Effect of Teletherapy-supported Training on Nursing Students
NCT ID: NCT06295276
Last Updated: 2025-05-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
48 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-01-31
Study Completion Date
2024-12-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Low Back Pain
Neck Pain
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Parallel comparative randomized controlled trial
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Allocation concealment:
The results of the allocation sequence are placed in sequentially numbered, opaque, and sealed envelopes by an independent researcher to ensure confidentiality.
The results of the allocation sequence are placed in sequentially numbered, opaque, and sealed envelopes by an independent researcher to ensure confidentiality.
Study Groups
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Intervention
a six-week muscle training program with 5 exercises 3 times a week as video-guided exercises for homework alone and the same exercises once a week guided by Zoom. The program lasts 6 weeks
Group Type
EXPERIMENTAL
teletherapy-guided exercise programme
Intervention Type
OTHER
Exercise program guided by online sessions. Subjects perform this exercise program three times a week at home, so that they complete four sessions per week for six weeks. The duration of a session is approximately twenty minutes. There are six exercises with three sets and about fifteen repetitions. Subjects in the treatment group also receive an instructional video. The subjects keep a diary in which they record their adherence to the treatment protocol at home.
At the beginning of the intervention and after the sixth week, participants are assessed with ODI, NDI and SF36-Short and NRS-11 scales. At the end, we use the Global Rating Scale.
Waiting list/control intervention/delayed teletherapy intervention
After the 6 weeks, participants are offered the opportunity to take part in the intervention program (see above)
Group Type
OTHER
Waiting list/control intervention/delayed teletherapy intervention
Intervention Type
OTHER
Subjects in the control group will be advised to maintain their daily routine but will be asked to refrain from other treatments to avoid co-interventions during the 6-week study period. However, the use of painkillers such as non-steroidal anti-inflammatory analgesics (NSAIDs) taken by study participants in all groups for more than 3 months is allowed and will be documented (taking a pragmatic approach). Any change in medication will be monitored and documented by the PT at each visit.
Interventions
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teletherapy-guided exercise programme
Exercise program guided by online sessions. Subjects perform this exercise program three times a week at home, so that they complete four sessions per week for six weeks. The duration of a session is approximately twenty minutes. There are six exercises with three sets and about fifteen repetitions. Subjects in the treatment group also receive an instructional video. The subjects keep a diary in which they record their adherence to the treatment protocol at home.
At the beginning of the intervention and after the sixth week, participants are assessed with ODI, NDI and SF36-Short and NRS-11 scales. At the end, we use the Global Rating Scale.
Intervention Type
OTHER
Waiting list/control intervention/delayed teletherapy intervention
Subjects in the control group will be advised to maintain their daily routine but will be asked to refrain from other treatments to avoid co-interventions during the 6-week study period. However, the use of painkillers such as non-steroidal anti-inflammatory analgesics (NSAIDs) taken by study participants in all groups for more than 3 months is allowed and will be documented (taking a pragmatic approach). Any change in medication will be monitored and documented by the PT at each visit.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Nursing students between 18 and 60 years of any gender
* Self-reported chronic neck and back pain in the last six months (more than three months as described by the International Association for the Study of Pain (IASP)).
* Speak and understand German
* Self-reported chronic neck and back pain in the last six months (more than three months as described by the International Association for the Study of Pain (IASP)).
* Speak and understand German
Exclusion Criteria
Surgery in the last year on the spine, cervical, thoracic, or lumbar spine
* Currently on sick leave
* Acute back pain
* Severe neurological injuries or symptoms
* Acute trauma to the musculoskeletal system
* Renal insufficiency, dialysis
* Severe impairment of the ability to grip with the hand, e.g., rheumatoid arthritis.
* Severe cardiovascular diseases, e.g. heart failure
* Severe respiratory diseases, e.g., Chronic Obstructive Pulmonary Disease-COPD
* Nystagmus
* Falling tendency/balance disorders
* Latex allergy, as rubber band may be made of latex
* Lack of ability to stand, inability to stand safely without the help of a person or object.
* A spine-specific pain therapy drug treatment within the last three months
* Currently on sick leave
* Acute back pain
* Severe neurological injuries or symptoms
* Acute trauma to the musculoskeletal system
* Renal insufficiency, dialysis
* Severe impairment of the ability to grip with the hand, e.g., rheumatoid arthritis.
* Severe cardiovascular diseases, e.g. heart failure
* Severe respiratory diseases, e.g., Chronic Obstructive Pulmonary Disease-COPD
* Nystagmus
* Falling tendency/balance disorders
* Latex allergy, as rubber band may be made of latex
* Lack of ability to stand, inability to stand safely without the help of a person or object.
* A spine-specific pain therapy drug treatment within the last three months
Minimum Eligible Age
18 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hochschule Osnabruck
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Diakonie Pflege Schule
Osnabrück, Lower Saxony, Germany
Site Status
Countries
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Germany
References
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Related Links
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https://drive.google.com/file/d/1pjgPQwPqNod6kXGwLzJg2Tys2hdWb_Pv/view?usp=drive_link
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HSOsnabruck
Identifier Type: -
Identifier Source: org_study_id
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