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Completed

NCT Number: NCT07372534

Efficacy of Craniosacral Therapy in Patients With Gonarthrosis

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Yıldırım Beyazıt University

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Craniosacral therapy

Other

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 program

Other

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.

Primary outcomes

  1. 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."

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 28, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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