Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295276
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-02-28
Brief Title:
Effect of Teletherapy-supported Training on Nursing Students
Sponsor:
Hochschule Osnabruck
Organization:
Hochschule Osnabruck
Study Overview
Official Title:
Does a Teletherapy-guided Exercise Programme Improve Pain Intensity Disability and Quality of Life in Nursing Students With Back and Neck Pain Compared to a Control Group
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
Design This study is a pilot randomized controlled trial RCT with two-arm parallel groups the gold standard for determining treatment efficacy The flowchart see appendix provides an overview of the study design Participants are randomized and stratified by age into intervention group and waiting list group
The intervention is teletherapy-supported muscular training for 20 minutes 4 times a week
The duration of the intervention is six weeks in total At the beginning Neck Disability Index NDI Oswestry Disability Index ODI Short-Form-36 SF36 and the Numerical rating Scale NRS are collected After six weeks the same outcome measures and the global rating scale
The intervention is teletherapy-supported muscular training for 20 minutes 4 times a week
The duration of the intervention is six weeks in total At the beginning Neck Disability Index NDI Oswestry Disability Index ODI Short-Form-36 SF36 and the Numerical rating Scale NRS are collected After six weeks the same outcome measures and the global rating scale
Detailed Description:
Intervention of interest As already mentioned the protocol of interest is an exercise program supported by online sessions teletherapy Exercise routines related to the individual areas of the spine as a functional unit were created based on evidence-based conclusions especially considering muscle chain activity and appropriate loading parameters
The teletherapy exercise program is carried out once a week via ZOOM by a physiotherapist with thirty years of experience in treating patients with musculoskeletal disorders Participants are also encouraged to carry out this exercise program themselves at home three times a week so that they have four sessions per week for six weeks The duration of each session is approximately twenty minutes per session There are six exercises with three sets and about fifteen repetitions within thirty seconds per set Exercise description with rationale for exercise selection Subjects in the treatment group will also receive a video rhythm and music files and written materials to help them follow the exercise routines at home as well as a rubber band Subjects are also asked to keep a diary in which they record their adherence to the home treatment protocol
At the beginning of the intervention and after the seventh week the participants are each assessed with the Patient Reported Outcomes PROMs namely ODI NDI and SF36 short and NRS 11-point scales At the end of the intervention participants are interviewed using the Global Rating Scale Below is a brief description of these instruments
Control group
Subjects in the control group will be advised to maintain their daily routine but will be asked to refrain from other treatments such as physical Therapy PT osteopathy chiropractic as well as other therapeutic exercise TE therapies to avoid co-interventions during the 6-week study period However pain medication taken by study participants for more than 3 months in all groups such as non-steroidal anti-inflammatory analgesics NSAIDs will be permitted and documented taking a pragmatic approach Any change in medication will be monitored and recorded by the PT at each visit
The teletherapy exercise program is carried out once a week via ZOOM by a physiotherapist with thirty years of experience in treating patients with musculoskeletal disorders Participants are also encouraged to carry out this exercise program themselves at home three times a week so that they have four sessions per week for six weeks The duration of each session is approximately twenty minutes per session There are six exercises with three sets and about fifteen repetitions within thirty seconds per set Exercise description with rationale for exercise selection Subjects in the treatment group will also receive a video rhythm and music files and written materials to help them follow the exercise routines at home as well as a rubber band Subjects are also asked to keep a diary in which they record their adherence to the home treatment protocol
At the beginning of the intervention and after the seventh week the participants are each assessed with the Patient Reported Outcomes PROMs namely ODI NDI and SF36 short and NRS 11-point scales At the end of the intervention participants are interviewed using the Global Rating Scale Below is a brief description of these instruments
Control group
Subjects in the control group will be advised to maintain their daily routine but will be asked to refrain from other treatments such as physical Therapy PT osteopathy chiropractic as well as other therapeutic exercise TE therapies to avoid co-interventions during the 6-week study period However pain medication taken by study participants for more than 3 months in all groups such as non-steroidal anti-inflammatory analgesics NSAIDs will be permitted and documented taking a pragmatic approach Any change in medication will be monitored and recorded by the PT at each visit
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?:
None
Is an FDA AA801 Violation?:
None