Efficacy of Craniosacral Therapy in Patients With Gonarthrosis

February 22, 2026 updated by: Rabia Tugba Kilic, Ankara Yildirim Beyazıt University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06010
        • Ankara Yıldırım Beyazıt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between forty and eighty-five years
  • Diagnosis of knee osteoarthritis
  • Ability to understand the study procedures and provision of written informed consent

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Craniosacral Therapy + Home Exercise Program
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.).
Other: Craniosacral Therapy
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.
Other: Home-Based Exercise Program
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.
Active Comparator: Home-Based Exercise Program
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..
Other: Home-Based Exercise Program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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."
Time Frame: Baseline and six weeks
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.
Baseline and six weeks
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.
Baseline and six weeks
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.
Baseline and six weeks
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.
Baseline and six weeks
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.
Baseline and six weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Pain, Joint Stiffness, and Physical Function Assessed by WOMAC
Time Frame: Baseline and six weeks
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.
Baseline and six weeks
Change in Health-Related Quality of Life Measured by SF-36
Time Frame: Baseline and six weeks
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.
Baseline and six weeks
Change in Self-Efficacy Measured by the Arthritis Self-Efficacy Scale
Time Frame: Baseline and six weeks
Self-efficacy will be evaluated using the Arthritis Self-Efficacy Scale (ASES), which includes pain, hand/arm function, and leg/foot function subdomains.
Baseline and six weeks
Change in Kinesiophobia Measured by the Tampa Scale for Kinesiophobia
Time Frame: Baseline and six weeks
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.
Baseline and six weeks
Change in Body Image Perception Measured by the Body Image Scale
Time Frame: Baseline and six weeks
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.
Baseline and six weeks
Change in Functional Mobility Measured by the Timed Up and Go Test
Time Frame: Baseline and six weeks
Functional mobility will be evaluated using the Timed Up and Go (TUG) test. Shorter completion times indicate better functional mobility.
Baseline and six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Yildirim Beyazıt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings