Neck PainNCT06620965
A Comparison of the Effectiveness of PNF and Mulligan Mobilization Techniques with Neck Pain
A study testing Mulligan Mobilization Technique and Proprioceptive Neuromuscular Facilitation (PNF) Technique in people with Neck Pain, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effectiveness of PNF (Proprioceptive Neuromuscular Facilitation) and Mulligan Mobilization techniques with classical physiotherapy modalities in individuals with neck pain. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Mulligan Mobilization Technique and Proprioceptive Neuromuscular Facilitation (PNF) Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Sep 2022to 14 Jun 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Complaint of neck pain for at least 3 months
- Volunteer between the ages of 18-55
- Receiving a diagnosis of chronic neck pain by a physician
Who cannot join
- Having undergone a surgical procedure for the spine
- Exercise therapy and/or physical therapy within the last 1 year
- History of fracture in the cervical region
- Radiculopathy, myelopathy (motor and sensory loss), or neurological impairment
- Presence of Cardiac Pacemaker
- Positive vertebrobasilar artery test
Show all 11Show fewer
- Having a blood clotting disorder
- Presence of cancer
- Being diagnosed with rheumatoid arthritis
- Those with systemic diseases targeting the cervical region
- Presence of active infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital
Kahramanmaraş, 46040
About this study
Official title: A Comparison of the Effectiveness of PNF and Mulligan Mobilization Techniques with Classic Physiotherapy Modalities in People with Neck Pain
The aim of this study is to compare the effectiveness of PNF (Proprioceptive Neuromuscular Facilitation) and Mulligan Mobilization techniques with classical physiotherapy modalities in individuals with neck pain.
Read the detailed description
Forty individuals with neck pain aged between 18-55 years will be randomly divided into two groups, PNF and Mulligan group. Classical physiotherapy modalities will be applied to all individuals 5 days a week. PNF group will receive PNF techniques three days a week and Mulligan group will receive Mulligan mobilization techniques three days a week. Participants will be treated for 4 weeks. The pain level of the patients whose demographic data were recorded; Visual Analog Scale (VAS), pressure pain threshold; algometer, range of motion (ROM); universal goniometer, functionality; Neck Disability Index, kinesiophobia; Tampa Kinesiophobia Scale, quality of life; SF-36 Quality of Life Scale, mood; Beck Depression Inventory, cervical muscle performance level; cervical performance tests will be measured before and after treatment.
Post-treatment pain intensity, kinesiophobia and depression level; the effectiveness of pressure pain threshold, ROM, functionality, quality of life and cervical muscle performance level will be compared within and between groups.
- Conditions
- Neck Pain
- Being tested
- Mulligan Mobilization Technique, Proprioceptive Neuromuscular Facilitation (PNF) Technique
- Keywords
- Neck pain, Rehabilitation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan Mobilization TechniqueProcedure or surgery
NAGs (Natural Apophyseal Glides) involve passive oscillatory movements of a spinal facet joint in an anterocranial direction, performed with the patient seated. SNAGs (Sustained Natural Apophyseal Glides) maintain facet glides during active movements, aiming to reach the joint\'s end range. In SNAGs, the patient actively participates, and overpressure is applied at the end of movements to enhance the range of motion. Techniques include increasing rotation, lateral flexion, flexion, and extension. These were applied by a certified physiotherapist three times a week for four weeks, aiming to improve joint mobility without causing pain.
Proprioceptive Neuromuscular Facilitation (PNF) TechniqueProcedure or surgery
Proprioceptive Neuromuscular Facilitation (PNF) Technique: PNF consists of four movement patterns in two diagonals:
Flexion-left rotation and extension-right rotation Flexion-right rotation and extension-left rotation 3 PNF techniques were applied.
Combined Isotonic Contractions: This technique involves concentric, eccentric, and stabilizing contractions of a muscle group (agonist). The goal is to increase active range of motion (ROM), strength, and improve control and coordination.
Dynamic Stabilization (Stabilizing Reversal): This involves applying resistance in various directions to prevent movement, aiming to enhance dynamic stability, strength, and agonist-antagonist coordination.
Hold-Relax Technique: This relaxation method involves isometric contractions against maximum resistance without movement to increase passive ROM and reduce pain. These were applied by physiotherapist three times a week for four weeks, aiming to improve joint mobility without causing pain.
| Study group | Role | What they receive |
|---|---|---|
| Mulligan Mobilization Group | Active comparator | Mulligan mobilization techniques will be applied Receives: Procedure: Mulligan Mobilization Technique |
| PNF group | Active comparator | Proprioceptive Neuromuscular Facilitation techniques will be applied Receives: Procedure: Proprioceptive Neuromuscular Facilitation (PNF) Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The intensity of pain was assessed separately during rest and activity using the Visual Analog Scale (VAS). The patient was informed that on a 10 cm ruler, a score of 0 indicated no pain and a score of 10 represented the most severe pain imaginable, and was asked to mark the point that represented their pain level. The marked point was then measured in centimeters on the ruler and recorded as the pain intensity data.
Measured: From enrollment to the end of treatment at 4 weeks
Pressure pain threshold test
In the pressure pain threshold assessment, algometer capable of measuring up to 200 Newtons with a precision of 0.1 Newton was used. The pressure application surface of the algometer was blunt and non-sharp, with a diameter of 1 square centimeter. The individual was seated in a relaxed posture, facing away from the physiotherapist during the measurement. Prior to the assessment, the painful tender area was identified through palpation based on the patient's guidance. Before the application, the individual was informed, and the compression pressure was gradually increased perpendicularly to the surface. The patient was asked to indicate the moment when the pressure sensation transitioned to pain. Three measurements were taken at one-minute intervals, and the average of these measurements was recorded as the pressure pain threshold value.
Measured: From enrollment to the end of treatment at 4 weeks
Assessment of Joint Range of Motion (ROM)
Active cervical range of motion for flexion, extension, right-left rotation, and right-left lateral flexion was assessed by the researcher using a Universal Goniometer. The goniometer was positioned at the pivot point of each movement, and the individual was instructed to move their neck to its full extent. During the assessment, patients were asked to keep their feet on the ground, sit with their hands resting on their thighs, and maintain a neutral pelvis. Movements were performed at a steady pace with shoulders and back stabilized, and a 5-10 second rest in a neutral position was required after each movement.
For cervical flexion and extension, the physiotherapist stood beside the individual, aligning the pivot with the acromion and following the ear's midline projection. For lateral flexion, the physiotherapist stood behind the individual, aligning the pivot with the C7 spinous process and following the cervical vertebrae's spinal protrusions.
Measured: From enrollment to the end of treatment at 4 weeks
Assessment of Functional Level
To assess patients' functional levels, the Turkish version of the Neck Disability Index (NDI) was used. This test evaluates disability in daily life due to neck pain. Each section is scored from 0 to 5, with 5 indicating complete disability and 0 indicating no disability, resulting in a total of 6 possible scores. Scores range from 0 to 50. The 10-section test assesses the impact of pain on pain level, personal care, lifting, reading, headaches, concentration, work, driving, sleep, and recreational activities. Scores are categorized as follows: 0-4 indicates no disability, 5-14 indicates mild disability, 15-24 indicates moderate disability, 25-34 indicates severe disability, and 35 or above indicates complete disability.
The test-retest reliability of the Turkish version, as assessed by Telci and colleagues, has an Intraclass Correlation Coefficient (ICC) value of 0.979, indicating excellent reliability.
Measured: From enrollment to the end of treatment at 4 weeks
Assessment of Kinesiophobia
To measure fear of movement and re-injury in patients, the Tampa Scale for Kinesiophobia, developed by Kori and colleagues, was used. The Turkish version, adapted by Tunca-Yılmaz and their team in 2011, has demonstrated excellent test-retest reliability with an Intraclass Correlation Coefficient (ICC) of 0.806 (95% confidence interval = 0.720-0.867). The test comprises 17 questions, with scores ranging from a minimum of 17 to a maximum of 68. Higher scores indicate a higher level of kinesiophobia in the individual.
Measured: From enrollment to the end of treatment at 4 weeks
Assessment of Quality of Life
Patients' health-related quality of life was assessed using the Turkish version of the Short Form-36 (SF-36), validated and reliability-tested by Koçyiğit and colleagues. Reliability was evaluated using Cronbach's alpha coefficients, which ranged from 0.7324 to 0.7612, indicating acceptable internal consistency. Item-total score correlations, which measure the relationship between each item and the total score, ranged from 0.4712 to 0.8872. Validity was assessed by examining correlations with other measures, with correlation coefficients ranging from 0.44 to 0.65.
The SF-36 consists of 36 items across 8 subscales: physical function, social function, general health, vitality, mental health, pain, and role limitations due to physical and emotional problems. Each subscale is scored from 0 to 100, with higher scores indicating better quality of life.
Measured: From enrollment to the end of treatment at 4 weeks
Emotional State Assessment
Patients' emotional state was evaluated using the Turkish version of the Beck Depression Inventory. The Turkish validity and reliability study was conducted by Hisli in 1988. Reliability analysis, including item analysis (r: 0.80) and split-half techniques (r: 0.74), showed good correlation coefficients. For validity, the correlation coefficient with the Minnesota Multiphasic Personality Inventory scale was r: 0.50 (moderate).
The questionnaire consists of 21 items, each with 4 response options. Patients were asked to select the option that best describes how they felt over the past week. Each item is scored from 0 to 3, with a maximum possible score of 63.
Measured: From enrollment to the end of treatment at 4 weeks
Assessment of Muscular Endurance
Cervical Flexors: To evaluate cervical flexors, the patient was instructed to lie supine. The physiotherapist placed their hand under the patient's occiput. The patient's head was positioned in flexion, approximately 2.5 cm off the surface, and held straight. The patient was asked to maintain this position as long as possible, and the duration was recorded in seconds. The timing was stopped and recorded when the patient could no longer maintain the position or if the flexion was disrupted.
Cervical Extensors: For evaluating cervical extensors, the patient was positioned face down, with their arms at their sides and head hanging off the edge of the bed. The physiotherapist supported and positioned the patient accordingly. Once the patient achieved the correct position, the test and stopwatch were started simultaneously. The test ended and the duration was recorded in seconds when the patient lost the position.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start21 Sep 2022
- Primary completion6 Jan 2023
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck 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
- There are two groups: the Mulligan group, which applies Mulligan mobilization techniques, and the PNF group, which applies PNF techniques.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faruk Daniisman, Kahramanmaras Sutcu Imam University
- Investigators
- Faruk Danışman, Ph.D, Principal investigator, Kahramanmaraş Sütçü İmam Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620965
- Sponsor's protocol ID
- PNFvsMULLIGAN
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 2 Oct 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 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effectiveness of PNF and Mulligan Mobilization Techniques with Classic Physiotherapy Modalities in People with Neck Pain
- ClinicalTrials.gov ID
- NCT06620965
- Acronym / sponsor ID
- PNFvsMULLIGAN
- Conditions
- Neck Pain
- Keywords
- Neck pain, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 1 Oct 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.
The aim of this study is to compare the effectiveness of PNF (Proprioceptive Neuromuscular Facilitation) and Mulligan Mobilization techniques with classical physiotherapy modalities in individuals with neck pain.
Detailed description
Forty individuals with neck pain aged between 18-55 years will be randomly divided into two groups, PNF and Mulligan group. Classical physiotherapy modalities will be applied to all individuals 5 days a week. PNF group will receive PNF techniques three days a week and Mulligan group will receive Mulligan mobilization techniques three days a week. Participants will be treated for 4 weeks. The pain level of the patients whose demographic data were recorded; Visual Analog Scale (VAS), pressure pain threshold; algometer, range of motion (ROM); universal goniometer, functionality; Neck Disability Index, kinesiophobia; Tampa Kinesiophobia Scale, quality of life; SF-36 Quality of Life Scale, mood; Beck Depression Inventory, cervical muscle performance level; cervical performance tests will be measured before and after treatment.
Post-treatment pain intensity, kinesiophobia and depression level; the effectiveness of pressure pain threshold, ROM, functionality, quality of life and cervical muscle performance level will be compared within and between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There are two groups: the Mulligan group, which applies Mulligan mobilization techniques, and the PNF group, which applies PNF techniques.
| Arm | Type | Receives |
|---|---|---|
| Mulligan Mobilization Group | Active comparator | Procedure: Mulligan Mobilization TechniqueMulligan mobilization techniques will be applied |
| PNF group | Active comparator | Procedure: Proprioceptive Neuromuscular Facilitation (PNF) TechniqueProprioceptive Neuromuscular Facilitation techniques will be applied |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Complaint of neck pain for at least 3 months
- Volunteer between the ages of 18-55
- Receiving a diagnosis of chronic neck pain by a physician
Key exclusion criteria (11 listed)
- Having undergone a surgical procedure for the spine
- Exercise therapy and/or physical therapy within the last 1 year
- History of fracture in the cervical region
- Radiculopathy, myelopathy (motor and sensory loss), or neurological impairment
- Presence of Cardiac Pacemaker
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 |
|---|---|---|
| Mulligan Mobilization TechniqueNAGs (Natural Apophyseal Glides) involve passive oscillatory movements of a spinal facet joint in an anterocranial direction, performed with the patient seated. SNAGs (Sustained Natural Apophyseal Glides) maintain facet glides during active movements, aiming to reach the joint\'s end range. In SNAGs, the patient actively participates, and overpressure is applied at the end of movements to enhance the range of motion. Techniques include increasing rotation, lateral flexion, flexion, and extension. These were applied by a certified physiotherapist three times a week for four weeks, aiming to improve joint mobility without causing pain. | Procedure or surgery | Mulligan Mobilization Group |
| Proprioceptive Neuromuscular Facilitation (PNF) TechniqueProprioceptive Neuromuscular Facilitation (PNF) Technique: PNF consists of four movement patterns in two diagonals: Flexion-left rotation and extension-right rotation Flexion-right rotation and extension-left rotation 3 PNF techniques were applied. Combined Isotonic Contractions: This technique involves concentric, eccentric, and stabilizing contractions of a muscle group (agonist). The goal is to increase active range of motion (ROM), strength, and improve control and coordination. Dynamic Stabilization (Stabilizing Reversal): This involves applying resistance in various directions to prevent movement, aiming to enhance dynamic stability, strength, and agonist-antagonist coordination. Hold-Relax Technique: This relaxation method involves isometric contractions against maximum resistance without movement to increase passive ROM and reduce pain. These were applied by physiotherapist three times a week for four weeks, aiming to improve joint mobility without causing pain. | Procedure or surgery | PNF group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: From enrollment to the end of treatment at 4 weeks
The intensity of pain was assessed separately during rest and activity using the Visual Analog Scale (VAS). The patient was informed that on a 10 cm ruler, a score of 0 indicated no pain and a score of 10 represented the most severe pain imaginable, and was asked to mark the point that represented their pain level. The marked point was then measured in centimeters on the ruler and recorded as the pain intensity data.
Pressure pain threshold test
Time frame: From enrollment to the end of treatment at 4 weeks
In the pressure pain threshold assessment, algometer capable of measuring up to 200 Newtons with a precision of 0.1 Newton was used. The pressure application surface of the algometer was blunt and non-sharp, with a diameter of 1 square centimeter. The individual was seated in a relaxed posture, facing away from the physiotherapist during the measurement. Prior to the assessment, the painful tender area was identified through palpation based on the patient's guidance. Before the application, the individual was informed, and the compression pressure was gradually increased perpendicularly to the surface. The patient was asked to indicate the moment when the pressure sensation transitioned to pain. Three measurements were taken at one-minute intervals, and the average of these measurements was recorded as the pressure pain threshold value.
Assessment of Joint Range of Motion (ROM)
Time frame: From enrollment to the end of treatment at 4 weeks
Active cervical range of motion for flexion, extension, right-left rotation, and right-left lateral flexion was assessed by the researcher using a Universal Goniometer. The goniometer was positioned at the pivot point of each movement, and the individual was instructed to move their neck to its full extent. During the assessment, patients were asked to keep their feet on the ground, sit with their hands resting on their thighs, and maintain a neutral pelvis. Movements were performed at a steady pace with shoulders and back stabilized, and a 5-10 second rest in a neutral position was required after each movement. For cervical flexion and extension, the physiotherapist stood beside the individual, aligning the pivot with the acromion and following the ear's midline projection. For lateral flexion, the physiotherapist stood behind the individual, aligning the pivot with the C7 spinous process and following the cervical vertebrae's spinal protrusions.
Assessment of Functional Level
Time frame: From enrollment to the end of treatment at 4 weeks
To assess patients' functional levels, the Turkish version of the Neck Disability Index (NDI) was used. This test evaluates disability in daily life due to neck pain. Each section is scored from 0 to 5, with 5 indicating complete disability and 0 indicating no disability, resulting in a total of 6 possible scores. Scores range from 0 to 50. The 10-section test assesses the impact of pain on pain level, personal care, lifting, reading, headaches, concentration, work, driving, sleep, and recreational activities. Scores are categorized as follows: 0-4 indicates no disability, 5-14 indicates mild disability, 15-24 indicates moderate disability, 25-34 indicates severe disability, and 35 or above indicates complete disability. The test-retest reliability of the Turkish version, as assessed by Telci and colleagues, has an Intraclass Correlation Coefficient (ICC) value of 0.979, indicating excellent reliability.
Assessment of Kinesiophobia
Time frame: From enrollment to the end of treatment at 4 weeks
To measure fear of movement and re-injury in patients, the Tampa Scale for Kinesiophobia, developed by Kori and colleagues, was used. The Turkish version, adapted by Tunca-Yılmaz and their team in 2011, has demonstrated excellent test-retest reliability with an Intraclass Correlation Coefficient (ICC) of 0.806 (95% confidence interval = 0.720-0.867). The test comprises 17 questions, with scores ranging from a minimum of 17 to a maximum of 68. Higher scores indicate a higher level of kinesiophobia in the individual.
Assessment of Quality of Life
Time frame: From enrollment to the end of treatment at 4 weeks
Patients' health-related quality of life was assessed using the Turkish version of the Short Form-36 (SF-36), validated and reliability-tested by Koçyiğit and colleagues. Reliability was evaluated using Cronbach's alpha coefficients, which ranged from 0.7324 to 0.7612, indicating acceptable internal consistency. Item-total score correlations, which measure the relationship between each item and the total score, ranged from 0.4712 to 0.8872. Validity was assessed by examining correlations with other measures, with correlation coefficients ranging from 0.44 to 0.65. The SF-36 consists of 36 items across 8 subscales: physical function, social function, general health, vitality, mental health, pain, and role limitations due to physical and emotional problems. Each subscale is scored from 0 to 100, with higher scores indicating better quality of life.
Emotional State Assessment
Time frame: From enrollment to the end of treatment at 4 weeks
Patients' emotional state was evaluated using the Turkish version of the Beck Depression Inventory. The Turkish validity and reliability study was conducted by Hisli in 1988. Reliability analysis, including item analysis (r: 0.80) and split-half techniques (r: 0.74), showed good correlation coefficients. For validity, the correlation coefficient with the Minnesota Multiphasic Personality Inventory scale was r: 0.50 (moderate). The questionnaire consists of 21 items, each with 4 response options. Patients were asked to select the option that best describes how they felt over the past week. Each item is scored from 0 to 3, with a maximum possible score of 63.
Assessment of Muscular Endurance
Time frame: From enrollment to the end of treatment at 4 weeks
Cervical Flexors: To evaluate cervical flexors, the patient was instructed to lie supine. The physiotherapist placed their hand under the patient's occiput. The patient's head was positioned in flexion, approximately 2.5 cm off the surface, and held straight. The patient was asked to maintain this position as long as possible, and the duration was recorded in seconds. The timing was stopped and recorded when the patient could no longer maintain the position or if the flexion was disrupted. Cervical Extensors: For evaluating cervical extensors, the patient was positioned face down, with their arms at their sides and head hanging off the edge of the bed. The physiotherapist supported and positioned the patient accordingly. Once the patient achieved the correct position, the test and stopwatch were started simultaneously. The test ended and the duration was recorded in seconds when the patient lost the position.
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 2 Oct 2024.
- 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.
Faruk Danışman, Ph.D principal investigator
Kahramanmaraş Sütçü İmam Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulligan Mobilization Technique and Proprioceptive Neuromuscular Facilitation (PNF) Technique in people with Neck Pain, run by Kahramanmaras Sutcu Imam 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 3 inclusion and 11 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 2 Oct 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: From enrollment to the end of treatment at 4 weeks). The study lists 8 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 2 Oct 2024.