Efficacy of Craniosacral Therapy in Patients With Gonarthrosis

NCT07372534 | Completed

• 1 other identifier: 2023-149
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Gonarthrosis; Knee Osteoarthritis

Keywords

craniosacral therapy; knee osteoarthritis; osteoarthritis; gonarthrosis; Home Exercise Program; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (6)

• 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."

  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.

  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.

  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.

  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.

  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.

  Baseline and six weeks

Secondary Outcomes (6)

• Change in Pain, Joint Stiffness, and Physical Function Assessed by WOMAC

  Baseline and six weeks

• Change in Health-Related Quality of Life Measured by SF-36

  Baseline and six weeks

• Change in Self-Efficacy Measured by the Arthritis Self-Efficacy Scale

  Baseline and six weeks

• Change in Kinesiophobia Measured by the Tampa Scale for Kinesiophobia

  Baseline and six weeks

• Change in Body Image Perception Measured by the Body Image Scale

  Baseline and six weeks

Study Arms (2)

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.).

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..

Other: Home-Based Exercise Program

Interventions

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.

Craniosacral Therapy + Home Exercise Program

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.

Craniosacral Therapy + Home Exercise Program; Home-Based Exercise Program

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, 06010, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PT, PhD Candidate

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 28, 2026
• Study Start: April 15, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: February 24, 2026

Record last verified: 2025-11

Locations

TU (1)