Gonarthrosis, Knee Osteoarthritis
Conditions
Keywords
craniosacral therapy, knee osteoarthritis, osteoarthritis, gonarthrosis, Home Exercise Program, Randomized Controlled Trial
Brief 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. 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.
Interventions
OTHERCraniosacral 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.
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.
Sponsors
Ankara Yildirim Beyazıt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Measured by Visual Analog Scale (VAS) | 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 | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain, Joint Stiffness, and Physical Function Assessed by WOMAC | 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. |
| Change in Health-Related Quality of Life Measured by SF-36 | 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. |
| Change in Self-Efficacy Measured by the Arthritis Self-Efficacy Scale | 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. |
| Change in Kinesiophobia Measured by the Tampa Scale for Kinesiophobia | 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. |
| Change in Body Image Perception Measured by the Body Image Scale | 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. |
| Change in Functional Mobility Measured by the Timed Up and Go Test | Baseline and six weeks | Functional mobility will be evaluated using the Timed Up and Go (TUG) test. Shorter completion times indicate better functional mobility. |
Countries
Turkey (Türkiye)
Outcome results
None listed