GonarthrosisNCT07372534
Efficacy of Craniosacral Therapy in Patients With Gonarthrosis
A study testing Craniosacral Therapy and Home-Based Exercise Program in people with Gonarthrosis and Knee Osteoarthritis, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial was designed to investigate the effects of craniosacral therapy on pain, heart rate variability, joint stiffness, physical function, quality of life, body image, kinesiophobia, and dynamic balance in adult patients with gonarthrosis. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Gonarthrosis, Knee Osteoarthritis
- What is being tested?
- Craniosacral Therapy and Home-Based Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 31 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between forty and eighty-five years
- Diagnosis of knee osteoarthritis
- Ability to understand the study procedures and provision of written informed consent
Who cannot join
- Consumption of caffeine within the last four hours or use of tobacco within the last forty-eight hours prior to assessment
- Use of alcohol or recreational drugs within the last week
- Eating within two hours before the assessment
- History of neuropathic disorders
- History of unexplained syncope episodes
- Inability to move independently
Show all 12Show fewer
- Presence of uncontrolled medical conditions, such as cardiac (e.g., angina) or respiratory (e.g., asthma) diseases
- Presence of neurological disorders, including Parkinson's disease or multiple sclerosis
- History of vascular surgery or open knee surgery, or receipt of a knee injection within the last one month
- Presence of somatic dysfunction symptoms or musculoskeletal injuries that may interfere with assessments
- Diagnosis of pregnancy, sarcopenia, cognitive impairment, or osteoporosis
- Any medical condition affecting the autonomic nervous system or immune system, including autonomic neuropathy, pure autonomic failure, autoimmune diseases, or acquired immunodeficiency syndrome
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University
Ankara, 06010
About this study
Official title: Effects of Craniosacral Therapy Added to a Home Exercise Program on Pain, Heart Rate Variability, and Functional Outcomes in Patients With Gonarthrosis: A Randomized Controlled Trial
This randomized controlled trial was designed to investigate the effects of craniosacral therapy on pain, heart rate variability, joint stiffness, physical function, quality of life, body image, kinesiophobia, and dynamic balance in adult patients with gonarthrosis. The primary research question is whether craniosacral therapy, when added to a standard home exercise program administered by physical therapists, is more effective than a home exercise program alone.
Participants will be randomly allocated into two groups. Both groups will perform a standardized home exercise program for six weeks. In addition, the experimental group will receive craniosacral therapy once weekly for six weeks, whereas the control group will receive the home exercise program only. Outcome measures will be assessed at baseline and after the six-week intervention period to compare the effectiveness of the two treatment approaches.
Read the detailed description
Gonarthrosis is a prevalent degenerative joint disease characterized by pain, joint stiffness, impaired physical function, and reduced quality of life. In addition to biomechanical impairments, individuals with gonarthrosis often experience alterations in autonomic nervous system activity, psychosocial factors such as kinesiophobia and body image disturbances, and limitations in functional mobility. While therapeutic exercise is considered a cornerstone of conservative management, complementary manual therapy approaches may provide additional benefits by targeting pain modulation and neurophysiological regulation.
Craniosacral therapy is a gentle manual therapy approach that aims to influence the craniosacral system and may contribute to pain reduction and autonomic regulation. However, evidence regarding its effectiveness as an adjunct to exercise-based rehabilitation in patients with gonarthrosis remains limited.
This randomized controlled trial was designed to investigate the effects of craniosacral therapy added to a standard home exercise program on pain, heart rate variability, joint stiffness, physical function, quality of life, body image, kinesiophobia, and dynamic balance in adult patients diagnosed with gonarthrosis. The primary objective is to determine whether the addition of craniosacral therapy to a home exercise program administered by physical therapists results in superior clinical outcomes compared with a home exercise program alone.
Eligible participants will be randomly allocated into two parallel groups. Both groups will perform a standardized home exercise program for a duration of six weeks. Participants in the experimental group will additionally receive craniosacral therapy once weekly for six weeks, whereas participants in the control group will receive the home exercise program only. All outcome assessments will be conducted at baseline and after the six-week intervention period by a physiotherapist blinded to group allocation.
The home exercise program will be prescribed and monitored by physiotherapists and will include exercises targeting knee joint mobility, muscle strength, flexibility, and functional performance. Craniosacral therapy sessions will be delivered by a trained physiotherapist following standardized clinical principles. Adherence to the exercise program will be monitored throughout the intervention period.
Outcome measures will include pain intensity, heart rate variability parameters, joint stiffness, physical function, quality of life, self-efficacy, kinesiophobia, body image perception, and functional mobility. The findings of this study are expected to contribute to the understanding of the potential role of craniosacral therapy as an adjunct to exercise-based rehabilitation in the management of gonarthrosis.
- Conditions
- Gonarthrosis, Knee Osteoarthritis
- Being tested
- Craniosacral Therapy, Home-Based Exercise Program
- Keywords
- craniosacral therapy, knee osteoarthritis, osteoarthritis, gonarthrosis, Home Exercise Program, Randomized Controlled Trial
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craniosacral TherapyOther
Craniosacral therapy will be administered once weekly for six weeks by a physiotherapist certified in craniosacral therapy under the supervision of an osteopath. Each session will last forty minutes and will follow a standardized protocol including frontal and parietal lifting-spreading, ear pulling, temporal internal rotation, atlanto-occipital release, dural tube traction, rib lifting, and diaphragm harmonization techniques according to the Frymann method.
Home-Based Exercise ProgramOther
All participants will perform a standardized home-based exercise program consisting of stretching, strengthening, and range-of-motion exercises targeting the muscles surrounding the knee joint. The program will be prescribed to be performed daily for six weeks. Participants will receive an illustrated exercise booklet, and adherence will be monitored through weekly telephone calls and exercise diaries.
| Study group | Role | What they receive |
|---|---|---|
| Craniosacral Therapy + Home Exercise Program | Experimental | Participants in the craniosacral therapy plus home exercise (CST+HBE) group will receive one forty-minute craniosacral therapy session per week for six weeks. The standardized intervention protocol will include frontal and parietal lifting-spreading, ear pulling, temporal internal rotation, atlanto-occipital release, dural tube traction, rib lifting, and diaphragm harmonization techniques, applied according to the Frymann method. All sessions will be delivered by a physiotherapist certified in craniosacral therapy under the supervision of an osteopath (Doctor of Osteopathy, R.T.T.). Receives: Other: Craniosacral Therapy; Other: Home-Based Exercise Program |
| Home-Based Exercise Program | Active comparator | All participants will follow a standardized, step-by-step home-based exercise program consisting of stretching, strengthening, and range-of-motion exercises targeting the muscles surrounding the knee joint. The program will be prescribed to be performed daily for six weeks. To enhance adherence, participants will be provided with an illustrated exercise booklet and adherence will be monitored through weekly telephone calls and exercise diaries.. Receives: Other: Home-Based Exercise Program |
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)
Pain intensity will be measured using a ten-centimeter Visual Analog Scale (VAS), where zero indicates "no pain" and ten indicates "worst imaginable pain."
Measured: Time Frame: Baseline and six weeks
Change in Low-Frequency (LF) Power
Low-Frequency (LF) Power will be assessed using the Polar H10 heart rate monitor (Polar Electro, Finland). Following a fifteen-minute seated rest period, an eight-minute supine recording will be obtained. Low-frequency (LF) power will be analyzed using the Elite HRV© application.
Measured: Baseline and six weeks
Change in High-Frequency (HF) Power
High-Frequency (HF) Power will be assessed using the Polar H10 heart rate monitor (Polar Electro, Finland). Following a fifteen-minute seated rest period, an eight-minute supine recording will be obtained. High-frequency (HF) power will be analyzed using the Elite HRV© application.
Measured: Baseline and six weeks
Change in LF/HF Ratio
LF/HF Ratio will be assessed using the Polar H10 heart rate monitor (Polar Electro, Finland). Following a fifteen-minute seated rest period, an eight-minute supine recording will be obtained. The LF/HF ratio will be calculated using the Elite HRV© application.
Measured: Baseline and six weeks
Change in SDNN
Standard deviation of all normal-to-normal intervals (SDNN) will be assessed using the Polar H10 heart rate monitor (Polar Electro, Finland). Following a fifteen-minute seated rest period, an eight-minute supine recording will be obtained. The standard deviation of all normal-to-normal intervals (SDNN) will be calculated using the Elite HRV© application.
Measured: Baseline and six weeks
Change in RMSSD
Root mean square of successive differences between normal-to-normal intervals (RMSSD) will be assessed using the Polar H10 heart rate monitor (Polar Electro, Finland). Following a fifteen-minute seated rest period, an eight-minute supine recording will be obtained. The root mean square of successive differences between normal-to-normal intervals (RMSSD) will be calculated using the Elite HRV© application.
Measured: Baseline and six weeks
Secondary outcomes (6)
Change in Pain, Joint Stiffness, and Physical Function Assessed by WOMAC
Pain, stiffness, and physical function will be evaluated using the twenty-four-item Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Items are scored on a five-point Likert scale (0-4), with higher scores indicating worse symptoms.
Measured: Baseline and six weeks
Change in Health-Related Quality of Life Measured by SF-36
Quality of life will be assessed using the thirty-six-item Short Form Health Survey (SF-36), with scores ranging from zero to one hundred, where higher scores indicate better perceived health status.
Measured: Baseline and six weeks
Change in Self-Efficacy Measured by the Arthritis Self-Efficacy Scale
Self-efficacy will be evaluated using the Arthritis Self-Efficacy Scale (ASES), which includes pain, hand/arm function, and leg/foot function subdomains.
Measured: Baseline and six weeks
Change in Kinesiophobia Measured by the Tampa Scale for Kinesiophobia
Kinesiophobia will be measured using the Tampa Scale for Kinesiophobia (TSK), with total scores ranging from seventeen to sixty-eight. Higher scores indicate greater fear of movement.
Measured: Baseline and six weeks
Change in Body Image Perception Measured by the Body Image Scale
Body image perception will be assessed using the Body Image Scale, a forty-item self-report questionnaire. Total scores range from 40 to 200, with higher scores indicating a more positive body image perception, which reflects better outcomes.
Measured: Baseline and six weeks
Change in Functional Mobility Measured by the Timed Up and Go Test
Functional mobility will be evaluated using the Timed Up and Go (TUG) test. Shorter completion times indicate better functional mobility.
Measured: Baseline and six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start15 Apr 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonarthrosisStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Model description
- Participants will be randomly assigned to one of two parallel groups. Both groups will receive a standardized home exercise program for six weeks. In addition, the experimental group will receive craniosacral therapy once weekly for six weeks, while the control group will receive the home exercise program alone. Outcomes will be assessed at baseline and after the six-week intervention period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Tugba Kilic, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372534
- Sponsor's protocol ID
- 2023-149
- Status last verified
- Nov 2025
- First submitted
- 19 Dec 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Craniosacral Therapy Added to a Home Exercise Program on Pain, Heart Rate Variability, and Functional Outcomes in Patients With Gonarthrosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07372534
- Acronym / sponsor ID
- 2023-149
- Conditions
- Gonarthrosis, Knee Osteoarthritis
- Keywords
- craniosacral therapy, knee osteoarthritis, osteoarthritis, gonarthrosis, Home Exercise Program, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 28 Jan 2026 (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 randomized controlled trial was designed to investigate the effects of craniosacral therapy on pain, heart rate variability, joint stiffness, physical function, quality of life, body image, kinesiophobia, and dynamic balance in adult patients with gonarthrosis. The primary research question is whether craniosacral therapy, when added to a standard home exercise program administered by physical therapists, is more effective than a home exercise program alone.
Participants will be randomly allocated into two groups. Both groups will perform a standardized home exercise program for six weeks. In addition, the experimental group will receive craniosacral therapy once weekly for six weeks, whereas the control group will receive the home exercise program only. Outcome measures will be assessed at baseline and after the six-week intervention period to compare the effectiveness of the two treatment approaches.
Detailed description
Gonarthrosis is a prevalent degenerative joint disease characterized by pain, joint stiffness, impaired physical function, and reduced quality of life. In addition to biomechanical impairments, individuals with gonarthrosis often experience alterations in autonomic nervous system activity, psychosocial factors such as kinesiophobia and body image disturbances, and limitations in functional mobility. While therapeutic exercise is considered a cornerstone of conservative management, complementary manual therapy approaches may provide additional benefits by targeting pain modulation and neurophysiological regulation.
Craniosacral therapy is a gentle manual therapy approach that aims to influence the craniosacral system and may contribute to pain reduction and autonomic regulation. However, evidence regarding its effectiveness as an adjunct to exercise-based rehabilitation in patients with gonarthrosis remains limited.
This randomized controlled trial was designed to investigate the effects of craniosacral therapy added to a standard home exercise program on pain, heart rate variability, joint stiffness, physical function, quality of life, body image, kinesiophobia, and dynamic balance in adult patients diagnosed with gonarthrosis. The primary objective is to determine whether the addition of craniosacral therapy to a home exercise program administered by physical therapists results in superior clinical outcomes compared with a home exercise program alone.
Eligible participants will be randomly allocated into two parallel groups. Both groups will perform a standardized home exercise program for a duration of six weeks. Participants in the experimental group will additionally receive craniosacral therapy once weekly for six weeks, whereas participants in the control group will receive the home exercise program only. All outcome assessments will be conducted at baseline and after the six-week intervention period by a physiotherapist blinded to group allocation.
The home exercise program will be prescribed and monitored by physiotherapists and will include exercises targeting knee joint mobility, muscle strength, flexibility, and functional performance. Craniosacral therapy sessions will be delivered by a trained physiotherapist following standardized clinical principles. Adherence to the exercise program will be monitored throughout the intervention period.
Outcome measures will include pain intensity, heart rate variability parameters, joint stiffness, physical function, quality of life, self-efficacy, kinesiophobia, body image perception, and functional mobility. The findings of this study are expected to contribute to the understanding of the potential role of craniosacral therapy as an adjunct to exercise-based rehabilitation in the management of gonarthrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. Both groups will receive a standardized home exercise program for six weeks. In addition, the experimental group will receive craniosacral therapy once weekly for six weeks, while the control group will receive the home exercise program alone. Outcomes will be assessed at baseline and after the six-week intervention period.
| Arm | Type | Receives |
|---|---|---|
| Craniosacral Therapy + Home Exercise Program | Experimental | Other: Craniosacral Therapy, Other: Home-Based Exercise ProgramParticipants in the craniosacral therapy plus home exercise (CST+HBE) group will receive one forty-minute craniosacral therapy session per week for six weeks. The standardized intervention protocol will include frontal and parietal lifting-spreading, ear pulling, temporal internal rotation, atlanto-occipital release, dural tube traction, rib lifting, and diaphragm harmonization techniques, applied according to the Frymann method. All sessions will be delivered by a physiotherapist certified in craniosacral therapy under the supervision of an osteopath (Doctor of Osteopathy, R.T.T.). |
| Home-Based Exercise Program | Active comparator | Other: Home-Based Exercise ProgramAll participants will follow a standardized, step-by-step home-based exercise program consisting of stretching, strengthening, and range-of-motion exercises targeting the muscles surrounding the knee joint. The program will be prescribed to be performed daily for six weeks. To enhance adherence, participants will be provided with an illustrated exercise booklet and adherence will be monitored through weekly telephone calls and exercise diaries.. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between forty and eighty-five years
- Diagnosis of knee osteoarthritis
- Ability to understand the study procedures and provision of written informed consent
Key exclusion criteria (12 listed)
- Consumption of caffeine within the last four hours or use of tobacco within the last forty-eight hours prior to assessment
- Use of alcohol or recreational drugs within the last week
- Eating within two hours before the assessment
- History of neuropathic disorders
- History of unexplained syncope episodes
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 |
|---|---|---|
| Craniosacral TherapyCraniosacral therapy will be administered once weekly for six weeks by a physiotherapist certified in craniosacral therapy under the supervision of an osteopath. Each session will last forty minutes and will follow a standardized protocol including frontal and parietal lifting-spreading, ear pulling, temporal internal rotation, atlanto-occipital release, dural tube traction, rib lifting, and diaphragm harmonization techniques according to the Frymann method. | Other | Craniosacral Therapy + Home Exercise Program |
| Home-Based Exercise ProgramAll participants will perform a standardized home-based exercise program consisting of stretching, strengthening, and range-of-motion exercises targeting the muscles surrounding the knee joint. The program will be prescribed to be performed daily for six weeks. Participants will receive an illustrated exercise booklet, and adherence will be monitored through weekly telephone calls and exercise diaries. | Other | Craniosacral Therapy + Home Exercise Program, Home-Based Exercise Program |
Primary outcome
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: Time Frame: Baseline and six weeks
Pain intensity will be measured using a ten-centimeter Visual Analog Scale (VAS), where zero indicates "no pain" and ten indicates "worst imaginable pain."
Change in Low-Frequency (LF) Power
Time frame: Baseline and six weeks
Low-Frequency (LF) Power will be assessed using the Polar H10 heart rate monitor (Polar Electro, Finland). Following a fifteen-minute seated rest period, an eight-minute supine recording will be obtained. Low-frequency (LF) power will be analyzed using the Elite HRV© application.
Change in High-Frequency (HF) Power
Time frame: Baseline and six weeks
High-Frequency (HF) Power will be assessed using the Polar H10 heart rate monitor (Polar Electro, Finland). Following a fifteen-minute seated rest period, an eight-minute supine recording will be obtained. High-frequency (HF) power will be analyzed using the Elite HRV© application.
Change in LF/HF Ratio
Time frame: Baseline and six weeks
LF/HF Ratio will be assessed using the Polar H10 heart rate monitor (Polar Electro, Finland). Following a fifteen-minute seated rest period, an eight-minute supine recording will be obtained. The LF/HF ratio will be calculated using the Elite HRV© application.
Change in SDNN
Time frame: Baseline and six weeks
Standard deviation of all normal-to-normal intervals (SDNN) will be assessed using the Polar H10 heart rate monitor (Polar Electro, Finland). Following a fifteen-minute seated rest period, an eight-minute supine recording will be obtained. The standard deviation of all normal-to-normal intervals (SDNN) will be calculated using the Elite HRV© application.
Change in RMSSD
Time frame: Baseline and six weeks
Root mean square of successive differences between normal-to-normal intervals (RMSSD) will be assessed using the Polar H10 heart rate monitor (Polar Electro, Finland). Following a fifteen-minute seated rest period, an eight-minute supine recording will be obtained. The root mean square of successive differences between normal-to-normal intervals (RMSSD) will be calculated using the Elite HRV© application.
6 secondary outcomes
Change in Pain, Joint Stiffness, and Physical Function Assessed by WOMAC
Time frame: Baseline and six weeks
Change in Health-Related Quality of Life Measured by SF-36
Time frame: Baseline and six weeks
Change in Self-Efficacy Measured by the Arthritis Self-Efficacy Scale
Time frame: Baseline and six weeks
Change in Kinesiophobia Measured by the Tampa Scale for Kinesiophobia
Time frame: Baseline and six weeks
Change in Body Image Perception Measured by the Body Image Scale
Time frame: Baseline and six weeks
Change in Functional Mobility Measured by the Timed Up and Go Test
Time frame: Baseline and six weeks
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 24 Feb 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Craniosacral Therapy and Home-Based Exercise Program in people with Gonarthrosis and Knee Osteoarthritis, run by Ankara Yildirim Beyazıt 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 12 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 24 Feb 2026. 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) (time frame: Time Frame: Baseline and six weeks). The study lists 6 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 24 Feb 2026.