Central SensitizationNCT05937503
Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain
A study testing manual therapy and conventional physiotherapy in people with Central Sensitization and Manual Therapy, run by Atılım University at 2 sites in Turkey (Türkiye).
Trial summary
Central sensitization (CS) is defined as the increased responsiveness of nociceptive neurons in the central nervous system to normal or subthreshold afferent input. CS has been proposed as an underlying mechanism of chronic pain in musculoskeletal disorders including low back pain (LBP). Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Central Sensitization, Manual Therapy
- What is being tested?
- manual therapy and conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 17 Jul 2023to 30 Aug 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- non-spesific low back pain patients with pain longer than 12 weeks
- aged between 20-64 years male and female participants
Who cannot join
- concomitant disease that would interfere with treatment
- pregnancy
- have had any spinal surgery or fracture
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Naime Ulug
Ankara, Select State, 06830
Atılım University
Ankara
About this study
Official title: Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain.A Randomized Controlled Study.
Central sensitization (CS) is defined as the increased responsiveness of nociceptive neurons in the central nervous system to normal or subthreshold afferent input. CS has been proposed as an underlying mechanism of chronic pain in musculoskeletal disorders including low back pain (LBP).
The aim of this study is to investigate the effect of manual therapy on central sensitization in patients with nonspecific chronic LBP.
Read the detailed description
A total of 40 LBP patients aged between 24-64 with CSS will be randomized into two groups. The manual therapy group will receive a 4-week manual therapy (two sessions/week) plus the conventional physiotherapy program, while the control group will only receive conventional physiotherapy. Before and after the interventions pain intensity (VAS), and scores of three questionnaires: Oswestry Disability Index (ODI), Central Sensitization Inventory (CSI), and the 36-item Short Form Health Survey Questionnaire (SF-36) will be recorded.The outcomes of the study will be analyzed by appropriate statistical methods.
- Conditions
- Central Sensitization, Manual Therapy
- Being tested
- manual therapy, conventional physiotherapy
- Keywords
- central sensitization, manual therapy, non-specific low back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual therapyOther
Also called conventional physiotherapy
The manual therapy group will receive a 4-week manual therapy plus conventionel physiotherapy.
conventional physiotherapyOther
Control group will only receive conventionel physiotherapy intervention.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy | Experimental | Manual therapy group Receives: Other: manual therapy; Other: conventional physiotherapy |
| Conventional physiotherapy | Other | Conventional physiotherapy group Receives: Other: manual therapy; Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
A 10 cm Visual Analog Scale will be used to determine the severity of pain, with numbers ranging from "0" (no pain) to "10" (unbearable pain)
Measured: Up to one month
Central Sensitization
Central Sensitization Inventory (CSI) scale will be used severity of central sensitization.The total score range of the scale, which consists of a total of 25 questions, is between 0-100 points. Central sensitization with a score of 40 and above is considered positive. An increase in the total score indicates an increase in the level of central sensitization.
Measured: Up to one month
Secondary outcomes (3)
Oswestry Disability Index
Oswestry Disability Index (ODI) will be used to measure disability level
Measured: Up to one month
Health Survey
36-item Short Form Health Survey Questionnaire (SF-36) will be used
Measured: Up to one month
Hospital Anxeity and depresssion
Hospital Anxeity and Depression Scale will be used. The cut-off points for caseness of anxiety or depression is 8/21 for anxiety or depression. For anxiety (HADS-A) this gave a specificity of 0.78 and a sensitivity of 0.9. For depression (HADS-D) this gave a specificity of 0.79 and a sensitivity of 0.83.
The scores of the scale are as follows: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Measured: Up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start17 Jul 2023 (estimated)
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central SensitizationStudies 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
- prospective randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NAİME ULUG, Atılım University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937503
- Sponsor's protocol ID
- E-59394181-604.01.02-33380
- Status last verified
- Jul 2023
- First submitted
- 27 Jun 2023
- Last updated
- 18 Jul 2023
- 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 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain.A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05937503
- Acronym / sponsor ID
- E-59394181-604.01.02-33380
- Conditions
- Central Sensitization, Manual Therapy
- Keywords
- central sensitization, manual therapy, non-specific low back pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 17 Jul 2023 (estimated)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 10 Jul 2023 (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.
Central sensitization (CS) is defined as the increased responsiveness of nociceptive neurons in the central nervous system to normal or subthreshold afferent input. CS has been proposed as an underlying mechanism of chronic pain in musculoskeletal disorders including low back pain (LBP).
The aim of this study is to investigate the effect of manual therapy on central sensitization in patients with nonspecific chronic LBP.
Detailed description
A total of 40 LBP patients aged between 24-64 with CSS will be randomized into two groups. The manual therapy group will receive a 4-week manual therapy (two sessions/week) plus the conventional physiotherapy program, while the control group will only receive conventional physiotherapy. Before and after the interventions pain intensity (VAS), and scores of three questionnaires: Oswestry Disability Index (ODI), Central Sensitization Inventory (CSI), and the 36-item Short Form Health Survey Questionnaire (SF-36) will be recorded.The outcomes of the study will be analyzed by appropriate statistical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | Experimental | Other: manual therapy, Other: conventional physiotherapyManual therapy group |
| Conventional physiotherapy | Other | Other: manual therapy, Other: conventional physiotherapyConventional physiotherapy group |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- non-spesific low back pain patients with pain longer than 12 weeks
- aged between 20-64 years male and female participants
Key exclusion criteria (3 listed)
- concomitant disease that would interfere with treatment
- pregnancy
- have had any spinal surgery or fracture
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 |
|---|---|---|
| manual therapyAlso: conventional physiotherapyThe manual therapy group will receive a 4-week manual therapy plus conventionel physiotherapy. | Other | Conventional physiotherapy, Manual therapy |
| conventional physiotherapyControl group will only receive conventionel physiotherapy intervention. | Other | Conventional physiotherapy, Manual therapy |
Primary outcome
Pain intensity
Time frame: Up to one month
A 10 cm Visual Analog Scale will be used to determine the severity of pain, with numbers ranging from "0" (no pain) to "10" (unbearable pain)
Central Sensitization
Time frame: Up to one month
Central Sensitization Inventory (CSI) scale will be used severity of central sensitization.The total score range of the scale, which consists of a total of 25 questions, is between 0-100 points. Central sensitization with a score of 40 and above is considered positive. An increase in the total score indicates an increase in the level of central sensitization.
3 secondary outcomes
Oswestry Disability Index
Time frame: Up to one month
Health Survey
Time frame: Up to one month
Hospital Anxeity and depresssion
Time frame: Up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual therapy and conventional physiotherapy in people with Central Sensitization and Manual Therapy, run by Atılım University at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Pain intensity (time frame: Up to one month). 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 18 Jul 2023.