Shoulder Stiffness Clinical Trial
— VitCOfficial title:
Can Vitamin C Reduce the Risk of Postoperative Shoulder Stiffness? A Multi-center, Double-blinded, Randomized and Placebo-controlled Study
| Verified date | June 2024 |
| Source | Lindenhofgruppe AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Postoperative shoulder stiffness is a common complication after shoulder surgery (incidence 10-15%). The symptoms consist primarily in a painful impairment of the mobility of the glenohumeral joint, usually after initially good course. Cause and origin are not clear. Vitamin C is known as an inactivator of free radicals and plays a key role in building collagen tissue. Vitamin C thus has a modulating role in inflammatory reactions. Injured and ill people have been shown to have significantly increased vitamin C needs, which underlines this role. Evidence was also found that vitamin C has a positive influence on similar diseases such as the complex regional pain syndrome (CRPS, Morbus Sudeck) on the wrist and postoperative arthrofibrosis on the knee joint. The Investigators want to investigate whether vitamin C intake can positively influence the incidence and / or severity of postoperative shoulder stiffness after shoulder surgery. The primary objective of this study is to investigate the effect of vitamin C on the external rotational ability of the operated shoulder in the glenohumeral joint compared to the opposite side at 12 weeks post surgery. Secondary objectives of this study are to investigate other shoulder mobility tests, patient-reported outcomes (level of pain, ability/return to work, smoking habits), patient-reported questionnaires (Constant Score, Oxford shoulder score, DASH score) and the incidence of a frozen shoulder at 6, 12, 26, and 52 weeks post surgery. Total duration of study: 2.5 years.
| Status | Terminated |
| Enrollment | 46 |
| Est. completion date | April 21, 2024 |
| Est. primary completion date | May 16, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Informed Consent as documented by signature - 18 years or older at the time of informed consent signature - Complication-free rotator cuff* or shoulder arthroscopy** with or without resection of the acromioclavicular joint at the orthopedics Sonnenhof. The rotator cuff operations are basically open or in mini-open technique, usually with additional tenotomy / tenodesis of the long biceps tendon. * rotator cuff surgery can include tenotomy/tenodesis of long biceps tendon, intra-articular debridement with or without resection of the coracoacromial ligament and/or acromioplasty, biopsies, diagnostic arthroscopy ** Arthroscopic procedures include subacromial debridement (including partial resection of the coracoacromial ligament & acromioplasty), diagnostic arthroscopy, tenotomy of the long biceps tendon, intra-articular debridement, resection of calcium depots for treatment of tendinitis calcarea, biopsies, stabilizations (only without postoperative immobilization) - Sufficient knowledge of German to understand the patient information and informed consent, follow instructions by study personnel, and complete patient questionnaires & diary Exclusion Criteria: - Contraindications to ascorbic acid or one of the excipients, e.g. known hypersensitivity or allergy to the investigational product - Planned single or multiple intake of vitamin supplements during the study period, which results in an additional daily intake of > 50 mg ascorbic acid - Known pregnancy or breast feeding - Known or suspected non-compliance, for example drug or alcohol abuse - Inability to follow the procedures of the study, e.g. due to psychological disorders, dementia, etc. - Participation in another interventional study within the 30 days preceding and during the present study - Previous enrollment into the current study - Enrollment of the investigator, his / her family members, employees and other dependent persons - Current or previous frozen shoulder (no matter on which side) - Pre-surgery on the affected shoulder joint (preoperative procedures include all procedures examined in this study, including all other procedures involving the glenohumeral joint and / or acromioclavicular joint. In addition, all interventions, which as a result, negatively influence the mobility of the shoulder with great likelihood up to the current time) - Known current unstable medical problem on the not-affected shoulder joint according to the judgment of the investigator - Taking a cortisone preparation or an immunomodulatory drug (for example methotrexate or similar) - Alcoholism (defined as intake of more than 12g (women) or 24g (men) alcohol per day) - Regular hemodialysis - Known diabetes mellitus - Known Addison's disease - Known not correctly adjusted thyroid metabolism - Known Parkinson's disease and similar CNS disorders (Diffuse Lewy Body Disease, Corticobasal Degeneration, Multisystem Atrophy, Progressive Supranuclear Paralysis, Essential Tumor, Huntington's Disease, Multiple Sclerosis) - Known diseases / injuries of the peripheral nerves (Isaac's Syndrome, Stiff-Person Syndrome, Guillain-Barré Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy, Hereditary Neuropathies, Amyotrophic Lateral Sclerosis, Hereditary Motor Neuropathies Prone to Pressure Paralysis, Motor Neurone Diseases, Myasthenia Gravis, Spinal Muscular Atrophies, Thoracic Outlet Syndromes) - Known infection in the shoulder joint to be operated - Known Hyperlipidemia - Known Uremia - Known Thalassemia - Known iron storage diseases - Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency - Planned further operation of any kind within the next 50 days after shoulder surgery |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Spital Aaberg | Aarberg | Bern |
| Switzerland | Orthopädie Sonnenhof | Bern |
| Lead Sponsor | Collaborator |
|---|---|
| Lindenhofgruppe AG |
Switzerland,
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* Note: There are 25 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference between the external glenohumeral joint rotations of the operated shoulder and the opposite shoulder | The primary endpoint of this study is the difference between the external glenohumeral joint rotations of the operated shoulder and the opposite shoulder ("Delta ?").
The external glenohumeral joint rotation was chosen as primary measure for shoulder performance because this is the component of movement in the shoulder joint, which is the first and most severely impaired in postoperative shoulder stiffness and which normalizes as the last after the symptomatology subsides. Delta ? was chosen as an outcome measure, since the standard deviation of the external rotation capability in the population is very high. The external glenohumeral joint rotation of both shoulders is measured using a smartphone with the App "GetMyROM". |
12 weeks post surgery | |
| Secondary | Delta ? of the external glenohumeral joint rotation | The external glenohumeral joint rotation of both shoulders is measured using a smartphone with the App "GetMyROM" | after 6, 26, and 52 weeks post surgery | |
| Secondary | Delta ? of abduction | - Abduction will be assessed using the GetMyROM-App. Abduction will be done passively with the glenohumeral joint fixed. | after 6, 26, and 52 weeks post surgery | |
| Secondary | Delta ? of internal rotation | -Internal rotation will be assessed using typical landmarks in clinical practice (Trochanter major, Gluteus maximus/Buttocks, Belt, lumbar spine, thoracolumbar junction, breast spine, interscapular) | after 6, 26, and 52 weeks post surgery | |
| Secondary | Delta ? of flexion | -Flexion will be assessed using the GetMyROM-App. Flexion will be done passively with the glenohumeral joint fixed. | after 6, 26, and 52 weeks post surgery | |
| Secondary | Level of pain | Secondary endpoints include the Level of pain of the operated shoulder preoperatively and level of pain (at rest and in motion) will be assessed using the VAS pain scale | daily during the first 50 days post surgery, and at 12, 26, and 52 weeks post surgery as a criterion for the occurrence of postoperative frozen shoulder | |
| Secondary | Work ability | Secondary endpoints include work ability (back-to-work ratio) post surgery. The (partial) ability to work is requested. | 6, 26, and 52 weeks post surgery | |
| Secondary | Oxford shoulder score | Secondary endpoints include the Oxford shoulder score as a measure of the pain and the utilizability of the shoulder as well as the patient satisfaction. Will be recorded by the patient getting a questionnaire, which he or she fills out in the waiting room before the appointment with the doctor. The practical part of the Constant score is subsequently filled in by the doctor during the clinical follow-up examination. | preoperatively and after 6, 12, 26, and 52 weeks | |
| Secondary | Constant Score | Secondary endpoints include the Constant Score as a measure of everyday utilizability of the shoulder and patient satisfaction. Will be recorded by the patient getting a questionnaire, which he or she fills out in the waiting room before the appointment with the doctor. The practical part of the Constant score is subsequently filled in by the doctor during the clinical follow-up examination. The Force measurement in the Constant score is performed with the following device: IsoForceControl®EVO2 - Dynamometer 10-400N. | preoperatively and depending on the procedure after 6 and 12 weeks (strata 3 & 4), and after 26 and 52 weeks (all strata) | |
| Secondary | DASH score | Secondary endpoints include the DASH score as a measure of the pain and the utilizability of the shoulder as well as the patient satisfaction. Will be recorded by the patient getting a questionnaire, which he or she fills out in the waiting room before the appointment with the doctor. The practical part of the Constant score is subsequently filled in by the doctor during the clinical follow-up examination. | preoperatively and after 6, 12, 26, and 52 weeks | |
| Secondary | Smoking habits | Secondary endpoints include the influence of smoking habits on the outcome and possibly on the effect of the study drug. The (current) smoking habits are documented. | end of the study, up to 2.5 years | |
| Secondary | Frozen shoulder | Secondary endpoints include the incidence of frozen shoulder. There is no standard definition for frozen shoulder in the literature. The diagnosis is made clinically. The frozen shoulder in this study is defined as a further decrease in external rotation of the glenohumeral joint in the postoperative period. | end of the study, up to 2.5 years |