 patients aged 18 to 65 who presented to Düzce University Faculty of Medicine Emergency Department between January and June 2024 with non-specific acute low back spasm.
Patients will be divided into two groups based on documented treatment: (1) those receiving pharmacological treatment only, and (2) those receiving both pharmacological and physiotherapy interventions. Physiotherapy interventions include spinal mobilization, myofascial release, TENS (Transcutaneous Electrical Nerve Stimulation), and individualized exercise protocols.
Primary outcomes include changes in pain intensity (measured by Visual Analog Scale), medication consumption, re-admission rates within 8 weeks, and overall patient satisfaction. The study also incorporates a cost analysis based on national reimbursement tariffs (SUT) to evaluate the financial impact of integrating physiotherapy into emergency care.
This study does not involve any direct intervention, and data are collected exclusively from existing electronic health records. Ethical approval has been obtained. The findings are expected to guide future protocols involving the integration of physiotherapy into emergency departments in Turkey.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacologic Treatment Only Group | – | Drug: Standard Pharmacologic TreatmentPatients who received standard pharmacologic treatment only, including NSAIDs, muscle relaxants, and analgesics, without any physiotherapy intervention. |
| Pharmacologic + Physiotherapy Group | – | Drug: Standard Pharmacologic Treatment, Other: Physiotherapy InterventionPatients who received standard pharmacologic treatment along with physiotherapy interventions, including spinal mobilization, electrotherapy (TENS), and individualized exercise programs. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include adult patients aged 18 to 65 who are admitted to the Emergency Department of Düzce University Faculty of Medicine between June 1, 2025, and December 25, 2025, with a diagnosis of non-specific acute lumbar spasm. The study will retrospectively analyze data from electronic medical records to evaluate physiotherapy and pharmacologic treatment outcomes.
Key inclusion criteria (5 listed)
- Adults aged between 18 and 65 years
- Presented to the emergency department with non-specific acute lumbar spasm
- No serious pathology on initial evaluation (e.g., infection, malignancy, fracture)
- No contraindications to physiotherapy or physical activity
- Agreed to participate in the study and signed the informed consent (if applicable in prospective cases)
Key exclusion criteria (6 listed)
- History of chronic low back pain
- Presence of neurological deficits (e.g., paresis, paralysis)
- Diagnosed with serious medical conditions such as infection, malignancy, or spondylodiscitis
- Pregnancy or contraindications related to reproductive health
- History of spinal surgery within the past year
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 |
|---|---|---|
| Standard Pharmacologic TreatmentStandard pharmacologic management including nonsteroidal anti-inflammatory drugs (NSAIDs), muscle relaxants (e.g., thiocolchicoside), and analgesics (e.g., paracetamol, tramadol) for acute lumbar spasm. | Drug | Pharmacologic + Physiotherapy Group, Pharmacologic Treatment Only Group |
| Physiotherapy InterventionPhysiotherapy interventions included spinal mobilization (Maitland techniques), myofascial release, transcutaneous electrical nerve stimulation (TENS), and personalized exercise programs, as documented in patient medical records. | Other | Pharmacologic + Physiotherapy Group |
Primary outcome
Change in Pain Intensity Measured by Visual Analog Scale (VAS) From Admission to Discharge
Time frame: VAS score (0-10 scale)
At Emergency Department Admission and at Time of Discharge (up to 12 hours)
1 secondary outcome
Level of Patient Satisfaction Recorded at Discharge
Time frame: At Discharge (within 12 hours of Emergency Department Admission)
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 8 Sep 2025.
- Derived from this study: PubMed 41614542Uludag V, Tekin RT, Bogan M, Senguldur E, Demir MC. Integrating physiotherapy into the emergency department for acute low back spasm: a retrospective comparative study. Physiother Theory Pract. 2026 Jan 30:1-10. doi: 10.1080/09593985.2026.2624519. Online ahead of print.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the retrospective nature of the study and the use of sensitive patient information obtained from electronic medical records. The study does not include prior consent for data sharing, and confidentiality regulations prohibit the distribution of such data.
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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?
An observational study of Acute Low Back Pain and Musculoskeletal Pain, run by Duzce 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 8 Sep 2025. 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 in Pain Intensity Measured by Visual Analog Scale (VAS) From Admission to Discharge (time frame: VAS score (0-10 scale)). 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 NCT06987656, which also lists 1 linked publication.
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 8 Sep 2025.