Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04445727
Status:
UNKNOWN
Last Update Posted:
2020-06-26
First Post:
2020-06-14
Brief Title:
Efficacy of Vitamin C Supplement vs Spinal Manipulation to Treatment in Lateral Epicondylitis
Sponsor:
Universidad Rey Juan Carlos
Organization:
Universidad Rey Juan Carlos
Study Overview
Official Title:
Efficacy of Vitamin C Supplement Addiction vs High-speed Spinal Manipulation to Routine Physiotherapy Treatment in Lateral Epicondylitis
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized clinical trial will be conducted 130 subjects diagnosed with lateral epicondylitis will be studied 3 intervention groups will be formed Experimental group 1 will receive a 1000mg daily vitamin C supplement along with the usual practice of manual therapy and TENS Group 2 will undergo high-speed vertebral manipulations along with manual therapy and TENS In group 3 or control manual therapy and transcutaneous electrotherapy TENS will be applied All groups will receive the same manual therapy program and TENS one session per week for 6 consecutive weeks Data analysis The data will be entered in the SPSS statistical package version 210 for analysis Statistical analysis will be performed with a 95 confidence interval meaning that those whose P is 005 will be considered significant values
Detailed Description:
The 130 subjects will be randomized into 3 groups Experimental group 1 will receive a supplement of vitamin C ascorbic complex of the Bonusan brand a daily dose of 1000mg should be consumed along with the usual practice of manual therapy and TENS This group will maintain the daily intake of vitamin C for the 6 weeks that the treatment lasts they will be informed of the possible side effects of adaptation to the supplement such as for example diarrhea since excess vitamin C in the case if there is it lodges in the large intestine which attracts fluid and produces osmotic diarrhea This group will have direct communication with the doctor who collaborates in this investigation for any situation query or unwanted symptom Vitamin C has been used in other degenerative-type pathologies of collagen tissue such as Achilles tendinopathies and supraspinatus musculature The investigators have also found references to the effect of vitamin C as pain treatment Group 2 will undergo high-speed vertebral manipulations along with manual therapy and TENS Vertebral manipulations would seek a reflexogenic effect through the sympathetic nerve pathway of the lower cervical ganglion The transcutaneous TENS-type stimulation is evidenced to have an analgesic effect using self-adhesive patches placed longitudinally at the myo-junction tendon with a size of 50X50 mm a frequency of 100 Hz and a pulse duration of 200μs for 25 minutes Both the vertebral manipulation intervention and the TENS placement will be performed by a professional health physiotherapist with 27 years of clinical experience in the application of the aforementioned techniques
In group 3 or control manual therapy and transcutaneous electrotherapy TENS will be applied All groups will receive the same manual therapy program and TENS one session per week for 6 consecutive weeks
All the aforementioned interventions will be included in a 45 minute session for the 3 groups alike They will be in charge of a highly qualified physiotherapist for all the therapies when carrying out which expresses his consent for the study in Said professional uses all these therapies in consultation daily
8 The aforementioned therapies can generate some adverse effects that the participants should be aware of and that is reflected in the informed consent that they must complete before the start of the evaluation and the interventions In the first place in the TENS no bibliography has been found that warns of any unwanted effect which it can refer to is an increase in skin tone under the patch due to the local effect and heat conduction of the same which should disappear within 30 minutes after application
In high-speed vertebral manipulation in the cervical region in 6 of cases post-manipulation dizziness may occur due to the local vascular change that occurs The vitamin C supplement can produce some type of heartburn diarrhea especially in the first days of taking since this vitamin is absorbed in the intestine
Alterations at the elbow can cause pain and functional limitation To quantify these effects there are different measurement scales The evaluation to quantify the pain will be carried out with the numerical pain scale 0-10 The Disabilities of the Arm Shoulder and Hand DASH questionnaire will be used to determine the functionality of the upper limb the Shoulder Pain and Disability Index SPADI will be used to assess shoulder function Global perception of change will also be evaluated Global Rating of Change Scale GROC a 15-point scale where -7 indicates much worse than before 0 the same as before and 7 much better than before Finally the pressure pain threshold PDU will be evaluated using a digital algometer
Measurement variables will be analyzed before treatment after it and at 3 and 6 months after the last treatment session
In group 3 or control manual therapy and transcutaneous electrotherapy TENS will be applied All groups will receive the same manual therapy program and TENS one session per week for 6 consecutive weeks
All the aforementioned interventions will be included in a 45 minute session for the 3 groups alike They will be in charge of a highly qualified physiotherapist for all the therapies when carrying out which expresses his consent for the study in Said professional uses all these therapies in consultation daily
8 The aforementioned therapies can generate some adverse effects that the participants should be aware of and that is reflected in the informed consent that they must complete before the start of the evaluation and the interventions In the first place in the TENS no bibliography has been found that warns of any unwanted effect which it can refer to is an increase in skin tone under the patch due to the local effect and heat conduction of the same which should disappear within 30 minutes after application
In high-speed vertebral manipulation in the cervical region in 6 of cases post-manipulation dizziness may occur due to the local vascular change that occurs The vitamin C supplement can produce some type of heartburn diarrhea especially in the first days of taking since this vitamin is absorbed in the intestine
Alterations at the elbow can cause pain and functional limitation To quantify these effects there are different measurement scales The evaluation to quantify the pain will be carried out with the numerical pain scale 0-10 The Disabilities of the Arm Shoulder and Hand DASH questionnaire will be used to determine the functionality of the upper limb the Shoulder Pain and Disability Index SPADI will be used to assess shoulder function Global perception of change will also be evaluated Global Rating of Change Scale GROC a 15-point scale where -7 indicates much worse than before 0 the same as before and 7 much better than before Finally the pressure pain threshold PDU will be evaluated using a digital algometer
Measurement variables will be analyzed before treatment after it and at 3 and 6 months after the last treatment session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None