Overview

Sacroiliac joint dysfunction (SIED) is one of the major causes of chronic mechanical low back pain and is associated with pain, postural control impairment, and functional limitations. While manual therapy approaches are commonly used in the treatment of sacroiliac joint pain, evidence regarding the clinical superiority of different manual techniques is limited.

This study was designed as a prospective, randomized controlled trial to compare the effects of myofascial release techniques and sacroiliac joint mobilizations, applied in addition to a traditional physical therapy program, on pain intensity, spinal mobility, postural control, and functional status in women diagnosed with sacroiliac joint dysfunction.

The study plans to include female individuals aged 18-65 years with a Visual Analog Scale (VAS) score ≥3 who have been diagnosed with sacroiliac joint dysfunction according to international diagnostic criteria. Participants will be randomly assigned to two groups: one group will receive traditional treatment combined with myofascial release techniques, while the other group will receive traditional treatment combined with sacroiliac joint mobilizations. Interventions will be performed three days per week for six weeks.

Primary and secondary outcome measures will include pain intensity (VAS), postural control (Biodex Balance System), spinal mobility, and postural endurance (Spinal Mouse) assessments. Participants will be randomly assigned to two groups: one group will receive traditional treatment combined with myofascial release techniques, while the other group will receive traditional treatment combined with sacroiliac joint mobilizations. Interventions will be performed three days a week for six weeks.

Primary and secondary outcome measures will include pain intensity (VAS), postural control (Biodex Balance System), spinal mobility, and postural endurance (Spinal Mouse) assessments. All assessments will be conducted before treatment and at the end of the six-week intervention period.

This study aims to provide clinical evidence regarding the comparative effectiveness of manual therapy approaches in the conservative treatment of sacroiliac joint dysfunction and to contribute to clinical decision-making processes.

Eligibility

Inclusion Criteria:

1. Subjects aged between 18 and 75 (including 18 and 75) of both genders;
2. Expected survival time ≥3 months;
3. Pancreatic adenocarcinoma confirmed by histology/cytology;
4. Locally advanced lesions meeting any of the following criteria without distant metastasis: ① Pancreatic head and neck tumors: a. The tumor invaded the Superior Mesenteric Artery (SMA) more than 180°; b. The tumor invaded the celiac trunk more than 180°; c. Unresectable reconstruction of superior mesenteric vein or portal vein due to tumor invasion or embolism (tumor thrombus or thrombus); d. The tumor extensively invaded the distal jejunal drainage branch of the superior mesenteric vein. ② Pancreatic body/tail tumor: a. The tumor invaded the superior mesenteric artery or celiac trunk more than 180°; b. Celiac trunk and abdominal aorta involvement; c. The superior mesenteric vein or portal vein cannot be resected and reconstructed due to tumor invasion or embolism (tumor thrombus or thrombus).
5. At least one measurable lesion according to revised RECIST version 1.1;
6. ECOG score 0-1;
7. Be able to receive gemcitabine for injection and paclitaxel for injection (albumin-bound) combined therapy according to medical advice;
8. Able to operate tumor treating fields independently or with the help of nursing staff;
9. AE should be restored to normal or CTCAE1 grade after previous treatment;
10. The serum pregnancy test results of female subjects of reproductive age were negative. Female subjects of reproductive age agree to use effective contraception (e.g. hormonal or barrier methods or abstinence) during the study period and for 6 months after the last dose of chemotherapy drugs;
11. Male subjects agree to use effective birth control (such as barrier method or abstinence) and not to donate sperm during the study and within 3 months after the last chemotherapy drug administration;
12. Voluntarily sign the informed consent.

Exclusion Criteria:

1. The subjects has previously received first-line treatment for pancreatic adenocarcinoma;
2. Subjects with contraindications to treatment with gemcitabine for injection and/or paclitaxel for injection (albumin-bound) or known severe allergies to gemcitabine for injection and/or paclitaxel for injection (albumin-bound);
3. Patients had cancer requiring other antitumor therapy within 2 years before enrollment, excluding treated stage I prostate cancer, cervical cancer in situ, breast cancer in situ, and non-melanoma skin cancer;
4. Abnormal bone marrow, heart, liver and kidney function: a. Neutrophil count \< 1.5 × 10\^9/L, platelet count \< 100 × 10\^9/L, hemoglobin \< 90g/L; The use of blood transfusion, platelet transfusion and erythropoietin was prohibited within 14 days before C1D1, and the use of Leukocytotropic drug such as G-CSF, fegrasstim, pefegrasstim, etc., was prohibited within 7 days before C1D1.b. Total bilirubin \> 1.5× Upper Limit of Normal (ULN); Subjects with a total bilirubin \> 2×ULN that is elevated due to pancreatic cancer compression of the bile duct but has been fitted with a bile duct stent for drainage can be enrolled. AST and/or ALT\> 2.5×ULN; the use of drugs that improve liver function, such as reducing transaminase was prohibited within 7 days before C1D1. c. Serum creatinine \> 1.5×ULN; d. A history of severe cardiovascular disease, including but not limited to second or third degree heart block; Severe ischemic heart disease; New York Heart Association (NYHA) class II or higher congestive heart failure (mild physical activity limitation; Comfortable at rest, but normal activities can cause fatigue, palpitations, or difficulty breathing);
5. Subjects who were required to receive systemic corticosteroids (doses equivalent to \> 10 mg prednisone/day) or other immunosuppressive agents within 14 days before enrollment or during the study period. Subjects were eligible for enrollment if: a. The use of topical or inhaled glucocorticoids is permitted; b. Allow short-term (≤7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases;
6. Those who had severe infection before the first dose were judged ineligible for the study by the investigator;
7. History of human immunodeficiency virus (HIV) infection (known HIV1/2 antibody positive);
8. The presence of active hepatitis B, active hepatitis C, or other active infections that may affect the patient's treatment as determined by the investigator;
9. Subjects with a clear history of neurological or psychiatric disorders, such as epilepsy, dementia, or substance abuse (including alcohol) within the last year, and possibly affecting compliance;
10. Infected, ulcerated or unhealed wounds exist on the skin where the tumor treating fields is applied;
11. Having an implantable electronic medical device, such as a pacemaker;
12. Metal medical instruments are implanted in the chest and abdomen such as bone nails;
13. Known allergies to medical adhesives or hydrogels;
14. Pregnant or breastfeeding;
15. Subjects participated in clinical trials of other drugs within 3 months before enrollment, or participated in clinical trials of other devices within 1 month before enrollment;
16. Subjects with poor compliance or other factors as judged by the investigator.