Trial · NCT06984068
Effect of Vitamin D Supplementation on the Rehabilitation of Patients After Rotator Cuff Tear Repair
NCT06984068, Not applicable, Not yet recruiting, Chinese University of Hong Kong
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Vitamin D Supplementation on the Rehabilitation of Patients After Rotator Cuff Tear Repair. Trials, record NCT06984068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06984068
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Vitamin D Supplementation on the Rehabilitation of Patients After Rotator Cuff Tear Repair
- NCT number
- NCT06984068
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 44 participants, estimated
- Lead sponsor
- Chinese University of Hong Kong
- Conditions
- Rotator Cuff Tear
- Interventions
- Vitamin D, Placebo
- First posted
- 2025-05-22
- Last updated
- 2025-05-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | External and internal rotation isometric strength of the shoulder | Baseline, 3 months, 6 months and 12 months post-intervention | Isometric shoulder strength will be tested using an isokinetic dynamometer (Biodex System 2, Shirley, New York). Following the protocol described by Hughes and colleagues, strength testing will be performed at the following joint positions: coronal-plane abduction (ABD) at 30° of abduction, internal rotation (IR) at 15° of frontal-plane elevation and 0° of humeral rotation, and external rotation (ER) at 15° of frontal-plane elevation and 0° of humeral rotation. To isolate shoulder strength and minimize the likelihood of compensation with other muscle groups, patients will be secured to the Biodex system with 2 hook-and-loop straps diagonally across their torso. Three trials will be performed at each position, with at least 2 minutes of rest between each trial. The average of the 3 trials will be calculated and recorded as the patient's maximum isometric strength. Both shoulders will be tested, and the testing order will be randomized. To account for any inherent differences in strengt |
| Secondary | Visual Analog Scale (VAS) | Baseline, 3 months, 6 months and 12 months post-intervention | The VAS is used for determination of the pain intensity. The VAS scale is represented as a 10 cm-long line. The left side of the line (0) corresponds to "no pain" and the right side (10) represents "the worst pain ever" |
| Secondary | the American Shoulder and Elbow Surgeons (ASES) score | Baseline, 3 months, 6 months and 12 months post-intervention | The ASES questionnaire is used for evaluation. The ASES score consists of two subscales: activities of daily living (ADL) and pain. It is a patient-reported outcome measure, ranging from 0 (severe pain and complete loss of function) to 50 (no pain and good function) for each subscale. The total score is obtained by summing the two subscale scores, with a maximum possible score of 100 points |
| Secondary | the University of California, Los Angeles (UCLA) score | Baseline, 3 months, 6 months and 12 months post-intervention | The UCLA Shoulder Score is a widely used scale for evaluating shoulder function following rotator cuff repair. It primarily assesses shoulder pain, function, range of motion, and patient satisfaction with the outcomes of shoulder treatment |
| Secondary | the Constant-Murley score | Baseline, 3 months, 6 months and 12 months post-intervention | The Constant-Murley Score, introduced by Constant and Murley, is another commonly used questionnaire for shoulder assessment. It evaluates various aspects of shoulder function, including range of motion, strength, and overall functionality. The range of motion assessment is comprehensive, covering forward flexion, external rotation, abduction, and internal rotation. The total score ranges from 0 to 100, with higher scores indicating better shoulder function |
| Secondary | Range of motion (ROM) | Baseline, 3 months, 6 months and 12 months post-intervention | ROM is measured using a goniometer and includes forward flexion (anterior elevation in the sagittal plane), abduction (posterolateral elevation in the coronal plane), external rotation (forearm abduction of 90° with outward rotation), and internal rotation (arm abduction of 90° with extension behind the back or inward rotation). The test will be repeated twice and the mean values will be analyzed |
| Secondary | Magnetic resonance imaging (MRI) | Baseline, 12 months post-intervention | Magnetic resonance imaging (MRI) was performed on all patients, including coronal, sagittal, and axial T2-weighted echo scans. Tendon integrity was classified according to Sugaya et al. into five types. Type I describes an intact tendon with normal thickness and uniform signal. Type II corresponds to an intact tendon with normal thickness but increased internal signal. Type III describes a repaired tendon with a thickness reduced by up to 50% compared to a healthy tendon, with increased internal signal. Type IV represents a partial rupture, and Type V represents a complete rupture or lack of tendon integration. Atrophy of the supraspinatus muscle was assessed at the "Y-shaped" view on the T1-weighted sagittal cut that included both the scapular spine and the corocoid using a tangent sign. The tangent sign is positive for atrophy if the superior border of the supraspinatus muscle is below a line drawn from the superior aspects of the scapular spine and corocoid. |
| Secondary | Serum vitamin D assays | Baseline, 12 months post-intervention | Blood samples will be taken under non-fasting conditions. Blood samples will be collected four times: Blood samples will be collected four times: before Vitamin D supplementation, at 3 months of supplementation, at 6 months of supplementation, and 6 months after the intervention. Each time, 5 ml of blood will be collected. Serum / plasma obtained will be immediately stored at -80°C until analysis. Serum 25 (OH) Vit-D assay: Serum 25 (OH) Vit-D levels will be measured by commercial 25 (OH) Vitamin D ELISA kit (Abcam ab213966) according to the manufacturer's instruction, providing the quantitative determination of 25 (OH) Vitamin D3 and 25 (OH) Vitamin D2. Sensitivity: 1.98 ng/ml (Range: 0.5 ng/ml - 1010 ng/ml). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06984068
GET https://conductscience.org/api/trials/v1/NCT06984068/registered